Rise and shine. Another busy day is on the way. And it is also a noisy one here on the sunny and breezy Pharmalot campus, thanks to the return of the local water company and its sewer project. We plan to cope by quaffing cups of stimulation. Feel free to join us for whatever reason motivates you. And now, on with the show. As always, here are some tidbits. Hope your day goes well and you conquer the world …
French prosecutors have started an involuntary manslaughter investigation in connection with a trial in which one volunteer died and five others were hospitalized, Le Figaro reports. Although investigations by other authorities indicated the drug given trial participants was not adulterated and the study protocol was followed, prosecutors want to know if criminal mistakes were made or whether the tragedy was the result of clinical risks involved.
GlaxoSmithKline’s Moncef Slaoui, who runs the vaccines division and has spent nearly 30 years with the drug maker, plans to retire next year, Bloomberg News notes. The decision comes as Glaxo chairman Philip Hampton searches for a new chief executive to replace Andrew Witty, who is leaving next March amid consternation over the strategic direction he has taken the company.
As an Aug. 2 vote nears on Sanofi’s hostile, $9.3 billion bid for Medivation, the companies sent dueling letters to Medivation shareholders Monday, TheStreet writes. Sanofi argued that Medivation management is diminishing their holdings by rejecting the bid. Medivation fired back by that value can be created with its existing plan. Analysts say that Sanofi should simply increase its offer.
India’s Central Drugs Standards Control Organization is planning to draft a new Drugs & Cosmetics Act in order to get up to speed with global regulatory authorities, PharmaBiz tells us.
A KemPharm opioid painkiller was rejected by the US Food and Drug Administration one month after an agency advisory panel recommended approval, Reuters says.
Catalyst Pharmaceuticals reached agreement with the FDA on a confirmatory Phase 3 protocol for its Firdapse treatment for Lambert-Eaton myasthenic syndrome and hopes to start the trial this year.
The UK’s Medicines and Healthcare products Regulatory Agency found manufacturing problems at an Akums Drugs & Pharmaceuticals plant in India, InPharmaTechnologist reports.
Reliance Lifesciences has launched the world’s first biosimilar version of Avastin in India, according to the Economic Times.
A former Merck employee remains free on $10,000 unsecured bail while awaiting sentence for allegedly stealing a mechanism that controlled machinery at a Pennsylvania plant, the Intelligencer writes.
Shire is buying the rights to a drug for treating inflammatory bowel disease from Pfizer, according to Reuters, which adds the medicine has completed mid-stage studies.