FDA Decisions 2023: New FDA Approvals for Sandoz, Gilead Sciences and More | BioSpace

The FDA was on a roll in the first half of 2023, approving more than two dozen novel treatments. 

And if the first six months is any indication, the biopharma industry should expect several more novel therapies to be greenlit, including a few more first-in-class treatments. But it’s not always good news that companies have to deliver to their stakeholders; the year has already seen its fair share

Aug 24: 

Sandoz, the generics and biosimilars arm of Novartis, has earned FDA approval for the first biosimilar drug to treat multiple sclerosis. Tyruko (natalizumab-sztn) is a biosimilar of Biogen’s treatment Tysabri (natalizumab), a monotherapy used to treat adults with relapsing forms of MS. The biosimilar is also approved to treat adults with Crohn’s disease, another approved indication for Tysabri. Both drugs come with the risk of opportunistic viral infection progressive multifocal leukoencephalopathy and will carry a boxed warning about the potentially severe complication.  

Aug 24: 
Gilead Sciences’ antiviral drug Veklury (remdesivir) earned a label expansion from the FDA, now cleared for COVID-19 patients with all stages of liver disease. The dose will be the same as it was for its originally approved uses in adult and pediatric patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19. Veklury was the first drug to get full FDA approval for COVID-19. In July, the FDA approved another supplemental NDA that allowed it to be used across all stages of renal disease. 
The FDA based its expansion for all stages of liver disease on the data from a Phase I trial that showed no new safety signals. Hepatic laboratory testing is recommended for all patients and the drug may need to be discontinued if alanine transaminase levels hit 10 times the high end of the normal range or liver inflammation develops. 

Aug 21:
Pfizer’s respiratory syncytial virus vaccine Abrysvo won FDA approval for use in pregnant women to prevent RSV-associated lower respiratory tract disease in infants. Abrysvo is an unadjuvanted bivalent RSV prefusion F vaccine composed of two proteins that were selected specifically to optimize against the RSV A and B strains.
The vaccine was first approved in June 2023 for use in adults aged 60 years and above. However, the shot can now also be administered to pregnant women at 32 through 36 weeks of gestation to elicit immunity in their infants.
Data from the Phase III MATISSE trial supported the FDA’s approval. At the study’s prespecified interim analysis, Abrysvo had a vaccine efficacy of 81.8% for preventing medically attended severe RSV-associated lower respiratory tract disease (LRTD) 90 days after birth. This waned slightly to 69.4% at 180 days. The findings were published in The New England Journal of Medicine in April 2023.

Aug 18:
Neurocrine Biosciences got FDA approval to expand Ingrezza’s (valbenazine) label to include chorea in Huntington’s disease. Approved in 2017 to treat tardive dyskinesia, Ingrezza is a selective vesicular monoamine transporter 2 inhibitor.
In the company’s supplemental NDA, Neurocrine included data from the Phase III KINECT-HD trial and the ongoing KINECT-HD2 open-label study to establish the safety and efficacy of Ingrezza in the proposed indication. Data in a Lancet Neurology publication in May showed that Ingrezza treatment significantly reduced scores in the Unified Huntington’s Disease Rating Scale Total Maximal Chorea score by 3.2 units versus placebo, an effect that was statistically significant.
Ingrezza also outperformed placebo on secondary endpoints, including the Clinical Global Impression of Change and Patient Global Impression of Change response status. In clinical studies of Huntington’s disease, treatment-emergent adverse events included somnolence and sedation, urticaria, rash and insomnia.

Aug 18:
Regeneron Pharmaceuticals’ Veopoz (pozelimab) secured FDA approval as the first and only treatment indicated specifically for CHAPLE disease, also known as CD55-deficient protein-losing enteropathy, an ultra-rare hereditary disease that can cause potentially life-threatening gastrointestinal and cardiovascular symptoms. A fully human monoclonal antibody, Veopoz is approved for the treatment of adult and pediatric CHAPLE patients 1 year of age and older.
In February 2023, the FDA gave Priority Review to Regeneron’s investigational antibody, which works by binding to the C5 complement factor, thereby disrupting the complement cascade and preventing associated diseases. Regeneron presented Phase II/III data in its application for regulatory approval showing “rapid and sustained normalization” of albumin, one of the key markers of CHAPLE disease, in all 10 patients at 24 weeks. The treatment also eased symptoms such as increased bowel movements and abdominal pain.

Aug 18:
The FDA has expanded the label of Regeneron’s blockbuster eye therapy Eylea (aflibercept), allowing the administration of a higher 8-mg dose. Under the new high-dose regimen, Eylea injections will be given every four weeks for the first three months across all indications.
In diabetic retinopathy, the treatment can be administered every eight to 12 weeks thereafter, while the dosing interval can stretch up to 16 weeks in patients with wet age-related macular degenerationand diabetic macular edema. Eylea was previously approved in these indications but was limited to 2-mg doses.

Aug 16:
After two prior setbacks, Ipsen’s palovarotene finally earned FDA approval to treat fibrodysplasia ossificans progressive (FOP), the first treatment for the ultra-rare bone disease. Now to be sold under the brand name Sohonos, the oral medication is indicated for the reduction of heterotrophic ossification in adults and children with FOP.
The FDA approval is the culmination of a long and bumpy road for Ipsen’s FOP drug. The biotech first tried for an approval in 2021 but voluntarily withdrew its application in August of that year after the regulator asked for more data. Ipsen filed a resubmission a few months later, which the FDA rejected in December 2022 and requested additional information regarding the data that the company had already provided.
The FDA’s approval this week was backed by data from the Phase III MOVE trial, which according to Ipsen is the first and largest multicenter, open-label study in this space involving both adult and pediatric patients. In the trial, palovarotene reduced the annualized heterotrophic ossification by 54% compared with standard of care without introducing new safety signals. 

Aug 14:
Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma. Hepzato is a drug-device combination of melphalan—a well-established chemotherapeutic agent—and the company’s Hepatic Delivery System, which can directly administer the drug to the liver.
Delcath first sought FDA approval in August 2012. More than a year later, in September 2013, the regulator rejected the application, asking the company to perform another well-controlled randomized trial to better determine the safety and efficacy of the investigational product. In February 2023, nearly 10 years later, Delcath resubmitted its NDA.
The application contained data from the Phase III FOCUS study, a single-arm, open-label trial which enrolled 91 patients who were treated every six to eight weeks for up to a maximum of six cycles. FOCUS found that the drug-device combination had an overall response rate of 36.3%, including seven complete responders and 26 partial responders, with treatment response lasting for a median of 14 months. Patients treated with Hepzato saw a 73.6% disease control rate.

