The stock market has been a lousy prognosticator of late. Prior to the election, Mr. Market seemed utterly convinced of a Clinton win. (It didn’t happen.) Then, as the outcome looked clear, it predicted panic—then galloped giddily into euphoria. (Hapless traders trying to chase these ups and downs no doubt mistimed them—because, well, it’s a sucker’s game to try to time the market. But then you knew that…)
That said, the market has seemed to send a more consistent message regarding the pharma and biotech industries. After the news of Trump’s victory, stocks of drug makers shot up—a sharp reversal from the previous few months of mostly steady decline when, to many, a Clinton presidency seemed inevitable. Shareholders were also buoyed by the defeat of Prop 61, the California ballot initiative that promised to lower drug prices by pegging what state agencies paid to prices negotiated by the U.S. Department of Veterans Affairs—an effort the drug industry reportedly spent $109 million to defeat.
And on first glance, the recent enthusiasm makes sense: Clinton signaled that she would come down hard on drug company “price gouging” in September, which sent stocks reeling. (Favorite hyperbolic headline: “Clinton Delivers Poison Pill to Biotech ETFs”). Trump, for his part, has said little on the matter. Clinton looked as if she would continue a cautious regulatory approach at the FDA. Trump has said he wants to cut “the red tape at the FDA,” claiming “there are over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.” (No, the “4,000” drug backlog doesn’t refer to what you think—and isn’t true in any case.) Clinton would largely keep Obamacare; and Trump, well, I wrote about this on Nov. 9.
Which brings me to whether our friend Mr. Market is right or wrong on pharma’s future in the Trump era. The answer is neither. (Psst—It doesn’t know.) The confusion doesn’t just center over what happens (and when) to the ACA—or on any prospective new drug-pricing regulation, for that matter. Trump has said he favors introducing more competition into the healthcare marketplace, including letting Medicare negotiate on drug prices. And market competition will do more to lower prices than anything. A case in point: Gilead’s steep stock drop in October had nothing to do with any political rhetoric on sky-high drug costs, but rather with the fact that its $80,000 or so Hep C combination therapy (Harvoni) might face pricing pressure from rivals J&J and Abbvie—adding another challenge to a company already facing a drop in its HCV drug sales.
Nor will a change at the helm at FDA do much to alter the pharma horizon. The drags on the industry today revolve around a paucity of innovation and the expensive, late-stage failures of drugs that continue to plague it. Those are two problems that drug makers will have to fix on their own.
More news below.
The NIH is funding a study of an artificial pancreas. In late September, the Food and Drug Administration green lighted the first-ever "artificial pancreas," Medtronic's MiniMed 670G. Now, the National Institutes of Health (NIH) funded International Diabetes Closed Loop Trial is enlisting Dexcom, Tandem Diabetes Care, and the digital health firm TypeZero Technologies to create a "closed-loop" insulin delivery system to treat type 1 diabetes. The experimental system will incorporate a glucose sensor made by Dexcom, an insulin pump from Tandem, and a smartphone app developed by TypeZero. With an artificial pancreas, insulin levels can be adjusted continuously in response to changes in blood sugar, which are monitored by the system. And the device will also give users the option to manually administer higher doses, such as before meals. (FiercePharma, Fortune)
Google honors insulin pioneer Frederick Banting. Google regularly pays respects to scientific luminaries. And on Monday, the company's search engine homepage has a "doodle" featuring Sir Frederick Banting, a Nobel laureate in Medicine who was the first person to use insulin in humans. Banting was able to isolate insulin from the pancreases of dogs and calves alongside his partners Dr. Charles Best (with whom Banting would eventually share his Nobel prize money) and J.J.R. Macleod, with whom he shared the prize itself.
