Bio Roundup: Migraine Data, Cancer Drug Combos, Azar Hearing & More

Xconomy National — 

A pair of migraine drugs made a splash in biotech news this week with published data suggesting that they can reduce the frequency of headaches.

These drugs still await an FDA decision, and their impact on patients over the long term are being watched closely. As many as 38 million Americans suffer from migraines, according to the Migraine Research Foundation. Migraine sufferers and their physicians and patients are looking for new treatment options.

In other pharma news this week, U.S. Senators grilled a former pharmaceutical industry executive, a cancer DNA test won a landmark approval, more immunotherapy data emerged, and a tiny biotech company raised $114 million to develop a cell therapy for diabetes. Let’s start the roundup in our nation’s capital.


—In a three-hour Senate committee hearing, Health and Human Services secretary nominee Alex Azar faced a barrage of questions about drug prices and his former role as an Eli Lilly (NYSE: LLY) executive.

—Republican efforts to reform taxes could also affect healthcare. The Senate’s tax bill includes a provision to cripple the Affordable Care Act’s individual mandate, the requirement that everyone have health insurance or pay a penalty. A Los Angeles Times analysis found that removing the mandate would disproportionately affect rural parts of the country, leaving those regions with fewer and more expensive health plans.

—In what could be an important step forward for the mainstream acceptance of broad cancer genetic tests, a product from Foundation Medicine (NASDAQ: FMI), the FoundationOne CDx, simultaneously won FDA approval and got a coverage determination from the Centers for Medicare & Medicaid Services.


—An emerging group of drugs meant to prevent migraines, not just deal with their symptoms, took center stage in the New England Journal of Medicine this week as two studies were published outlining the Phase 3 trials of rival experimental therapies from Amgen (NASDAQ: AMGN) and Teva Pharmaceutical (NYSE: TEVA). Yet some doctors expressed concern that a potentially high price tag will make them unaffordable for many patients who desperately need them.

—While it didn’t disclose specific details, Roche’s Genentech division reported that its immunotherapy atezolizumab (Tecentriq), when combined with chemotherapy and another one of its drugs, bevacizumab (Avastin), helped keep the tumors of newly diagnosed lung cancer patients in check longer than bevacizumab and chemotherapy alone. The trial could shake up the already competitive, fast-changing landscape of treatments for lung cancer.

—The New York Times reported that gene therapy companies are struggling to find supplies of viral vectors, a crucial component of the cutting-edge drugs. Cambridge, MA-based Bluebird Bio (NASDAQ: BLUE) announced it has bought its own virus-making facility, a site in Durham, NC.

—Pfizer (NYSE: PFE) and partner Merck KGaA’s effort to best rival immunotherapies in gastric cancer fell short, as their checkpoint inhibitor avelumab failed to beat chemotherapy in a Phase 3 study.

—Regeneron Pharmaceuticals (NASDAQ: REGN) scrapped development of a combination treatment it had been developing for age-related macular degeneration. The failure is a blow to the company’s efforts to protect flagship drug aflibercept (Eylea), and the latest combo therapy to flunk a study in AMD.

—-Cytokinetics’ (NASDAQ: CYTK) lead experimental treatment for amyotrophic lateral sclerosis (ALS) failed a Phase 3 study, leaving the South San Francisco, CA, company to shift its focus to a second compound for the disease that’s still in mid-stage clinical trials.


—Moving on from the clinical trial failure of its eye drug combo treatment, Regeneron entered a partnership with … Next Page »

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