Aug 14:
In what is expected to become a multibillion-dollar blockbuster, Pfizer’s BCMAxCD3 bispecific antibody Elrexfio (elranatamab-bcmm) has secured an FDA accelerated approval as another off-the-shelf treatment option for patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy. Elrexfio is being touted by Pfizer as the first off-the-shelf, ready-to-use fixed-dose subcutaneous therapeutic that targets the BCMA protein.
The FDA’s accelerated approval was supported by data from the Phase II MagnetisMM-3 study, which found that in heavily pretreated RRMM patients who had not yet received BCMA-directed therapy, Elrexfio had an overall response rate of 58%, with around 82% of responders maintaining improvements for at least nine months. In those with prior exposures to BCMA-directed therapies, Elrexfio elicited an overall response rate of 33%. The therapy comes with a boxed warning for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.

Aug 14:
Biotech company Revance Therapeutics has received its first therapeutic indication for Daxxify (daxibotulinumtoxinA-lanm) for the treatment of cervical dystonia in adults. Revance won approval based on data from the Phase III ASPEN 1 and ASPEN OLS trials in which Daxxify was found to be safe and effective at two separate injected doses with a median duration of effect of 24 and 20.3 weeks for the respective groups.
Daxxify, a neuromuscular blocking agent and acetylcholine release inhibitor that’s positioned as a rival to AbbVie’s Botox, was approved in September 2022 for the temporary improvement of moderate to severe frown lines in adults. According to Revance, the total U.S. therapeutic neuromodulator market opportunity for Daxxify is $2.5 billion, including the $345 million cervical dystonia market.

Aug 11:
J&J’s Janssen got the FDA’s greenlight for its PARP inhibitor Akeega (niraparib and abiraterone acetate), which is now authorized to treat BRCA-mutated metastatic castration-resistant prostate cancer. Akeega is the first dual-action tablet that combines the activity of a PARP inhibitor with abiraterone acetate, an androgen biosynthesis inhibitor sold by the company under the brand name Zytiga.
The approval covers a combination regimen of Akeega with prednisone and is based on data from the Phase III MAGNITUDE study, a randomized, double-blinded and placebo-controlled trial with 765 participants. Compared with Zytiga plus prednisone, the Akeega-based regimen significantly improved radiographic progression-free survival by 47% in BRCA-positive patients.

Aug 10:
Janssen also won the FDA’s accelerated approval for its first-in-class bispecific T cell engager Talvey (talquetamab) as a treatment for relapsed or refractory multiple myeloma. By targeting both the CD3 and the GPRC5D proteins, Talvey works by bringing together T cells and myeloma cells, allowing the body’s immune system to exert its anti-cancer effects.
The accelerated approval was based on a Phase II study in which an overall response rate of 73.6% was seen in patients with at least four prior lines of therapy. Response was durable for a median of 9.5 months in the lower dosing group. Median duration of response was not yet reached in the higher dose arm. Like Pfizer’s Elrexfio, Talvey comes with a boxed warning for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.

Aug 9:
Nearly three years after first winning accelerated FDA approval of Gavreto (pralsetinib) in metastatic non-small cell lung cancer (NSCLC) with RET fusions, Genentech (Roche) and Blueprint Medicines announced the drug’s conversion to full approval.
RET fusions are present in just 1-2% of NSCLC cases, according to Genentech. The original FDA nod was based on an overall response rate (ORR) of 57% and median duration of response (DoR) that had not yet been reached in 114 patients in the Phase I/II ARROW study. The conversion to traditional approval was granted based on an additional 123 patients and 25 months of further follow-up. Treatment-naïve patients saw a median DoR of 13.4 months with a 78% ORR, while patients previously treated with platinum-based chemotherapy had an ORR of 63% and DoR of 38.8 months.

Aug 9:
Shares of Galera Therapeutics plummeted more than 80% Wednesday after the FDA rejected the company’s application for avasopasem manganese (avasopasem). The drug was being proposed to treat severe oral mucositis (SOM)—or mouth sores—resulting from radiotherapy in patients with head and neck cancer.
In its Complete Response Letter, FDA said results from the Phase III ROMAN trial, in combination with the GT-201 trial, were “not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety” in reducing these mouth sores. Galera will need to provide results from an additional clinical trial in order to resubmit the application, the Malvern, Penn–based company said in a press release. Impacts for the company’s workforce were swift, as Galera announced it would reduce its numbers by approximately 70% in order to extend its cash runway.
Aug 4:

In another milestone moment, the FDA approved Biogen and Sage Therapeutics’ zuranolone—henceforth Zurzuvae—as the first pill for postpartum depression (PPD). Zurzuvae is only the second treatment for this indication and the first pill that can be taken at home. The drug—a neuroactive steroid that works as a positive allosteric modulator of GABA-A receptors—also acts much more quickly than other approved depression treatments, with improved symptoms seen in trials in as few as three days.
Despite the significance of the approval, Sage and Biogen had sought a much larger slice of the depression market, but this will have to wait as the FDA rejected zuranolone for the treatment of major depressive disorder (MDD). In its Complete Response Letter, the FDA stated that the application did not provide “substantial evidence of effectiveness” to support its approval and that further research would be required. On a conference call following the decision, Sage CEO Barry Greene said only that the companies are “reviewing the feedback and evaluating next steps.”

Aug 4:
Mesoblast will have to provide more data before the FDA may approve its BLA for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). In response to the FDA’s complete response letter (CRL), announced Friday by Mesoblast, the New York–based biopharma will “conduct a targeted, controlled study in the highest-risk adults with the greatest mortality.” Mesoblast noted that the adult study is in line with its overall commercial strategy, which involves a progression from pediatric to adult SR-aGVHD indications. This is the second rejection for remestemcel-L, after the FDA first turned down Mesoblast’s application in 2020, despite a 9-1 advisory committee vote in its favor.

Aug 3:
In 2019, the FDA approved the first vaccine for Ebola, a deadly viral hemorrhagic fever, for adults 18 years and older. Now, that vaccine—Ervebo, developed by Merck—is available to children 12 months and older. The FDA’s decision follows a recommendation on July 20 by the European Medicines Agency's Committee for Medicinal Products for Human Use to expand Ervebo’s label to children one year and older. The vaccine is only FDA-approved to protect against the Zaire ebolavirus and not other species of Ebola or Marburgvirus and the duration of protection is unknown, according to Merck.
Aug 2:
Taiho Oncology picked up a label expansion for its cancer drug Lonsurf (tipiracil), alone or as part of a combination regimen with Roche’s Avastin (bevacizumab) in metastatic colorectal cancer (mCRC). The nod came nearly eight years after Lonsurf first won approval as a monotherapy for mCRC in Sept. 2015. The expansion pertains to patients who had previously been treated with an anti-VEGF biologic agent and fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Patients whose cancer has the wild-type RAS protein and who have previously received an anti-EGFR therapy are also eligible for the new combination.
The FDA’s decision was supported by the Phase III SUNLIGHT trial, where the Lonsurf–Avastin combination led to a median overall survival of 10.8 months versus 7.5 months on Lonsurf monotherapy, for a 39% reduction in risk of death.

