The FDA sent a complete response letter (CRL) to Allergan plc, an Abbvie Inc. company, and Molecular Partners AG, of Zurich, Switzerland, regarding the BLA for abicipar pegol, their VEGF-A inhibitor-Darpin therapy for patients with wet age-related macular degeneration (AMD).
LONDON – Sosei Heptares has attracted a third pharma partner to its G protein-coupled receptor (GPCR) discovery platform, signing a potential $1 billion-plus deal with Abbvie Inc. in inflammatory and autoimmune diseases.
The worldwide option and license agreement Alpine Immune Sciences Inc. drew up with Abbvie Inc. for ALPN-101, a dual CD28/ICOS co-stimulation antagonist for treating systemic lupus erythematosus and other autoimmune diseases, heartily strengthened Alpine’s stock and supports its planned operations into 2023.
DUBLIN – Shares in Genmab A/S gained 5% during trading on Nasdaq June 10 on news of an oncology alliance with Abbvie Inc., in which it is banking $750 million up front and up to $3.15 billion in development, regulatory and commercial milestones for up to seven next-generation antibody-based therapeutics.
BEIJING – Five-year-old Jacobio Pharmaceuticals Co. Ltd., of Beijing, has found itself a strong global partner to help advance its two SHP2 inhibitors, JAB-3068 and JAB-3312, both financially and later in the regulatory process. The Chinese startup will work with pharma giant Abbvie Inc., of North Chicago, to develop and commercialize the programs.
CYBERSPACE – At a series of new drugs on the horizon sessions at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting I, a variety of companies presented preclinical and clinical data for promising early stage oncology products.
Given the evolving COVID-19 situation, U.S. House committee chairs are asking the White House Office of Management and Budget (OMB) to direct federal agencies to immediately extend all public comment periods by at least 45 days beyond the end of the declared national emergency, whenever that may be.
Following a public backlash to Monday’s news that the FDA had granted Gilead Sciences Inc. an orphan drug designation for remdesivir, an antiviral in development to treat COVID-19, the Foster City, Calif., company is taking the unprecedented step of rescinding its request for the designation.
