BioSpace News Archive

FDA

Merck’s Keytruda Approved for High-Risk Bladder Cancer

Merck’s checkpoint inhibitor Keytruda (pembrolizumab) continues moving toward the projections of becoming the world’s best-selling drug.

January 9, 2020
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3 min read
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Mark Terry
Drug Development

Connect Biopharma Reports Positive Topline Data from Moderate-to-severe Atopic Dermatitis (AD) Phase 1b Study of CBP-201

Data show superior efficacy after four weeks of treatment and more rapid onset of action for CBP-201 compared with data from studies of current standard of care therapy for AD

January 9, 2020
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7 min read
Policy

HHS Awards Sanofi $226 Million to Expand Flu Vaccine Manufacturing Capabilities

The site location is in Swiftwater, Pennsylvania.

January 9, 2020
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3 min read
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Mark Terry
Drug Development

Long-Term Data Bolsters DBV Technologies’ BLA for Viaskin Peanut

DBV announced positive topline results from its Phase III PEPITES trial evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children aged 4 to 11 years.

January 9, 2020
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2 min read
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Alex Keown
Policy

Is the FDA Approving Drugs Too Quickly?

A recent study questions if the FDA and other regulatory agencies worldwide rush certain approvals, particularly at the end of the year in a kind of “desk-clearing” activity.

January 9, 2020
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4 min read
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Mark Terry
BioCapital

Research Roundup: Sleep Difficulties in Autistic Children, C. Diff Infections and More

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

January 9, 2020
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4 min read
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Mark Terry
Bio NC

BioSpace Movers & Shakers, Jan. 10

Pharma and biotech companies bolster their executive leadership teams and boards of directors with this week’s appointments.

January 9, 2020
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8 min read
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Alex Keown
Red Flags and Green Lights: How Employers View You

This article looks at job seeker traits that experts and employers characterize as red flags and offers suggestions to mitigate those obstacles.

January 9, 2020
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4 min read
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Katharine Hansen, PhD
Sebia enters into agreement with Sanofi to develop multiple myeloma diagnostic test

Test will specifically adjust for isatuximab-induced interference in complete response assessment of multiple myeloma patients

January 9, 2020
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3 min read
ProBioGen Inks Next Commercial GlymaxX® License with Roche

ProBioGen AG has signed a commercial license agreement with Roche for applying ProBioGen’s proprietary GlymaxX® technology to boost the antibody’s ADCC anti-tumor activity.

January 9, 2020
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1 min read