Morning Briefing
Summaries of health policy coverage from major news organizations
By Mapping Proteins, Scientists Can Potentially See How Cancers Grow
A new analysis found unique networks of hundreds of proteins that may drive the growth of breast, head and neck cancers, according to three studies out today. Cancers differ in many aspects, including their mutations. But, there are some common systems of cells involved, including protein networks, that may affect cancer growth and scientists hope to target them with therapies. (O'Reilly, 9/30)
Scientists have unveiled new maps of the protein networks underlying different types of cancer, offering a potentially clearer way to see what鈥檚 driving the disease and to find therapeutic targets. Sequencing the genetic information of tumors can provide a trove of data about the mutations contained in those cancer cells. Some of those mutations help doctors figure out the best way to treat a patient, but others remain more of a mystery than a clear instruction manual. Many are exceedingly rare, or there are so many mutations it鈥檚 not clear what鈥檚 fueling the cancer. (Joseph, 9/30)
In other pharmaceutical and biotech industry news 鈥
Hundreds of clinics pushing unproven stem cell procedures caught a big break from the U.S. government in 2017: They would have three years to show that their questionable treatments were safe and worked before regulators started cracking down. But when the Food and Drug Administration鈥檚 grace period expired in late May 鈥 extended six months due to the pandemic 鈥 the consequences became clear: Hundreds more clinics were selling the unapproved treatments for arthritis, Alzheimer鈥檚, COVID-19 and many other conditions. (Perrone, 9/30)
In a closely watched battle over regulatory decision-making, a federal appeals court ruled the U.S. Food and Drug Administration wrongly approved a rare disease medicine made by a small, family-run company because another drug maker already held the exclusive right to market a similar treatment. The lawsuit was filed by Catalyst Pharmaceuticals (CPRX), which accused the agency of violating federal law two years ago when it unexpectedly approved a medicine made by Jacobus Pharmaceuticals for treating children with a rare neuromuscular disorder called Lambert-Eaton myasthenic syndrome, or LEMS. The FDA had previously endorsed a Catalyst drug to treat LEMS, but only for adults. (Silverman, 9/30)
Hormone replacement therapy (HRT) is, for the most part, not linked with an increased risk of developing dementia, according to a large study of women in the United Kingdom. However, the study -- which published in the BMJ medical journal Wednesday -- did show a slightly increased risk of developing Alzheimer's disease, a specific form of dementia, among women who used estrogen-progestogen therapies for between five and nine years and for 10 years or longer. That translated into five and seven extra dementia cases, respectively, per 10,000 women. (Hunt, 9/30)
The surgical robot market, long dominated by one company, has a new entrant hoping to disrupt the industry with a more immersive, 3D experience for surgeons 鈥 even as the need for surgical robots in most procedures remains hotly debated. Robot-assisted surgery has boomed in the past 20 years, led by Intuitive, the company that makes the popular da Vinci robot. Vicarious Surgical, the new company that went public last month, claims it can do better than what exists on the market 鈥 鈥渓egacy systems,鈥 as co-founder and roboticist Adam Sachs refers to them, declining to critique Intuitive specifically. (Cueto, 10/1)
In today鈥檚 biotech job market 鈥 where competition for people with in-demand experience is fiercer than ever 鈥 it鈥檚 become critical for biotech startups and venture capitalists to ensure people have a smooth exit when their companies downsize or go under. Biotech is a notoriously small world, especially in regions like Boston and the Bay Area. If an employee leaves a job with hard feelings or a bad taste in their mouth, it may not be the last time an executive team will see them. And biotech companies often fail 鈥 in one recent analysis, more than half of all the studied biotech startups failed. (Sheridan, 10/1)
In corporate news 鈥
Merck & Co. agreed to buy Acceleron Pharma Inc. for about $11.5 billion, building out its portfolio of therapies to treat rare diseases.聽Acceleron shareholders will get $180 a share in cash, a 34% premium over the price at the end of last month but below the stock鈥檚 intraday highs this week. (Davis, Hammond and Court, 9/30)
Merck will continue to search out more acquisitions after its $11 billion purchase of biotech firm Acceleron Pharma, the company鈥檚 CEO told STAT in an interview Thursday. But the CEO, Rob Davis, said he also believes that investors have not yet come to realize the value of the experimental drugs Merck is developing. (Herper, 9/30)
The National Community Pharmacists Association is calling on federal regulators to block UnitedHealth Group's $13 billion deal to buy Change Healthcare, saying independent pharmacies already struggle to compete against the two companies and that a merger would create an anticompetitive corporate behemoth. UnitedHealth Group announced in January that its fastest-growing subsidiary, Optum, would pay approximately $8 billion to acquire revenue cycle management and data analytics company Change Healthcare. Optum also plans to pay off $5 billion in debt Change Healthcare owes. At the time, analysts predicted the acquisition would allow Optum to expand its OptumInsight provider business, inform its value-based care initiatives and increase patient engagement. (Tepper, 9/30)
Centene Corp. will pay a combined $71 million to Illinois and Arkansas to settle allegations that the St. Louis-based insurer overcharged the states' Medicaid departments for drugs. The company has reserved $1.1 billion for future settlements related to its Envolve pharmacy benefit manager, which it has since restructured to serve solely as a third-party administrator to process customer claims. Kansas, Georgia, Oklahoma and New Mexico are reportedly also investigating their Medicaid programs' PBMs and considering litigation through the Liston & Deas and Cohen & Milstein law firm, according to The Wall Street Journal. (Tepper, 9/30)