Rise and shine. Another busy day is on the way. And this appears it will also be a steamy one here on the Pharmalot campus, where the short people are sleeping in and the official mascots are chatting around the water bowl. As for us, we are motoring along thanks to a few cups of stimulation. As always, you are invited to join us. And of course, here are a few items of interest to help you along. Have a great day, everyone, and do keep in touch …
Medivation signed confidentiality agreements with Sanofi and other drug makers, including Pfizer and Celgene, that are interested in buying the company, the Wall Street Journal writes. At the same time, Medivation rejected a sweetened bid from Sanofi, which initially made a $9.3 billion hostile offer. Sanofi had increased its offer from $52.50 a share to $58.00, plus another $3.00 in the form of a contingent value right.
Quest Life Sciences may appeal a decision by the UK’s Medicines and Healthcare products Regulatory Agency to suspend marketing for drugs that were approved based on its clinical studies, Reuters reports. The regulator suspended marketing authorizations over data integrity concerns at the contract research organization, which maintains its quality control has been updated since the 2014 inspection.
Wall Street is questioning whether Joseph Papa, the new chief executive at Valeant Pharmaceuticals, can succeed in revitalizing the beleaguered drug maker, the Wall Street Journal says. In his previous role running Perrigo, Papa relied, to some extent, on big price hikes for certain drugs, a move that undermined Valeant. Since he joined the company on May 2, Valeant stock has fallen about 40 percent.
The European Medicines Agency forwarded an update to an inquiry into Roche for failing to comply with reporting procedures for 19 of its products. The European Commission will decide whether to pursue the case and impose financial penalties. Meanwhile, the EMA has not identified any important new safety concerns and its review did not lead to any changes in marketing authorizations, according to this notice.
The Obama administration is increasing the number of patients that doctors can treat for opioid addiction with buprenorphine to 275 from 100, the Wall Street Journal tells us. The restrictions were instituted to thwart black market trade, but the limits have left many patients unable to find a doctor who can prescribe them the drug. About 650,000 Americans received buprenorphine to treat opioid addiction in 2014.
There is concern whether commercial institutional review boards can effectively serve as human subject safety nets and protect the hundreds of thousands of people who enroll in clinical trials each year, STAT writes. The issue arises as the National Institutes of Health wants US-funded trials that are conducted at multiple research centers to use just one review board.
Bristol-Myers Squibb agreed to pay up to $520 million to buy Cormorant Pharmaceuticals and gain access to a cancer drug pipeline, Xconomy informs us.
The US Food and Drug Administration accepted an application for injectable and oral treatments for community-acquired bacterial pneumonia from Cempra, which hopes to win approval later this year.
Sanofi and the US Army formed a partnership to expand research and development of an experimental Zika vaccine that has shown promise in early laboratory studies, Reuters reports.
Kidney Cancer UK wants the National Institute for Health and Care Excellence to reverse a preliminary decision to bar patients with kidney cancer from access to the Opdivo immunotherapy, PharmaTimes writes.
The FDA approved an absorbable heart stent from Abbott Laboratories called Absorb that cardiologists call a significant advance in treating coronary artery disease, the Wall Street Journal says.
Bind Therapeutics, which is in bankruptcy proceedings, reached a deal to sell most of its assets to Pfizer for $20 million, according to PMLive.