Brainstorm Health: GW Pharma’s Next Step, GE Health Unit Spinoff, Justice Kennedy Retirement and Abortion
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On Monday, GW Pharmaceuticals made history by becoming the first company to ever win Food and Drug Administration (FDA) approval for a marijuana plant-based prescription drug, dubbed Epidiolex. The approval was widely expected after a panel of FDA advisers unanimously recommended its regulatory clearance back in April; still, it was a milestone on the federal level. Until this week, the only existing (legal) prescription treatments involving cannabis were of the synthetic variety, not those that actually came from a marijuana plant.
Epidiolex, whose active ingredient is a formulation of the marijuana component cannabidiol (CBD)—i.e., not the high-causing “THC” part of weed—was approved for children two years of age and older with certain intractable childhood epilepsy disorders called Dravet syndrome and Lennox-Gastaut syndrome. Now that it’s done, the flood gates could open for other companies in the cannabis space—and for GW Pharma itself, the company’s CEO Justin Gover tells Fortune.
“Epidiolex can get more indications, primarily within the epilepsy sphere, as well as potentially other indications,” Gover said in a telephone interview. So what else might be next? GW could “start to accelerate investment in other types of cannabinoids,” including another treatment in its pipeline called Sativex. That drug has actually already been approved in several countries outside the U.S. to treat spastic muscle movements in multiple sclerosis (MS) patients; the firm may try and expand it into America now that the FDA has signaled a willingness to consider marijuana-derived treatments that are backed up by clinical trial data.
That latter point is critical to GW Pharma and its overall ambitions, particularly winning over the doctors who would have to prescribe the company’s cannabis-based medicines. “The fact that the Epidiolex program was designed and conceived with the medical community wanting to see real science in the field of cannabinoids” is what gives it a leg up, Gover explains.
As for looser definitions of “medical marijuana” to treat pain and other conditions? Don’t expect a blessing from the FDA anytime soon—agency commissioner Scott Gottlieb has stressed that far more rigorous studies need to be done on the medical effects of weed at large.
Read on for the day’s news.
GE spins off its health care unit. In a major shakeup following the appointment of John Flannery as GE’s CEO last August, the company is spinning off its health care business into an independent entity. The move is part of Flannery’s strategy to home in on key units like jet engine and power generator production after some intensely rocky years for General Electric. It’s also striking given Flannery’s history leading a turnaround at the health care unit, which has pursed numerous projects including advanced medical imaging technologies and snazzy AI-fueled services. “There’s a lot of change in that industry,” Flannery told CNBC about the sector, predicting future success for GE Healthcare. “Artificial intelligence, machine learning … cell therapy, immunotherapy. There’s just a constant stream of investment ideas we could pursue better in that fashion.”
AstraZeneca oncology biz boosted by Lynparza results. New clinical trial results for British drugmaker AstraZeneca’s cancer treatment Lynparza could significantly raise the drug’s fortunes in the marketplace, especially if the FDA approves it as a first-in-line, go-to medicine for ovarian cancer. The drug helped women with the condition live longer and without a worsening of the disease when it was given to them as their first treatment—and an approval along those lines could lift sales by more than $1 billion per year, according to some analysts. (Reuters)
THE BIG PICTURE
Kennedy retirement sets off wave of speculation about abortion. A bombshell from Justice Anthony Kennedy set off a wave of hand-wringing about the future of abortion rights in the U.S. Wednesday. The Supreme Court justice, often considered a swing vote in an otherwise 5-4 conservative majority institution, is retiring at the end of July, meaning that President Donald Trump will be able to appoint his second justice after Neil Gorsuch. But Kennedy was seen as a firewall against efforts to dismantle abortion rights enshrined under the landmark Roe v. Wade decision in the 1970s—and anti-abortion groups are already gearing up to challenge abortion laws across the country in the wake of Kennedy’s retirement, which could potentially have an effect on other health care-related issues such as the future of the Affordable Care Act.
Supreme Court Rules Against Unions in Mandatory Fees, and Anthony Kennedy Retires, by Bloomberg
Microsoft Improves Biased Facial Recognition Technology, by Erin Corbett and Jonathan Vanian
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|Produced by Sy Mukherjee|
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