BioSpace News Archive

Drug Development

Takeda Stumbles to be First EoE Treatment to Market Following FDA CRL

Takeda hoped that its experimental therapy could become the first FDA-approved treatment for EoE. However, the FDA wants the company to initiate another clinical study with TAK-721.

December 22, 2021
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2 min read
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Alex Keown
Global Roundup: BICO Group Snaps up Biosero and its Software Solutions

Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.

December 22, 2021
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6 min read
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Alex Keown
Business

BioSpace Movers & Shakers, Dec. 24

With all eyes on a new year, life sciences companies and organizations are making last-minute appointments to strengthen their leadership teams and board with these Movers & Shakers.

December 22, 2021
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5 min read
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Alex Keown
Drug Development

Novartis Bolsters Retinal Gene Therapy Position with $1.5 Billion Acquisition

Novartis believes Gyroscope’s investigational Phase II gene therapy for geographic atrophy has the potential to become the first therapy that demonstrates sustained efficacy for GA patients.

December 22, 2021
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2 min read
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Alex Keown
Drug Development

Allakos Reports Mixed Results for Two Eosinophilic GI Disease Studies

Allakos reported mixed results on two clinical trials, the Phase II ENIGMA 2 and Phase II/III KRYPTOS trials of lirentelimab.

December 22, 2021
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3 min read
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Mark Terry
Drug Development

DBV Continues to Fight for Viaskin Peanut, Initiates New Phase III Study after FDA Rejection

The new Phase III study will include an enhanced version of the Viaskin Peanut patch, approximately 50% larger than the patch initially rejected by the FDA.

December 22, 2021
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2 min read
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Alex Keown
Business

Korify Capital Launches New $100 Million Fund in Longevity Space

The company aims to use the $100 million investment to support biotechnology firms involved in treating mental diseases and longevity projects.

December 22, 2021
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2 min read
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Alvin Clavines
FDA

FDA Authorizes First Oral COVID Antiviral Drug

The U.S. Food and Drug Administration granted Emergency Use Authorization to Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) for high-risk adults and pediatric patients 12 years and older to treat COVID-19.

December 22, 2021
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3 min read
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Mark Terry
Money on the Move: December 15 – 21

These biotech companies made the nice list, earning them far more than a lump of coal.

December 22, 2021
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3 min read
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Kate Goodwin
Drug Development

FDA Places Hold on Gilead HIV Trials Over Vial Quality Concerns

Ten studies are halted completely. Oral formulations of the drug will continue. Gilead stated that it is confident about the future of the drug’s potential and is working to resolve the vial quality problem.

December 22, 2021
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3 min read
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Mark Terry