BioSpace News Archive

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Manufacturing

Novo-Acquired Catalent Plant Plagued by Unresolved Pest, Contamination Issues, FDA Finds

Among the problems cited were cat hair, bacterial contamination and instrument defects.

August 22, 2025

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2 min read

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Tristan Manalac

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Regulatory

Krystal Cuts Melanoma Study of Viral Immunotherapy as FDA ‘Uncertainty’ Muddies Approval Pathway

Krystal Biotech’s decision follows the FDA’s rejection last month of Replimune’s RP1, which works similarly to Krystal Biotech’s KB707. The biotech said this has introduced “heightened uncertainty” regarding a potential accelerated pathway for the candidate.

August 22, 2025

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2 min read

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Tristan Manalac

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Regulatory

After Court Win, Vanda Asks Makary To Review ‘Unacceptable’ Approval of Rival Generics

Vanda claims that two generics to its sleep disorder drug Hetlioz were approved despite inadequate data and is requesting that FDA Commissioner Marty Makary revisit the decision.

August 22, 2025

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2 min read

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Tristan Manalac

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Approvals

Ionis Wins Approval For First RNA-Targeted Prophylactic for Rare Swelling Disease

The drug, for hereditary angioedema, is Ionis’ second wholly owned asset.

August 22, 2025

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2 min read

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Tristan Manalac

Tariffs

Trump Administration Settles on 15% Generic Drug Tariff Rate for EU

There’s still much more to come from the White House on tariffs, but the European Union has now reached a trade agreement with the U.S.

August 22, 2025

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1 min read

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Annalee Armstrong

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Weight Loss

Oral Obesity Candidates Disappoint With Novo Emerging as Leader of the Pack

With results from highly anticipated trials of Eli Lilly’s orforglipron and Viking Therapeutics’ VK2735 “underwhelming” investors, William Blair’s Andy Hsieh predicts weight loss pills will play a bigger role in low- and middle-income countries than in the U.S.

August 22, 2025

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5 min read

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Heather McKenzie

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Weight loss

Which Weight Loss Treatments Will Be Most Effective?

While it’s impossible to make apples-to-apples comparisons of the many obesity candidates with so many differences across clinical trials, we at BioSpace are giving it our best shot.

August 22, 2025

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1 min read

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Annalee Armstrong

Press Releases

Crinetics Receives FDA Orphan Drug Designation for Atumelnant in the Treatment of Congenital Adrenal Hyperplasia (CAH)

August 22, 2025

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7 min read

Press Releases

Protagenic Therapeutics Advances PT00114 into Multiple-Dose Phase 1 Trial; Positioning for Phase 2 in Stress & Mood Disorders