Bayer Shifts Drug Research Away From Women’s Health

Reuters: 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. (Burger and Weiss, 3/24)

Fierce Biotech: Bayer, With New Leadership Stepping In, Deprioritizes Women's Health R&D
The company said in a statement that it would focus instead on four core therapeutic areas: oncology, cardiovascular, neurology and rare diseases/immunology. The news was first reported by Reuters. ... The decision comes as investments in women-specific health care have failed to garner much attention from the biopharma industry. A report from McKinsey found that only 1% of R&D investments outside oncology in 2020 were for female-specific conditions. Clinical stage investments in female-specific cancers sat at 4%. (Bayer, 3/24)

In updates from the FDA —

Reuters: 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. (3/24)

Reuters: 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. (Esunny and Mandowara, 3/24)

In other pharmaceutical news —

The Washington Post: Their Child’s Obesity Drug Was Working. Then Their Plan Refused To Pay
Debra Tyler’s younger daughter was always on the larger side. She was only 5 when doctors noticed her lipids were elevated, 8 when they put her on cholesterol-busting drugs, and 11 when she faced the danger of liver failure — a condition typically seen in those decades older. “We tried everything. Nothing helped her,” said Tyler, who lives in Killingworth, Conn. Not a diet and exercise program. Not countless hours of counseling. It was then that doctors turned to Ozempic, a Novo Nordisk medication that is part of a new generation of diabetes and weight-loss drugs, and it worked almost overnight. (Cha, 3/26)

Fox News: Why Antibiotics May Not Help Patients Survive Their Viral Infections: New Research
Most patients who are admitted to hospitals with acute viral infections are given antibiotics by their doctors or health care providers as a precaution against bacterial co-infection. Yet new research suggests this practice may not improve their survival rates. Researchers investigated the impact of antibiotic use on survival in more than 2,100 patients in a hospital in Norway between the years 2017 and 2021, Reuters reported. (Mackey, 3/26)

The Baltimore Sun: Johns Hopkins Study Highlights Promise Of IV Mistletoe Extract For Cancer Therapy
Ivelisse Page already had 15 inches of her colon and 28 lymph nodes removed to treat her colon cancer, but in the winter of 2008 she received more devastating news. The cancer had spread to her liver. Page’s doctor, Dr. Luis Diaz – an oncologist at the Memorial Sloan Kettering Cancer Center in New York and professor at the Johns Hopkins University School of Medicine — gave her an 8% chance of living for more than two years. (Roberts, 3/24)

KHN: Journalists Delve Into Insulin Costs And Prior Authorization Policy 
KHN senior correspondent Angela Hart discussed California’s contract with Civica to make lower-cost insulin on KQED’s “Forum” on March 23. She also discussed California’s potential plan to use Medicaid funding to cover up to six months of rent for low-income enrollees on KCBS’ “State of California” on March 22. (3/25)