Blueprint Medicines Corp. found a new U.S. commercialization home for Gavreto (pralsetinib) through an agreement with Rigel Pharmaceuticals Inc. potentially worth $117.5 million, now that Roche Holding AG has relinquished all rights. The product, a once-daily oral small-molecule kinase inhibitor of wild-type RET (rearranged during transfection) and oncogenic RET fusions, received accelerated approval in 2020 by the U.S. FDA, under priority review and with orphan drug designation, to treat adults with metastatic RET fusion-positive non-small-cell lung cancer. Read More
In its second big collaboration of the past six months, privately held Tentarix Biotherapeutics LP plans to discover and develop biologics for treating oncology and immunology indications with Abbvie Inc. The deal comes at a time of change at Abbvie, which is getting a new CEO, watching the marketplace erosion of bestselling Humira (adalimumab) and digesting two major acquisitions at a cost of billions. Read More
Instead of inter partes review (IPR) being a streamlined alternative to costly patent litigation as intended, a precedential decision by the U.S. Circuit Court of Appeals for the Federal Circuit could make appeals of IPR decisions, regardless of their merits, another way to delay competition. Read More
As chronic drug shortages continue in the U.S., yet another congressional investigation into the problem has been launched. But instead of a wholistic search for the root causes, this one, launched by the Democratic members of the House Oversight Committee, focuses on three drug companies – Pfizer Inc., Sandoz Inc. U.S. and Teva Pharmaceuticals USA Inc. Read More
Kazia Therapeutics Ltd. stopped its two-part paxalisib plus radiotherapy phase I trial early based on positive safety and promising clinical responses in patients with phosphoinositide 3-kinase pathway mutation brain metastases from solid tumors. The company plans to meet with the U.S. FDA to discuss a pivotal registrational trial. Read More
Discover a wealth of industry insights with BioWorld’s extensive collection of infographics, covering the latest trends and developments in both biopharma and med-tech. Our weekly infographics are curated to provide concise summaries of key topics: financings (IPOs, private financings, public/other and follow-on offerings), deals and M&As (top deals, and monthly value and volume), regulatory (including U.S. FDA and worldwide approvals), clinical trials and more. In addition, you’ll find access to BioWorld’s year-in-review reports, as well as special infographics about obesity, pain and addiction, biosimilars and the aging space. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astrazeneca, Atyr, BMS, Gracell, Immune-onc, Immunocore, Roche. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cantargia, Ensysce, Janssen, Jcyte, Regeneron, Treadwell. Read More
