In early 2017, Scott Gottlieb was considered the most moderate of the potential candidates to head the Food and Drug Administration, which is the most powerful regulator of medical products in the world.
It wasn’t a high bar to clear. Libertarians who had questioned some of the basic premises of the FDA were in the mix, and even their laissez-faire attitudes had some advocates of a speedier agency worried, as Xconomy reported in early 2017.
Still, Gottlieb had spent time in the George W. Bush FDA, then years as a life-sciences investor and conservative op-ed writer. His potential financial conflicts, combined with President Trump’s vow to slash FDA rules, made Democrats and others shy away.
Other than the age-old “spending more time with family” (Gottlieb and his wife have three kids under 10, including twins), no clear reason has emerged as of late Thursday. He took on the tobacco-vape industry and, in denouncing anti-vaccine activism, has clashed with a movement that President Trump himself has encouraged. But there’s no indication those stances led to his departure. The agency under Gottlieb won biopharma industry kudos for continuing Obama-era reforms to speed reviews and clarify regulation of new kinds of medicines, like gene therapy. But it also moved for new rules against Big Pharma tactics that block generic competition.
The announcement sent biopharma indices south. The drug industry and its investors hate uncertainty. And now that there’s yet another personnel hole that the Trump administration needs to fill, there’s uncertainty in buckets.
Any interest? You can apply now. Or you can apply yourself to the rest of this week’s roundup.
LAW, POLICY, AND PRICES
—Amid several US measles outbreaks, the Senate’s health committee held a hearing on vaccines. The opening statement from chair Lamar Alexander (R-TN) echoed Gottlieb’s 2017 confirmation-hearing remarks before the same committee. Saying “vaccines save lives,” Alexander lit into antivaccine activists and the information they spread online: “Just because you found it on the Internet doesn’t make it true.”
—Purdue Pharma is exploring bankruptcy to manage mounting lawsuits that claim the drug maker contributed to the nation’s opioid crisis, Reuters reported.
—Amid new generic competition and scrutiny of rising drug prices, Eli Lilly (NYSE: LLY) announced an authorized generic version of its fast-acting insulin Humalog that will sell for half the price.
—A bipartisan Senate bill emerged this week to clear up the so-called “patent thickets” that, as Gottlieb has previously said, large drug makers accumulate only to deter biosimilar versions of their protein-based drugs.
—The Wall Street Journal reports that Martin Shkreli is running his old drug company from his prison cell in New Jersey.
DEALS, DEALS, DEALS
—Biogen (NASDAQ: BIIB) will pay $800 million to buy Nightstar Therapeutics (NASDAQ: NITE), a developer of gene therapies for rare eye diseases. The acquisition is part of a wave of gene therapy deals and comes weeks after Biogen dumped a partnership with AGTC (NASDAQ: AGTC), a Nightstar rival.
—Drama surrounding Bristol-Myers Squibb’s (NYSE: BMY) proposed buyout of Celgene (NASDAQ: CELG) continued. Bristol defended the deal amidst mounting opposition, and its executives have met with institutional investors several times the past few weeks, CNBC reported. Meanwhile, the Loncar Cancer Immunotherapy ETF became the third investor to come out against the deal, following Wellington Management and Starboard Value.
—Paris-based Seventure Partners closed a $224 million fund to invest in microbiome therapies, nutrition, and digital health.
—Precision BioSciences of Durham, NC, filed for an IPO to fund human tests of a cancer cell therapy developed with its proprietary gene-editing technology.
—Beam Therapeutics of Cambridge, MA, raised a $135 million Series B round as it pushes ahead with medicines that use base editing, a more precise form of CRISPR gene editing technology.
—San Diego startup Erasca, formed by Ignyta founder Jonathan Lim, added another $22 million to its Series A and provided more insight into its plans to develop targeted cancer drugs with the help of artificial intelligence.
—Pacira Pharmaceuticals of Fremont, CA, is paying $120 million upfront for Myoscience, a maker of a painkiller delivery device. Pacira could pay an additional $100 million.
—Shionogi & Co. will pay Akili Interactive $20 million upfront for rights to sell its digital medicines for ADHD (AKL-T01) and autism spectrum disorder (AKL-T02) in Japan and Taiwan.
CLINICAL YEAS & NAYS
—The FDA approved the Johnson & Johnson (NYSE: JNJ) drug esketamine (Spravato), making the fast-acting nasal spray the first new type of medicine for treatment-resistant depression in decades. The approval, however, comes with a safety warning and restrictions. As a close relation to “Special K,” the addictive … Next Page »