The latest global regulatory news, changes and updates affecting biopharma, including: CBO model touts savings of H.R. 3; FDA to ODAC: Are data ripe for 2nd TNBC Keytruda approval?; Fifth Circuit reiterates no liability remedy for generics; Consultant faces insider trading charges.
LONDON – A follow-up study of participants in the phase II/III U.K. trial of Astrazeneca plc’s COVID-19 vaccine has shown it remains effective against the new B.1.1.7 variant of SARS-CoV-2.
The week finished with flurry of biotech IPOs, seven of them, a record number in a single day, according to BioWorld stats. Last year was a record year for IPOs as 106 new offerings were completed and raised $22.5 billion, more than double the previous record of $10.7 billion set in 2018. The seven companies that priced Feb. 5 are anticipating total gross proceeds of about $1.06 billion.
While it’s too late to save the contingent value rights connected with the acquisition of Celgene Inc., Bristol Myers Squibb Co.’s CD19-targeted CAR T therapy, lisocabtagene maraleucel, for treating certain types of relapsed or refractory large B-cell lymphoma patients who have received at least two prior therapies, won FDA approval.
Executives of TG Therapeutics Inc. have promised a big year in 2021 and the company got off to strong start with accelerated FDA approval of umbralisib in marginal zone lymphoma and follicular lymphoma. Branded Ukoniq, the drug is the first oral, once-daily inhibitor of PI3K delta and CK1 epsilon and TG’s first commercial product. Pricing for Ukoniq has not yet been disclosed.
Covicept Therapeutics Inc., a young San Diego-based company focused on developing a small molecule to inhibit the replication and spread of SARS-CoV-2 and other RNA viruses, has launched with $2.3 million in seed funding from European VC firm Forbion. The company, spun out of research at the University of California, San Diego, aims to initiate its first clinical study in the middle of 2021.
RSS
