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. Read More
In the wake of Study 045’s failure with Translarna (ataluren) in nonsense mutation Duchenne muscular dystrophy, PTC Therapeutics Inc. is “trying to thread the needle between the notion of getting Study 041 completed in the third quarter of 2022 vs. getting accelerated approval now,” CEO Stuart Peltz said. Read More
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. Read More
Biopharma financings have done it again. Breaking all kinds of records in January, the year appears to be off to an extraordinary start. The industry raised $10.15 billion during the month through a total of 158 financings. This represents a significant climb above the previous records, according to BioWorld data going back to the year 2000. Read More
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. Read More
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. Read More
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. Read More
Biopharmas raising money in public or private financings, including: Aim, Assertio, Biovaxys, Eyepoint, Inmed, Oncocyte, Orchard, Pharnext, Silence, Tryp and Veracyte. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achilles, Astrazeneca, Covaxx, GSK, I-Mab, PTC, Sanofi, Spark, Spero. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alphageneron, Curevac, Diamond, Hyloris, Multimmune, Onxeo, Pfizer, Purna . Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Actinogen, BMS, Celltrion, Innocare, J&J, Novavax, RDIF, TG. Read More
