It was a busy week for the U.K.’s drugs regulator, the Medicines and Healthcare Products Regulatory Authority (MHRA), which fast tracked decisions on novel drugs for cancer and eczema and made a ruling on booster COVID-19 jabs from Astrazeneca plc and Pfizer Inc. But even as Prime Minister Boris Johnson tweeted his support over the approval of Amgen Inc.’s cancer drug Lumykras, there are questions over the future of the regulator as it faces a round of job cuts because of a lack of funding following Brexit. Read More
Apellis Pharmaceuticals Inc.’s win with one phase III trial and narrow miss with an identical one testing pegcetacoplan in geographic atrophy secondary to age-related macular degeneration caused Wall Street to punish the company while rewarding competitor Iveric Bio Inc. Read More
Shares of antibody drug conjugate developer Mersana Therapeutics Inc. (NASDAQ:MRSN) fell 39.1% to $8.56 on Sept. 10 after the company disclosed a second death from pneumonitis in the ongoing phase I trial testing its antibody drug conjugate, upifitamab rilsodotin against tumor types likely to express the sodium-dependent phosphate transport protein NaPi2b, such as ovarian cancer. Read More
Delivering antibodies in the form of their DNA could enable their therapeutic use under several circumstances where traditional antibodies fall short. One of those is resource-poor settings where the current cost of antibodies makes them a nonstarter. Perhaps the largest opportunity to expand antibody use in such settings is for HIV, where broadly neutralizing antibodies have the potential to be the next best thing to a vaccine or a cure – if they can be made to last, for cheap. Read More
Lucrative partnerships lately in the targeted protein degradation (TPD) space have shone an even brighter light on the already-intriguing approach, and among the firms to spark enthusiasm is Monte Rosa Therapeutics Inc., pursuing programs aimed solely at drugs that deploy molecular “glue” – an E3 ligase enzyme affixed to a target substrate. Read More
DUBLIN – In biopharma, U.S. patent grants hardly represent big news. Without them, you simply don’t get to sit at the table. So Onk Therapeutics Ltd.’s receipt of U.S. patent no. 11104735 covering CISH gene knockouts in natural killer (NK) cell therapies for cancer is not a major event in the general scheme of things. At the same time, it is a vitally important enabler for a company that is, paradoxically, both an early mover in the field but also a laggard in the highly competitive race to move NK cells into clinical development. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alvotech, Apellis, Astrazeneca, Azurx, Cartargia, Cassiopea, Cytodyn, Mersana, Rezolute, Scpharmaceuticals, Senhwa, Sunovion. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acorda, Agenus, Amolyt, Applied, BDSI, Beroni, Betterlife, Biofactura, Blue Water, Clarus, Codexis, Dr. Reddy’s, Elicio, Endo, Exothera, Eyam Vaccines and Immunotherapeutics, Gemini, Genequine, Ginkgo Bioworks, ICER, Insilico Medicine, Lyra, Medical College of Wisconsin, Merck, Nymox, Paq, Penao, Peptidream, Siga Technologies, Veristat. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cantargia, Mirror. Read More
