Companion diagnostics-focused Celcuity Inc. CEO Brian Sullivan said the deal with Pfizer Inc. for rights to pan-PI3K/mTOR inhibitor gedatolisib was “an organically developed opportunity, because of the research we had done on gedatolisib” in the course of investigating PI3K inhibitors. “We hadn’t shifted our strategy and said, ‘Oh, let’s start in-licensing drugs.’” Read More
After climbing nearly 37% since the start of the week, shares of Greenwich Lifesciences Inc. (NASDAQ:GLSI) gained another 6% on April 9 as it disclosed new data bolstering the case for its cancer immunotherapy candidate, GP2. The data, to be presented at the American Association for Cancer Research annual meeting on Saturday, showed that when HER2-positive breast cancer patients had GP2 added to standard-of-care Herceptin (trastuzumab, Roche Holding AG) following breast cancer surgery, no recurrences of their cancer were observed, even after a median follow-up of five years. Read More
The FDA told Provention Bio Inc. that its BLA under priority review for teplizumab needs some work but the May 27 advisory committee meeting to discuss the application in full is still on the calendar. Read More
The newly renamed Hutchmed (China) Ltd., previously known as Hutchison China Meditech Ltd. (Chi-Med), plans to sell $100 million of its American depository shares at $30.50 per ADS in a private placement to funds affiliated with Baring Private Equity Asia. Read More
CAJICA, Colombia – Following the start of phase III trials for its COVID-19 vaccine, Soberana 02, Cuban researchers have started phase III trials for Abdala (CIGB-66), another vaccine candidate developed in the island country. Read More
In science there are often too many choices to make. Nammi Therapeutics Inc.’s CEO, David Stover, told BioWorld that he makes narrowing therapeutic options a core company principle. The redundancy of immune regulatory pathways in cancer treatments is a case in point. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research Annual Meeting 2021, including: Affimed, Atyr, Chemocentryx, Greenwich, Humanigen, Imcheck, In8bio, Iovance, Mina, Nimbus, Onxeo, Sana, Sanofi, Surface Oncology, Transgene, Turning Point. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: BMS, Celcuity, Cytodyn, Mersana, Oncoinvent, Redhill, Tenax. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aelis, Bioaegis, Deargen, Galapagos, Gilead, Kempharm, Regeneron, Repare, Theralase. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aprea, Provention, Ryvu, Syndax, Therapeuticsmd. Read More
