The latest global regulatory news, changes and updates affecting biopharma, including: HIV trial networks streamlined; Grants to advance use of RWD, RWE; GAO, National Academies, report on AI in health care; ICER not sold on roxadustat; Teva, Cephalon latest EC targets; Hungary looks to Russian vaccine.
The latest global regulatory news, changes and updates affecting biopharma, including: WHO maps end of the road for some tropical diseases; MHRA updates import licensing guidance.
DUBLIN – Shares in AC Immune SA were off more than 40% Sept. 23 on news that its tau-directed antibody, semorinemab, which is partnered with Genentech, failed to demonstrate efficacy in a phase II trial in Alzheimer’s disease.
LONDON - Scenic Biotech BV has signed up Genentech as first partner for its high-throughput platform for identifying genetic modifiers that can suppress or even completely block the effect of a disease-causing mutated gene, as starting points for drug discovery and development. Under the terms of the agreement, Scenic will identify modifiers in undisclosed therapeutic areas, with Genentech, part of the Roche Group, having an option to take multiple targets into development.
DUBLIN – Genentech has succeeded where Sanofi SA and its partner, Regeneron Pharmaceuticals Inc., have failed, in obtaining some sort of a positive signal from a clinical trial of an interleukin-6 (IL-6) inhibitor in COVID-19.
The FDA’s approval of Genentech Inc.’s Gavreto (pralsetinib) for treating adults with metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) follows the FDA’s May approval of Eli Lilly and Co.’s Retevmo for patients whose tumors have a RET alteration. Gavreto will be commercialized in the U.S. by Genentech, part of the Roche Group, along with Blueprint Medicines Corp., which developed the once-daily oral therapy. Outside the U.S., Roche will handle commercialization.
More than two weeks ahead of its expected PDUFA date, PTC Therapeutics Inc.’s spinal muscular atrophy (SM) drug, risdiplam, gained FDA approval, making it the first at-home, oral treatment intended for use in adults and children 2 months and older.
DUBLIN – Blueprint Medicines Corp. is banking $775 million, including $675 million up front and another $100 million as an equity investment, from a co-commercialization deal with Roche Holding AG and its Genentech subsidiary involving RET inhibitor pralsetinib. The deal also includes up to $927 million in development, regulatory and commercial milestones, $90 million of which are described as “near-term,” plus tiered royalties on ex-U.S. sales, ranging from the high-teens to mid-twenties.
DUBLIN – The Genentech arm of Roche Holding AG plans to move its interleukin-6 inhibitor, Actemra, into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection.
DUBLIN – The Genentech arm of Basel, Switzerland-based Roche Holding AG plans to move its interleukin-6 (IL-6) inhibitor, Actemra (tocilizumab), into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection.
