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FDA Authorizes Additional Omicron COVID Booster for Seniors and People With Weak Immune Systems
The Food and Drug Administration on Tuesday authorized an additional dose of Pfizer and Moderna’s COVID-19 vaccines targeting the Omicron variant for seniors and people with weak immune systems.
Seniors who are 65 years of age or older and who have already received a vaccine targeting the Omicron BA.5 subvariant are now eligible to receive another dose at least four months after their last shot, according to the FDA. People with weak immune systems can receive another Omicron shot at least two months after their last dose and receive additional shots at the discretion of their doctor.
Children 6 months through 5 years of age who are unvaccinated can now receive the full two-dose series of Moderna’s Omicron vaccine. Kids 6 months through 4 years of age can receive three doses of Pfizer’s shot that targets Omicron.
Children who are 5 years old can receive either two doses of Moderna or a single dose of Pfizer. Children under age 5 who have already started their vaccination series with the old COVID vaccines that target the original strain of the virus can receive the Omicron shots to finish their course, though how many doses they receive will depend on whether they took Pfizer or Moderna vaccines.
J&J Talc Unit Again Seeks to Halt 38,000 Cancer Lawsuits
A Johnson & Johnson subsidiary is again asking a U.S. judge to pause tens of thousands of lawsuits alleging that the company’s baby powder and other talc products cause cancer, as it takes another shot at resolving the litigation in bankruptcy after a federal appeals court found its first attempt improper.
At a Tuesday hearing in Trenton, New Jersey, LTL Management will argue that the so-called “automatic stay” under bankruptcy law that stops lawsuits against it from moving forward while it is in Chapter 11 proceedings, should also protect J&J, which has a market value of over $430 billion and has not filed for bankruptcy itself.
Two groups of cancer plaintiffs and the U.S. Department of Justice’s bankruptcy watchdog have opposed the company’s bid for a stay, arguing that it is a fraudulent attempt to evade the earlier court ruling and that the second bankruptcy has “slim to nonexistent prospects” of success.
More than 38,0000 talc lawsuits have been on hold since LTL first filed for bankruptcy in 2021, but cancer victims argue that they should be allowed to proceed with their lawsuits after a federal appeals court nixed the company’s attempt to offload the litigation in bankruptcy.
Before the talc lawsuits could resume, LTL filed for bankruptcy a second time, re-opening the legal battle over the bankruptcy’s legitimacy.
China ‘Began Developing Two COVID Vaccines’ Before Official Outbreak
The Telegraph via Yahoo!News reported:
Chinese researchers may have begun developing two COVID vaccines in November 2019, before the official start of the outbreak, a U.S. Senate report has claimed. The claims come in a 300-page document, which concluded that the pandemic most likely came from a lab leak and was the result of a “research-related incident” in Wuhan.
The report argued that Chinese researchers appeared to begin the development of at least two COVID vaccines at the Wuhan Institute of Virology (WIV) in November 2019, meaning “SARS-CoV-2 would have been present at the WIV before the known outbreak of the pandemic”.
The claims give further credence to the lab leak theory and support accusations that China covered up early cases of the outbreak.
The 300-page report, released to Axios, was the full version of a 35-page summary published in October by the Senate Health, Education, Labor and Pensions Committee. It said: “The COVID-19 pandemic was, more likely than not, the result of a research-related incident. It concluded: “The preponderance of information affirms the plausibility of a research-related incident that was likely unintentional resulting from failures of biosafety containment during vaccine-related research.”
The Pregnancy Risks of Ozempic and Wegovy Need More Attention
After neuroscientist Martha Bagnall read a recent New Yorker article about Ozempic — the “buzzy” “celebrity weight loss jab” that’s upending obesity medicine — she emailed a colleague to dish on what she felt were gaps in the discussion about the drug’s effects on the brain. His reply blew her away.
“Another aspect that’s not talked about much,” he wrote to her, “is that Ozempic is not recommended for use during pregnancy.” The colleague, an obesity researcher, was referring to studies in rats, rabbits, and monkeys, which were treated with the injectable drug and had higher rates of miscarriage. Their offspring were also born smaller and had more birth defects than would normally be expected.
The animal studies are the basis for Food and Drug Administration warnings that both Ozempic — approved only for diabetes but used off-label for weight loss — as well as the higher-dose obesity formulation, Wegovy, should be discontinued at least two months prior to pregnancy. The agency has also required the drugmaker, Novo Nordisk, to organize follow-up studies that investigate health outcomes in people exposed to Wegovy during pregnancy.
Bagnall had been following the news about the medicines for months, reading all about their promise for patients and how they were redefining beauty standards, especially for women, but she had not picked up on the pregnancy concerns, not in the media coverage, nor in online drug ads. “Given the prevalence of Ozempic ads with women in them,” she said, “you think that’s a pretty big [potential] side effect to draw attention to.”
The Latest Promising Long COVID Treatment? Psychedelic Drugs
After more than a year of being short of breath, tired, and riddled with heart, motor, cognitive, gastrointestinal and menstrual issues, Ruth was willing to try anything to make her Long COVID go away. So she turned to psychedelic drugs.
