Positive top-line data from the pivotal phase III study of AAV5-based etranacogene dezaparvovec by Uniqure NV, shows 54 patients met the primary endpoint in treating severe to moderate hemophilia B.
With the FDA’s required safety milestone notched in their phase III study of COVID-19 vaccine candidate BNT-162b2, Pfizer Inc. and Biontech SE said they will request emergency use authorization “within days.”
The FDA has issued Sanofi SA a complete response letter (CRL) regarding its complement pathway inhibitor sutimlimab, citing deficiencies found during a pre-license inspection of a third-party manufacturing facility.
Seed Therapeutics Inc. signed a massive deal with Eli Lilly and Co. on Nov. 12, a date that resonated deeply with Seed’s CEO, Lan Huang. Twenty-one years earlier to the day she published a pioneering paper on cancer signaling pathways involving p53 degradation in Science. “It’s a magical coincidence that exactly 21 years later we have this deal with Lilly,” she told BioWorld, a deal with protein degradation at its core. In the new research collaboration and license agreement, Seed will receive $10 million cash up front to fund research along with a $10 million equity investment from Lilly.
Metagenomi Inc. has raised a $65 million series A financing to expand its gene editing abilities, advance its research and validate its pipeline in preclinical studies. The company’s CRISPR-based systems use algorithms for screening thousands of genomes from microorganisms to advance therapies for use in oncology, genetic diseases and possibly much more.
Though founded in 2018, Inipharm Inc. has just closed on a $35 million series A financing designed to push its lead program through an IND filing and into the clinic to treat liver-related diseases.
Now that the FDA has granted emergency use authorization to Eli Lilly and Co.’s bamlanivimab, the company plans to manufacture up to 1 million doses of the therapy by year-end with worldwide distribution to mild to moderate COVID-19 patients ages 12 and older in early 2021.
Lenzilumab, the lead candidate from Humanigen Inc., has taken two large steps forward with positive interim phase III data and some support from the federal government. That, along with an Asia-Pacific region licensing from earlier in the week, has the relatively small company successfully “punching above our weight,” the CEO told BioWorld.
