Shares of Voyager Therapeutics Inc. and its partner, Neurocrine Biosciences Inc., fell in early trading Dec. 23 after Voyager announced an FDA clinical hold on the phase II Restore-1 trial of VY-AADC, an adeno-associated virus-based gene therapy Neurocrine is developing as NBIb-1817 for the treatment of Parkinson's disease. The trial had been paused since at least November as its data safety monitoring board reviewed MRI abnormalities in some study participants. Read More
Following a better-than-expected commercial liftoff for the overactive bladder medicine Gemtesa (vibegron) in its first market, Japan, the Dec. 23 FDA approval for the medicine opens a new commercial chapter for Urovant Sciences, a company that’s on its way to being a wholly owned subsidiary of Sumitomo Dainippon Pharma Co. Ltd.'s Sumitovant Biopharma Ltd. Read More
CAJICA, Colombia – The 33 countries across Latin America, Central America and the Caribbean are taking vastly different approaches to secure, acquire and distribute COVID-19 vaccines. A handful of the region’s wealthier countries have signed deals with vaccine suppliers or plan to manufacture them, but it is unclear how others will source or distribute vaccines to protect roughly 657 million people. Many are counting on the COVAX initiative. Read More
With record financings and now record deals in 2020, as well as a respectable value accumulated through completed mergers and acquisitions, the biopharma industry has managed to circumvent a crippling economic slowdown during the COVID-19 pandemic. Read More
Scientists at Duke University School of Medicine in Durham, North Carolina, have developed a small-molecule inhibitor of the cellular stress-protective transcription factor, heat-shock factor 1, which showed developmental promise against treatment-resistant prostate cancer and other cancers. Read More
HONG KONG – With the sale of a group of noncore assets to a little-known Chinese company, Takeda Pharmaceutical Co. Ltd. took another step in a multibillion-dollar string of divestitures that is part of a plan to cut debt and focus on five key business areas. Takeda announced on Dec. 21 the sale of a portfolio of noncore prescription drugs marketed in China to Hasten Biopharmaceutic Co. Ltd. (China). Read More
In an exclusive interview with BioWorld on the challenges facing a deeply divided Congress and some of the highlights of his years in the U.S. House, retiring Congressman Greg Walden (R-Ore.) said that once the COVID- 19 pandemic is over, federal policymakers should hold a summit with officials from states and major cities to look at a new preparedness partnership that would ensure the availability of strategic medical supplies. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: BMS, Dynavax, Evaxion, Macrogenics, Modag, Oramed, Palvella, Rakuten, Revive, Serum Institute of India, Spectrum, Supernus. Read More
