Hello, everyone, and how are you today? We are just fine and managing to keep cool, despite the balmy temperatures in our part of the world. We hope you are doing the same. Meanwhile, we will be stepping out to participate in a forum for pharma types, so please forgive us for sporadic posting. And now, on to the main event. Here are your tidbits. Hope you have a smashing day and, as always, keep us in mind when something juicy pops up.
Despite the recent Brexit vote, GlaxoSmithKline plans to invest $360 million into its United Kingdom manufacturing network. The drug maker operates nine sites employing approximately 6,000 people. The investment will fund construction of an aseptic sterile plant for making new and existing drugs, as well as another facility for producing active ingredients for respiratory medicines.
An Arkansas legislator says Pfizer has no standing to complain that state prison officials will use its drug in executions, the Associated Press reports. Arkansas obtained vecuronium bromide for use in executions, even though the company doesn’t want its drugs used for that purpose. Representative Doug House says the state obtained the drug legally, “fair and square.” Pfizer’s only complaint might be with a vendor that sold the drug to the state.
The US Food and Drug Administration continues to reduce its backlog of generic drug applications, Regulatory Focus tells us. The agency slashed its pile of abbreviated new drug applications by about 500 applications in the first six months of 2016. Meanwhile, the agency also approved 315 more ANDAs over that same time period and sent 66 more complete responses letters — or rejections — to drug makers.
A closely watched treatment for Alzheimer’s disease fell short in a late-stage trial, marking the latest setback in a field marked by years of failure, STAT reports. The drug, which is being developed by TauRx, failed to do better than a placebo in improving patient scores on tests of cognitive and physical function, according to data presented early Wednesday at the Alzheimer’s Association International Conference in Toronto.
The FDA followed through on plans to upgrade warnings for the fluoroquinolone antibiotics by limiting their use to patients with no alternatives. The antibiotics include Johnson & Johnson’s Levaquin, Bayer’s Cipro extended-release tablets, and Merck’s Avelox. The agency had already added a black box warning in 2008 about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed.
Eli Lilly chief executive John Lechleiter, who has headed the drug maker since 2008, will retire at the end of the year and be succeeded by senior vice president David Ricks on Jan. 1.
Tokai Pharmaceuticals ended a clinical trial of an experimental prostate cancer drug after an independent committee concluded it is unlikely to meet its goal of improving progression-free survival for patients, the Boston Globe writes. Its stock dropped 78 percent.
Recro Pharma says an intravenous version of its lead painkiller was successful in the first of two pivotal late-stage trials, Reuters says, noting the news boosted shares by 50 percent in after-market trading.
Lupin, which is India’s third-largest drug maker, is in talks with Japan’s Astellas and Shionogi to buy their off-patent medicines, the Economic Times tells us.
GlaxoSmithKline bought global rights to an experimental drug from Johnson & Johnson for up to $230 million, raising a bet on a new generation of biotech medicines for severe asthma, Reuters says.
The FDA identified “significant deviations” from manufacturing standards a facility in Denmark operated by ALK-Abello, InPharma Technologist notes.