Ruth, 31, who asked to be identified by only her first name, had tried psychedelics a few times in the past and was familiar with the research on their therapeutic use. Feeling like she had nothing to lose, she took a five-gram dose of psilocybin, the psychoactive component of magic mushrooms, in December 2021.
That single trip changed her life. She woke up the next morning with a normal heart rate, breathing more freely than she had in a long time. After that, her period stabilized and her brain fog and motor dysfunction cleared. She got her energy back. She still has a few lingering symptoms, and though it’s impossible to say for sure what happened, Ruth credits psilocybin for her renewed health. “That’s probably difficult for a lot of people to process or believe,” she says. “But it really worked.”
Dr. Sue Sisley, who researches psilocybin at Scottsdale Research Institute in Phoenix and also works in a community Long COVID clinic, recently advised lawmakers on a bill working its way through the Arizona state legislature, which would provide up to $30 million to research the therapeutic potential of psilocybin for 13 different conditions, including Long COVID.
Her hunch is that psilocybin may help Long COVID patients by stimulating new neuronal connections and tissue growth in the brain and reducing inflammation throughout the body. The research funding earmarked in the bill could help suss out whether those hypotheses are right.
FDA Approves Tepezza for Wide Use to Treat Thyroid Eye Disease, Amid Reports of Irreversible Hearing Damage
As Horizon Therapeutics faces a growing number of Tepezza lawsuits, alleging that users were not adequately warned about the risk of irreversible hearing damage, the drug maker is pushing for wider use of the infusion treatment for thyroid eye disease (TED).
In a press release issued on April 14, the Tepezza manufacturer announced that the U.S. Food and Drug Administration (FDA) has granted approval for Tepezza to be used by a wider number of individuals.
The expanded FDA Tepezza approval comes as the drug maker already faces criticism for over-promoting the thyroid eye disease treatment, and withholding information from users and the medical community about the risk of long-term hearing loss or tinnitus.
Hundreds of former users are now coming forward to report that they experienced various forms of hearing problems from Tepezza, including persistent ringing in the ears known as tinnitus, and complete hearing loss. In many cases, the problems persist long after the thyroid eye disease treatments, leaving users with irreversible hearing damage.
Nigeria Regulator Grants Approval to Oxford’s Malaria Vaccine
Nigeria has granted provisional approval to Oxford University’s R21 malaria vaccine, its medicines regulator said on Monday, making it the second country to do so after Ghana last week.
The approvals are unusual as they have come before the publication of final-stage trial data for the vaccine.
“A provisional approval of the R21 Malaria Vaccine was recommended and this shall be done in line with the WHO’s Malaria Vaccine Implementation Guideline,” Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) said.
It was unclear when the R21 vaccine may be rolled out in Nigeria or Ghana as other regulatory bodies, including the WHO, are still assessing its safety and effectiveness.
Moderna Shares Fall Despite Promising Data From Cancer Vaccine Trial
Shares of Moderna fell Monday as Wall Street chewed over new trial results on the personalized cancer vaccine it is developing with Merck. Merck’s shares were essentially flat.
The experimental mRNA vaccine, when combined with Merck’s blockbuster drug Keytruda, cut the risk of recurrence of skin cancer melanoma by 44% compared with Keytruda alone, the companies said Sunday in their first detailed presentation of results from a key phase two trial.
Moderna and Merck said they will initiate a phase three trial in 2023 and will “rapidly expand” their research to study the treatment’s effect on additional tumor types, including a major type of lung cancer.
Analysts from SVB Securities said the results suggest the personalized cancer vaccine shows promise. But they also wrote in a Sunday note that the treatment’s path to approval is new and untested, adding that the firm does not believe accelerated approval is an option.
The Top 20 Pharma Companies by 2022 Revenue
For the first time in biopharma history, a company has topped the $100 billion mark in annual revenue. Pfizer passed that milestone, propelled by its massive haul from its COVID-19 products. Its BioNTech-partnered vaccine, Comirnaty, raked in $37.8 billion, and oral antiviral Paxlovid made $18.9 billion.
Subtract the COVID treatments from Pfizer’s top line and its revenue would be $43 billion, which is right in line with the company’s pre-pandemic sales. The Big Pharma’s sales gradually increased from $40.8 billion in 2018 to $41.6 billion in 2020.
With its windfall, Pfizer displaced Johnson & Johnson as the industry’s No. 1 revenue generator. J&J had occupied that position for a decade and had been closing in on the $100 billion mark. Sales for 2021 and 2022 came in at $93.8 billion and $94.9 billion, respectively.
U.S. Supreme Court Rebuffs Novartis Bid to Revive MS Drug Gilenya Patent
The U.S. Supreme Court on Monday declined to hear Novartis Pharmaceuticals Corp’s (NOVN.S) bid to revive a key patent on its blockbuster multiple sclerosis drug Gilenya that was invalidated amid a legal dispute with China’s HEC Pharm Co Ltd (1558.HK).
The justices turned away an appeal by Novartis of a lower court’s decision to cancel the patent, a ruling that paved the way for some generic versions of Gilenya.
Novartis sold $1.1 billion worth of Gilenya in the U.S. last year, a 19% drop from 2021 that was caused in part by generic competition, according to a company report.
