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Morning Briefing

Summaries of health policy coverage from major news organizations

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Monday, Mar 27 2023

Full Issue

Bayer Shifts Drug Research Away From Women's Health

Reuters reports women's health has been a "traditional pillar" of the drugmaker, Germany's largest, but now in statement it says it will focus on oncology, cardiovascular, neurology, and rare diseases. Also: the FDA's approval process for cancer drugs, insulin costs and more.

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)

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%.聽(Bayer, 3/24)

In updates from the FDA 鈥

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)

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 鈥

Debra Tyler鈥檚 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 鈥 a condition typically seen in those decades older. 鈥淲e tried everything. Nothing helped her,鈥 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)

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.聽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.聽(Mackey, 3/26)

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鈥檚 doctor, Dr. Luis Diaz 鈥 an oncologist at the Memorial Sloan Kettering Cancer Center in New York and professor at the Johns Hopkins University School of Medicine 鈥 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聽

KHN senior correspondent Angela Hart discussed California鈥檚 contract with Civica to make lower-cost insulin on KQED鈥檚 鈥淔orum鈥 on March 23. She also discussed California鈥檚 potential plan to use Medicaid funding to cover up to six months of rent for low-income enrollees on KCBS鈥 鈥淪tate of California鈥 on March 22. (3/25)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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