Hello, everyone, and how are you today? A warm, shiny sun is enveloping the serene Pharmalot campus, which is exceedingly quiet, since the official mascots are snoozing on the office furniture and the local water company is drilling elsewhere. We are reveling in the calm by enjoying a few cups of stimulation and, of course, invite you to join us. No prescription is required. Meanwhile, here are some tidbits. Have a smashing day and do stay in touch …
Sanofi filed papers with the US Securities and Exchange Commission to remove and replace each member of the Medivation board with eight independent candidates. The move comes one month after Sanofi made a $9.3 billion offer that Medivation has repeatedly rebuffed. “This has left us no choice,” said Sanofi chief executive Olivier Brandicourt. You can see the list of people he is suggesting for the board right here.
The SEC reviewed Valeant Pharmaceuticals’ accounting practices and criticized certain disclosures as “potentially misleading,” according to newly revealed correspondence between the agency and the drug maker, the Wall Street Journal says. “This correspondence is concerning, as it shows, in our opinion, the SEC’s lack of comfort with and its criticism of Valeant’s reporting,” Wells Fargo analyst David Maris wrote to investors.
Novartis chief executive Joe Jimenez says the drug maker is willing to sell its nearly $14 billion stake in Roche without demanding a premium, according to Reuters. Meanwhile, Novartis executives told a meeting of investors and analysts that they are confident the Entresto heart failure drug, which has met resistance from payers and physicians in the US, will eventually generate $5 billion in annual sales (here is the slideshow).
A US Food and Drug Administration advisory panel Tuesday voted 16-0 to recommend approval of a new diabetes drug made by Novo Nordisk, Reuters informs us. The medication, called iDegLira, combines two of its existing treatments — the Tresiba insulin and the Victoza GLP-1 agonist — in a fixed-dose for patients with type 2 diabetes. Wednesday, the panel will review a similar drug from Sanofi.
The Colombian government appealed to the World Health Organization to help it override the patent on a Novartis cancer drug, which would allow the country to buy cheaper, generic versions for its citizens, Colombia Reports tells us. The move comes after staff from the US Senate Finance Committee and the US Trade Rep’s office pressured the Colombian embassy in Washington, D.C., not to proceed.
India’s Delhi High Court has again asked Roche to explain why it is suing the Drug Controller General of India and Hetero Drugs over the approval of a biosimilar version of its Avastin breast cancer drug, the Economic Times says. Roche argued that Hetero’s drug is not a biosimilar and so should not be allowed to use bevacizumab, the chemical name for the drug, to market it in the country.
UK cost regulators backed the use of three type 2 diabetes treatments: Janssen’s Invokana, AstraZeneca’s Forxiga, and Jardiance from Boehringer Ingelheim and Eli Lilly, Pharma Times writes.
Croatian regulators say that a pharmaceutical ingredients plant operated by Dhanuka Laboratories does not comply with good manufacturing practices, according to InPharma Technologist.
Pfizer and the borough of West Chester, Pa., settled long-running litigation over maintenance of a waste water treatment plant, according to the Daily Local.