FDA Approvals, Surges, and Struggles: Health News Roundup

Recent health news includes FDA expanding GSK's RSV vaccine to adults 50-59, Geron's stock surge after blood disorder drug approval, Pfizer's Paxlovid failing as a long COVID treatment, a deadly bird flu virus strain in ferrets, and insights on Eli Lilly's Alzheimer's drug safety. Additionally, Kroger revamps weight management programs and AbbVie's hold on Humira raises biosimilar market concerns.


Reuters | Updated: 08-06-2024 18:28 IST | Created: 08-06-2024 18:28 IST
FDA Approvals, Surges, and Struggles: Health News Roundup
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Following is a summary of current health news briefs.

US FDA expands GSK's RSV vaccine approval to adults aged 50 to 59

The U.S. Food and Drug Administration approved the expanded use of GSK's respiratory syncytial virus (RSV) vaccine on Friday in adults aged between 50 and 59, making it the first shot endorsed for that age group. The shot, branded Arexvy, and vaccines from rivals Pfizer and Moderna are already approved for people aged 60 and older for the virus.

Geron surges after winning first US FDA approval for blood disorder drug

Shares of Geron surged more than 20% on Friday, a day after the company gained its first approval from the U.S. Food and Drug Administration for its blood disorder drug. The health regulator's nod allows the injectable drug, branded as Rytelo, to be used for treating transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS), a group of blood cancers.

Pfizer's Paxlovid fails as 15-day treatment for long COVID, study finds

A 15-day course of Pfizer's COVID-19 antiviral treatment Paxlovid did not relieve symptoms of long COVID, according a study by Stanford University researchers. Currently, there are no proven treatments specifically for long COVID in which a host of symptoms can last for many months after initial coronavirus infection.

Texas bird flu strain kills ferrets used to mimic disease in humans, US CDC says

The bird flu virus strain that infected a Texas dairy farm worker in March was lethal to ferrets in experiments designed to mimic the disease in humans, the U.S. Centers for Disease Control and Prevention (CDC) reported on Friday. Seasonal flu, by contrast, makes ferrets sick but does not kill them, the CDC said.

US FDA staff raise no major concerns about Eli Lilly Alzheimer's drug

An FDA analysis of trial data for Eli Lilly's experimental Alzheimer's drug donanemab released on Thursday revealed no red flags, but raised questions about safety of the treatment for patients with early-stage disease. The drug is a potential rival to Eisai and Biogen's Leqembi, which won approval last July.

Kroger Health revamps weight management program to include GLP-1 drugs

Kroger Health, the arm of grocer Kroger that runs pharmacies and clinics across the U.S., said on Friday it had revamped its weight management program to allow patients to explore medical treatments, including access to GLP-1s such as Wegovy, Zepbound and others. Kroger joins retail peer Costco Wholesale in offering access to the vastly popular GLP-1 agonists, a class of highly effective diabetes and obesity drugs.

US to research possible respiratory spread of bird flu in cows

U.S. federal and state agencies are planning research into potential respiratory spread of bird flu among dairy cattle, according to a Reuters interview with Michigan state agriculture and public health officials. Scientists and government officials hope the research will guide efforts to contain the virus and reduce exposure to humans. Respiratory spread could give the virus more opportunity to evolve, they said.

Novo Nordisk braces for generic challenge to Ozempic, Wegovy in China

Novo Nordisk is facing the prospect of intensifying competition in the promising Chinese market where drugmakers are developing at least 15 generic versions of its diabetes drug Ozempic and weight loss treatment Wegovy, clinical trial records showed. The Danish drugmaker has high hopes that demand for its blockbuster drugs will surge in China, which is estimated to have the world's highest number of people who are overweight or obese.

WHO says bird flu case in Australia followed travel to Kolkata, India

The World Health Organization on Friday said the child with H5N1 bird flu reported by Australia last month had traveled to Kolkata, India, and the family said they did not have any known exposure to infected people or animals while there. The WHO said on Friday that the child, Australia's first case of H5N1 in a person, had traveled to Kolkata from Feb. 12 to Feb. 19 and returned to Australia on March 1.

AbbVie's tight grip on Humira market raises concerns about biosimilars

AbbVie's top-selling arthritis drug Humira has held onto more than 80% of patients after facing nine lower-priced rivals in the U.S. in the last year, raising questions about whether the market for prescription biosimilars can survive in its current form, drug pricing experts and analysts say. Humira, which lists for almost $7,000 a month, is the first top-selling drug to compete with a slew of biosimilars, which are close but not exact copies of branded biologic medicines.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)

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