Boston, San Francisco, and a few other metro areas might dominate the US life sciences, but some weeks, all bio-related eyes are on the nation’s capital. Health concerns about vaping continue to mount, and the feds could get involved. Meanwhile, try to find someone in the federal government who isn’t involved in the drug-price debate. OK, that’s a rhetorical flourish—we are talking about politics, after all—but with the debut of the House drug-price legislation this week, there are now plans of various stripes in both houses of Congress and the White House.
There was plenty of news beyond the Beltway, from opioid lawsuits to Alzheimer’s failures to a surprising billion-dollar deal. This isn’t a question that crops up often, but … are you roundup ready? Good. Let’s get to it.
LAW & POLICY
—House leaders unveiled the Democrats’ long-awaited plan to address high drug prices, with a central role for the government to negotiate prices for its Medicare insurance program. The plan must thread a needle between the party’s restive left flank, which wants the legislation to target a wider swath of drugs, and Republicans who have already dismissed it.
—If the Pelosi-led bill passes the House, it will require compromise with a Senate bill, authored by finance committee chair Charles Grassley (R-IA), and the White House. Grassley’s bill has run into opposition within his own party.
—Purdue Pharma filed for bankruptcy to settle more than 2,600 lawsuits dealing with its role in the nation’s opioid epidemic. The Sackler family would pay $3 billion and relinquish ownership of Purdue as part of the settlement. But several states have objected to the deal, which a bankruptcy judge must approve to take effect.
RESEARCH & DEVELOPMENT
—Biogen (NASDAQ: [[ticker:BIIB]]) and Eisai pulled the plug on Alzheimer’s drug elenbecestat in Phase 3 due to unspecified safety problems.
—Also due to safety concerns, Biogen halted Phase 2 testing of its fibrosis drug BG00011, acquired through its 2012 buyout of Stromedix.
—In April, Novartis disclosed that a spinal muscular atrophy patient died in a clinical trial of gene therapy Zolgensma, and that the death was “possibly” related to treatment. This week, following an autopsy, Novartis said there was “no evidence” of the gene therapy playing a part.
—Amidst a rise in vaping-related lung illnesses and growing efforts to ban e-cigarettes, a study published in the New England Journal of Medicine found that their use continues to rise among adolescents, and 12 percent of school seniors vape nicotine on a near-daily basis. Here’s more from the Washington Post.
—Stat reported on the possibility of using CRISPR to edit the DNA of human embryos who would be born as “savior siblings” and donate bone marrow to a living child with a deadly disease.
—ACE-083, an experimental drug from Acceleron Pharma (NASDAQ: [[ticker:XLRN]]), failed a Phase 2 study in facioscapulohumeral muscular dystrophy. With the beta thalassemia drug luspatercept, Acceleron could notch its first drug approval next year.
—Shares of Aclaris Pharmaceuticals (NASDAQ: [[ticker:ACRS]]) climbed 60 percent after A-101, its cream for common warts, succeeded in a Phase 3 trial.
THE FDA SAYS…
—Late last Friday, an FDA advisory panel voted to recommend approval of an Aimmune Therapeutics (NASDAQ: [[ticker:AIMT]]) therapy developed to desensitize patients to peanut allergy. The FDA will make an approval decision by the end of January.
—Merck (NYSE: [[ticker:MRK]]) could become the first approved maker of Ebola vaccine in the US. The FDA will make an approval decision by next March 14. The vaccine is already under review in Europe.
DEALS & DOLLARS
—Danish firm Lundbeck agreed to pay $1.95 billion for Bothell, WA-based Alder BioPharmaceuticals (NASDAQ: [[ticker:ALDR]]), whose migraine drug eptinezumab is currently under FDA review.
—Boston-based synthetic biology company Ginkgo Bioworks raised a $290 Series E round to expand the breadth of its technology for reprogramming cells.
—Boundless Bio debuted in San Diego with $46 million to pursue cancer treatments based on mutations found in genetic material not attached to chromosomes.
—Amplyx Pharmaceuticals licensed an experimental drug from Novartis for BK viral disease, an infection that can afflict patients who receive kidney or stem cell transplants.
—Healthcare Royalty Partners is paying up to $150 million for a royalty stream from sales of selinexor (Xpovio), the Karyopharm Therapeutics (NASDAQ: [[ticker:KPTI]]) multiple myeloma drug.
—Edgewise Therapeutics of Boulder, CO, closed $50 million in Series B funding to bring its lead drug into