July
July 31:
GSK’s Jemperli (dostarlimab-gxly) won FDA approval as a frontline treatment for primary advanced or recurrent endometrial cancer. The regulatory nod is the first new frontline treatment for patients whose cancer is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) in decades, according to GSK. Jemperli is also the first immuno-oncology treatment and PD-1 inhibitor to be authorized for frontline use in this patient population.
Jemperli, an anti-PD-1 antibody, was first approved in April 2021 for recurrent or advanced dMMR endometrial cancer. The FDA accepted the supplemental BLA to move the drug into the frontline setting on June 6 and set a target action date of Sept. 23, meaning Monday’s approval came nearly two months ahead of schedule.

July 29:
Citius Pharmaceuticals’ plans to bring a reformulated version of Eisai’s withdrawn cancer drug Ontak were put on hold on Saturday after the FDA rejected its BLA for Lymphir (denileukin diftitox). Citius acquired the drug from Dr. Reddy's Laboratories in Sept. 2021.
An engineered IL-2-diphtheria toxin fusion protein being developed to treat relapsed or refractory cutaneous T-cell lymphoma (CTCL), Lymphir specifically binds to IL-2 receptors to precisely deliver its toxic payload, thereby preventing protein synthesis in malignant T cells. The drug also targets the immunosuppressive regulatory T cells, which allows the body to mount a stronger immune response against the cancer.
In its announcement of the Complete Response Letter, Citius said the FDA will require it to “incorporate enhanced product testing and additional controls” into the BLA. No clinical efficacy or safety issues were raised and Citius stated it will continue working toward FDA approval of Lymphir.  

July 28:
The FDA approved RiVive, a 3 milligram (mg) naloxone hydrochloride nasal spray manufactured by Harm Reduction Therapeutics, as the second over-the-counter (OTC) naloxone rescue option for opioid overdose. The approval comes just four months after the regulator greenlit Narcan, a 4-mg naloxone hydrochloride nasal spray, as the first OTC naloxone product. Narcan is manufactured by Emergent BioSolutions. Naloxone rapidly reverses the effects of opioid overdose—a long-running epidemic that claimed the lives of more than 105,000 people in the U.S. in the year ending in February 2023, according to the FDA.
In a press release announcing RiVive’s approval, FDA Commissioner Robert Califf stated the regulator’s commitment to making naloxone accessible and encouraged other manufacturers of these products to discuss potential nonprescription development programs with the FDA.

July 26:
Octapharma secured approval for Balfaxar (prothrombin complex concentrate) for the reversal of the blood-thinner Warfarin in emergency surgery and invasive procedures. Warfarin increases the risk of bleeding—a serious complication during surgery. Balfaxar works to quickly increase blood levels of key clotting factors and antithrombotic proteins. A lyophilized powder, it is reconstituted in a device developed by Octapharma.
While Balfaxar met the primary endpoint of hemostatic efficacy in a Phase III study and was non-inferior to the comparator, Kcentra, fatal and non-fatal arterial and venous thromboembolic complications were observed in clinical trials and post-marketing studies, and healthcare providers are advised to monitor patients for signs of thromboembolic events.
The approval is the third for Balfaxar, which is already marketed in Canada and the EU as octaplex.

July 25:
People with an eyelid disease called demodex blepharitis now have a treatment option as the FDA approved Tarsus Pharmaceuticals’ Xdemvy. A prescription eyedrop, Xdemvy aims to eradicate the root cause of the disease—demodex mites that burrow in the eyelash follicles of sufferers. Xdemvy is the first therapy approved for the condition. 
Approval for Xdemvy was granted based on two randomized, multicenter, double-masked, vehicle-controlled studies of 833 patients, in which 415 patients received the treatment. A significant improvement was seen in each study by day 43, Tarsus stated in its approval announcement, adding that the therapy was “generally safe and well-tolerated.” 
Tarsus will have a significant market for Xdemvy as demodex blepharitis affects around 25 million people in the U.S. and accounts for more than two-thirds of all blepharitis cases, according to Tarsus. 

July 24:
The FDA has approved the first treatment for adults and children two years and older with molluscum contagiosum, a viral skin infection that affects around 6 million people in the U.S. every year.  A topical solution developed by Verrica Pharmaceuticals, YCANTH is a drug-device combination that contains a GMP-controlled formulation of cantharidin, a substance derived from the blister beetle Cantharis vesicatoria. It works by causing a blister to form on the wart or growth, eventually lifting it off the skin. 
YCANTH’s approval is based on data from two randomized, double-blind, multicenter Phase III trials. In each trial, a clinically and statistically significant number of patients treated with YCANTH achieved complete clearance of all treatable molluscum lesions, meeting the primary endpoint. No serious adverse reactions were reported in either trial. The company expects to make YCANTH available to patients and caregivers by September, Ted White, Verrica’s president and CEO, said in a statement.

July 20:
Four years after it was rejected by the FDA due to safety concerns, Daiichi Sankyo’s Vanflyta (quizartinib) won approval to treat patients with acute myeloid leukemia that has a FLT3-ITD gene mutation. In 2019, an FDA advisory committee voted that the benefit conferred by quizartinib did not outweigh the safety risks. Thursday’s approval comes with a Boxed Warning for three heart disorders: QT prolongation, torsades de pointes and cardiac arrest, and will only be available through a restricted Risk Evaluation and Mitigation Strategy (REMS) program.
Daiichi Sankyo supported its NDA, accepted last Fall, with data from a Phase III trial that showed the quizartinib regimen—combined with standard induction and consolidation chemotherapy and continued as a single agent)—reduced the risk of death by 22.4% compared to patients on chemotherapy alone. After 39.2 months of follow-up, quizartinib more than doubled the overall survival advantage, the company stated in a press release.

July 20:
Emergent BioSolutions secured approval for Cyfendus, a vaccine intended for use after exposure to bacillus anthracis, a bacterium that causes anthrax. Cyfendus is required to be used in combination with “recommended” antibacterial drugs, according to Emergent’s announcement. The approval was based on a series of studies, including a pivotal Phase III trial assessing the vaccine’s consistency, immunogenicity and safety in healthy adults. Even before the approval, Emergent had been supplying Cyfendus to the U.S. Department of Health and Human Services under pre-Emergency Use Authorization for four years. 

July 17:
Infants and children at severe risk of RSV have another treatment option after the FDA approved Sanofi and AstraZeneca’s Beyfortus (nirsevimab). A monoclonal antibody, Beyfortus is just the second RSV drug authorized in the U.S. for high-risk children, the other being Synagis (palivizumab), which was approved in 1998. The companies’ bid for approval was backed by three late-stage trials that demonstrated the antibody’s safety and efficacy. Beyfortus will be available in the U.S. ahead of the 2023/2024 RSV season for children entering their first RSV season and those at severe risk up to 24 months, Sanofi stated in a press release.

