BioSpace News Archive

Genetown

COVID-19 in the News: Heart Inflammation, Vaccine Effectiveness and More

There’s a fair amount of new information coming out about COVID-19 and vaccines. Here’s a roundup of some of the top stories.

May 7, 2021
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5 min read
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Mark Terry
Drug Development

Pfizer/BioNTech and Moderna Seek Full FDA Approval for COVID-19 Vaccines

Six months after receiving Emergency Use Authorization from the U.S. FDA for COVID-19 vaccines, Pfizer/BioNTech and Moderna are planning to seek full approval for the preventative medications.

May 7, 2021
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2 min read
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Alex Keown
Drug Development

FDA Adcom Almost Evenly Split Vote on ChemoCentryx’s Vasculitis Drug

The FDA released a briefing document that expressed concerns over ChemoCentryx’s avacopan. Company shares plummeted 46.5% at the news.

May 7, 2021
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3 min read
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Mark Terry
Drug Development

Disappointing Study Results Force Galapagos NV to Refocus Pipeline, Adjust Operations

Galapagos NV will refocus its clinical pipeline and make some cost adjustments to save the company €150 million after disappointing studies assessing therapies for rheumatoid arthritis and idiopathic pulmonary fibrosis.

May 7, 2021
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2 min read
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Alex Keown
Deals

IPO and SPAC Boom Continues as More Life Sciences Companies Announce Terms

With 2020 holding a record number of biotech IPOs, this year is lining up to come close. Three more Bay Area life science companies are just about ready to hit the Nasdaq, adding to the growing list for 2021.

May 7, 2021
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3 min read
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Kate Goodwin
FDA

FDA Action Alert: Heron, Apellis, Sanofi, Merck and ADC

May is a busy month for the U.S. Food and Drug Administration (FDA)’s calendar for new drug reviews. Here’s a look.

May 7, 2021
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4 min read
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Mark Terry
Drug Development

AstraZeneca’s Tremelimumab Offers Survival Benefit With IMFINZI in Advanced Lung Cancer

A final analysis of AstraZeneca’s Phase III POSEIDON trial shows IMFINZI (durvalumab), offered improvements in overall survival (OS) when added to tremelimumab and chemotherapy versus chemotherapy alone in patients with Stage IV (metastatic) non-small cell lung cancer.

May 7, 2021
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2 min read
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Brandon May
Business

Science 37 Jumps Onto SPAC Wagon With Billion-Dollar Deal

Boosted by increased clinical research business in 2020, Science 37 is planning a SPAC merger that will land itself on the Nasdaq and a company value of more than $1 billion and $280 million in gross proceeds.

May 7, 2021
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2 min read
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Alex Keown
Policy

Pharma Industry Leaders: COVID-19 Vaccine IP Waiver Concept Flawed

On Thursday, Pfizer Chief Executive Officer Albert Bourla who is “not at all” in favor of the U.S. position, stated that the real challenge is manufacturing capacity.

May 7, 2021
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2 min read
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Heather McKenzie
Drug Development

Clinical Catch-Up: May 3-7

It was a busy week for clinical trial news. Here’s a look.

May 7, 2021
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7 min read
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Mark Terry