Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because this is quickly shaping up to be another busy stretch. The agenda includes a regulatory meeting, a congressional hearing, and ongoing intrigue at Valeant Pharmaceuticals. To cope, we are quaffing cups of stimulation. Feel free to join us. Meanwhile, here are some tidbits. Have a grand day and do keep in touch …
Click here to watch a US Food and Drug Administration advisory panel meeting that is being held Monday to review the Sarepta Therapeutics drug for combating Duchenne muscular dystrophy. The agency is under pressure to balance approval standards while endorsing drugs for unmet medical needs. Sarepta is relying on one small clinical trial with a surrogate endpoint to win approval. FDA staffers took a negative view of the drug.
Novartis is considering selling its stake in Roche, which is worth about $14 billion, Reuters reports. The move, which has been the subject of speculation for a few years, could be used to fuel mergers and acquisitions. The timing also reflects the pressure that Novartis chief executive Joe Jimenez is under to bolster growth after a slow start for the new Entresto heart failure drug and a disappointing performance from the Alcon eye care unit.
Perrigo has decided to allow Joseph Papa, the chief executive, to join Valeant Pharmaceuticals as chief executive and replace him with John Hendrickson, who is currently president, according to Bloomberg News. The Perrigo board agreed to waive a non-compete restriction in Papa’s employment contract. He joins Valeant as the beleaguered drug maker struggles to restore confidence among investors and payers.
Drug pricing will be a focus in Washington this week, The Hill tells us. Monday, the Campaign for Responsible Drug Pricing will present a slate of “policy solutions” to control price increases. Tuesday, the Center for American Progress holds a drug pricing summit, featuring Representative Lloyd Doggett (D-Texas) and representatives from AARP and Memorial Sloan Kettering Cancer Center. And on Wednesday, the Senate Special Committee on Aging will hold a hearing where Michael Pearson, the outgoing Valeant Pharmaceuticals chief executive, will testify.
Five plaintiffs suing Johnson & Johnson over its Pinnacle hip implants asked a federal judge in Texas to let them collect the full $360 million in punitive damages they were awarded last month, saying a state cap that could reduce it to less than $10 million is unconstitutional, Reuters writes.
The Medicines Patent Pool and ViiV Healthcare have extended a licensing agreement for the Tivicay HIV drug to all lower-middle-income countries.
Brexit would create regulatory uncertainty, delay the launch of biosimilars, and prevent the UK from saving money on biosimilars, a trade group argued, according to InPharma Technologist.