Health News Roundup: US FDA approves Pharming's immune disorder drug; GSK loses bid to keep experts out of upcoming Zantac trial and more
Following is a summary of current health news briefs.
Bayer's pharma chief hopes EU takes time to improve drug rules reform
The European Union's decision to postpone rule changes for the pharmaceutical industry could open the way for a rethink of a decision to cut intellectual drug property protection, the head of Bayer's pharmaceuticals division said. The European Commission said this week that the publication of a first draft of a planned revision of drug legislation in the bloc would be "slightly later" than March 29, as initially planned.
US FDA proposes higher bar for accelerated approvals for cancer drugs
The U.S. health regulator on Friday proposed cancer drug developers in most cases conduct more rigorous trials to seek accelerated approval for their candidates. The Food and Drug Administration's proposed recommendation follows criticism for the accelerated approval pathway, as well as an independent federal review into it after the controversial nod for Biogen Inc's Alzheimer's treatment Aduhelm.
US FDA approves Pharming's immune disorder drug
The U.S. Food and Drug Administration (FDA) on Friday approved Pharming Group's drug to treat a rare genetic disorder that leads to a weakened immune system, the Dutch company said. Leniolisib, to be sold under the brand name Joenja, becomes the first approved drug in the United States to treat activated phosphoinositide 3-kinase delta syndrome (APDS), a primary immunodeficiency that affects about 1 to 2 people in a million.
GSK loses bid to keep experts out of upcoming Zantac trial
A California judge on Thursday denied GSK Plc's bid to keep expert testimony linking its discontinued heartburn drug Zantac to cancer out of an upcoming trial, a setback for the British drugmaker facing lawsuits over the medicine in courts across the United States. GSK shares were down 3.6% on Friday.
Bayer says drug research focus no longer on women's health
Bayer said the focus of its drug research would shift away from women's health, a traditional pillar of Germany's largest drugmaker, to hone in on neurology, rare diseases and immunology. "When it comes to research and the subsequent clinical phases, we will no longer have an explicit focus on women's health," the head of Bayer's pharmaceuticals unit, Stefan Oelrich, told Reuters on Friday.Bayer, the maker of the Yasmin brand of birth-control pills and the Mirena intrauterine device, added it would nevertheless continue to pursue the development of non-hormonal menopausal symptoms relief elinzanetant as one of its four most promising pharma products.
Sanofi, Regeneron unveil 'blow-out' smoker's lung drug data
Sanofi's asthma drug Dupixent met all targets in a trial to treat "smoker's lung", potentially adding billions to the French drugmaker's growth prospects, but also underscoring a heavy reliance on its bestseller. In a late stage trial Dupixent, jointly developed with Regeneron, led to a 30% reduction in moderate or severe acute exacerbations of chronic obstructive pulmonary disease (COPD), a potentially deadly disease marked by progressive lung function decline.
US FDA seeks to allow salt substitutes in everyday foods
The U.S. Food and Drug Administration (FDA) on Friday said it was proposing a rule to allow the use of salt substitutes in everyday foods including cheese, frozen peas and canned tuna, in a bid to cut Americans' salt consumption. The FDA had in 2021 set a new voluntary goal for manufacturers and chain restaurants to cut salt levels by an average of 12% in packaged foods, because excessive salt consumption has been linked to high blood pressure, a leading cause of heart attack and stroke.
Moderna signs licensing deal with Generation Bio in push beyond COVID
Moderna Inc has entered a licensing deal with Generation Bio Co to develop treatments targeting the immune system and liver, the latest such transaction by the vaccine maker as it expands beyond its COVID shots. Generation Bio's shares rose about 13.14% to $4.40 in premarket trading on Thursday.
COVID pandemic erased gains in early autism identification -US report
U.S. gains in the early identification of children with autism, considered critical in enabling them to reach their full potential, were largely wiped out by disruptions in evaluations in the early months of the COVID-19 pandemic, U.S. health officials reported on Thursday. Such disruptions in connecting children to the services they need "could have long-lasting effects,” Dr. Karen Remley, director of U.S. Centers for Disease Control and Prevention's (CDC) National Center on Birth Defects and Developmental Disabilities, said in a statement.
Analysis-In US abortion pill case, FDA could soften blow of court-ordered restrictions
A conservative federal judge in Texas could soon order the U.S. Food and Drug Administration to reconsider its 22-year-old approval for a pill used in the most common form of abortion in the United States, or order the approval revoked outright. Of the various potential rulings possible in the case involving the abortion pill mifepristone, either of those outcomes would be unprecedented judicial intervention in the agency's regulatory process.
(With inputs from agencies.)