July 13:
The FDA approved Perrigo Company’s Opill (norgestrel)—a progestin-only daily oral contraceptive—as the first-ever birth control pill available over the counter in the U.S. Perrigo expects Opill to be available online and in-person at drug stores, convenience stores and grocery stores in the first quarter of 2024. In a prepared statement, Perrigo President and CEO Patrick Lockwood-Taylor said the approval “marks a truly momentous day for women's health

 nationwide.” 
July 6:
A short workweek in the U.S. ended with big news as the FDA granted traditional approval to the first anti-amyloid antibody—and the first disease-altering drug—for Alzheimer’s disease. The accelerated approval for Eisai and Biogen’s Leqembi (lecanemab) was converted to a full approval based on results from the confirmatory Clarity-AD trial, which the FDA said in its statement verified the drug’s benefit. With the approval, Medicare coverage for Leqembi is expected to begin right away, with the requirement of a patient registry intended to collect further information on the effectiveness of this drug class in Alzheimer’s. 

July 3:
Amneal Pharmaceuticals received a Complete Response Letter for IPX203—a novel oral formulation of carbidopa/levodopa (CD/LD), a well-established combination for the management of Parkinson’s disease. In its rejection letter, the FDA said that while Amneal was able to adequately establish the safety of levodopa, it was not able to sufficiently do so for carbidopa. The regulator has requested additional pharmacokinetic data. The New Jersey–based company stated it plans to meet with the FDA to determine the best path forward for the treatment.

June
June 29:
Capping a busy week, the FDA approved BioMarin’s Roctavian (valoctocogene roxaparvovec-rvox) as the first gene therapy for adults with severe hemophilia A. Hemophilia is a rare genetic bleeding disorder caused by a mutation in the gene that encodes factor VIII (FVIII), which is necessary for blood to clot. A one-time gene therapy, Roctavian contains a healthy gene for factor VIII. Delivered through an adeno-associated virus (AAV) vector, the gene is expressed in the liver to increase blood levels of FVIII, thereby reducing the risk of uncontrolled bleeding. 

June 28:
The FDA notched another milestone with the approval of the first cellular therapy for type 1 diabetes. Lantidra (donislecel) developed by Chicago-based CellTrans, is a cell therapy made from the pancreatic islet cells of deceased donors. It is intended for adult patients whose repeated hypoglycemic episodes leave them unable to hit average blood glucose levels. In a clinical trial of 30 patients, 21 were insulin-free for at least a year; 11 didn’t require insulin for between one and five years and 10 were insulin-free for more than five years. Five patients failed to achieve any days of insulin independence.

June 28:
Pfizer’s bet on OPKO Health’s human growth hormone analog paid off as the FDA approved the treatment—which will be marketed as Ngenla—to treat children whose production of growth hormones is impaired. Pfizer purchased exclusive global commercialization rights for the then-experimental treatment in December 2014 for $295 million upfront and a promise of up to $275 million in milestones. This was the partners’ second try for FDA approval after the regulator rejected Ngenla’s first bid in January 2022. Pfizer and OPKO did not state the reasons for the initial denial.

June 28:
The FDA declined to approve Eton Pharmaceuticals’dehydrated alcohol injection for the treatment of methanol poisoning, citing concerns related “primarily to Chemistry Manufacturing and Controls.” This is the second Complete Response Letter issued to Eton for this proposed treatment. In the first, issued in March 2021, the FDA indicated that travel restrictions due to the COVID-19 pandemic prevented a timely inspection of the company’s European contract manufacturing site.

June 27:
The FDA approved UCB’s Rystiggo (rozanolixizumab), a subcutaneously administered humanized IgG4 monoclonal antibody, to treat generalized myasthenia gravis, a rare muscle-wasting autoimmune disease. Rystiggo is the only treatment approved to treat patients who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive. The regulatory green light was based on a Phase III trial that showed Rystiggo led to significant improvements in symptoms related to breathing, talking, swallowing and rising from a chair.

June 23:
The FDA greenlit Pfizer’s Litfulo (ritlecitinib) for the treatment of patients as young as 12 years with severe alopecia areata, an autoimmune disease characterized by patchy or complete hair loss on the scalp, face or body. Litfulo inhibits Janus kinase 3 and the tyrosine kinase and is believed to work by blocking the signaling of cytokines and cytolytic activity of T cells, which are implicated in alopecia areata.

June 22: 
In one of the year’s most-anticipated regulatory decisions, the FDA approved Sarepta’s Elevidys—formerly SRP-9001—for children 4 to 5 years with Duchenne muscular dystrophy. Elevidys is the first-ever gene therapy for DMD, a neuromuscular disease characterized by progressive muscle weakness and atrophy that strikes primarily young boys. The gene therapy was approved via the FDA’s accelerated approval pathway based on data that established it increased the expression of the Elevidys micro-dystrophin protein.

June 21:
Eli Lilly and Boehringer Ingleheim’s Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) picked up another indication, becoming the first and only SGLT2 inhibitors approved for children 10 years and older with type 2 diabetes. Previously, there had only been one oral drug for this indication: metformin, which was approved in 2000.

June 20:
Argenx will bring to market the first subcutaneous injectable for generalized myasthenia gravis (gMG), a rare muscle-wasting autoimmune disease. Vyvgart (efgartigimod) was first approved in 2021 as a one-hour intravenous infusion. Vyvgart is an antibody fragment that binds to the neonatal Fc receptor to prevent recycling of immunoglobulin G back into the blood. This includes a reduction in abnormal AChR antibodies, which are present in approximately 85% of gMG patients. AChR antibodies block the acetylcholine receptors from being able to receive signals from the nerve to stimulate a muscular response. Their normalization should ostensibly improve muscular function.
Heather McKenzie is a senior editor at BioSpace, focusing on neuroscience, oncology and gene therapy. You can reach her at heather.mckenzie@biospace.com. Follow her on LinkedIn and Twitter @chicat08.
Most Read Today
 

FDA Decisions 2023: Sandoz, Gilead Sciences and More | BioSpace

Violence In The Healthcare Workplace

The next time you are in a hospital your nurse may be the target of a verbal or physical assault. The most common location is in the emergency department

Violence in the healthcare workplace is a significant issue affecting healthcare services and workers worldwide. It has far-reaching implications for the well-being of healthcare staff and can jeopardize patient care. Let's delve into the information provided to gain insights into the incidence, trends, and causes of violence in the healthcare workplace and explore measures to address this problem. 

Incidence and Trends of Workplace Violence in Emergency Departments (EDs) in the United Kingdom:A study conducted in the United Kingdom from January 2017 to March 2022 examined workplace violence (WPV) incidents in emergency departments (EDs). The research found that there were statistically significant increases in WPV during the COVID-19 pandemic in March and May 2020. 