HIMSS health IT conference will feature IBM chief and former House Speaker Boehner. The Healthcare Information and Management Systems Society (HIMSS) annual meeting is arguably the most important health IT conference to take place each year. In 2017, it's going to feature an all-star roster of keynote speakers including IBM CEO Ginni Rometty, former House Speaker John Boehner, and Shark Tank investors Robert Herjavec and Kevin O'Leary. After stepping down as Speaker, Boehner joined the board of tobacco giant Reynolds American and the D.C. law firm Squire Patton Boggs. HIMSS 2017 will run from February 19-23, 2017, in Florida and will focus on a host of topics including interoperability, cybersecurity, health data analytics, and more. (Healthcare IT News)
FDA proposes studying a key issue in pharma's digital marketing. The regulations surrounding drug marketing haven't exactly kept up with the digital age. Since 2009, biopharma firms have had trouble promoting their products on platforms like Twitter because U.S. rules require all drug ads to present comprehensive (and lengthy) safety and side effect information. Companies figured that including an outside link to safety information in social media drug ads would suffice; the FDA disagreed. But the agency in now proposing a study to see whether or not these links can be just as effective for giving patients the information they need. And if regulators eventually conclude that drug makers can use this tactic in their social media marketing, it could open up an entirely new horizon in digital medicine promotion. (FiercePharma)
PTC Therapeutics can keep its controversial Duchenne drug on the market. PTC Therapeutics got a massive break on Friday when European regulators decided to allow Translarna, the company's controversial treatment for Duchenne muscular dystrophy, a devastating genetic disorder that leads to loss of motor function, to remain on the market. Many analysts had expected the drug's marketing approval to be revoked given its checkered efficacy. But the advisory body to the European Medicines Agency is recommending that sales be allowed to continue as long as PTC can prove significant efficacy through a pair of larger studies (which won't conclude until 2021). PTC shares soared more than 88% in Friday trading and is up about another 9% in early Monday trading. (Fortune)
Novartis may snap up generic drug maker Amneal for $8 billion. Sources tell Bloomberg that pharma giant Novartis may be close to hammering out a deal for the closely held U.S. generics firm Amneal Pharmaceuticals, which could be valued at as much as $8 billion. The company makes generic treatments for conditions like herpes and epilepsy, and Novartis' generic drug unit Sandoz could get a boost from an acquisition—especially in light of Teva's $40.5 billion buyout of Allergan's generic drug portfolio. Still, as Bloomberg notes, the deal could come at a difficult time for the generic industry given ongoing Justice Department investigations into potential widescale price fixing and collusion on copycat medicines. (Bloomberg, Fortune)
FDA rejects Dynavax's hepatitis B vaccine (again). Shares of Dynavax plummeted 63% in early Monday trading after the company announced that the Food and Drug Administration had, once again, declined to approve its hepatitis B vaccine Heplisav-B. Dynavax's stock has been on a bit of a roller coaster this year; shares flew in early 2016 on the strength of late-stage clinical trials demonstrating Heplisav-B's efficacy. But the firm is now in dire straits with the latest FDA setback—and CEO Eddie Gray says that the embattled biotech will need a partner to help get the experimental treatment to market. "[T]he time and resources that will be required to gain approval leads us to consider that we may not be able to advance this program on our own and we are moving swiftly to identify a potential pharmaceutical or financial partner," he said in a statement. (Endpoints)
THE BIG PICTURE
President-elect Trump may keep some major parts of Obamacare. In a seemingly stunning reversal, President-elect Donald Trump told both the Wall Street Journal and 60 Minutes that he's open to keeping some of Obamacare's most popular provisions, including guaranteed insurance coverage for Americans with pre-existing conditions and allowing young people to remain on their parents' health policies up until the age of 26. It's unclear how that would work in tandem with Trump's and the Congressional GOP's promises to dismantle the law, including repeal of its mandate requiring Americans to purchase insurance. That provision is meant to prevent adverse selection in the market, since otherwise consumers could simply wait until they got sick to buy coverage. And Trump's transition website endorses the use of high-risk pools for people with pre-existing conditions, which wouldn't be necessary with guaranteed issue (although it's possible that's what Trump is referring to when he says he likes the pre-existing condition provision). Trump said that his Oval Office sit down with President Obama helped convince him to consider keeping those parts of the law. (Fortune)
There are new bird flu outbreaks in Germany, Switzerland, and Austria. Europe's bird flu problem got worse over the weekend as Germany, Switzerland, and Austria all announced new outbreaks of H5N8, a dangerous and severe bird flu strain that's also popped up in the Netherlands, Denmark, Hungary, and Poland, in poultry. Regulators and food safety officials announced that they would be culling tens of thousands of chickens at affected farms and set up a safety radius of 1.2 square miles surrounding the affected regions. (Fortune)
Trump's win is fueling a huge demand for IUDs and donations to Planned Parenthood. Trump's election last week helped fuel a massive surge in Obamacare enrollment on Wednesday. It's also leading to substantial donations to Planned Parenthood and huge demand for IUDs out of fear that a Republican Congress will de-fund the family planning services provider over abortion procedures. The Planned Parenthood Federation of America has received more than 80,000 new donations from across the country following Trump's victory, and several local Planned Parenthood affiliates have reported big spikes in appointment requests for long-acting contraceptives such as IUDs. (Fortune)
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