BioSpace News Archive

Drug Development

AbbVie’s SKYRIZI Offers New Option for Psoriatic Arthritis Sufferers

The U.S. Food and Drug Administration has approved SKYRIZI (risankizumab-rzaa), AbbVie’s proposed treatment for adults diagnosed with active psoriatic arthritis (PsA).

January 24, 2022
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2 min read
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Vanessa Doctor, RN
Pharm Country

Clinical Catch-Up: January 17-21

Last week was a relatively quiet week for clinical trial news, particularly around COVID-19. Here’s a look.

January 24, 2022
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4 min read
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Mark Terry
Drug Development

Pfizer and OPKO’s Growth Hormone Deficiency Drug Denied by FDA

FDA rejected OPKO’s once-weekly human growth hormone, somatrogon, which it co-developed with Pfizer for the treatment of growth hormone deficiency (GHD) in pediatric patients.

January 24, 2022
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2 min read
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Alex Keown
Drug Development

Six Companies Hit the Clinic with Innovative Therapeutic Candidates

TScan Therapeutics, Lyell, SQZ Biotech and others secured clearance from the U.S. Food and Drug Administration for their Investigational New Drug Application.

January 24, 2022
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4 min read
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Alex Keown
Drug Development

Oncopeptides Withdraws Withdrawal of First Marketed Drug Pepaxto

Oncopeptides has discontinued the marketing of Pepaxto drug in the US. But, in a recent turnaround, they decided to withdraw this decision of stopping the production.

January 24, 2022
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2 min read
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Jill Gartz
FDA

1 in 5 Americans Have had COVID-19, Veklury Approved in New Indication

It’s a landmark no one expected or wanted — more than 70 million confirmed COVID-19 cases in the U.S. with 866,000 deaths. For that and more COVID-19 news, continue reading.

January 24, 2022
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6 min read
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Mark Terry
Drug Development

MaaT Pharma on Accelerated Development Plan as Proof of Engraftment Attained

MaaT Pharma decided today to end the Phase Ib CIMON study for MaaT03, the company’s second drug candidate and first oral formulation in Phase 1b clinical trial, following positive interim engraftment data of the drug.

January 24, 2022
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2 min read
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Alvin Clavines
Learn Dealing With A Micromanager At Work

Dealing with a micromanager boss or coworker can be challenging. Read the full article on Biospace to find out how to deal with a micromanager at work.

January 24, 2022
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6 min read
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Alina Zahid
Business

ReCode Enlists New CEO to Drive Assets into the Clinic

Suliman anticipates filing an Investigational New Drug application with the FDA for the PCD asset this year, and next year filing one for the cystic fibrosis asset.

January 24, 2022
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5 min read
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Alex Keown
Drug Development

Merck Remains Committed to Chronic Cough Drug Following FDA Rejection

The U.S. Food and Drug Administration issued a Complete Response Letter to Merck & Co. for its New Drug Application for gefapixant for refractory chronic cough or unexplained chronic cough.

January 24, 2022
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2 min read
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Mark Terry