BioSpace News Archive

Business

BMS Flying High in May With Opdivo, Zeposia FDA Approvals

Bristol Myers Squibb has been busy the last two weeks with a string of approvals, positive clinical trial updates and deals. Here’s a look.

May 28, 2021
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3 min read
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Mark Terry
Policy

ISCGT Meeting Calls for Systemic Ecosystem Innovation Across the Industry

To develop and commercialize them with maximum efficiency, the FDA, scientists and developers must innovate, according to panelists speaking during the Presidential Plenary on Commercialization at the International Society of Cell & Gene Therapy on May 26.

May 28, 2021
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5 min read
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Gail Dutton
Business

Biopharma Leaders Look to Leverage Lessons Learned from the Pandemic

Several biotech executives provided their thoughts on lessons learned from the pandemic and what they hope or expect to see moving forward in the industry.

May 28, 2021
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4 min read
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Mark Terry
Drug Development

Fennec Tries Again for FDA Approval of Chemotherapy-Induced Hearing Loss Drug PEDMARK

Fennec is looking for a second chance to approve PEDMARK, its pediatric chemotherapy-induced hearing loss prevention drug, as it resubmits its NDA for the agent to the U.S. FDA.

May 28, 2021
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3 min read
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Brandon May
FDA

FDA Lays Out Roadmap to Clear Inspection Backlog as Biomanufacturing Booms

The FDA has a massive backlog of site inspections due to the pandemic. To address the problem, the agency made its Resiliency Roadmap outlining its priorities.

May 28, 2021
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3 min read
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Alex Keown
FDA

FDA Panel Gives Narrow Nod of Approval to Provention’s Diabetes Drug

The question before the committee was whether the benefits of teplizumab outweigh the risks as it voted 10-7 in favor of the drug to delay clinical type 1 diabetes mellitus.

May 28, 2021
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2 min read
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Alex Keown
Drug Development

Clinical Catch-Up: May 24-28

Heading into the U.S. Memorial Day holiday weekend and the official start of summer, it was a moderately busy week for clinical trial news. Take a look.

May 28, 2021
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6 min read
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Mark Terry
FDA

FDA Action Alert: Alkermes, Myovant & Pfizer, Scynexi and Liminal

The U.S. FDA is starting off the summer months with a busy week after the Memorial Day holiday in the U.S. Here’s a look.

May 28, 2021
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5 min read
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Mark Terry
Policy

Study: COVID-19 More Dangerous for Those With High Cholesterol, Heart Disease

A real-world study published by the FH Foundation confirms COVID-19 increased heart attack rates significantly in patients with these conditions.

May 28, 2021
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2 min read
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Kate Goodwin
Business

Biopharma Industry Continues to Address Inequality, Inequity in the Life Sciences

The biopharma industry strives to bring in more voices at the corporate level and clinical trials. But, there is still a long way to go, especially with companies helmed by minorities.

May 28, 2021
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3 min read
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Alex Keown