BioSpace News Archive

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Government

FDA to Rehire Scientists After Trump’s Firing Spree: Reuters

Around 300 FDA staffers laid off last week are being asked to return. So far, the Trump administration has terminated some 1,000 employees from the agency.

February 24, 2025

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2 min read

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Tristan Manalac

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Government

Trump Threatens Big Pharma With Tariffs—Unless They Reshore Manufacturing: Bloomberg

President Trump also refused to promise pharma execs that he would hamstring the IRA’s drug negotiation program.

February 24, 2025

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2 min read

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Tristan Manalac

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Infectious disease

Small Harvard Start-Up Launches to Fight Huge Problem of Antimicrobial Resistance

The World Health Organization names antimicrobial resistance as one of the most urgent public health threats, but it remains an unattractive target for the pharmaceutical industry due to its weak profitability.

February 24, 2025

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2 min read

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Tristan Manalac

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Pain

Vertex’s Journavx Changes the Pain Treatment Landscape But Opioids Here to Stay

Non-opioid pain therapies are entering an unprecedented era, marked by the landmark FDA approval of Vertex’s Journavx and a growing number of alternative approaches. Their ultimate uptake, however, remains to be seen.

February 24, 2025

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9 min read

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Tristan Manalac

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Drug Development

RNA Editing Hits the Clinic, Fueling New Hope for Rare and Common Diseases

With the modality now in early clinical trials, experts say more efficiency, broader editing capabilities and delivery breakthroughs are needed to propel RNA editing to the next stage.

February 24, 2025

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6 min read

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Heather McKenzie

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Drug Development

Opinion: AI Is Pushing the I&I Pendulum From Biologics to Small Molecules

Drug development powered by artificial intelligence is countering incentives from the Inflation Reduction Act and making small molecules more attractive in the complex inflammatory & immunology disease space.

February 24, 2025

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6 min read

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Christian Antoni

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Approvals

Mirum Establishes Liver Expertise With First FDA Nod for ‘Very Rare’ Disease

Ctexli’s approval further entrenches Mirum as a leader in rare liver diseases, alongside its cornerstone product Livmarli and upcoming drug volixibat.

February 24, 2025

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2 min read

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Tristan Manalac

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Gene therapy

Regeneron’s Gene Therapy Restores Hearing in Patients with Rare Genetic Condition

The treatment, called DB-OTO, is one of several early-stage gene therapies being developed to treat relatively straight-forward causes of genetic deafness.

February 24, 2025

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4 min read

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Dan Samorodnitsky

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COVID-19

FDA Shoots Down Invivyd’s Bid to Expand EUA for COVID-19 Antibody

Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent requirements for antibody activity boxed out its potential use as a post-exposure treatment.

February 24, 2025

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1 min read

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Dan Samorodnitsky

Press Releases

Seer to Participate in the TD Cowen 45th Annual Health Care Conference

February 24, 2025

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1 min read