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The U.S. Department of Justice has slapped BioMarin Pharmaceutical with a subpoena in connection with its sponsored testing programs for the rare disease therapies Vivizim and Naglazyme.
Despite a patent extension, Merck’s muscle relaxant reversal injection is now facing potential generic competition from Hikma Pharmaceuticals, which is seeking the FDA’s approval for a copycat version.
The oral antibiotic, which is also in development for uncomplicated urinary tract infections, demonstrated non-inferiority to the most common treatment for gonorrhea.
Boehringer Ingelheim and Zealand Pharma’s dual glucagon/GLP-1 receptor agonist elicited significant topline Phase II results in metabolic dysfunction-associated steatohepatitis.
Approved earlier this month for children and adults with one or more food allergies, Xolair in a Phase III study reduced severe allergic reactions in patients suffering from multiple food allergies.
Johnson & Johnson and Legend Biotech got a positive opinion from a European Medicines Agency panel for earlier lines of treatment, as they ready for a March FDA advisory committee meeting.
On Friday, Alvotech and Teva Pharmaceuticals finally secured the FDA’s greenlight for their Humira biosimilar Simlandi, which now has the regulator’s interchangeability designation.
Representing Denali Therapeutics, I recently participated in a workshop that brought together FDA representatives, patient advocates, academic physicians and scientists and industry to discuss strategies to speed therapies for patients with rare degenerative illnesses.
GSK terminated their collaboration with Vir to research, develop and commercialize the biotech’s monoclonal antibodies for the prevention, treatment, or prophylaxis of the influenza under a 2021 agreement.
German-based Earlybird Health discussed its plans with BioSpace for its latest venture capital fund that will finance early-stage to late-stage European companies including biotech.
The cancer space has been aflutter with notable approvals so far this year, but there are several more candidates with significant data expected over the next four months. BioSpace takes a closer look.
Thanks to the success of outgoing CEO Richard Gonzalez, biopharma executives will be studying for years to come how AbbVie navigated the decline of blockbuster Humira.
PRESS RELEASES
ZEISS and Concept Life Sciences announce partnership
Dr. Young brings more than 30 years of drug discovery leadership and expertise, as Terray’s AI-driven internal and partnered programs continue to accelerate toward patients in need
Advances INM-901 program, addressing multiple key biological pathways implicated in Alzheimer’s disease pathology Further develops INM-089 demonstrating neuroprotection in the treatment of dry Age-related Macular Degeneration Cash of $11.1M to support pharmaceutical developments into the fourth quarter of calendar year 2026
Registration Link Below for September 30, 2025 12 PM EST Presentation and Live Q&A