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Bio Roundup: Trump’s Triumph, Election Fallout, CRISPR Arguments & More

Xconomy National — 

The presidential election ended with Donald Trump’s stunning victory and Republican retention of the House and Senate. Now, the U.S. healthcare sector will try to figure out what it all means. Drug company stocks got a boost with the defeat of Hillary Clinton, a vocal critic of drug prices. But Trump’s plans are unclear. Will he take a softer stance on drug prices? If Obamacare is repealed, what will replace it? What are the implications of a Trump administration for life science research, or next year’s reauthorization of the Prescription Drug User Fee Act? Who will be in charge of the Department of Health and Human Services, which oversees the FDA, National Institutes of Health, and Medicare and Medicaid? Are the Obama administration’s Cancer Moonshot and Precision Medicine programs doomed?

The Trump transition team posted an outline of their healthcare agenda Thursday, but so much is up in the air. Here’s what we know: There’s news to round up. Let’s get to it.

TOP STORIES

—One reason why Hillary Clinton won the U.S. popular vote but lost the electoral college is her run-up of support in California. But her near doubling of Trump (62 to 33 percent) didn’t translate into support for drug price controls. Golden State voters rejected Prop. 61, which aimed to tie the state’s drug purchases to the prices paid by the U.S. Department of Veterans Affairs. Voters did approve full legalization of marijuana, which might come in handy to help the deep-blue state through the Trump years.

—The day after the election, The Nasdaq Biotechnology Index (NASDAQ: IBB) climbed nearly 9 percent, its highest one-day bump in more than eight years.

—Celgene (NADSAQ: CLEG) executive Rich Bagger was tabbed by Politico as a “longshot” HHS secretary candidate in the Trump administration. Bagger is helping run the transition.

—Xconomy rounded up some post-election thoughts from several local tech and life science leaders, which included a mix of outrage, resiliency, hope, rationalizing, grandstanding, and some calls for calm and reason.

—Check out these stories from Nature, Reuters, TheStreet.com, and Forbes for more on the potential election fallout for life science companies, scientific research, and Obamacare.

CRISPR DEVELOPMENTS

—Oral arguments in the landmark patent fight over ownership of the gene editing technology CRISPR-Cas9 were set for Dec. 6 at the U.S. Patent and Trademark Office. The battle between two camps, led by the University of California, Berkeley on one side and the Broad Institute of MIT and Harvard on the other, is now before a special board in a rare head-to-head contest.

—Despite the patent fight, CRISPR work continues apace. A Stanford University research team published Monday a potential treatment for sickle cell and other blood diseases, using the gene editing system in bone marrow stem cells. They are part of a crowded academic field pursuing sickle cell treatments with CRISPR. The team leader told Reuters that clinical trials could start in 2018.

DEALS, DELAYS, AND DATA…

—Cambridge, MA-based Biogen (NASDAQ: BIIB) and partner Ionis Pharmaceuticals (NASDAQ: IONS), of Carlsbad, CA, reported positive data from a second Phase 3 trial of spinal muscular atrophy drug nusinersen (Spinraza), which could become the first approved therapy for the disease by the end of this year. The data show nusinersen might positively impact multiple forms of SMA, not just the most severe type that afflicts newborns.

—According to Reuters, Pfizer (NYSE: PFE) might sell or spin off its consumer healthcare business, which has about $3.5 billion in yearly sales.

—Bristol-Myers Squibb (NYSE: BMY) paid Japanese firm Nitto Denko $100 million upfront for rights to a drug to combat liver fibrosis, or scarring, due to hepatitis C or NASH, a fatty liver disease. Several companies hope to treat NASH with drugs in late-stage clinical trials and have sometimes paid surprising premiums to acquire them. The Nitto drug is in a Phase 1b study.

—Separately, Bristol reported that nivolumab (Opdivo) became the first cancer immunotherapy drug to help patients with certain forms of stomach cancer live longer than they would on standard chemotherapy. The Phase 3 results will be presented at a future medical meeting.

—Alexion Pharmaceuticals (NASDAQ: ALXN), of New Haven, CT, delayed filing its quarterly earnings report to investigate allegations made by a former employee about improper sales practices at the company. Alexion says it has not yet found wrongdoing.

FDA GIVETH AND TAKETH…

—An FDA advisory committee voted 7-6 in favor of solithromycin, an antibiotic from Chapel Hill, NC-based Cempra (NASDAQ: CEMP). The FDA will decide by the end of December whether to approve it to treat bacterial pneumonia.

—Shares of Pasadena, CA-based Arrowhead Pharmaceuticals (NASDAQ: ARWR) fell more than 30 percent after the FDA halted a Phase 2 trial of its lead drug candidate, for hepatitis B.

—The FDA lifted a partial clinical hold, meanwhile, on a planned cell therapy study from Philadelphia and U.K.-based Adaptimmune (NASDAQ: ADAP).

FINALLY…

—IBM Watson Health and the Broad Institute have teamed up on a five-year, $50 million research project to study why tumors become resistant to cancer drugs.

—A month after Cambridge, MA-based Merrimack Pharmaceuticals (NASDAQ: MACK) restructured and its CEO resigned, Reuters reported that the company has hired investment bankers to explore a possible sale.

—Parsippany, NJ-based Medicines Co. (NASDAQ: MDCO) discontinued development of experimental heart disease drug MDCO-216.

—NovaVax (NASDAQ: NVAX) of Gaithersburg, MD, maker of a troubled RSV vaccine candidate, is cutting 30 percent of its workforce.

—New York-based Kadmon Holdings (NASDAQ: KDMN), which went public in July with plenty of debt on its balance sheet, is also restructuring. The company has cut 21 jobs since pricing its IPO and cut a deal to defer debt payments until August 2017.

—Florida Keys voters said yes to one measure allowing the release of genetically modified mosquitoes aimed at fighting Zika virus and dengue, but said no to another. Both measures were non-binding, and the local mosquito abatement district must make the final decision.

Alex Lash contributed to this report