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CDC Recommends RSV Vaccines From Pfizer, GSK for Adults 60 and Older
The Centers for Disease Control and Prevention on Thursday recommended that adults ages 60 and above receive a single dose of RSV vaccines from Pfizer and GSK after consulting their doctors.
Outgoing CDC Director Rochelle Walensky signed off on the recommendation, which an advisory panel of outside experts made last week. That endorsement says seniors should work with their healthcare providers to decide if taking a shot is right for them. The CDC said the shots are expected to be available to the public this fall when respiratory syncytial virus — along with COVID and the flu — typically begins to spread at higher levels.
Walensky’s decision comes a month after the U.S. Food and Drug Administration approved the vaccines, making them the world’s first authorized jabs against RSV.
The panel raised concerns about the lack of efficacy data on subgroups of the elderly population at the highest risk of severe RSV.
Funding Brings First New TB Vaccine in a Century a Step Closer
Two major players in global health philanthropy are joining forces to fund the final stage of trials for what could be the first new vaccine against tuberculosis (TB) in more than 100 years. Wellcome and the Bill & Melinda Gates Foundation will invest around $550 million in total for the Phase III trials of the M72 vaccine.
Earlier this year, Bill Gates lambasted the world for failing to fund new TB tools. His organization will provide the bulk of the financing for the new trial: around $400 million. But the organization is also looking for commercial partners to deliver the vaccine at scale if the trial is successful.
“We need a vaccine manufacturer. That’s what we are in discussions around. We have a couple of partners that are interested,” Trevor Mundel, president of global health at the Gates Foundation, told Reuters.
The trial is set to take 4-6 years, he said, among 26,000 people at more than 50 sites across Africa and Southeast Asia. The vaccine will be tested to see how well it prevents latent TB, which may infect up to a quarter of people worldwide, from becoming active TB and causing illness. The trial will include people with HIV.
Ex-Pfizer Employee Charged With Insider Trading After 2,400% Gain on COVID Drug News
A former Pfizer employee was charged with insider trading by the Securities and Exchange Commission after booking gains of 2,458% by buying out-of-the-money call options one day ahead of the company’s Paxlovid announcement, the SEC alleges.
Former Pfizer statistician Amit Dagar and his close friend and business partner, Atul Bhiwapurkar, were charged in connection with the company’s November 5, 2021 announcement that a randomized, double-blind study of its COVID-19 antiviral treatment, Paxlovid, was successful — which sent the company’s stock up nearly 11%.
The complaint against the pair was filed in U.S. District Court for the Southern District of New York and charges both men with violating the antifraud provisions of Section 10(b) of the Securities Exchange Act of 1934 and Exchange Act Rule 10b-5 thereunder and seeks injunctive relief, disgorgement with prejudgment interest, and civil penalties.
Meanwhile, the U.S. Attorney’s Office for the Southern District of New York announced parallel criminal charges against Dagar and Bhiwapurkar.
Sanofi Says It’s Back to the Drawing Board on mRNA Flu Vaccines
Sanofi (SASY.PA) said that trials show the currently available mRNA technology behind the most successful COVID-19 shots will not be effective against influenza and it is already working on the next generation of shots.
The French drugmaker, one of the world’s largest vaccine makers, said early-stage testing on humans of its experimental influenza shot based on mRNA, or messenger RNA, showed a strong immune response against A strains of the virus but missed the mark on less prevalent B strains.
Both A and B viruses are responsible for seasonal flu epidemics each year and currently available flu shots work against both strains.
Rival Moderna (MRNA.O) in February unveiled similar trial results for a vaccine candidate called mRNA-1010 and said in April a further candidate was not successful in a trial.
Cancer Plaintiffs Drill Down on J&J’s Support for $8.9 Billion Talc Deal
The lead negotiators for Johnson & Johnson‘s proposed $8.9 billion settlement of thousands of talc lawsuits faced intense questioning in U.S. bankruptcy court on Wednesday about how much support the company has for the deal.
During a multi-day court hearing in Trenton, New Jersey, attorneys for plaintiffs alleging that J&J’s baby powder and other talc products sometimes contained asbestos and caused ovarian cancer and mesothelioma drilled down on J&J’s public statements that it has “secured commitments from over 60,000 current claimants” for the settlement and that the “majority” of talc claimants support it.
The deal has divided lawyers representing cancer victims, many of whom claim that J&J has created the illusion of widespread support for a settlement that would deny plaintiffs just compensation.
Missourians Are Drowning in Opioids but Can’t Afford Prescriptions. Rein in Big Pharma
The Kansas City Star reported:
All too often, people with drug problems blame themselves. This is dangerous because they may feel too embarrassed to ask for help. By withdrawing into themselves, they often pull away from friends and family who could help them, and instead suffer alone. Too often, this suffering ends in death.
