Another week of White House chaos and American gun violence. Amid it all, we tried to parse what the Trump administration’s 2019 budget proposal meant for the biomedical and life-science worlds.
There was talk of tackling high drug prices in the budget document, but nothing to give Medicare direct negotiating power with drug companies or allow importation of cheaper drugs from other countries—ideas Trump has embraced on occasion. A related paper from the White House council of economic advisers shone more light on the administration’s view of the problem.
How else might the budget proposal affect the life sciences and biomedicine? It allots more money to combat the opioid-abuse crisis. The FDA would get a boost, too, and the agency released an outline of how it plans to spend it.
Instead of major cuts to the National Institutes of Health, as it has proposed in the past, the White House aims to keep NIH funding roughly flat. Perhaps the administration’s friends in the drug industry made them read this paper.
Big caveat on all this: The White House budget is just a proposal. Congress has its own ideas about the importance of, say, NIH funding.
With that out of the way, let’s hit the headlines for more politics and policy, deals of the week, and clinical data ups and downs—including an unusual note from Biogen (NASDAQ: BIIB) that sent its stock reeling. It’s roundup time.
BELTWAY NEWS AND VIEWS
—In a chat at the BIO CEO & Investor conference in New York, Rachel Sherman, the FDA’s second-in-command, discussed a slew of topics the agency is confronting, from Right to Try legislation to its looming succession problems.
—A report from Senator Claire McCaskill (D-MO) detailed more than $10 million that drug makers paid to patient advocate groups, many of which lobbied for broader opioid prescriptions. Purdue Pharma, the maker of OxyContin and biggest donor listed in the report, said last week it would stop marketing opioids to doctors.
—Ex-Celgene (NASDAQ: CELG) chairman Bob Hugin announced a run for the U.S. Senate in his home state of New Jersey. Hugin has close ties to Gov. Chris Christie and President Trump. If he wins the GOP primary he would likely run against incumbent Democrat Bob Menendez, who was recently tried for corruption. The trial ended in a hung jury.
ALZHEIMER’S DATA AND MORE
—Merck (NYSE: MRK) said its drug verubecestat wasn’t likely to help people with early Alzheimer’s symptoms and pulled the plug early on a trial called APECS. The bad news comes one year after verubecestat failed in a Phase 3 study of people with mild to moderate symptoms.
—Biogen (NASDAQ: BIIB) disclosed that it has added 510 patients to closely watched Phase 3 trials of Alzheimer’s drug aducanumab. CMO Al Sandrock said “variability” of results in earlier data convinced the company to boost the statistical sample, which some analysts said was “not a good sign.” Shares dipped about 7 percent before a slight rebound Thursday.
—Axovant Sciences (NASDAQ: AXON) CEO David Hung resigned, along with chief operating officer Marion McCourt and three members of the board. The departures follow the clinical trial failures of lead drug intepirdine in Alzheimer’s and dementia with Lewy bodies.
—CRISPR pioneers Jennifer Doudna (University of California, Berkeley) and Feng Zhang (Broad Institute) published papers on potential diagnostic uses of the genome-editing system. Doudna’s lab developed a test for cancer-causing human papillomavirus strains, and Zhang’s test looks for lung cancer mutations as well as traces of dengue and Zika virus.
—A panel of executives at the BIO CEO & Investor Conference discussed side effects, reimbursement, patient selection and other factors that could hamper broader adoption of cancer immunotherapy.
—Eli Lilly (NYSE: LLY) released encouraging preliminary Phase 3 results from a study of ixekizumab (Taltz) as a treatment for ankylosing spondylitis, an arthritic condition affecting the spine and pelvis.
—Vertex Pharmaceuticals (NASDAQ: VRTX) posted positive Phase 2 results for experimental pain drug VX-150, that is part of its plan to diversify beyond its core cystic fibrosis franchise.
APPROVALS, IPOS, AND DEALS
—With numbers more akin to a blockbuster buyout, Bristol-Myers Squibb (NYSE: BMY) is paying Nektar Therapeutics (NASDAQ: NASDAQ) $1.85 billion upfront for partial rights to a cancer immunotherapy drug and a 5 percent stake in the company. The companies will test Nektar’s NKT-214 in combinations with BMS’s two approved checkpoint inhibitors.
—Roche has spent almost the exact same amount, $1.9 billion, to buy Flatiron Health, a maker of cancer-specific electronic health records. Flatiron says it will keep its autonomy.
—The FDA approved Vertex’s combination cystic fibrosis drug ivacaftor/tezacaftor (Symdeko). The approval is the Boston company’s third for the inherited disorder and broadens the pool of patients its drugs can treat.
—Astellas said it has paid $102.5 million for Seattle’s Universal Cells, a developer of experimental stem cell therapies.
—BioXcel Therapeutics of Branford, CT, joined the IPO queue and plans to use the proceeds to test two drugs it found with artificial intelligence-based drug discovery technology.
—Celgene spinout Celularity raised $250 million that the Warren, NJ, startup will use to develop therapies derived from placenta cells to treat cancers and other diseases.
—The FDA approved a Banyan Biomarkers blood test developed to diagnose concussions. The test, which measures the levels of two proteins the brain releases after a head injury, is the first of its kind to receive an FDA nod.
—The FDA also cleared apalutamide (Erleada), the prostate cancer drug Johnson & Johnson (NYSE: JNJ) acquired when it bought Aragon Pharmaceuticals in 2013. The drug is approved for patients who haven’t responded to hormone therapy but whose cancer hasn’t yet spread.
Ben Fidler, Corie Lok, and Frank Vinluan contributed to this report.
White House photo by jason goulding via Creative Commons 2.0.