Hello, everyone, and how are you today? We are just fine, thank you. The shortest of short people has left for the local schoolhouse, and the official mascots are happily snoozing away. As for us, we are quaffing more cups of stimulation and tackling our to-do list. No doubt, you can relate. So time to get cracking. As always, here is the latest menu of tidbits. Hope your day goes well and you conquer the world. Good luck …
Pfizer is in advanced talks to buy Allergan for as much as $380 per share, or $150 billion, in what would be the drug industry’s largest-ever deal, Bloomberg News reports. At the same time, US Treasury Secretary Jacob Lew wrote a letter to four lawmakers that the Obama administration plans to release “targeted guidance to deter and reduce” the economic benefits of tax inversions. Pfizer is pursuing an inversion to lower its tax rate, a controversial move.
Two years after retiring most of its research chimps, the US National Institutes of Health is now ending the program entirely, according to Nature. The 50 remaining chips will be sent to sanctuaries. “I think it is a significant moment,” NIH director Francis Collins told STAT. “The conclusion seems to have been very strongly leaning in the direction of saying it’s better to stop.”
All sorts of treatments have jumped in price as common hospital drugs are increasingly, and often critically, in short supply, Bloomberg News reports. The reasons for shortages are varied: problems at manufacturing plants that spurred an ongoing FDA crackdown on quality control, companies exiting markets for more lucrative opportunities, and fewer producers following mergers and acquisitions.
The European Union is willing to discuss its ban on 700 drugs as a separate matter so that stalled negotiations on a free-trade agreement can resume, The Economic Times reports. India postponed trade talks in August after the EU banned 700 generic drugs that were tested by GVK Biosciences. An inspection by French regulators questioned the reliability of clinical trial data performed by the contract research organization.
Companies that run clinical trials may be required to post consent forms publicly under new rules proposed by the US Department of Health and Human Services, Outsourcing Pharma says.
Immuno Biotech chief executive David Noakes was found guilty of sex discrimination and ordered to pay about $16,000 for inappropriate remarks made about his former personal assistant, The Telegraph reports.
The Food and Drug Administration approved the first nasal spray — a form of naloxone — for reversing opioid overdoses, according to STAT.
Pfizer and Servier bought the rights to CAR T cell therapy developed by Cellectis for fighting blood cancers, according to Reuters.
Hikma Pharmaceuticals brought its injectables factory in Portugal back into compliance after a warning from the FDA over quality problems, Reuters says.
Drug makers in India have until Dec. 15 to register with a database that will be used to generate reports analyzing production, imports, and pricing, The Economic Times says.
The UK’s National Institute for Health and Care Excellence has OK’d Bayer’s Xofigo for treating certain patients with prostate cancer, but only after chemotherapy, Pharma Times writes.
European regulators may decide Friday whether to approve a biosimilar version of Enbrel that was developed by Samsung Bioepis, according to Reuters.