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On the heels of Merck’s and BMS’ lawsuits, the pharma industry’s lobbying group Wednesday filed a complaint in federal court asserting that the price-setting provisions in the Inflation Reduction Act are unconstitutional.
The Huntington’s disease space saw a flurry of activity Wednesday as PTC and uniQure released data from their respective mid-phase trials.
FDA
Argenx’s Vyvgart will now be available in the U.S. as a more convenient subcutaneous formulation 18 months after its first approval.
The startup launches with $50 million to improve its Chemilogics platform, which is designed to speed up the identification and development of small molecule drug candidates.
Here are the top biotech companies in California hiring now on BioSpace’s life sciences–focused job board.
FDA
The FDA has approved Jardiance and Synjardy as the first SGLT-2 inhibitors to treat pediatric Type 2 diabetes, providing a new class of oral medicines.
Following an FDA warning in May, Novo Nordisk has filed several lawsuits against spas, clinics and pharmacies selling compounded version of semaglutide.
An International Chamber of Commerce arbitration tribunal has dismissed Boehringer’s attempt to seek indemnification from Sanofi for the ongoing Zantac lawsuits faced by the companies.
Biopharma executives suggested that some companies might seek to bypass the U.S. government’s national health insurance program altogether, among other sweeping changes to drug development.
The latest round of layoffs comes just two months after Thermo Fisher announced plans to close three sites in San Diego, bringing the total to nearly 600 jobs cut in 2023.
The study participant who died was apparently ineligible for the treatment according to the trial protocol, Arcellx announced Monday. The company has since retrained the study’s clinical sites.
Eli Lilly stands to gain access to DICE Therapeutics’ DELSCAPE platform, which enables the design of orally available molecules for autoimmune and inflammatory diseases.
FDA
Following the FDA’s approval in March, India-based Lupin is launching its generic thiamine hydrochloride injection USP in the U.S. for treating vitamin B1 deficiency.
As geopolitical tensions rise in the region, AstraZeneca is looking at potentially spinning off its China unit into its own independent business.
While the German biotech that partnered with Pfizer on a COVID vaccine sees its first lawsuit, legal experts don’t expect similar cases in the U.S.
Following disappointing Phase IIb results, BioSenic is pausing the development of its tibial fracture cell therapy ALLOB derived from mesenchymal stem cells.
In the first head-to-head trial of CGRP antagonists, Lilly’s Emgality failed to demonstrate that it was significantly better than Pfizer’s Nurtec ODT at easing migraine headaches.
On the heels of a legal challenge to the Inflation Reduction Act by Merck, Bristol Myers Squibb on Friday filed its own lawsuit claiming that the law’s drug price negotiation provision is unconstitutional.
The company reported results Friday from the KEYNOTE-811 trial in which the anti-PD-1 therapy took an important step toward FDA approval for rare esophageal tumors.
The data for Reproxalap, Aldeyra Therapeutics’ drug for treating allergic conjunctivitis and dry-eye disease, could potentially pave the way for an alternative to over-the-counter eye drops.