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Good morning, everyone, and welcome to another working week. We hope the weekend respite was fruitful and relaxing, because that familiar routine of meetings, deadlines and whatnot has returned. But you knew this would happen, yes? As always, we are coping with a cup or three of stimulation and foraging for interesting items. On that note, here are some tidbits to help you along. Have a smashing day and please do keep in touch …

Drug makers are making big bets on cancer immunotherapies that appear unprecedented in scale and scope, the Cancer Letter writes. The database lists 803 registered trials — testing 20 drugs — that are in various stages of completion and have slots for more than 166,700 patients. Merck has 50 percent more trials running for its Keytruda drug than Bristol-Myers Squibb does for Opdivo, notes Sanford Bernstein analyst Tim Anderson.


Valeant Pharmaceuticals plans to raise prices of neurology, urology, and gastrointestinal drugs between 2 percent to 9 percent, effective immediately, but committed to leaving prices for its eye and skin drugs at current levels. The move is designed to keep price hikes to single-digit percentages, although it is worth noting that Valeant recently raised prices for three eye drugs by 9.9 percent.

Device makers are required to report to the Food and Drug Administration whenever they learn that a product may have injured someone, but the FDA has accepted late reports, the Minneapolis Star-Tribune reports. And these reports to the FDA cover hundreds of thousands of incidents, sometimes years after the incident occurred, and has created a program that lets device makers keep the details out of view.

The Obama administration released new rules that will make it easier for Cuban drug makers to obtain FDA approval for their medicines and US citizens to conduct joint medical research with Cuban nationals. The move is part of a larger effort by the administration to ease trade, travel and financial restrictions that have been in place for decades.


The New York City public hospital system struck a deal with Merck to purchase its Zepatier hepatitis C drug at a discount, Politico reports. The discount was not revealed, but combined with additional funding from the city, the arrangement is expected to treat 100 patients, three times more than currently. The program budget is $4.4 million this fiscal year, which means the public hospital system will spend roughly $44,000 per inmate on hepatitis C drugs.

PTC Therapeutics says the FDA denied its appeal of the agency’s rejection earlier this year of its Duchenne muscular dystrophy treatment. The drug maker intends to escalate its appeal to the “next supervisory level” at the FDA and anticipates that “multiple cycles of appeals to progressively higher levels of the FDA may be required.” PTC believes that an advisory committee meeting should be held to review trial data.

Vertex Pharmaceuticals is getting an additional $75 million in funding from the Cystic Fibrosis Foundation, the Boston Globe writes. The drug maker will also receive up to $6 million a year for developing new cystic fibrosis medicines under an amended research agreement. The nonprofit foundation previously invested $120 million to company develop the Kalydeco and Orkambi treatments to market, and also received royalties based on sales.

Regeneron Pharmaceuticals and Teva Pharmaceuticals say the FDA placed a clinical hold on a mid-stage study of their experimental drug for chronic lower back pain, Reuters writes.

An experimental Celgene pill for Crohn’s disease helped more patients than Wall Street expected, reinforcing positive results of an earlier study and likely boosting confidence in chances of approval, Bloomberg News says.

Doctors Without Borders is asking the 16 countries that are negotiating the Regional Comprehensive Economic Partnership trade agreement to reject any terms in the deal that will harm access to medicines.

  • Technically, the NDA from PTC was not a “rejection”. The FDA issued a “Refusal to File”, which means the application was so bad that the agency would not even review it. Very few applications receive this distinction. Until the FDA files the application none of PTC’s remonstrations will be relevant.

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