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Home » Newsletters » BioWorld

BioWorld

Dec. 23, 2020

View Archived Issues
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FDA puts Parkinson's trial on hold amid imaging abnormalities

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

FDA approves Urovant's Gemtesa as overactive bladder treatment

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
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Latin America awaits COVID-19 vaccine; race in the region is on

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
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Biopharma deals at their height; 2020 hard to beat

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
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HSF1 inhibition directly targets treatment-resistant prostate cancer

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
Takeda headquarters

Takeda’s sales spree continues in deal with China’s Hasten

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
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Walden looks at the challenges ahead, milestones behind

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

Holiday notice

BioWorld's offices will be closed in observance of Christmas. No issues will be published Thursday, Dec. 24 or Friday, Dec. 25. Read More

Appointments and advancements for Dec. 23, 2020

New hires and promotions in the biopharma industry, including: Allakos, Cytomx, Haima, Iterum, Q32. Read More

Financings for Dec. 23, 2020

Biopharmas raising money in public or private financings, including: Arch, Cellectar, CNS, Cyclo, Epsilon Molecular, Genprex, Gracell, Greenwich, Gritstone, Inhibikase, Proteostasis, Transcenta, Vistagen, Yumanity. Read More

In the clinic for Dec. 23, 2020

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

Other news to note for Dec. 23, 2020

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: A2, Abivax, Amgen, Arbor, Astrazeneca, Bioinvent, Biontech, Bridgebio, Celcuity, Cocrystal, Compugen, Cytokinetics, Halberd, Helix, Hyundai, Jaguar, Merck & Co., Open Orphan, Prep Biopharm, Pfizer, Recce, Regenxbio, Tonix, Vincera. Read More

Regulatory actions for Dec. 23, 2020

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Abionyx, Allogene, Amryt, Avacta, CASI, Cerecor, Halozyme, Hoth, Innovent, J&J, Juventas Cell Therapy, Moderna, Neurocrine, Novadip, Polarean, RFID, Ridgeback, Roche, Shenyang Tonglian, SOBI, Spectrum, Tarsus, VBI, Voyager. Read More

Regulatory front for Dec. 23, 2020

The latest global regulatory news, changes and updates affecting biopharma. Read More

Biggest gainers and losers for the week of Dec. 21-23, 2020

The top 10 biopharma stock gainers and losers for the week. Read More

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