Additionally, there were rising trends of WPV in specific regions like London and North-West England over the years preceding the pandemic. The study revealed alarming increases in WPV incidents, indicating a concerning trend in the EDs of the United Kingdom, potentially leading to a demoralized workforce and staff shortages [1].Insights on Workplace Violence Incidents in Healthcare in the United States:A survey conducted by Premier in collaboration with the Agency for Healthcare Research and Quality (AHRQ) revealed that 40 percent of healthcare workers in the United States experienced workplace violence incidents in the last two years. 

The survey highlighted that nursing staff faced violence most frequently, with combative patients being responsible for more than half of all reported incidents. The survey also shed light on the profile of perpetrators, indicating that most were men between the ages of 35 and 65. A notable legislation, the Safety from Violence for Healthcare Employees (SAVE) Act of 2023, was introduced to enhance legal protections for healthcare workers against workplace violence [2].Workplace Violence in Healthcare Settings in the United States: According to an Occupational Safety and Health Administration (OSHA) report, three-quarters of all workplace assaults in the US occur in healthcare settings. 

Healthcare workers, especially nurses, are at an increased risk of being victims of workplace violence. Causes of violence in healthcare settings include factors like the opioid epidemic, reduced funding for behavioral healthcare, misinformation about COVID vaccinations, and restricted visits during isolation. New prevention standards have been mandated to address workplace violence in healthcare settings, emphasizing staff training, de-escalation techniques, and reporting processes [3].In conclusion, violence in the healthcare workplace is a serious concern affecting healthcare workers globally. It poses risks to staff well-being, patient care, and overall healthcare provision. Efforts to combat workplace violence include implementing preventative measures, providing staff training in de-escalation techniques, and enhancing legal protections for healthcare workers. Healthcare organizations need to prioritize employee safety and take comprehensive measures to address this issue effectively.

Women responding to the survey reported that incidents of workplace violence were evenly split between emotional or verbal assaults (50 percent of women responding) and physical or sexual abuse (50 percent). Men responding to the survey were more likely to experience physical abuse (62 percent) versus verbal or emotional assaults (38 percent). 

One in four nurses has been abused in the workplace. Overall, the likelihood of healthcare workers being exposed to violence is higher than prison guards or police officers.

Healthcare workers accounted for 73 percent of all nonfatal workplace injuries and illnesses due to violence in 2018.

The most frequent perpetrators are family of the patient.

Wave of mRNA Vaccines Coming - In Your Food

There has been a longstanding routine vaccination of our animals (cattle, pork) against diseases. In the past these were manufactured with classic non-mRNA methods.

Are you ready for the total transformation of our food supply? There are dozens of veterinary vaccines (and human vaccines, for that matter) in production utilizing the new mRNA technology that underpinned the COVID vaccines. This new technology is entering our food supply under the cover of darkness—granted by censorship imposed during the COVID era that power brokers seem intent on keeping in place.  

What’s often not appreciated is how fundamentally different these vaccines are from previous vaccines. They rely on synthetic biology, essentially blurring the line between biology and technology. This blurring is one of the characteristics World Economic Forum founder and chairman, Klaus Schwab, relates to his dystopian concept of the Fourth Industrial Revolution, which includes gene-edited humans or ‘designer beings’.

We debated GMOs for years, why aren’t we debating the latest bioengineering tech: mRNA? Action Alert!

There are major questions about the long-term consequences of using mRNA technology given its novelty, both for food animals and for humans. Yet there isn’t even a semblance of a public debate about how to move forward or the need for transparency of supply chains including foodstuffs derived from animals treated with mRNA vaccines. This needs to change, especially as mRNA vaccines may well become a mainstay in human and veterinary medicine.

The coming use of mRNA vaccines in livestock presents a massive issue pertaining to our right to know what is in our food. The use of mRNA vaccines in humans is of course another massive public health issue that we’ve written about a number of times over the last three years, such as here and here. It was with a similar sense of humility and caution in the face of this new vaccine technology that we issued a joint call with our colleagues at the Alliance for Natural Health International to protect autoimmune patients from compulsory COVID vaccination.Are you ready for the total transformation of our food supply? There are dozens of veterinary vaccines (and human vaccines, for that matter) in production utilizing the new mRNA technology that underpinned the COVID vaccines. This new technology is entering our food supply under the cover of darkness—granted by censorship imposed during the COVID era that power brokers seem intent on keeping in place.  

The field of mRNA vaccines is exploding. Vaccines based on this novel technology are being explored for cancer treatment, the flu, HIV, hepatitis C, malaria, tuberculosis, and dozens of other diseases. They are also viewed as a boon to the livestock industry by proponents hailing it as a “revolutionary technology.” Researchers are working on mRNA vaccines against porcine reproductive and respiratory syndrome, African swine fever, avian influenza, and other food-animal diseases. Note, however, that there are currently no mRNA vaccines licensed for use in livestock…yet. Additionally, a recent Chinese study broke new ground in demonstrating that mice could be vaccinated against COVID through ingesting milk loaded with mRNA.

To be clear: there are important differences between the mRNA technology used in COVID vaccines and RNA vaccines that have been used in veterinary medicine for some time. In fact, there appears to be little awareness among the public over how much of a departure these new COVID vaccines are from traditional vaccines, this being a direct result of draconian censorship justified by authorities and cop-opted media during the COVID crisis of 2020 to 2022. mRNA vaccines deliver synthetically-produced genetic instructions via a lipid nanoparticle into cells; these instructions then force the vaccinee’s cells to produce whatever protein has been encoded in the instructions. In the case of the COVID vaccines, this is modified and patented version of the spike protein in selected variants of the circulating SARS-CoV-2 virus. It isn’t widely recognized that the spike protein produced following vaccination is different to the spike on the wild virus.

Now that we are poised at this interface of applying the latest bioengineering technology to ourselves and the animals many rely on for food, in full appreciation that we can turn our bodies and those of farm animals into drug factories, we must be humble, not arrogant. Put simply, there are no long-term safety data for any mRNA vaccines whether used on humans or animals, and emerging safety data on COVID vaccines suggests considerably more problems than were anticipated by manufacturers and health authorities at the time of the launch of the mass vaccination program some two and a half years ago.

Any person or authority that claims COVID mRNA vaccines are safe to humans – like the CDC –  is misleading the public. We also have no idea about the long-term, potential effects of eating meat from animals treated with mRNA vaccines coding for different patented proteins once they are approved—especially given the data showing that the lipid nanoparticle coding for the patented spike protein enters the bloodstream and can travel to different areas of the body.

mRNA vaccine technology represents a radical departure from conventional pharmacology that’s ruled the roost in human and veterinary medicine for the last 80 or so years. This is why consumers deserve to know if our food has been treated with these products. We spent years as a society debating the ethics of genetically modified foods, with the public overwhelmingly supporting disclosure of foods with genetic modifications. This culminated in the unfortunate passage of a sham labeling bill that allows food companies to obscure the contents of their products—though legal challenges could improve this situation. But the point is, there was a national debate about this issue.

