Rise and shine, everyone, another busy but beautiful day is unfolding. And what better way to confront the challenges and possibilities than with a delicious cup of stimulation. We are quaffing a few ourselves, to be candid. The neurons can never get enough. Meanwhile, we would like to wish Mrs. Pharmalot a special birthday greeting. And now, time to get cracking. Here are some tidbits for you. Have a great day and do keep in touch …
Bristol-Myers Squibb suffered a setback in the UK, where the National Institute for Health and Care Excellence is not recommending coverage of its Opdivo drug for treating lung cancer, Pharma Times reports. The watchdog agency rejected coverage even after the drug maker offered several schemes to make Opdivo more cost-effective, including funding treatment after the first year.
Drug regulation has failed to keep up globalization, and governments need to harmonize oversight to improve patient access to new and innovative medicines, according to an essay in Science Translational Medicine by former US Food and Drug Administration commissioner Margaret Hamburg and Elias Zerhouni, who heads R&D at Sanofi (SNY) and is a former director of the US National Institutes of Health.
A Kentucky judge ordered documents about the marketing of the OxyContin painkiller to be unsealed, writes STAT, which went to court to force this move. The documents include the deposition of Dr. Richard Sackler, a former president of Purdue Pharma, which sells the addictive painkiller, and a member of the family that owns the privately held Connecticut company.
Theranos president and chief operating officer Sunny Balwani, who helped build the company into a major blood-testing lab, is leaving the company, the Wall Street Journal reports. He departs amid regulatory probes of the embattled firm and a subsequent reorganization. The company is also expanding its board, adding three members to beef up its scientific and medical expertise.
The UK Competition and Markets Authority, which is the government antitrust watchdog, is investigating whether an Allergan (AGN) subsidiary violated competition law by abusing its market dominance through the sale of hydrocortisone tablets, according to a US Securities and Exchange Commission filing on page 64.
FDA commissioner Dr. Robert Califf told an industry conference that he wants to develop a system for “real world evidence generation that can meet the demands of the next few decades,” according to Regulatory Focus.
AstraZeneca (AZN) said the FDA granted orphan status to its selumetinib cancer drug for treating late-stage thyroid cancer.
Bristol-Myers Squibb and AbbVie’s immunotherapy Empliciti was endorsed by the European Union for treating multiple myeloma, according to Pharma Times.
Gilead Sciences (GILD) says winning patent rights to its Sovaldi treatment in India should not change pricing there since the company already has a generic licensing program underway, the Economic Times says.
Grupo Ferrer Internacional agreed to pay almost $55 million to purchase Alexza Pharmaceuticals and its portfolio of central nervous system treatments, Genetic Engineering & Biotechnology News says.