Pathalys Pharma Inc., a privately held startup focused on developing new medicines chronic kidney disease, has emerged with an exclusive license from Tokyo-based EA Pharma Co. Ltd. to develop the small molecule calcimimetic upacicalcet for markets outside of Japan and Asia.
Amgen Inc.’s pioneering lung cancer drug, Lumykras (sotorasib), is set to become available to NHS patients in England, after cost-effectiveness body NICE recommended financing from the Cancer Drugs Fund (CDF) in final draft guidance.
Adagene Inc. has announced a research collaboration with Sanofi SA, to find “masked” monoclonal and bispecific antibodies that are safer than marketed drugs in oncology, in a deal worth up to $2.5 billion plus royalties. San Diego and Suzhou, China-based Adagene will generate masked versions of Sanofi antibodies, taking responsibility for early stage research activities using its Safebody technology. Sanofi will be responsible for later-stage research and all clinical, product development and marketing activities.
Janssen Pharmaceutical Cos. Inc. has become the second company to get a BCMA-targeting CAR T therapy to market with the approval of ciltacabtagene autoleucel for adults with relapsed or refractory multiple myeloma (MM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Shares in Glaxosmithkline plc ticked down after the U.K. pharma announced that enrolment and vaccination in three trials of its respiratory syncytial virus (RSV) maternal vaccine will stop, after a safety issue prompted a voluntary pause last week.
Europe’s pharmaceutical industry has warned the conflict in Ukraine is disrupting supplies of medicines and clinical trials, while pledging free medicines to the humanitarian effort to those caught in or fleeing from the Russian invasion. A representative of the European Federation of Pharmaceutical Industries and Associations, which has an affiliate in Ukraine, told BioWorld that the disruption has left pharma industry staff in that country taking to emergency shelters.
For years, a vaccine against respiratory syncytial virus (RSV) has been out of reach. But this could change thanks to several candidates in the late-stage pharma pipeline. Among them, Moderna Inc. became one of the front-runners in the race to develop a vaccine for the virus after this week announcing that its entrant in the contest, mRNA-1345, is moving into phase III development.
After a rejection by the FDA in June, it looks like Orphazyme A/S is headed for disappointment in Europe too with arimoclomol for Niemann-Pick disease type C, a rare and potentially fatal inherited condition in which fat builds in tissues and organs. The Copenhagen-based company said it was summoned before experts to give an “oral explanation” about the drug, something that only occurs if the European Medicines Agency’s CHMP has developed major doubts during its review.
U.K. biotech Complement Therapeutics Ltd has come out of stealth mode with €5 million ($5.7 million) in seed funding to tackle complement-related diseases, initially targeting the currently untreatable condition geographic atrophy due to dry age-related macular degeneration.
Biontech SE and Medigene AG have signed a three-year research collaboration to develop T-cell receptor (TCR) based immunotherapies against cancer. Medigene will receive €26 million ($29.5 million) up front and could receive hundreds of millions of euros per drug in milestone payments from the deal, which will also covers research funding for the period of the collaboration.
