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EU Regulators Back Authorization of First RSV Vaccine for Infants
The European Medicines Agency (EMA) recommended authorization on Friday of a vaccine for infants against Respiratory Syncytial Virus, or RSV, which is a leading cause of pediatric hospitalization in Europe.
If authorized by the European Commission, Abrysvo would be the first RSV vaccine that can be administered to infants from birth to six months of age after the mother is vaccinated during pregnancy.
Abrysvo was developed by the U.S. pharmaceutical company Pfizer. The vaccine was approved last month by U.S. regulators for older adults.
Last month, the European Commission approved a different RSV vaccine developed by GSK as its first for older adults.
U.S. FDA Approves Emergent BioSolutions’ Anthrax Vaccine
Emergent BioSolutions (EBS.N) said on Thursday the U.S. Food and Drug Administration has approved its anthrax vaccine for use in adults aged 18 through 65.
The vaccine, Cyfendus, has been approved for use following suspected or confirmed exposure to a type of bacteria and has to be administered together with antibacterial drugs.
Anthrax is a potentially deadly infectious disease caused by exposure to the bacterium Bacillus anthracis. The bacteria most commonly affect hoofed animals such as goats, but people who come in contact with the spores can also become infected.
Emergent has been delivering Cyfendus to the U.S. Department of Health and Human Services since 2019, under pre-emergency use authorization status, and will continue to work with the U.S. government to transition to post-approval procurement, the company said.
Punitive Damages Over Similac NEC Risks Cleared to Move Forward in Lawsuit Against Abbott
A federal judge has ruled that a Maryland mother will be allowed to seek punitive damages from Abbott Laboratories, in a lawsuit filed over the infant formula manufacturer’s failure to adequately warn the medical community about the risk of necrotizing enterocolitis (NEC) from Similac, which left her child with devastating, life-long injuries.
A complaint filed by Keosha Diggs is just one of a growing number of baby formula NEC lawsuits being pursued against the makers of Similac and Enfamil, each raising similar allegations that information was concealed for decades about the risks premature infants face from the cow’s milk-based infant formula.
According to allegations raised by Diggs and other parents pursuing a Similac lawsuit and Enfamil lawsuit, Abbott Laboratories and Mead Johnson placed a desire for profits before the health and safety of newborns by not only failing to adequately warn about the NEC risks but specifically marketing versions of their formula for use by vulnerable preemies instead of human breast milk.
Texas City Reports Syphilis Outbreak Amid ‘Limited Supply’ of Penicillin Drug
As syphilis cases continue to spike across the U.S. — with some cities and states recently reporting outbreaks — there is a growing concern about the availability of Bicillin, the injectable penicillin that is used to treat the sexually transmitted infection in adults and kids.
The city of Houston officially declared a syphilis outbreak on July 13. It cited a 128% increase in cases among women and a nine-fold rise in congenital syphilis in Houston and Harris County, according to an announcement from the Houston Health Department.
Last month, the Food and Drug Administration (FDA) announced that it expects a “limited supply and impending stock out situation” for select Bicillin medications.
Pfizer is the only pharmaceutical company that makes Bicillin, producing the drug in its Rochester, Michigan, facility. A Pfizer spokesperson told Fox News Digital said the drug is “definitely taxed” and in “constrained supply,” but denied that there is an official shortage.
Tornado Damage to Pfizer Plant Will Probably Create Long-Term Shortages of Some Drugs Hospitals Need
The fallout from a Pfizer factory being damaged by a tornado could put even more pressure on already-strained drug supplies at U.S. hospitals, experts say.
Wednesday’s tornado touched down near Rocky Mount, North Carolina, and ripped up the roof of a Pfizer factory that makes nearly 25% of Pfizer’s sterile injectable medicines used in U.S. hospitals, according to the drugmaker.
The North Carolina plant produces drugs that are injected or through an IV. The plant makes drugs for anesthesia, medicines that treat infections and drugs needed for surgeries. The latter are used in surgeries or intensive care units for patients who are placed on ventilators, said Mike Ganio, who studies drug shortages at the American Society of Health-System Pharmacists.
It will likely lead to some long-term shortages while Pfizer shifts production to other locations or rebuilds, said Erin Fox, senior pharmacy director at the University of Utah Health.
Bernie Sanders Wants to Replace Drug Patents With Prizes for Breakthrough Medicines
Sen. Bernie Sanders (I-Vt.) will finally get a study of his proposal to do away with drug patents and other intellectual property protections in favor of rewarding inventions with prize money. Sanders has been pushing the prize approach since he was a House representative, many years ago.
The measure directing the National Academies of Sciences, Engineering and Medicine to study the idea was added to the Pandemic All-Hazards and Preparedness Act a day before Sanders’ health committee passed the bill. Three Republicans voted against the overall bill, which renews several federal biodefense and pandemic-preparedness programs.
Though Democrats last year passed historic legislation to let Medicare negotiate drug prices and cap seniors’ annual out-of-pocket drug costs, Sanders is demanding more drug price controls. He is delaying President Biden’s pick for running the National Institutes of Health until the president releases a plan to control drug prices.
Novo Nordisk, Eli Lilly and Boehringer Ingelheim Back Bill to Bring Obesity Drug Coverage to Medicare
Despite the widespread hype surrounding new and powerful obesity medicines, the drugs are still out of reach for many Americans who could benefit.
One reason is that under current laws, Medicare is barred from covering obesity drugs. But under legislation backed by Novo Nordisk, Eli Lilly, Boehringer Ingelheim and many other organizations, a group of lawmakers aims to change that.
As the lawmakers note, many common conditions such as heart disease and diabetes are associated with obesity. They say the bill would “work to directly prevent these comorbidities through expanded coverage of new healthcare specialists and chronic weight management medications for Medicare recipients.”
Eli Lilly, Novo Nordisk and Boehringer Ingelheim have also endorsed the legislation, according to the lawmakers’ release.
