Good morning, everyone, and how are you today? We are just fine, thank you, and busy as ever. We are, in fact, on the road as we plan to huddle with the Stat folks about the upcoming launch of the Stat site, which is where we will be housed. This calls for a celebratory cup of stimulation and, as always, we invite you to join us. And now, we present your daily menu of tidbits. Hope your day goes well and, of course, keep in touch…
A new deadline of Nov. 16 was set for the FDA and Pacira Pharmaceuticals to try to resolve a closely watched legal battle over off-label marketing and free speech, according to a court document. Pacira recently filed a lawsuit accusing the agency of overstepping its authority to thwart inappropriate marketing. The drug maker argues that the FDA has retroactively attempted to narrow the approved product labeling for a painkiller.
A GlaxoSmithKline plant in China, which suffered an explosion last summer, had its Good Manufacturing Practice certificate revoked by the UK medicines regulator, InPharma Technologist tells us. However, the drug maker was experiencing problems going back as far as 2005, including discoloration in stability samples, yet the regulator noted no action was taken.
Sanofi’s new ceo Olivier Brandicourt is expected to show how he will get the drug maker back on track, after being hit by lagging diabetes sales and boardroom rows, when he presents his five-year strategic plan on Nov. 6, Reuters says. And Diabetic Investor writes that Sanofi may announce cutbacks as part of a reorganization and speculates whether the deal to market the Afrezza inhaled insulin, which has not fulfilled its promise, may be scrapped.
African heads of state plan to urge Indian Prime Minister Narendra Modi to resist growing pressure from the US and Western drug multinationals on India to stop exporting cheap generics to Africa, The Wire writes.
A former sales representative for Biomet, now part of Zimmer Biomet, filed a lawsuit claiming his former employer fired him for blowing the whistle on an alleged kickbacks scheme, Mass Device informs us.
Perrigo ceo Joseph Papa believes that shareholders are unlikely to accept a hostile $27.1 billion takeover bid from Mylan, according to Bloomberg News.
Merck’s approved Keytruda lung cancer treatment provided superior overall survival to chemotherapy in a late-stage study of patients with advanced disease whose tumors produce the PD-L1 protein, Reuters reports.
The number of clinical trials approved in Russia has increased 13% in the third quarter of the year, which could be thanks in part to a reduction in red tape, Outsourcing Pharma writes.
The FDA says there is no evidence of increased cardiovascular risks related to Stalevo, a Novartis treatment for Parkinson’s disease, according to Reuters.
The FDA approved Johnson & Johnson’s chemotherapy to treat specific soft-tissue sarcomas that have spread to other parts of the body or cannot be removed by surgery, Reuters tells us.Print This Post