It is a sign of the times that reasonable questions about the risks and benefits of novel mRNA vaccine platforms are dismissed so readily as anti-vaxxer “misinformation.” If the public can overwhelmingly agree that we need transparency about the contents of our food, the same logic must apply here: we deserve to know if our food has been treated with mRNA technology—whether to immunize the animal against a disease, or in a more Orwellian twist, as a means to deliver a vaccination to those who ingest the food, a possibility raised by the Chinese study referenced above.

As with the GMO labeling issue, states are leading the charge on this. Missouri, Tennessee, and Arizona have bills that require disclosure on food products that have been treated with mRNA vaccines or gene therapy products—though none of these bills appear to be moving forward.

This comes down to the basic issue of transparency, traceability and truth in labeling that allows consumers to make informed decisions about the foods they buy. Given the unknowns with the long-term health effects of the new mRNA vaccination platforms, it is critical that consumers are afforded the opportunity to choose whether they want to ingest foods treated with these vaccines or not.

Are you ready for the total transformation of our food supply? There are dozens of veterinary vaccines (and human vaccines, for that matter) in production utilizing the new mRNA technology that underpinned the COVID vaccines. This new technology is entering our food supply under the cover of darkness—granted by censorship imposed during the COVID era that power brokers seem intent on keeping in place.  

As with the GMO labeling issue, states are leading the charge on this. Missouri, Tennessee, and Arizona have bills that require disclosure on food products that have been treated with mRNA vaccines or gene therapy products—though none of these bills appear to be moving forward.

Action Alert! Write to Congress in support of transparency in labeling on meat products in the event they are treated with mRNA vaccines. Please send your message immediately.

Wave of mRNA Vaccines Coming - Alliance for Natural Health USA - Protecting Natural Health

 mRNA became a fashionable eponym in 2020 when it was necessary to develop a vaccine for COVID 19 to mitigate the world wide pandemic.

It is a novel way to manufacture a vaccine by only using the "protein spike" of the viral particle.

Prior to the pandemic vaccines were manufactured using different platforms

Vaccine Platforms:

Different types of vaccines were developed using various platforms, including:

mRNA Vaccines (e.g., Pfizer-BioNTech, Moderna): These vaccines use a small piece of the virus's genetic material (mRNA) that encodes the spike protein. This mRNA is encapsulated in lipid nanoparticles. When injected, cells in the body use the mRNA to produce the spike protein, triggering an immune response.

Viral Vector Vaccines (e.g., Oxford-AstraZeneca, Johnson & Johnson): These vaccines use a harmless virus (not the coronavirus causing COVID-19) as a vector. The viral vector is modified to carry the genetic code for the spike protein. Once injected, the vector virus delivers this genetic information to cells, leading to spike protein production and immune response.

Protein Subunit Vaccines (e.g., Novavax): These vaccines contain purified pieces of the virus, such as the spike protein. They don't contain the live virus and can't cause the disease. The immune system recognizes these proteins as foreign and mounts an immune response.

1. **Expanded Vaccine Development:** Researchers were exploring the use of mRNA technology to create vaccines for other infectious diseases beyond COVID-19. This could include diseases like influenza, Zika virus, and more.

2. **Cancer Immunotherapy:** mRNA technology held promise in the field of cancer treatment. Personalized cancer vaccines based on a patient's tumor-specific antigens were being researched, with the potential to stimulate the immune system to target and destroy cancer cells.

3. **Rare Diseases and Genetic Disorders:** mRNA technology might be used to treat rare genetic disorders by delivering functional mRNA to correct genetic mutations.

4. **Therapeutic Proteins:** mRNA could be utilized to produce therapeutic proteins within the body, offering potential treatments for various conditions such as metabolic disorders.

5. **Infectious Disease Research:** Beyond vaccines, mRNA technology might enable the development of treatments for infectious diseases by producing proteins that interfere with the pathogen's life cycle.

6. **Drug Delivery:** mRNA delivery systems could potentially be used to deliver other types of therapeutic molecules, not just protein-coding information, opening up avenues for novel drug delivery methods.

7. **Research and Development:** Ongoing research aimed to improve the stability, delivery efficiency, and safety of mRNA-based therapies.

 

US Military Confirms Myocarditis Spike After COVID Vaccine Introduction | ZeroHedge

A military student pilot has cardiac arrest while at the controls of his aircraft. The instructor took over, landing the plane.  He was given CPR and a cardiac defibrillation.  He was dead for 11 minutes.

The military recently admitted that myocarditis has spiked after the COVID vaccine was mandated. This is not new information to anyone who follows us, as we’ve shown proof of this for a year and a half now. These events shouldn’t be brushed over or swept under the rug, but the DOD’s official stance is that the vaccine is “safe and effective,” therefore don’t ask questions and just get it

Cases of myocarditis soared among U.S. service members in 2021 after the COVID-19 vaccines were rolled out, a top Pentagon official has confirmed.

There were 275 cases of myocarditis in 2021—a 151 percent spike from the annual average from 2016 to 2020, according to Gilbert Cisneros Jr., undersecretary of defense for personnel and readiness, who confirmed data revealed by a whistleblower earlier this year.

The COVID-19 vaccines can cause myocarditis, a form of heart inflammation that can lead to mortality, including sudden death. COVID-19 also can cause myocarditis.

The rate of cases per 100,000 person-years, a way to measure risk across a certain period of time. In 2021, the rate was 69.8 among those with prior infection, compared to 21.7 among members who had been vaccinated.

“This suggests that it was more likely to be [COVID-19] infection and not COVID-19 vaccination that was the cause,” Mr. Cisneros said.

The diagnosis data comes from the Defense Medical Epidemiology Database.

Military officials have struggled to provide accurate data on 2021 diagnoses.

Whistleblowers revealed in 2021 that myocarditis, as reflected in the Defense Medical Epidemiology Database (DMED), had soared to 2,868 percent higher than the average from 2016 to 2020. They downloaded the data in August 2021.

The number of 2021 myocarditis diagnoses, though, had plummeted from 1,239 to 263 when the data was downloaded later, prompting concerns of manipulation.

Chaos and Confusion and Disinformation

Military officials said they reviewed the data and found it was “faulty.” They said the data for the years 2016 to 2020 were “corrupted” during a “database maintenance process,” which resulted in the display of only 10 percent of the actual medical encounters for that time period.

Officials told Mr. Johnson in 2022 that the problem had been fixed. The fix significantly changed the records. Instead of a 2,181 percent increase in hypertension in 2021, for instance, the increase was just 1.9 percent. Female infertility, instead of increasing 472 percent, increased 13.2 percent.

The updated percentages, though, were called into question when another whistleblower looked at the database in 2023 and found they were different.

Testicular cancer, initially pegged as increasing 369 percent, was placed at 3 percent by the military. But the actual increase was 16.3 percent, the whistleblower found. Pulmonary embolism was among the other conditions that occurred more often in 2021 than the military had conveyed.

