In the third-largest acquisition announced this year, pharma giant Eli Lilly and Co. is buying oral integrin therapies developer Morphic Holding Inc. for $3.2 billion. Morphic stock (NASDAQ:MORF) got a tremendous boost from the acquisition, with shares closing 75% upward at $55.74 each on July 8, the day the deal was announced. Read More
Hillevax Inc. is turning its attention to preventing moderate or severe acute gastroenteritis events (AGEs) in adults with norovirus after the phase IIb NEST-IN1 trial testing virus-like particle-based vaccine HIL-214 in infants missed its primary and secondary endpoints, news that sent shares of the company (NASDAQ:HLVX) plummeting 88% to close July 8 at $1.64, a significant drop from the IPO price of $17 two years ago. Read More
As developers in the oft-troubled TIGIT class forge onward, Roche Holding AG’s Genentech unit provided an unfavorable update July 5 on the phase II/III Skyscraper-06 study testing anti-TIGIT candidate tiragolumab plus Tecentriq (atezolizumab) and chemotherapy vs. Keytruda (pembrolizumab, Merck & Co. Inc.) and chemo as first-line treatment for non-squamous non-small-cell lung cancer (NSCLC). Read More
Ideaya Biosciences Inc. appears to be in the lead to develop a treatment for tumors with deletions in both copies of methylthioadenosine phosphorylase (MTAP). Despite the large market with an estimated annual incidence rate in the U.S. of approximately 75,000 patients, there are no FDA approved therapies for MTAP-deleted solid tumors. Read More
On the heels of positive phase II results of its extended-release ketamine (R-107) in treatment-resistant depression, Douglas Pharmaceuticals Ltd. is gearing up to begin phase III trials of its ketamine treatment that is safe enough to take at home without clinical supervision. Read More
Myricx Bio Ltd. has closed the largest series A for a European biotech this year, raising £90 million (US$115.4 million), to take forward antibody-drug conjugates based on novel payload chemistry. Read More
Bob Califf, commissioner of the U.S. FDA, has been laser-focused on misinformation recently, and the agency reissued a 2014 draft guidance that describes an enforcement policy about third-party communications about a drug or device. The draft appears to sidestep at least one major problem with the 2014 edition, but seems to suggest that manufacturers should consider addressing misinformation about an entire class of products. Read More
Nanjing, China-based Iaso Biotherapeutics Co. Ltd. has bought out global rights to human anti-B cell maturation antigen CAR T Fucaso (equecabtagene autoleucel) from partner Innovent Biologics Inc. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apeiron, Ascentage, Beigene, Boehringer Invios, Ligand, OSE, Recordati, Takeda. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Hutchmed, Roche. Read More
