BioSpace News Archive

Policy

2021 Biopharma Update on the Novel Coronavirus: March 2

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 2, 2021.

March 2, 2021
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5 min read
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BioSpace Editorial Staff
FDA

Last-Minute FDA Advisory Panel Puts a Kink in Approval Hopes for Anemia Drug Roxadustat

The U.S. FDA has decided to put together an advisory committee meeting of outside experts to review a New Drug Application for roxadustat, FibroGen and its partner AstraZeneca’s investigational anemia therapy.

March 2, 2021
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2 min read
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Brandon May
Drug Development

FDA Issues CRL Citing Safety, Data Issues for Athenex’s Oral Encequidar

Cancer therapy company Athenex suffered a regulatory setback with the receipt of a complete response letter from the U.S. Food and Drug Administration.

March 2, 2021
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2 min read
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Mark Zipkin
Business

Money on the Move: February 24 – March 2

With the overflow of investments into life sciences, who has time to keep up? Find your weekly snapshot of where the cash is headed in this week’s Money on the Move.

March 2, 2021
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8 min read
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Kate Goodwin
Business

While Life Sciences Industry Remains Strong, Some Big Names Face Layoffs

The biopharma industry remained strong, as demand for COVID-related products skyrocketed. However, some companies are facing layoffs. Here’s a brief overview.

March 2, 2021
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3 min read
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Mark Terry
Genetown

eGenesis Snags $125 Million for Cross-Species Organ Transplantation Tech

Xenotransplantation company eGenesis raised $125 million in a Series C financing round to drive the company’s lead programs in kidney and islet cell transplant into the clinic.

March 2, 2021
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2 min read
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Alex Keown
BioMidwest

AbbVie to Fund Mitokinin’s Parkinson Research with Option to Buy

AbbVie bought an exclusive right to acquire San Francisco-based Mitokinin after the company completes its Investigational New Drug-enabling studies on its lead program, PINK1, for Parkinson’s disease.

March 2, 2021
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2 min read
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Mark Terry
Drug Development

FDA Accepts NDA for Oyster Point’s Dry Eye Therapy OC-01

Eye disease company Oyster Point announced the New Drug Application for its dry eye disease therapy OC-01, submitted in December, has been accepted for regulatory review on the back of positive Phase III data.

March 2, 2021
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2 min read
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Mark Zipkin
Drug Development

Novavax Counting on COVID-19 Vaccine U.S. EUA by May

Novavax Chief Executive Officer Stanley Erck believes the U.S. Food and Drug Administration could grant Emergency Use Authorization for its COVID-19 vaccine by May.

March 2, 2021
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3 min read
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Alex Keown
Determining Value is as Critical to Commercial Success as Clinical Data

The shifting focus from drug pricing to drug value is having a significant effect on innovation, performance and even investments.

March 2, 2021
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5 min read
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Gail Dutton