But they are not solely at fault. Nobody can doubt that drugs are a major problem. Drug overdoses are the leading cause of death among those aged 18 to 44 in Missouri. These people, in the prime of life, are often just one mistake away from death. In 2021, more than 1,500 Missourians died from an opioid overdose, meaning 1 of every 47 deaths in the state was caused by an overdose. But these deaths don’t “just happen.”
People must be able to get opioids before they can use or misuse them. The drugs people are overdosing on include heroin, fentanyl, methadone, morphine and oxycodone, among other prescription and non-prescription pain relievers.
The long chain of prescription drug abuse begins when a company makes the drugs. Then another company distributes the drugs. Only then can the person at the end of the chain take the drugs and become addicted or overdose. One place to break this chain is by forcing Big Pharma — in particular the drug wholesalers, the companies that buy drugs from manufacturers then turn around and sell them to pharmacies — to take responsibility for their irresponsible actions.
Exclusive: Indian Firm Used Toxic Industrial-Grade Ingredient in Syrup
The Indian manufacturer of cough syrups that Uzbekistan said last year had poisoned 19 children used a toxic industrial-grade ingredient rather than the legitimate pharmaceutical version, two sources with knowledge of the matter told Reuters.
The company, Marion Biotech, bought the ingredient — propylene glycol (PG) — from trader Maya Chemtech India, as reported by Reuters. But Maya did not have a license to sell pharmaceutical-grade materials and “dealt in industrial-grade only,” according to a source at the firm with knowledge of the Marion investigation.
“We did not know Marion was going to use it to make cough syrups,” said the person, who declined to be identified while the case is investigated. “We are not told where our material is used.”
The two sources said the syrup was made with industrial-grade PG, a toxic material widely used in liquid detergents, antifreeze, paints or coatings, and to enhance the effectiveness of pesticides.
Beyond Flu Shots: Older Americans to Access More Vaccines Than Ever. Will They Take Them?
Vaccines aren’t just for children anymore. Adults, particularly older ones, are increasingly being encouraged to get vaccines, too.
In addition to the annual flu shot taken by about two-thirds of older Americans every fall and winter, older adults are now encouraged to get a vaccine against the pneumococcus bacteria and a two-dose regimen against shingles.
COVID-19 boosters are considered particularly important for those in higher decades. Moderna and Pfizer-BioNTech are studying the possibility of combining their COVID-19 vaccines with flu and possibly RSV so people would need one shot instead of three.
Pfizer-OPKO’s Growth Hormone Drug Gets U.S. Approval in Kids
The U.S. Food and Drug Administration has approved Pfizer Inc (PFE.N)and partner OPKO Health Inc’s (OPK.O) treatment for growth hormone deficiency in children, the companies said on Wednesday.
The approval, which comes after an initial rejection from the FDA in January last year, lifted Pfizer’s shares marginally and Opko Health’s nearly 19% in premarket trading.
The injectable hormone therapy, to be sold under the brand name Ngenla, was approved for the treatment of pediatric patients aged three years and older.
First AI-Generated Drug Enters Human Clinical Trials, Targeting Chronic Lung Disease Patients
The first-ever drug generated by artificial intelligence has entered Phase 2 clinical trials, with the first dose successfully administered to a human, Insilico Medicine announced yesterday.
The drug, currently referred to as INS018_055, is being tested to treat idiopathic pulmonary fibrosis (IPF), a rare, progressive type of chronic lung disease. The 12-week trial will include participants diagnosed with IPF.
“AI allows us to analyze massive quantities of data and find connections that human scientists might miss, and then ‘imagine’ entirely new molecules that can be turned into drugs,” said Insilico Medicine’s CEO Alex Zhavoronkov, Ph.D., in a statement to Fox News Digital.
Crime Briefs: Andover-Based Mail-Order Pharmacy Has to Pay $10 Million for Opioid Prescription Problems
It may not be a household name, but the feds say that Injured Workers Pharmacy is the largest purchaser of opioids among retail pharmacies in the U.S. — and that they’re on a $10 million hook for distributing the drugs regardless of obvious “red flags.”
“Last week brought disturbing reports that opioid overdose deaths only increased last year in Massachusetts. Pharmacies are on the front lines of the prescription pill and opioid epidemic devastating our communities,” said Acting U.S. Attorney Joshua Levy. “Pharmacies that distribute dangerous prescription pills have a solemn responsibility to comply with measures enacted to curb abuse and addiction.”
Federal prosecutors reached an agreement with the Andover-based mail-order pharmacy that makes the company admit that between 2014 and 2019 it ignored “red flags” that its clients displayed that indicated their opioid prescriptions may not have been issued legitimately. Those indications include high doses, early refills and dangerous prescription drugs medleys doctors would be unlikely to legitimately prescribe together, according to the agreement.
