US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News
This article was originally published in Scrip
This past week in US regulatory, legislative, legal and political news affecting the biopharmaceutical industry included new insight into how President Barack Obama's nominee to lead the FDA, Robert Califf, would run the agency and additional questions raised ahead of his confirmation by the Republican and Democratic leaders of the Senate Health Committee; Apotex Inc.'s strategy for winning a lawsuit involving its pegfilgrastim biosimilar brought by Amgen Inc., plus how supporters of the former company think the US Court of Appeals for the Federal Circuit should rule in the case; and the move by Valeant Pharmaceuticals International Inc., which is under investigation by federal prosecutors and Capitol Hill lawmakers, to substitute Howard Schiller for ailing CEO Michael Pearson; plus other Washington news.
Califf: What Can FDA Do To Enable Innovators?
Robert Califf, who is on the verge of an expected confirmation as commissioner of the FDA, wants to make one thing perfectly clear: He has "never stated, implied or argued" the "barrier" of US regulation over medical products should be lowered or removed. But with the appropriate requirements and "barriers" in place, Califf argued it was "reasonable" to ask "what can FDA do to enable innovators" to develop new approaches and technologies, while maintaining the same standards, but reducing the cost and time, so Americans can get access to new safe and effective medical products and investors will continue to invest.
'Norplant' Ghosts Haunt Titan/Braeburn Buprenorphine Implant
Even with new data, US regulators appeared to question whether Titan Pharmaceuticals Inc. and its partner privately held Braeburn Pharmaceuticals Inc. can safely market Probuphine, a matchstick-size subdermal implant intended to deliver buprenorphine to treat opioid dependence. Investors' immediate reaction to the FDA's briefing documents, released ahead of the Jan. 12 meeting of the agency's Psychopharmacologic Drugs Advisory Committee (PDAC), was to drive shares of Titan down nearly 18% in morning trading. But the stock quickly climbed back up, gaining almost 10%, before closing at $3.52, up 8 cents, or 2.3%
Apotex Allies: Amgen's Views Distort Congress' Biosimilars Goals
If a Florida district court's ruling is upheld granting Amgen Inc.'s motion for a preliminary injunction blocking Apotex Inc. from marketing its pegfilgrastim biosimilar for 180 days after US approval, it would distort Congress' intent in enacting the Biologics Price Competition and Innovation Act, supporters of the latter company's views said in friend-of-the-court briefs.
A Biosimilar Must Say It's A Biosimilar: PhRMA/BIO
To ensure prescribers and patients are informed a product is a biosimilar and not a brand-name biologic, and to protect against any inadvertent substitution of the two, the labeling for the copycat medicines should clearly state they are indeed, biosimilars, the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization said in a new petition to the FDA.
Volatile Valeant Substitutes Schiller For Ailing CEO
With investors growing increasingly edgy over the lingering absence of Valeant Pharmaceuticals International Inc.'s ailing chairman and CEO Michael Pearson – whose hospitalization late last month due to severe pneumonia came in the midst of the company's struggle to rebuild its image after being mired in a scandal over its business practices and the ongoing investigations by Capitol Hill lawmakers and federal prosecutors – the firm's board on Jan. 6 appointed former chief financial officer Howard Schiller to take the helm in the interim.
Surprisingly, Fewer 'Expedited' New Drug Approvals In 2015
Even though the FDA's Richard Pazdur and his Office of Hematology and Oncology Products appeared to be on fire in 2015 – approving many medicines well ahead of their Prescription Drug User Fee Act action date – there were fewer applications for novel drugs and biologics overall cleared for marketing under the agency's expedited pathways than a year earlier.
June Verdict Expected For Gilead Sofosbuvir/Velpatasvir Combo
Gilead Sciences Inc. has won a priority review from the FDA for the firm's new drug application for its once-daily fixed-dose combination of sofosbuvir, a nucleotide analogue NS5B polymerase inhibitor, which is marketed as a single agent under the brand name Sovaldi, and velpatasvir, an investigational pan-genotypic NS5A inhibitor, as a treatment for chronic hepatitis C virus.
Apotex: Amgen's Biosimilar Injunction An 'Abuse Of Discretion'
A Florida district judge's decision to grant a preliminary injunction to Amgen Inc. against Apotex Inc. preventing it from marketing its biosimilar of Neulasta (pegfilgrastim) was an "abuse of discretion" and amounts to a de facto 180-day extension of the 12-year exclusivity protection for innovator drugs provided by the Biologics Price Competition and Innovation Act, the latter company said in newly filed court documents.
FDA's Califf Up For 1st Confirmation Vote Next Week
The Senate Health, Education, Labor and Pensions Committee set Jan. 12 as the day for its vote on whether to confirm former Duke University professor and researcher Robert Califf as the new head of the FDA.
This and past US Capitol Capsule columns are available at http://www.scripintelligence.com/capitolcapsule/