BioSpace News Archive

Drug Development

Aduhelm Takes Another Hit as EMA Votes Against the Drug

Biogen and Eisai reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency had decided not to recommend the drug for its MAA.

December 17, 2021
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3 min read
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Mark Terry
Policy

As Officials Prep for Rapid Spread, AZ Antibody Shows Efficacy Against Omicron

With the holidays around the corner and people expected to gather, public health officials have expressed concerns over a possible increase in COVID-19 cases, particularly with the highly infectious Omicron variant on the rise.

December 17, 2021
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5 min read
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Mark Terry
Business

Omega’s New Fund Has $650 Million to Invest in Life Science Companies

Omega raised $650 million, which it plans to invest in life science companies in the U.S. and Europe.

December 17, 2021
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2 min read
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Mark Terry
Policy

Judge Demands Sacklers Face the Music for the Damage Purdue Caused

U.S. District Judge Colleen McMahon rejected a bankruptcy plan that shielded the Sackler family from potential lawsuits related to the opioid crisis.

December 17, 2021
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3 min read
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Alex Keown
This Year’s Flu Vaccine a “Major Mismatch” to Prevalent Strain

Another flu season, another less than effective flu vaccine. The shape-shifting virus has mutated already and this year’s flu vaccine is a poor match to fight it.

December 17, 2021
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3 min read
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Kate Goodwin
FDA

Global Blood Therapeutics’ Oxbryta Greenlit for Pediatric SCD Patients Ages 4 to 11

Shares of Global Blood Therapeutics were up more than 10% in late-afternoon trading following regulatory approval of a supplemental New Drug Application for oral Oxbryta (voxelotor) tablets for the treatment of pediatric sickle cell disease.

December 17, 2021
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2 min read
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Alex Keown
Policy

Pfizer and Moderna Preferred for American’s Booster Shots

In a unanimous vote made by U.S. health officials, the advisers decided the safer Pfizer and Moderna vaccines should be given as boosters.

December 17, 2021
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3 min read
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Sreetama Dutt
FDA

FDA Action Alert: Aquestive, BMS, GBT and Strongbridge/Xeris

Although the U.S. FDA largely cleared its calendar ahead of the holidays, it still has a couple open PDUFA dates leading up to January 1, 2022. Here’s a look.

December 17, 2021
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3 min read
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Mark Terry
Drug Development

Clinical Catch-Up: December 11-17

It was an enormously busy week with plenty of announcements from the American Society of Hematology meeting and numerous companies working to get the news out ahead of the holidays and year-end. Here’s a look.

December 17, 2021
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16 min read
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Mark Terry
Job Trends

Life Sciences Global Expansions: New Sites, Bigger Facilities, More Jobs

Biopharma companies are eying the establishment of new facilities across the globe that will bolster their manufacturing strategies. BioSpace rounds up some of the latest announcements.

December 17, 2021
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3 min read
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Alex Keown