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Pharmalot.. Pharmalittle.. Good Morning.. Catching up on Valeant, Allergan, Novartis and..

leaves pic thx to oregon dept of transportation on flickr creative commons [1]

leaves pic thx to oregon dept of transportation on flickr creative commons

Hello, everyone, and how are you today? We are doing fine, thank you, especially given that this is the middle of the week. Perhaps you can relate. Of course, we will forge ahead, as always, since the alternatives appear bleak. This calls for a cup of stimulation, though, and so we invite you to join us. By the way, we would like to note that, next week, we will shift over to Stat [2], so please adjust your reading habits. Meanwhile, here are some tidbits. Have a smashing day…

Valeant Pharmaceuticals is offering discounts and, in some cases, giving dermatological drugs away for free in a bid to retain market share, Bloomberg News [3] writes. The drug maker says it is holding talks with payers, but specifics were not revealed. Investors, meanwhile, are concerned about debt covenants, The Wall Street Journal [4] says. And many of Canada’s top money managers are keeping client cash away from its stock, Business News Network [5] reports.

The Japanese health ministry plans to censure Novartis for failing to report serious side effects from some of its drugs within a certain period of time, The Japan Times [6] reports. The case centers on side effects observed in around 5,500 patients, which should have been reported to the state within a few weeks of discovery. This would be the third administrative penalty to be imposed on the company over its reporting delays.

Pfizer and Allergan are moving toward a plan to make Brent Saunders chief executive officer if the two drug giants reach a takeover agreement, according to Bloomberg News [7]. A combined drug maker would probably split into two companies eventually, with Allergan chief executive Saunders taking the helm of the faster-growing business of new brand-name drugs. The other unit would contain older products at or near the end of their patent lives.

India has taken step to ease norms for testing and clinical trials needed for introduction of drugs already approved in other countries, The Economic Times [8] tells us. The move – announced in this notice [9] – places greater responsibility on the official Ethics Committees, which vets clinical trials, and is expected to cut timelines for launch of new medicines, including biologics. Drug makers have long lobbied against repeat tests and data submissions.

Allergan chief executive Brent Saunders says some drugmakers are getting the scrutiny they deserve over how much they charge for their products. “There are a few companies that were very aggressive and perhaps took it too far, and deserve the attention they are getting,” he told Bloomberg News [10]. “I think it’s good. Transparency helps solve some of these issues.”

Robert Califf, who has been nominated as FDA commissioner, will be vetted next Tuesday during a hearing to be held by the US Senate Health, Education, Labor and Pensions Committee.

Drug makers are finding it difficult to recruit for high skilled roles in the UK because of a shallow pool of good quality candidates, raising the country’s standing in global R&D will be weakened, Pharma Times [11] says.

The FDA approved Roche’s Cotellic to be used in combination with its Zelboraf drug to treat BRAF V600 mutation-positive advanced melanoma, Reuters [12] reports.

MiRagen Therapeutics landed $41 million in venture backing to take a pair of experimental drugs into clinical development, The Denver Business Journal [13] writes.