Reuters Health News Summary
The deal is in line with Novo's aim to expand its focus on diabetes and weight-loss therapies to include cardiovascular disease treatments. Novo ready to seek German insurance coverage of Wegovy for heart use Novo Nordisk said it plans to seek coverage by Germany's public health insurance scheme for the use of its Wegovy drug to cut the risk of strokes and heart attacks, if the drug's extended indication wins European approval.
Following is a summary of current health news briefs.
Regeneron's blood cancer therapy faces setback as FDA raises trial concerns
Regeneron Pharmaceuticals said on Monday the U.S. FDA has declined approval for its blood cancer therapy for two forms of lymphoma on concerns over the progress of ongoing confirmatory trials. The FDA said in its response letter that it needs more data from enrollments in dose-finding and confirmatory portions of trials, delaying its decision on the drug, while confirming no issues with clinical efficacy or safety, trial design, labeling or manufacturing.
BioNTech gets US agency notice over default on COVID vaccine royalties
BioNTech said on Monday the U.S. National Institutes of Health has sent a notice to the German company regarding default on the payment of royalties and other amounts related to its COVID-19 vaccine. BioNTech, which partnered with U.S. pharma giant Pfizer for its COVID-19 vaccine, however, said it disagreed with the positions being taken by the NIH and intends to defend against all allegations of breach.
South Korea's medical professors join protests, reduce hours in practice
Medical professors in South Korea said they will cut back on the hours they spend in practice starting on Monday to support trainee doctors on strike for more than a month over a government plan to boost medical school admissions. "It is clear that increasing medical school admissions will not only ruin medical school education but cause our country's healthcare system to collapse," Kim Chang-soo, the president of the Medical Professors Association of Korea, told reporters.
Novo Nordisk strikes deal worth up to $1.1 billion to expand cardio business
Denmark's Novo Nordisk said on Monday it had agreed to buy Cardior Pharmaceuticals for up to 1.03 billion euros ($1.1 billion) to strengthen its cardiovascular pipeline. The deal is in line with Novo's aim to expand its focus on diabetes and weight-loss therapies to include cardiovascular disease treatments.
Novo ready to seek German insurance coverage of Wegovy for heart use
Novo Nordisk said it plans to seek coverage by Germany's public health insurance scheme for the use of its Wegovy drug to cut the risk of strokes and heart attacks, if the drug's extended indication wins European approval. German health agency G-BA said in guidance documents last week that regulation banning Germany's health system from paying for weight-loss drugs such as Wegovy would not apply in the case of other approved uses of the weekly injection, a boost for Novo Nordisk's efforts to convince governments of its wider medical benefits.
AbbVie to bolster immunity illness drug pipeline with Landos deal
AbbVie will buy drug developer Landos Biopharma for up to $212 million as the Humira-maker aims to expand its pipeline of medicines to treat immune system-related illnesses, the companies said on Monday. Landos is currently conducting a mid-stage study of its lead experimental drug NX-13 in a type of an inflammatory bowel disease called ulcerative colitis.
FDA proposes to ban certain shock devices for the second time
The U.S. Food and Drug Administration said on Monday it has proposed a ban of electrical stimulation devices intended to reduce or stop self-injurious or aggressive behavior. The health regulator said these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.
US Supreme Court abortion pill fight brings claims of distorted science
The abortion opponents who are seeking to convince the U.S. Supreme Court to limit access to the abortion pill mifepristone point to three studies by Gynuity Health Projects, a New York-based women's health research group, to back up their arguments that it is unsafe despite its regulatory approval decades ago. But the way the research has been prominently cited by the plaintiffs in their bid to limit how the pill is prescribed and distributed is bewildering to Dr. Beverly Winikoff, Gynuity's president, given that the conclusions broadly support easier access to the medication.
US detects avian flu in milk, says dairy supplies are safe
Samples of milk collected from sick cattle in Kansas and Texas tested positive for avian flu, but the nation's milk supply is safe, the U.S. Department of Agriculture said on Monday. The detections in milk and a dairy cow show the wide reach of the virus, known as bird flu, which has been found in poultry flocks and mammals around the world.
Axsome's sleep disorder drug succeeds in late-stage trial, shares rise
Axsome Therapeutics said on Monday its experimental therapy cut the frequency of disruptive episodes of muscle weakness tied to a sleep disorder called narcolepsy in a late-stage trial. The New York-based company is looking to expand its reach in the market for treatments against the chronic neurological disorder that causes excessive daytime sleepiness and inadvertent naps.
(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)
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