Drug Development, Protocols

Protocols: Hillary Clinton takes aim at drug profiteers; Arena spins out a GPCR biotech incubator

Amit Munshi, Arena CEO

Amit Munshi, Arena CEO

An ailing Arena Pharmaceuticals is spinning out a new incubator company called Beacon Discovery that will work on developing a pipeline of G-Protein Coupled Receptors (GPCRs). Beacon will hunt up pharma partners for the work and Arena will collaborate on the work and hopefully earn a revenue stream from the startup. CEO Amit Munshi, who jumped from a crumbling biotech focused on biosimilars to Arena earlier in the year, says it’s all part of the plan to transform the company into a “high-performing clinical development organization.”

Hot on the heels of Biogen’s hype fest for its Alzheimer’s drug aducanumab, the big biotech touted the FDA’s move to grant fast track designation to the treatment. Contrary to what a lot of reporters will parrot, though, the move is virtually meaningless. Just about any company that can follow the agency’s guidelines can routinely get a fast track designation for their drug.

Takeda is joining the race to develop a new vaccine for the zika virus, and it’s getting help from the US government. BARDA is putting up $19.8 million to cover development through Phase I, with up to $312 million if the group exercises all options to take the vaccine through Phase III trials and on to filing a Biologics License Application in the US.

Berkeley, CA-based Aduro held an official ribbon-cutting party for their new, 110,853-square-foot HQ building.

Hillary Clinton, credit: Max Goldberg

Hillary Clinton, credit: Max Goldberg

Hillary Clinton rounded out a week of campaigning on Friday by floating her first detailed plan to end the series of drug price scandals that have rocked the industry over the past year. According to The New York Times, she plans to field a team of specialists empowered to impose penalties on malefactors with new resources aimed at encouraging competition to high-priced treatments. They would also be tasked with “monitoring” prices, presumably to begin their own shaming process for any companies that follow in the footsteps of Mylan, Valeant or Turing. Drug pricing has become a potent political issue in 2016 as the trio took aging therapies and jacked up the price. The strategy, though, is an industry standard in biopharma, where most of the big players are likely to settle for more modest price hikes once or twice a year.


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