Millions of people might be on vacation as we hit the dog days, but drug makers and politicians aren’t taking a break from the gamesmanship over high drug prices.
After two years of blowing smoke, the Trump administration is threatening action on a few fronts, including against the powerful middlemen known as PBMs that decide which drugs become favorites, and which get excluded, from insurance plans.
Drug companies are feeling increasing heat, too, via the President’s tweets shaming companies for price hikes, as well as FDA rumblings about looser drug importation rules.
Pfizer’s chief executive, recently in Trump’s crosshairs over price hikes, seemed to side with the White House this week with a very public prediction. Meanwhile, the administration continued to hammer away against the Affordable Care Act, regulators in the U.S. and EU have many drug-approval decisions on their summer barbeque plates, and the biotech financing waves keep rolling into shore. Let’s bury our toes in the warm roundup sand, shall we?
POLICY & REGULATION
—Pfizer (NYSE: [[ticker:PFE]]) CEO Ian Read predicted that the pharmaceutical market will one day be free of rebates—the secret discounts negotiated by drug makers and pharmacy benefit managers who act on behalf of insurers and employers.
—The Trump administration will let people stay up to three years on so-called “skinny” insurance plans that are cheaper upfront and aren’t bound by certain requirements, such as coverage regardless of preexisting conditions. Under the Affordable Care Act, these plans were only allowed as three-month bridges to more comprehensive coverage.
—Politico reported that Trump and Republican efforts have “struggled to land a clear knockout blow” to the ACA, or Obamacare, and that, in fact, the ACA markets could be stabilizing.
—The FDA could soon approve for the first time a medicine that uses RNA interference. An approval of patisiran (Onpattro), from Alnylam Pharmaceuticals (NASDAQ: [[ticker:ALNY]]), would also mark a milestone for patients with the rare disease hereditary transthyretin amyloidosis. Xconomy previewed what the historic decision could mean for patients, clinicians, and payers.
—The FDA approved iobenguane (Azedra), a drug from New York-based Progenics Pharmaceuticals (NASDAQ: [[ticker:PGNX]]), for patients with two rare neuroendocrine cancers, pheochromocytoma or paraganglioma.
…AND ACROSS THE POND
—European regulators approved migraine drug erenumab (Aimovig), a decision that comes nearly two months after the FDA approved it. Amgen (NASDAQ: [[ticker:AMGN]]) and Novartis (NYSE: [[ticker:NVS]]) share commercial rights in the U.S., while Novartis holds rights in the rest of the world except for Japan.
—European regulators also approved the Bristol-Myers Squibb (NYSE: [[ticker:BMY]]) immunotherapy nivolumab (Opdivo) as an adjuvant treatment for patients with metastatic melanoma.
—The EU’s drug advisors recommended approval for a combination of Merck’s immunotherapy pembrolizumab (Keytruda) and chemotherapy for newly diagnosed lung cancer patients.
—The European advisors also recommended approval of patisiran.
CASH IN, CASH OUT
—Boston biotech Karuna Pharmaceuticals raised $42 million in a Series A financing, which it will use to advance an experimental schizophrenia drug into mid-stage studies.
—A business partly backed by Pernix Therapeutics (NASDAQ: [[ticker:PTX]]) completed its $73.5 million acquisition of Contrave, the weight loss drug that San Diego biotech Orexigen Therapeutics auctioned off in bankruptcy proceedings.
—Chinese biotech Ascletis went public on the Hong Kong exchange this week, the first company to do so under new rules intended to make IPOs more attractive to pre-revenue startups. Reuters reports that as many as 10 Chinese biotechs plan to list in Hong Kong, and some of them have dropped U.S. IPO plans in favor of Hong Kong.
—Another China-based biotech, BeiGene (NASDAQ: [[ticker:BGNE]]), already listed on Nasdaq, raised $903 million in a Hong Kong IPO. Here’s more from Reuters.
—Verana Health, a San Francisco startup whose software helps drug and medical device developers draw insights from patient data, raised $30 million in Series B financing.
—London biotech ReViral will use a $55 million Series B financing to push its lead drug candidate for respiratory synctitial virus into Phase 2b studies.
DATA DOWNERS & JOB NEWS
—SNA-001, a topical drug developed by Westlake Village, CA-based Sienna Biopharmaceuticals (NASDAQ: [[ticker:SNNA]]), failed two pivotal studies in patients with moderate-to-severe acne.
— Pleasanton, CA-based Astex Pharmaceuticals and its Japanese parent Otsuka Pharmaceutical announced that guadecitabine, an experimental treatment
