Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
Antibody for Infant RSV Prevention to Face FDA Panel — Nirsevimab Shot Also a Possibility for Some at-Risk Toddlers
An FDA advisory committee on Thursday will consider whether to recommend a shot of a monoclonal antibody against respiratory syncytial virus (RSV) to prevent lower respiratory tract disease in both infants and in at-risk children up to age 2 years.
The Antimicrobial Drugs Advisory Committee will examine a biologics license application approval for nirsevimab, a long-acting RSV fusion protein inhibitor monoclonal antibody that’s delivered via intramuscular injection. Nirsevimab’s developer is AstraZeneca.
Its proposed indication will be prevention of lower respiratory tract disease due to RSV in neonates and infants born during or entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.
Novavax Partners With Gates Foundation Offshoot in Efforts to Develop Malaria and TB Shots
American vaccine maker Novavax on Monday announced plans to share its powerful vaccine technology with the Bill & Melinda Gates Medical Research Institute, a nonprofit biotech spun out from the Bill & Melinda Gates Foundation five years ago, which could help develop shots for major health threats like malaria, tuberculosis and Shigella.
Novavax said it had signed a three-year deal to share its vaccine adjuvant, Matrix-M, with Gates MRI for the organization to use in preclinical research.
Novavax’s Matrix-M, derived from the bark of the Chilean soapbark tree, is one of only a handful of adjuvants licensed for human use and is already a key part of the company’s COVID-19 vaccine, the fourth to reach the U.S. market, as well as a highly-anticipated malaria vaccine approved in Ghana.
Merck Sues U.S. Government to Halt Medicare Drug Price Negotiation
Merck said it sued the U.S. government on Tuesday, seeking an injunction of the drug price negotiation program contained in the Inflation Reduction Act, which it argues violates the Fifth and First Amendments to the U.S. Constitution.
The lawsuit, expected to be filed in the U.S. District Court for the District of Columbia, argues that under the law, drugmakers would be forced to negotiate prices for drugs in the government’s Medicare health insurance program at below-market rates.
The pharmaceutical industry says the law, passed last year, will result in a loss of profits that will force them to pull back on developing groundbreaking new treatments.
After the government released its roadmap for price negotiations in March, industry lobbyists and lawyers told Reuters that drugmakers were likely to file lawsuits arguing that the government is not complying with the U.S. Constitution.
Moderna, Pfizer Hit With New Patent Lawsuits Over COVID Vaccines
Biotech firm Promosome LLC sued Moderna (MRNA.O), Pfizer (PFE.N) and BioNTech (22UAy.DE), in federal court in San Diego, California, on Tuesday, accusing their COVID-19 vaccines of infringing a patent related to messenger RNA technology.
The lawsuits add to a web of patent disputes between biotech companies over technology used in the coronavirus shots, including a case brought last year in Massachusetts by Moderna against Pfizer and its partner BioNTech.
Promosome accused the companies of copying technology that allows for doses of mRNA that are small enough to use safely and effectively in the vaccines.
Promosome asked the court for a share of royalties from the shots. Pfizer earned $37.8 billion from sales of its COVID-19 vaccine Comirnaty last year, while Moderna made $18.4 billion from its vaccine Spikevax.
After Missing Vaccine Glory in Pandemic, GSK Looks to Dominate Other Diseases
GSK has been developing vaccines under one corporate guise or another for 140 years, ever since a rural Pennsylvania doctor started pumping smallpox shots out of a converted chicken house in 1882, but the company may be most known today for the vaccine it didn’t build.
The British pharma elected not to develop its own COVID shot. It missed out on the fame and fortune and Pfizer-hyping TikToks that came with curbing a once-in-a-century pandemic. In the process, it also faced its own internal dissension and an exodus of top talent.
It’s Phil Dormitzer’s job to change that. A key figure in Pfizer’s COVID vaccine effort, Dormitzer jumped to GSK in December 2021 to be global head of R&D for a division that developed more than 20 licensed vaccines but seemed to be slipping behind new competitors with newer technologies.
Oral Estrogen-Only Use Riskier Than Patch or Vaginal Cream for Menopausal Women, Study Says
People who use estrogen-only pills during menopause were more likely to be diagnosed with high blood pressure than those using patches or creams, a new study found. However, doctors who treat menopause say estrogen-only pills are rarely prescribed for high-risk patients, and the overall benefits of hormone replacement therapy far outweigh the risks for many patients.
People taking estrogen-only pills during menopause were 14% more likely to be diagnosed with high blood pressure than those using estrogen-only patches, the study found. When compared to people using estrogen-only vaginal creams or suppositories, those taking the hormone orally were 19% more likely to be diagnosed with hypertension.
“This is the biggest study that’s only looked at women who are only taking estrogen and have never taken a progestin as HRT,” said senior study author Dr. Sofia Ahmed, a professor at the Cumming School of Medicine at the University of Calgary, Canada.
When taken as a pill, estrogen is predominately metabolized in the liver, where the hormone is turned inactive and then passes from the body via urine and feces. When applied as a patch on the skin, estrogen enters the bloodstream and bypasses the liver, while vaginal creams and suppositories are absorbed locally.
EU Approves Its First Vaccine for Common Respiratory Virus RSV
European regulators have approved the region’s first vaccine for respiratory syncytial virus (RSV), which causes thousands of hospitalizations and deaths annually.
The shot, called Arexvy, is made by British drugmaker GSK (GSK.L) and is designed to protect people aged 60 and over.
The approval on Wednesday by the European Commission, which follows a recent endorsement from the European Medicines Agency, comes about a month after the U.S. health regulator gave Arexvy the green light.
Australia Signs Deal With U.S. to Accelerate Vaccine Development
Queensland is hoping to create home-grown vaccines and become a major international vaccine hub after a partnership was announced at an international biotech conference in the U.S. on June 7.
The partnership between the University of Queensland (UQ) and Emory University in Atlanta would make Queensland a center for the Asia Pacific region, and a significant player in the burgeoning global biomedical industry, UQ’s Vice-Chancellor Professor Deborah Terry said at the conference.
The collaboration builds on over a decade of working together in drug discovery of UQ, Emory University, and Queensland Institute of Medical Research Berghofer (QIMR Berghofer), in an association known as the Queensland Emory Development Alliance. The Alliance was renewed today in Boston for a further 10 years.
