Pharma’s Public Image Has A Bruised Eye. This Man Wants To Restore Its Reputation.
Patrick O’Connor wants his group -- the Alliance to Protect Medical Innovation -- to be able to shine a light on pharmaceutical companies that he contends are taking big risks and developing innovative treatments to help patients. But he's facing a lot of skepticism. Meanwhile, cutting edge therapies are setting the health industry on fire, but their costs temper that excitement. In other pharmaceutical news: medication adherence, generics safety and more.
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An Industry Outsider Tries To Salvage Pharma's Bruised Reputation
Patrick O’Connor wants to emphasize that he’s not running a shadowy pharma front group. That’s why he’s attached his name to the group, the Alliance to Protect Medical Innovation, even as most of its donors have remained in the dark. It’s why he keeps repeating that the industry trade group PhRMA is not involved. And it’s why he agreed to sit down with STAT for this story, even though he cast himself as uninteresting. O’Connor is the executive director of APMI, a coalition that aims to “help educate policymakers and the public about medical breakthroughs developed by the biopharmaceutical industry.” (Swetlitz, 11/16)
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As New Therapies Arrive, Pressure Builds To Figure Out How To Pay For Them
The launch of a handful of inventive cell and gene therapies is already testing players in the health care system to figure out how to pay for them. But the real strain could be five years away, when a wave of these pioneering treatments could enter the market and overwhelm the system. That explains the growing pressure on drug companies, insurers, and others to develop value-based pricing — a mechanism to determine how much value any given therapy will provide over time. (Joseph, 11/15)
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This Biotech Wants To Make Daily Pills Last For A Week
It’s still very early, but if the company succeeds, its product may tackle a perpetual problem: medication adherence. Many people don’t take their pills as prescribed for a variety of reasons — because they’re nervous about side effects or it’s too expensive or it’s too difficult to keep track of a given regime, for example. But some researchers have found that more people stick to the program when they only have to take a drug once a week rather than every day. (Sheridan, 11/15)
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A Big Indian Generics Maker Failed An FDA Inspection, But How Bad Was It?
Two weeks ago, Dr. Reddy’s Laboratories released a very brief statement that the Food and Drug Administration had found some problems with a key plant where the drug maker hopes to produce several generic cancer medications. At the time, though, there were no details, but now the inspection report is available and the infractions do not appear to bode well for the company. During their visit last month to the facility in Visakhapatnam, India, FDA inspectors found what are called multiple repeat observations of various problems, which is regulatory parlance for manufacturing gaffes that were noted during previous inspections. In fact, half of the quality control problems that were seen had been spotted when FDA staff visited more than a year earlier. (Silverman, 11/15)
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A Veteran Of Pharma And Biotech Reflects On A Startup, Drug Prices, And Politics
Tony Coles has degrees from Johns Hopkins, Harvard, and Duke. He’s a cardiologist by training and practiced medicine at Massachusetts General Hospital. He’s a Big Pharma veteran, having spent time in executive positions at Merck and Bristol-Myers Squibb.But Coles is probably best known for his work in the biotech world. He led NPS Pharmaceuticals for a time, and then in early 2008, he was named CEO of Onyx Pharmaceuticals. It’s in this role that Coles really left his mark. He took over as CEO of the cancer drug maker when it was on some shaky ground with investors and its partner, the German pharma giant Bayer. ...Now CEO of Yumanity Therapeutics, Coles stopped by STAT’s Boston headquarters for a chat. This interview has been condensed and edited for clarity. (Feuerstein, Garde and Robbins, 11/16)
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United Therapeutics Licenses Arena Hypertension Drug For Up To $1.2B
Arena Pharmaceuticals is handing off one of its drug candidates to United Therapeutics in exchange for an eye-popping $800 million upfront payment, the company announced Thursday. The deal could ultimately be worth up to $1.2 billion. United will receive most of the rights to ralinepag, which Arena has been testing for pulmonary arterial hypertension. The drug is currently in Phase 3 clinical trials. (Sheridan, 11/15)
