BioSpace News Archive

Drug Development

Back to the Drawing Board: Galapagos and Servier’s Arthritis Knee Repair Drug Fails Phase II

Galapagos NV and Servier reported that their ROCELLA Phase II clinical trial of GLPG1972/S201086 failed to meet its primary endpoint in osteoarthritis knee repair.

October 16, 2020
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3 min read
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Mark Terry
Policy

WHO Study Casts Doubt on Effectiveness of Gilead’s Remdesivir for COVID-19

The WHO’s SOLIDARITY clinical trial evaluated remdesivir and three other drugs in 11,266 hospitalized COVID-19 patients and found that none of the drugs “substantially affected mortality” or decreased the need to ventilate patients.

October 16, 2020
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3 min read
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Mark Terry
Drug Development

Pfizer CEO Anticipates EUA for COVID-19 Vaccine in Late November

Pfizer will not seek Emergency Use Authorization for its COVID-19 vaccine until the end of November even if the readout from a Phase III study expected later this month is positive.

October 16, 2020
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3 min read
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Alex Keown
Drug Development

Clinical Catch-Up: October 12-16

It was another busy week for both COVID-19-related clinical trial news as well as trial updates for other indications. Here’s a look.

October 16, 2020
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8 min read
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Mark Terry
Business

Disruptive Technologies and Mature Regulatory Environment Vital for Cell Therapy Maturation

Immuno-oncology and CAR T cells energized the field of regenerative medicine, but for cell and gene to deliver on their promises, new, disruptive technologies and new modes of operation are needed.

October 16, 2020
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5 min read
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Gail Dutton
Business

Manufacturing a Personalized Cellular Universe: 3D Bioprinting in the Biotech Industry

By using naturally-derived scaffolds, human cells and other biocompatible materials, 3D bioprinting has ushered in opportunities for researchers to design, print and optimize patient personalized tissues for purposes ranging from transplantation to drug testing.

October 16, 2020
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6 min read
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Maggie Chen
Deals

Fresh Off a $110 Million Series C, Praxis Precision Medicines Eyes $190 Million IPO

This morning, the company, which was formerly known as EpiPM Therapeutics, will begin trading on the Nasdaq Global Select Market under the ticker symbol PRAX.

October 16, 2020
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2 min read
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Alex Keown
FDA

FDA Action Alert: Zosano, Spectrum, Regeneron, Kala and Merck

The U.S. Food and Drug Administration has several PDUFA dates for the rest of October, although two of them were already approved. Here’s a look.

October 16, 2020
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5 min read
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Mark Terry
Business

UCB Snags Eli Lilly U.K. Research Site, Plans to Invest £1 Billion Over Five Years for R&D

UCB is investing more than £1 billion over five years to expand its research and development capabilities in the U.K., which will include a transition to a newly acquired 47-acre R&D campus from Eli Lilly located in Windlesham, Surrey.

October 16, 2020
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2 min read
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Brandon May
Policy

Beckman Coulter Receives Grant to Detect Serious COVID-19 Complication in Kids

The grant was awarded by the U.S. Dept. of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA).

October 16, 2020
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2 min read
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Kate Goodwin