LONDON – Women’s health specialist Kandy Therapeutics Ltd. is to be acquired by Bayer AG for $425 million up front, with a further $450 million to come in milestone payments up to the launch of NT-814, a treatment for menopause symptoms that recently completed phase IIb.
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.
With Glaxosmithkline plc (GSK) having sailed through an FDA advisory panel meeting July 14 centered on its belantamab mafodotin (belantamab), an antibody-drug conjugate (ADC) for multiple myeloma (MM), others in the B-cell maturation antigen (BCMA) space such as Legend Biotech Corp. are further piquing Wall Street’s interest.
In deals worth billions, Sanofi SA and Glaxosmithkline plc (GSK) have made new agreements this week to supply the U.S. and U.K. governments with a COVID-19 vaccine. The two companies also are in advanced discussions with the European Union to supply up to 300 million doses of a vaccine.
Interludes of classical music. Little kids talking in the background. Unmuted mics as panelists multitask. Gurgles of “underwater” sound. Periods of silence as speakers forget to unmute. And then the technical problems – lots of them. Such are the challenges of addressing a virtual FDA advisory committee in the time of COVID-19.
LONDON – Glaxosmithkline plc (GSK) is putting £130 million (US$164.3 million) into one of the leading COVID-19 vaccines developers, Curevac AG, acquiring a 10% stake, and will also invest £104 million cash up front to fund research and development of the company’s mRNA vaccines.
Patients with triple-refractory multiple myeloma who are running out of options may soon have a new lifeline. That’s if the FDA follows the unanimous vote of its Oncologic Drugs Advisory Committee (ODAC) and grants accelerated approval to Glaxosmithkline plc’s (GSK) belantamab mafodotin as a fifth-line therapy for adults with relapsed or refractory multiple myeloma.
In a step toward what may become the new normal, at least for now, the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee is meeting virtually Wednesday and Thursday to review pediatric development plans for four cancer drugs.
Glaxosmithkline plc (GSK) will collaborate in three of Ideaya Biosciences Inc.’s synthetic lethality programs, MAT2A (methionine adenosyltransferase 2a), Pol Theta (polymerase theta) and Werner Helicase, in a deal that Ideaya estimated could be worth billions.
LONDON – The World Health Organization (WHO) is stepping up its effort to try and ensure equitable access to any approved COVID-19 vaccines and therapies, putting in place a system for sharing all intellectual property, information and clinical trials data needed to enable generic manufacturing.