The whistleblower alerted Mr. Johnson, the top Republican on the Senate Subcommittee on Investigations, who asked military officials for answers.

Mr. Cisneros acknowledged that the data given to the senator was incomplete. He said the change stemmed from December 2021 figures not being available when the corrected data was offered. There was a data “lag by about three months,” meaning the data wasn’t available in February 2022, when officials provided Mr. Johnson with the corrected data, Mr. Cisneros said.

Pentagon officials replicated the analyses from the whistleblower and found the data “are similar” to the data the whistleblower sent to Mr. Johnson, Mr. Cisneros said.

Military officials hadn’t previously mentioned any data lag previously while communicating with Mr. Johnson or the public, and they didn’t incorporate the available data when they sent him another missive in mid-2022.

“Without the whistleblower’s disclosure, I doubt DOD would have ever acknowledged that it provided incomplete information to my office in February 2022 and again in July 2022,” Mr. Johnson said.

He said the DOD had demonstrated “a complete disregard for transparency” and urged officials to make clear whether it has investigated whether any of the medical conditions for which diagnoses spiked are associated with the vaccines.

Pentagon Tracking 14 Cases of Heart Inflammation in Troops After COVID-19 Shots

 

US Military Confirms Myocarditis Spike After COVID Vaccine Introduction | ZeroHedge

Chronic Illness

Body and Soul

We have compiled a guide to dealing with a chronic illness.

Often a chronic illness will present with minor aches, pains or a myriad of signs and symptoms which are unexplained. At sometimes it will take months or years for the illness to become defined and accurately diagnosed.

Body and Soul authored by Gary M. Levin M.D. is a book with an overall approach to understanding a chronic illness such as hypertension, diabetes, autoimmune diseases, heart disease and genetic illness.

It is vital you find a primary care physician to manages your illness(es). If required he should manage referrals to specialists for an expert treatment plan.  Some conditions such as diabetes, hypertension can be managed by a PCP, however it is also useful to obtain a second opinion for new developments in managing your illness.

The book covers a variety of approaches to mental health, spiritual awareness and holistic or alternative medicine approaches.  Many PCPs are not trained in these areas and use allopathic medicines and only FDA approved treatments.   You should inquire of your physician about alternative approaches.

FDA approved treatments are limited to peer review studies, and can be misleading and incomplete because there are many off label treatments physicians use that are beneficial.

Not all treatments such as supplements are not easily studied by a clinical trial.

It is acceptable to use search engines such as Google, WebMD, MayoClinic to obtain information about your illness.  Discuss these sources with your PCP.  A competent physician should be open to discussions with you and can offer advice on the truthfulness of your research.

COVID19 and social media created much 'false information'. This created confusion, even among experts and there is still false information posted on Twitter X,  Substack and other social media sites.  At times TwitterX sensor posts that are filtered by algorithms (which are often incorrect as they use artificial intelligence that searches for keywords such as antivax, mRNA

Chronic Illness also affects your Mental Health creating depression and mood disorders. Consulting with a Behavioral specialist will add another component to use in managing chronic illness.

Chronic illness affects the entire family, spouse and children.  At times your family becomes a caregiver.

Build a Team

Poll: Public healthcare in America? - Robert Pearl, MD

 I was surprised by the results of this survey. I never imagined that 4 in 5 readers would vote for a public healthcare system.

If the United States went in that direction, it would be the final step ending the traditional fragmented, fee-for-service payment model of healthcare provision in this country.

Implementing this type of model would address the ongoing challenge of 30 million uninsured in the United States. And it would lead to lower costs for medical care.

However, as in other nations, this shift would most likely lead to delays in care for patients and continued dissatisfaction for providers. At the same time, it might be better than the delays and dissatisfaction of today. That would depend on exactly how the program were implemented.

I was equally surprised by how much readers would be willing to pay out of pocket to jump the line in this new public-healthcare system. Most people don’t spend anywhere near $5,000 to $10,000 per year of their own money on healthcare today.

One of the  factors which frustrate patients and providers more than anything is the chaos and lack of uniformity and regulations. While Medicare regulations are consistent, the majority of private payers, and private managed care programs are not uniform.

Poll: Public healthcare in America? - Robert Pearl, MD

This Healthcare Tech Company Has Become The First To Receive FDA De Novo Authorization For An OTC COVID-19 Test

There are still an average of over 2,000 patients with COVID-19 admitted to hospitals every day in the United States. For both the flu and COVID-19, early diagnosis and treatment are critical to preventing serious illness and even death.

The healthcare technology company Cue Health Inc.  has become the first company to get De Novo authorization from the U.S. Food and Drug Administration (FDA) for an over-the-counter COVID-19 test — as well as being the first FDA De Novo authorization for any over-the-counter molecular test for a respiratory disease. The Cue COVID-19 Molecular Test is designed for both at-home and point-of-care use. 

The at-home and point-of-care COVID-19 tests deliver lab-quality results to connected mobile smart devices in about 20 minutes. The test integrates into Cue Care, the company's state-of-the-art test-to-treatment service where patients can connect with a healthcare provider through the Cue Health App to discuss their results, form a treatment plan and have prescribed medications delivered straight to their door. 

COVID-19 Diagnostics Market Remains As The Disease Becomes Endemic

Cue’s De Novo authorization comes as public health officials and epidemiologists have been continuously reporting that COVID-19 has transitioned from pandemic to endemic. Similar to the flu, COVID-19 cases will likely continue to cycle between highs and lows, but in a relatively more predictable manner. Movement into endemic status only means that testing will be even more important and needed over a much longer period of time.

Early diagnosis of a respiratory illness can potentially lead to a milder infection and a decreased likelihood of hospitalization. Maintaining vigilance in preventing infection and opting for early detection and treatment at the first sign of symptoms (especially in households with children, senior citizens, family members with disabilities, or other at-risk individuals) can be crucial, especially for COVID-19.

Cue Health’s diagnostic platform is able to help both patients and care providers stay ahead of COVID-19 over the long term, as the disease enters its endemic stage. By providing fast and accurate results, the platform could help minimize the spread of the disease and the risk of hospitalizations.

Cue’s Molecular Diagnostic Platform — A Game Changer For Testing

Cue’s test is a NAAT (Nucleic Acid Amplification Test) that amplifies and detects the virus’s RNA. Because it can amplify the genetic material, Cue’s test is much more sensitive than an antigen test. In clinical studies, the Cue COVID-19 Molecular Test matched three FDA-authorized, lab-based PCR tests with 98% accuracy. The company’s innovative technology turned the complex test into a user-friendly kit that requires no advanced training. 

Cue’s molecular test is proven to deliver accurate results even in the early days after exposure whereas antigen results are not nearly as reliable. This is important as, according to the CDC, treatment must be started within days after you first develop symptoms to be effective. Cue's molecular test, which delivers results in 20 minutes, is also much faster than a PCR test, which can take anywhere from 12 hours to five days. 

