In the latest deal from the burgeoning antibody-drug conjugate (ADC) space, Eisai Co. Ltd. and privately held Bliss Biopharmaceutical (Hangzhou) Co. Ltd. reached a development and commercialization agreement that could be worth up to $2 billion. The massive collaboration is the eighth largest so far this year and one of three that involve ADCs in the year’s top 10 deals. The year’s biggest, according to BioWorld statistics, is the partnership extension between Evotec SE and Bristol Myers Squibb Co. to identify neurodegenerative disease therapies for eight years. The other ADC deals involve Synaffix BV, which signed a $2 billion pact in January with Amgen Inc., and a $2.2 billion expanded deal in February with Macrogenics Inc. Read More
Notching another deal in its efforts to extend the global reach of toripalimab, Junshi Biosciences Co. Ltd. granted Dr. Reddy’s Laboratories Ltd. rights to develop and commercialize the PD-1 inhibitor in a regional licensing agreement that could be worth as much as $728.3 million. Read More
Even though COVID-19 is transitioning from pandemic to endemic across the world, it will remain first in mind as U.S. lawmakers look to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) this year to ensure the country is better prepared for future threats. With a Sept. 30 deadline for reauthorizing PAHPA, the Senate Health, Education, Labor and Pensions (HELP) Committee has its work cut out for it. But it won’t be starting from scratch. In opening a May 4 hearing on the reauthorization, HELP Chair Bernie Sanders (I-Vt.) said the committee would build on the efforts started last year under then-Chair Patty Murray (D-Wash.) and now-retired Ranking Member Richard Burr (R-N.C.). Read More
Beijing Luzhu Biotechnology Co. Ltd. raised a net HK$242 million (US$31 million) from an IPO in Hong Kong but shares in the developer of vaccines and therapeutics for infectious diseases, cancer and autoimmune diseases plummeted on the first day of trading. Luzhu’s shares (HK:2480) started trading on May 8 at HK$31.50 and fell about 30% throughout the day to close at HK$22. Founded in 2001, Luzhu has yet to turn a profit. It recorded net losses of ¥725.2 million (US$92 million) in 2022 and ¥539.4 million in 2021. Read More
The idea for a new company, Ten63 Therapeutics Inc., started in 2015, when Gilda Szacher Frenkel passed away at age 62 from pancreatic cancer. After sequencing her tumor, her son Marcel discovered that her cancer was driven by mutations to key proteins that regulate cellular processes – all the “usual suspects,” he said. At the time, he remembers they were initially encouraged by the discovery and excited to search for developed drugs that could help her. “Here was this blueprint telling us what was wrong,” Marcel Frenkel said, “but, unfortunately, those mutations were unactionable. There were no drugs to modulate the main oncologic drivers.” Read More
In a draft guidance released May 2, the U.S. FDA provided recommendations for sponsors, investigators and other stakeholders for implementation of decentralized clinical trials to advance research in medical devices, drugs and biologics. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acorda, Adimune, Aditxt, Araris, Boehringer Ingelheim, Chance, Cyclica, Ginkgo, Lundbeck, Neuro3, Recursion, Scisparc, Selecta, TFF, Valence. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aimmax, Carsgen, Chiesi, Formosa. Read More
