Shattuck Labs Inc. opted, as one analyst put the matter, to do “the right thing early” by ending the clinical program with phase I-stage SL-172154 and shift resources to SL-325, a death receptor 3 antagonist, initially for inflammatory bowel disease, where TL1A/DR3-blocking antibodies have shown compelling monotherapy efficacy.
Akeso Pharmaceuticals Inc. scored two approvals from China’s National Medical Products Administration on Sept. 30 before the long Labor Day holiday – one for its PCSK9 inhibitor, ebronucimab, and the second to expand use of PD-1/CTLA4 bispecific antibody cadonilimab in unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, marking the second indication for cadonilimab in China.
In the year’s fourth-largest deal, Prime Medicine Inc. will collaborate with Bristol Myers Squibb Co. in a research collaboration and license agreement totaling $3.61 billion. The two companies plan to develop reagents for ex vivo T-cell therapies. While the programs and targets have yet to be disclosed, BMS is expanding its CAR T development, begun more than five years ago, with this deal.
Jiangsu Alphamab Biopharmaceuticals Co. Ltd. is out-licensing its anti-HER2 bispecific antibody-drug conjugate, JSKN-003, to JMT-Bio Technology Co. for China rights in a deal worth up to ¥3.08 billion (US$439 million) plus sales royalties.
China’s National Medical Products Administration (NMPA) has accepted NDAs for Innovent Biologics Inc.’s IL-23p19 antibody picankibart to treat moderate to severe plaque psoriasis, and Lepu Biopharma’s antibody-drug conjugate MRG-003, to treat recurrent or metastatic nasopharyngeal cancer.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) met for what chairperson Christopher Lieu called, at the end, “an incredibly long day” to decide whether approval of immune checkpoint inhibitors should be restricted in accordance with expression levels of PD-L1.
One of Australia’s newest biotech investment funds is set to triple investments on the back of its success and strong investor demand. The three-year old Merchant Biotech Fund (MBF) invested in several high growth ASX-listed and private life sciences companies and finished the past financial year up more than 70%. It is up 10% for the current financial year, Portfolio Manager Reece O'Connell told BioWorld.
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) on Sept. 26 will take up a controversy that’s hardly new: whether approval of immune checkpoint inhibitor drugs should be restricted in accordance with PD-L1 expression.
Radiopharmaceutical company Telix Pharmaceuticals Ltd. is continuing its buying spree to shore up dominance in the radiopharmaceutical market with its latest acquisition of RLS Radiopharmacies for $250 million to expand its U.S. manufacturing presence and establish a next-generation radiometal production network.
For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S. PDUFA date is set for the fourth quarter of the year.
RSS