The test can be used on adults or children with or without signs or symptoms of COVID-19 and it is self-contained, meaning it doesn’t involve mixing fluids or running an involved testing procedure. Users simply insert the cartridge into their Cue Reader, collect a nasal sample with a Cue Sample Wand, and insert the Wand into the cartridge. About 20 minutes later, results are sent to the Cue Health App on the user’s phone.

With its head start in the transition from EUA to permanent market authorization for its at-home COVID-19 molecular test and a slate of additional at-home tests compatible with the same Cue Reader device, analysts have expressed optimism about the healthcare tech company’s future earnings potential.

The device is still in development, pending FDA approval for marketing.

UnitedHealth cutting back on prior authorizations

Health payers are catching up on precision medicine.   Physicians are complaining about the increasing work burden and administrative expenses associated with providing services to patients.

Starting next month, UnitedHealthcare says it will move forward with plans to drop prior authorization requirements for a range of procedures, including dozens of radiology services and genetic tests, among others.

Why it matters: UnitedHealth is among the health insurance giants who have announced plans to cut back on prior authorization as federal regulators consider tougher curbs on the practice.

Catch up quick: Prior authorization is often criticized by patients and doctors, who complain they are an administrative burden or impede necessary care. Insurers, meanwhile, say prior authorization provides important guardrails against improper health care utilization, helping to keep costs down.

UnitedHealth, the largest commercial U.S. insurer, previously said its prior authorization removals will represent roughly 20% of its overall prior authorization volume.

Cigna and Aetna also announced plans to roll back some prior authorization requirements.

The Centers for Medicare and Medicaid Services proposed a rule to limit the amount of time insurers have to review requests on services for which they require prior approval, BenefitsPro previously reported.

Congress is also eyeing a plan to streamline and add transparency to the process by which Medicare Advantage plans can deny coverage for services via prior authorization.

Zoom in: UnitedHealth says the removals will take effect Sept. 1 and Nov. 1 across the vast majority of its plans.

The company also spelled out which procedures would see prior authorization requirements removed. For instance, hundreds of codes for genetic testing — accounting for tens of thousands of prior authorization requests a year from commercial and Medicaid members — are among those that will be removed, officials said.

A code for cardiology stress test prior authorization for Medicare Advantage members will also be eliminated, reducing roughly 316,000 prior authorization requests a year.

The company next year also will roll out a "gold card" program eliminating most prior authorization requirements for doctors who have high approval rates.

Flashback: Earlier this summer, UnitedHealth walked back a controversial plan to require prior authorizations for colonoscopies and other endoscopic procedures.

UnitedHealthcare, Cigna, Aetna revamping prior authorization ahead of CMS rule

UnitedHealth cutting back on prior authorizations

FREE E-BOOK -all you (never) wanted TO HAVE TO KNOW about the C19 mRNA injections - 156 pages of text and 20 pages of citations

 

Complete Text

Free e-book by some very smart people who actually give a crap about the quality of life and avoidance of needless death of people – as opposed to the Cult, that cares only about death – and causing billions of deaths along a “pathway” of suffering, poverty and disease.

mRNA Vaccine Toxicity – Doctors for COVID Ethics (doctors4covidethics.org)

It is split into these chapters and sections: (each section is clickable in the document - not from the below - from the main document contents page).

1 Introduction

1.1 Are mRNA vaccines dangerous in principle, or is the observed harm accidental?

1.2 COVID-19 vaccines were never about your health

1.3 The misuse of emergency use authorizations, and the breakdown of regulatory safeguards

1.4 Why this book was written

2 Some elements of virology and immunology

2.1 The life cycle of a virus

2.2 Immunity to viruses

2.3 How do the highly diverse T-cell and B-cell reservoirs originate?

2.4 Immunological memory

2.5 Cross-immunity

2.6 Who really controls viral infections: antibodies, or cytotoxic T-cells?

2.7 Immunity to respiratory viruses: systemic versus mucosal

2.8 Vaccination strategies

2.9 Appendix: some evidence of fraud in Pfizer’s clinical trials .

3 Immunological mechanisms of harm by mRNA vaccines

3.1 mRNA vaccines are distributed throughout the body and prominently affect the blood

3.2 The expression of spike protein in the body is widespread and long-lasting

3.3 The mRNA vaccine LNPs fly under the radar of the immune system

3.4 Induction of autoimmune disease

3.5 Vaccine-induced immunosuppression

3.6 The fundamental mechanism of damage by mRNA vaccines is completely general

4 Pathological evidence of immunological harm due to mRNA vaccines

4.1 Key techniques used in histopathology

4.2 Sources of evidence

4.3 Vasculitis induced by mRNA vaccination

4.4 Immune attack on organ-specific cells and tissues

5 Pharmacokinetics and lipid toxicity of mRNA vaccines

5.1 Structure and function of lipid nanoparticles

5.2 Pharmacokinetics of mRNA vaccines

5.3 Lipid nanoparticle toxicity

5.4 Appendix: Evidence of substandard manufacturing Quality of COVID-19 mRNA

6 Genotoxicity of mRNA vaccines

6.1 Genotoxicity of synthetic cationic lipids

6.2 Reverse transcription of vaccine mRNA sequences into DNA

6.3 Contaminating plasmid DNA in Pfizer’s and Moderna’s mRNA vaccines

6.4 Known and plausible risks posed by DNA copies of non-self

7 Epidemiology of COVID-19 mRNA Vaccine Adverse Events Margot DesBois, B.A. and Brian S. Hooker, Ph.D.

7.1 Introduction

7.2 General Adverse Events, Serious Adverse Events, Death, Hospitalization, Life-Threatening Events

7.3 Cardiac Events

7.4 Thrombotic Events

7.5 Neurological Events

7.6 Immunological Events

7.7 Reproductive Events

7.8 Conclusion

8 AIDS & HIV: The Blueprint for the Perversion of Medical Science David Rasnick, Ph.D.

8.1 AIDS does not behave like a novel contagious disease

8.2 AIDS and drug abuse

8.3 Peter Duesberg’s scientific critique of the HIV/AIDS

8.4 HIV is not sexually transmitted

8.5 Kary Mullis’ quest for evidence that HIV causes AIDS

8.6 The crucifixion of a dissident

8.7 AIDS in Africa

8.8 Thabo Mbeki’s ill-fated attempt to get at the truth about AIDS

8.9 Some evidence to challenge the AIDS orthodoxy

9 Summary and conclusions

9.1 The key mechanism of mRNA vaccine toxicity

9.2 The immunological mechanism of harm is completely general

9.3 Could a return to good manufacturing practices abolish the toxicity of the mRNA vaccines?

9.4 If mRNA vaccines are inherently dangerous, why are they urged and even forced on us?

9.5 What can we do?

Afterword by Catherine Austin Fitts