BioSpace News Archive

Policy

In Shocking Move, FDA Rejects Mesoblast’s Ryoncil for Pediatric GVHD

In mid-August, the FDA’s Oncologic Drugs Advisory Committee voted 9 to 1 to recommend the drug for that indication. Although the agency isn’t required to follow an advisory committee’s recommendation, it usually does.

October 2, 2020
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3 min read
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Mark Terry
Business

Trump Tests Positive for COVID-19; Age, Weight Place Him at Higher Risk of Complications

At 74 years old, Trump is in a category of older Americans who are at more vulnerable to infection, and at higher risk of developing more serious symptoms.

October 2, 2020
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2 min read
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Alex Keown
Business

With a Lasting Legacy, Merck’s R&D Chief to Retire Effective Jan. 1

Merck announced that Roger M. Perlmutter, the company’s executive vice president and president of Merck Research Laboratories, was retiring effective January 1, 2021. He will be succeeded by Dean Y. Li.

October 2, 2020
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3 min read
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Mark Terry
FDA

LabCorp Receives EUA from FDA for New High-Speed COVID-19 Test

The new high-speed test uses a high-throughput method comprising heat and technology to extract RNA from samples used for COVID-19 RT-PCR molecular testing.

October 2, 2020
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3 min read
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Brandon May
Business

Genentech and Vaccibody Come Together to Develop Cancer Vaccines

“We are very excited to have entered into this transformative agreement that marks the start of a new era for Vaccibody,” Michael Engsig, CEO of Vaccibody, said in a statement.

October 2, 2020
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2 min read
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Heather McKenzie
Policy

FDA Action Alert: Avenue/Fortress and Alexion

Although October doesn’t appear to be a very busy month for the U.S. Food and Drug Administration’s PDUFA dates, there are a few. Here’s a look at the next two weeks.

October 2, 2020
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3 min read
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Mark Terry
BioCapital

Clinical Catch-Up: September 28-October 2

Biopharma companies wrapped up September and headed into October with plenty of clinical trial news. Here’s a look.

October 2, 2020
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9 min read
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Mark Terry
Deals

C4 Therapeutics Raises $182 Million in Upsized IPO

Company stock began trading on the Nasdaq this morning under the ticker symbol CCCC. The upsized IPO is expected to close Oct. 6.

October 2, 2020
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2 min read
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Alex Keown
Deals

Covis Group to Acquire AMAG Pharmaceuticals in $647 Million Deal

“AMAG’s category-leading treatments are strong strategic complements to our existing therapeutic portfolio,” said Michael Porter, Covis’ chief executive officer.

October 2, 2020
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2 min read
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Mark Terry
Business

Pfizer CEO: COVID-19 Vaccine Moving at the “Speed of Science,” Not Politics

Pfizer CEO Albert Bourla responds to COVID-19 being brought into this week’s presidential debate with political terms, rather than scientific facts.

October 2, 2020
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2 min read
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Kate Goodwin