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New Drug to Protect Babies and Toddlers From RSV Gets FDA Approval Ahead of Cold Season
U.S. officials on Monday approved the first long-acting drug to protect babies and toddlers against a respiratory virus that sends tens of thousands of American children to the hospital each year.
The Food and Drug Administration approved the injection for infants and children up to 2 years old who face an increased risk of severe RSV.
AstraZeneca’s drug, to be sold under the brand name Beyfortus, is a laboratory-made version of an antibody that helps the immune system fight off RSV. Under the FDA approval, babies — including preterm infants — can receive a single injection to protect against their first season of RSV, which typically lasts about five months. Children up to age 2 can receive another dose to protect them during their second season facing the virus.
Beyfortus, which will be marketed in the U.S. by Sanofi, is already approved in Canada, Europe and the U.K. Sanofi did not immediately announce the U.S. price of the treatment.
Biden’s NIH Nominee Too Close to Pharmaceutical Industry: Watchdog
In a new report, the American Accountability Foundation, a right-leaning watchdog group, highlights National Institutes of Health nominee Dr. Monica Bertagnolli’s history with the industry.
It found that her associated research garnered more than $350 million in funding from pharmaceutical companies and that she opposed a key Trump administration policy meant to rein in drug prices.
“Our government’s medical institutions must serve the interests of the American people, not Big Pharma,” AAF told The Post in a statement. “However, Dr. Bertagnolli’s extensive financial ties to pharmaceutical companies raise serious questions about her ability to lead NIH in a manner that is not beholden to special or secret interests.”
AAF evaluated disclosure data to conclude that research associated with Bertagnolli received more than $350 million throughout her career. In 2022, for instance, her associated research accrued roughly $59 million from companies like Pfizer and AstraZeneca Pharmaceuticals, per OpenDataCMS.
Apellis Shares Sink on Reports of Rare Side Effects With New Vision Loss Drug
Apellis Pharmaceuticals’ shares lost one-fifth of their value Monday after a major medical organization flagged rare, but potentially severe, side effects among patients using the company’s new drug for a common type of vision loss.
In a letter issued to doctors over the weekend, a safety committee advising the American Society of Retinal Specialists said physicians have reported cases of eye inflammation in patients treated with the drug, called Syfovre and approved in February for geographic atrophy. The cases included six instances of occlusive retinal vasculitis, a potentially blinding type of inflammation that blocks blood flow through the vessels that feed the retina.
According to the letter, the side effects occurred one to two weeks after a patient’s first injection with Syfovre, which is given every 25 to 60 days. The organization said the events weren’t related to any specific batch of products, and added that their cause remains unclear. It urged “vigilance and reporting of any adverse treatment-related events,” as well as “close follow up” after the administration of Syfovre.
Australia Ceases Reporting Cases of Myocarditis Post-COVID Vaccination
Australia’s therapeutic goods administration (TGA) has announced that reports on myocarditis and pericarditis cases following mRNA-based COVID-19 vaccines by Pfizer and Moderna are not necessary anymore and will no longer be provided.
Australia’s national drug authority says this is because the rates have stabilized. However, the TGA will “continue to monitor and review these adverse effects and will communicate any updated safety advice if needed,” they said in a statement.
Both myocarditis (inflammation of the heart) and pericarditis (inflammation of the membrane around the heart) are considered side effects of mRNA vaccines manufactured by Pfizer and Moderna, according to the Food and Drug Administration.
In Australia, the total number of pericarditis cases resulting from a COVID-19 vaccine is 3,823, with six resulting in death, based on the administration’s Database of Adverse Event Notifications (DAEN) as of July 17. There have been 1,330 cases of myocarditis to date, with 17 resulting in death.
Drugs Like Ozempic Created a Gold Rush. These Drugmakers Want In.
The Wall Street Journal reported:
The sudden popularity of drugs like Ozempic and Wegovy for weight loss created a multibillion-dollar market overnight. Healthcare companies want a piece of it.
The weight-loss space is quickly maturing into a booming pharmaceutical segment like those for cancer and heart disease. Investors are making bets on the next breakthrough product and drugmakers are racing to test dozens of new therapies. Companies are developing diagnostic tests that could better match patients to drugs best suited for them.
For years, the weight-loss market was stagnant with products that were ineffective or carried irksome side effects. New therapies like Mounjaro from Eli Lilly and Ozempic and Wegovy, both from Novo Nordisk, changed that — and catapulted their manufacturers to the top of the industry. Now weight-loss drugs could become a top-12 global therapy valued at $54 billion by 2030, up from $2.4 billion last year, according to Morgan Stanley.
On Friday, Lilly said it agreed to acquire closely held Versanis Bio for up to $2 billion. Versanis’ lead drug candidate is an obesity pill that is designed to work differently than Mounjaro. The drug is designed to block fat accumulation, prompting the body to build muscle and burn fat instead.
How One U.S. Drugmaker Contributed to the Escalating Drug Shortage Crisis
When Akorn Pharmaceuticals shut its doors in February, hospitals across the country felt it.
The Lake Forest, Illinois-based drugmaker was responsible for producing 75 generic drugs, all of which were pulled from the market when the company closed down. In some cases, the company was the sole supplier of particular products.
The closure comes amid — and contributed to — an ongoing drug shortage crisis in the U.S. Akorn’s bankruptcy and subsequent shuttering are part of a bigger disaster caused by fewer manufacturers in the U.S. making cheaper generic drugs, scarce profits for the remaining companies and an overly complicated global supply chain that could leave patients scrambling for lifesaving medications for months or possibly years to come.
Roche Sues Biogen Over Biosimilar of Blockbuster Arthritis Drug
Roche (ROG.S) and two of its subsidiaries sued biotech company Biogen (BIIB.O) in Massachusetts federal court on Thursday, accusing its proposed similar version of Roche’s blockbuster rheumatoid arthritis drug Actemra of infringing several of their patents.
Roche, Genentech and Chugai Pharmaceutical told the court that Biogen’s biosimilar would infringe patents related to making and using their biologic drug.
The U.S. Food and Drug Administration approved Actemra in 2010 to treat rheumatoid arthritis and has since approved it for other uses including to treat hospitalized COVID-19 patients.
Switzerland-based Roche reported that it earned more than 2.7 billion Swiss francs — over $3.1 billion based on current exchange rates — from Actemra sales worldwide last year, down 22% from 2021 based on decreased demand for the drug as a COVID-19 treatment.
