Biogen Inc., one the world's top neurological disease specialists, is committing to invest more than $1 billion in cash and equity in Denali Therapeutics Inc. for rights to co-develop and co-commercialize a potential therapy for Parkinson's disease (PD) and options to secure up to four more neurodegenerative disease programs from its new partner. Read More
About two weeks after European regulators gave their go-ahead for Blenrep (belantamab mafodotin-blmf), the B cell maturation antigen (BCMA)-targeting therapy from Glaxosmithkline plc (GSK) for relapsed/refractory multiple myeloma (MM), the FDA did likewise. Read More
Out of 922 biopharma financings so far in 2020, nearly a quarter of them – 211 – were done by companies working on a COVID-19 therapeutic or vaccine. More strikingly, however, the $27.8 billion raised by those pandemic-focused firms represents about 40% of the $71.8 billion total collected through the end of July. That amount is the highest BioWorld has ever tracked. Read More
LONDON – A breakthrough technology for generating fully human T-cell receptors (TCR) is set to deliver next-generation T-cell therapies for treating solid tumors, following the €66 million (US$78.3 million) series A funding of T-knife GmbH. Read More
A promising but side effect-ridden phase III study by Novartis AG with oral imatinib in pulmonary arterial hypertension (PAH) led Boston-based Aerovate Therapeutics Inc. to start exploring two years ago an aerosol form of the kinase inhibitor, and the project has won backing to the tune of $72.6 million in series A money. Read More
HONG KONG – Following positive phase II data on Hanmi Pharmaceutical Co. Ltd.’s once-weekly GLP-1/glucagon receptor dual agonist, efinopegdutide, in nonalcoholic steatohepatitis (NASH), the Seoul-based company has exclusively licensed the drug to Kenilworth, N.J.-based Merck & Co. Inc. for the indication. Read More
While privately held Levo Therapeutics Inc.’s phase III study of LV-101 (intranasal carbetocin) for treating Prader-Willi syndrome (PWS) failed to meet its primary outcome measurements, the company’s CEO told Bioworld the first secondary endpoint showed a statistical significance that raised her hopes the FDA might approve the selective oxytocin-receptor agonist for the indication. Read More
With the economy and public health on the line, U.S. President Donald Trump thumped his Made in America pulpit again Thursday on a campaign swing through Ohio, in which he vowed to bring the pharmaceutical supply chain home over the next four years. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bioaegis, Boehringer, Dicerna, Idorsia, Levo, Medicinova, Nordic, Novartis, Personalized Stem Cells, Precigen, Rafael, Tessa. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adamis, Astrazeneca, Aveo, CSL, Daiichi, Galmed, Glaxosmithkline, Immatics, Iovance, Kyowa Kirin, Mirati, Oric, Seattle Genetics, Sab, Som, Veracyte. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anavex, Catalyst, GSK, Jaguar, Neurorx, Organicell, Redhill, Relief, Tonix, Y-mabs. Read More