BioSpace News Archive

FDA

Acceleron Finds Itself in FDA’s Crosshairs After Failure to Post Clinical Data Summary

The FDA is threatening Acceleron with a $10,000 fine or criminal prosecution, charging the company with failure to post a summary of study data on its cancer combo dalantercept and axitinib in the ClinicalTrials.gov online database.

April 29, 2021
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2 min read
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Brandon May
Business

Biden Proposes New $6.5 Billion Advanced Research Agency to End Cancer

Cancer doesn’t care if you’re Democratic, Republican, Libertarian or Green. It strikes without prejudice or consideration. As President Joe Biden said Wednesday night in his first major speech to Congress, “I know of nothing that is more bipartisan.”

April 29, 2021
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2 min read
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Kate Goodwin
Drug Development

COVID-19 Brief: Atea Initiates Phase III for Investigational Antiviral, BioNTech Tests Vaccine in Infants

The battle against COVID-19 rages on, and other therapeutics are making their way through the clinic, including monoclonal antibody treatments and antivirals. BioSpace takes a look at some of the ongoing efforts to stem the rate of infection from the virus.

April 29, 2021
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4 min read
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Alex Keown
Job Trends

Biopharma Companies Wrestle with Staffing Situations and Shortages from Pandemic

Work-at-home arrangements created to respond to the COVID-19 pandemic have forced numerous companies in most sectors to reevaluate their work deals. This has also resulted in rethinking site locations and real estate needs. Here’s a look.

April 29, 2021
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3 min read
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Mark Terry
Drug Development

Why Asymptomatic COVID-19 Transmission Is Dangerous

Asymptomatic individuals can transmit COVID-19. In fact, many cases worldwide are caused by people who are without symptoms.

April 29, 2021
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4 min read
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Lorenzo Soliman
FDA

Good Isn’t Good Enough: Moderna Continues Efforts to Improve COVID-19 Vaccine

Moderna, one of three companies to have a COVID-19 vaccine authorized in the U.S., isn’t resting on its accomplishments but is instead working to scale up production further and improve on its vaccine.

April 29, 2021
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2 min read
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Mark Terry
FDA

FDA Blocks Biogen’s sBLA for MS Drug

The U.S. FDA says it is unable to approve Biogen supplemental Biologic License Application (sBLA) for subcutaneously delivered TYSABRI® for the treatment of relapsing multiple sclerosis (MS), at least while the sBLA remains in its present form.

April 29, 2021
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2 min read
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Brandon May
BioForest

Research Roundup: Underlying Conditions, COVID-19 Severity and More

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

April 29, 2021
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5 min read
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Mark Terry
Career Advice

Set Post-Pandemic Career Goals with These Tips

If you’re setting new career goals, try including these tips to shape a path forward.

April 29, 2021
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2 min read
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Brandi Marcene
Drug Development

Four Biotechs Rake in Over $350 Million for Rare Diseases, Cancers and More

Ohio-based Forge Biologics secured $120 million in a Series B financing round to support the clinical development of its gene therapy program for rare diseases, including the typically fatal Krabbe disease.

April 29, 2021
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3 min read
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Alex Keown