Enacting provisions to control U.S. prescription drug prices remains a top priority with many members of Congress as they push through the Biden administration’s budget agenda – despite warnings that government price controls on drugs would come at the cost of innovation.
Abbvie Inc. and Regenxbio Inc. have announced a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy and other chronic retinal diseases. Under the terms of the agreement, Abbvie will pay Regenxbio $370 million up front, plus up to $1.38 billion in additional development, regulatory and commercial milestones. The deal gives '314 – already the most advanced gene therapy in wet AMD – another potential edge against its nearest competitor, Adverum Biotechnologies Inc.’s ADVM-022.
In another cautionary tale for JAK inhibitors, the U.S. FDA is requiring updated boxed warnings for three drugs in the class that are approved to treat inflammatory conditions – Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and Abbvie Inc.’s Rinvoq (upadacitinib).
Pfizer Inc. reported on Aug. 30, 2021, that its JAK inhibitor, abrocitinib, beat Dupixent (dupilumab, Regeneron Pharmaceuticals Inc./Sanofi SA) in a head-to-head study of patients with moderate to severe atopic dermatitis. In the JADE DARE study, a higher percentage of patients taking abrocitinib had a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline to week two compared to Dupixent.
The U.S. Federal Trade Commission (FTC) has made no secret of its intent to tighten its oversight of merger and acquisition (M&A) activity, an emphasis that has already been felt in the med-tech space. Soliton Inc., of Houston, said in its latest 8-K filing that the FTC wants to see more information about plans for the company to be acquired by Allergan Aesthetics plc, a demand that at the very least will delay – and potentially derail altogether – the acquisition.
LONDON – Mission Therapeutics Ltd. has honed down a collection of 100-odd deubiquitylating (DUB) enzymes, to identify two that degrade misfolded proteins in Parkinson’s and Alzheimer’s diseases, triggering a $20 million milestone from partner Abbvie Inc.
Citing a unanimous U.S. Supreme Court ruling in April that denied the Federal Trade Commission’s (FTC) ability to seek restitution or disgorgement, the FTC, on July 30, withdrew its remaining count against Abbvie Inc. involving sham litigation intended to delay generic competition to its blockbuster testosterone replacement drug, Androgel.
More than a decade after the Biologics Price Competition and Innovation Act became law and nearly six years after the first biosimilar launched in the U.S., the country’s first potential interchangeable is on deck awaiting an FDA decision.
The M&As that are the current business model of the drug and device world are in for increased scrutiny under the executive order U.S. President Joe Biden signed July 9. Answering the administration’s call for a whole-of-government-approach to increasing competition in the U.S., the Department of Justice “will closely examine its antitrust guidelines and policy statements to better educate the public on its enforcement priorities, and it will heighten its efforts to prevent mergers that would result in excessive consolidations of purchasing power,” U.S. Attorney General Merrick Garland said.
U.S. Rep. Carolyn Maloney (D-N.Y.) came out swinging against the biopharma industry’s innovation talking point July 8 when she released a House Oversight Committee staff report on U.S. drug prices and the games drug manufacturers play to delay competition.