BioSpace News Archive

Policy

Lessons from Past Wars Could Offer Insight for Biopharma During Ukraine War

Throughout history, many different countries have had their biopharma supply chains changed – sometimes profitably, sometimes detrimentally – by war.

March 2, 2022
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6 min read
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Hannah Chudleigh
FDA

FDA Formalizes Celyad CAR-T Trial Hold while Risks Evaluated

Belgium-based Celyad Oncology voluntarily paused a clinical trial with Merck after two deaths. Getting CAR T therapies to work in solid tumors has proven to be a difficult challenge.

March 2, 2022
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2 min read
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Mark Terry
Business

Vesalius, Rondo Debut to Redefine Treatment Paradigms

Flagship will pour in $75 million into Vesalius to support its beginnings, while Rondo raised $67 million to support the development of its preclinical pipeline.

March 2, 2022
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3 min read
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Vanessa Doctor, RN
Business

Adagene and Sanofi Tie Up in $2.5B Antibody Collab

Shares of Adagene Inc. are up more than 10% in premarket trading after the company announced a monoclonal and bispecific antibody collaboration with Sanofi valued at up to $2.5 billion.

March 2, 2022
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3 min read
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Alex Keown
Drug Development

COVID-19, Manufacturing Challenges Trip up Finch’s C. Difficile Trial

The FDA asked Finch to pause enrollment for the trial on CP101 in recurrent C. difficile infection, pending details on how SARS-CoV-2 donor samples will be shipped to the vendor.

March 2, 2022
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2 min read
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Vanessa Doctor, RN
Drug Development

Clinical Trials Paused in Russia as Conflict Hits Day 7

First Moscow State Medical University has paused recruiting new patients for its ongoing clinical trials following a disruption in the university’s ability to receive clinical trial samples.

March 2, 2022
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2 min read
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Hayley Shasteen
Drug Development

SEC Wades into Confusion Over FibroGen Safety Data in Anemia Drug

FibroGen is tangled up in a Securities Class Action Litigation and Derivative Litigation concerning clinical trial data for its drug Roxadustat.

March 2, 2022
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3 min read
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Mark Terry
Drug Development

Karyopharm’s Endometrial Cancer Treatment Hits FDA Roadblock

After Karyopharm submitted Phase III data from its SIENDO study on Selinexor, the FDA said that it is unlikely to support an sNDA approval for the drug.

March 2, 2022
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3 min read
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Hannah Chudleigh
FDA

Pfizer’s RSV Vaccine Reaches “Pivotal Next Step” with Breakthrough Therapy Designation

Pfizer announced its RSV vaccine candidate PF-06482077 or RSVpreF, received Breakthrough Therapy designation from the U.S. Food and Drug Administration.

March 2, 2022
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2 min read
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Alex Keown
Policy

Biden Pledges to Provide Free COVID-19 Treatment Following Positive Tests

President Biden announced updates to the “Test to Treat” initiative that will allow people to get tested for COVID at a pharmacy and receive a treatment round of Pfizer’s Paxlovid at no cost.

March 2, 2022
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3 min read
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Alex Keown