BioSpace News Archive

FDA

With Celgene CVR Dead, Investors Miss Out on $6.4 Billion Payday

Without an approval for liso-cel, Bristol Myers Squibb said the CVRs have now been terminated, are no longer eligible for payment and will no longer be allowed to trade on the New York Stock Exchange.

January 4, 2021
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2 min read
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Alex Keown
Policy

Operation Warp Speed in Talks with Moderna for Half-Doses of COVID-19 Vaccine

As Operation Warp Speed struggles to ramp up vaccinations, one of the approaches under consideration is cutting the doses of the Moderna vaccine.

January 4, 2021
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4 min read
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Mark Terry
Policy

Pfizer, OPKO One Step Closer to Approval of Pediatric Growth Hormone Deficiency Drug Somatrogon

Pfizer and OPKO Health are one step closer to receiving approval for their jointly developed pediatric growth hormone deficiency drug, somatrogon, after the U.S. FDA recently accepted the companies’ regulatory submission for the therapy.

January 4, 2021
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2 min read
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Brandon May
Drug Development

Calithera Cutting 35% of Workforce After Kidney Cancer Trial Failure

Calithera Biosciences reported that its CANTATA clinical trial of telaglenastat in patients with advanced or metastatic renal cell carcinoma (RCC) failed to hit the primary endpoint.

January 4, 2021
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3 min read
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Mark Terry
Business

With FDA Approval and Pfizer Deal in Hand, Myovant Appoints New CEO

Dr. Lynn Seely bows out as Myovant pivots to commercialize new drug.

January 4, 2021
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3 min read
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Kate Goodwin
Drug Development

2021 Biopharma Update on the Novel Coronavirus: January 5

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 5, 2021.

January 4, 2021
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3 min read
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BioSpace Editorial Staff
New Year, New Price Hikes on Hundreds of Prescription Drugs

As the sun rose on a new year, approximately 70 companies raised the price of hundreds of prescription drugs by an average of 3.3%.

January 4, 2021
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3 min read
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Alex Keown
WUSTL Researchers ID Elusive Cause of Chiari 1 Brain Malformation

This news, published in the American Journal of Human Genetics, enables researchers to develop early screening methods before the most serious symptoms arise, and thus intervene.

January 4, 2021
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4 min read
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Gail Dutton
Biggest Novel Drug Approvals in 2020

Here’s a look at the top 10 novel drug approvals of 2020, loosely based on projected earnings in the upcoming years.

January 4, 2021
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10 min read
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Mark Terry
Business

Pfizer CMO Steps Down, Stanford Professor to Transition into Role

With the new year comes a changing of the guard at Pfizer. After two years of helming the company’s pharma operations, Chief Medical Officer Mace Rothenberg announced his departure from Pfizer on social media.

January 4, 2021
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2 min read
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Alex Keown