BioSpace News Archive

FDA signage at its headquarters in Maryland

Manufacturing

AbbVie, Amgen, Lilly Lead Calls for FDA To Update Post-Approval Change Rules

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.

January 13, 2026

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5 min read

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Nick Paul Taylor

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Manufacturing

AbbVie Commits $100B in US R&D, Manufacturing, Winning Tariff, Pricing Exemptions

AbbVie has also pledged to participate in TrumpRx and offer many of its products, including Humira, on a direct-to-patient basis. In exchange, the pharma secured exemptions from tariffs and other future pricing directives.

January 13, 2026

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2 min read

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Tristan Manalac

Stairs Leading to Flying Paper Plane - Success, Growth, and Freedom, 3D Render

ADCs

Lung Cancer Trial to Proceed After FDA Releases Hold on Merck, Daiichi’s ADC

The FDA initially placed the Phase III IDeate-Lung02 study on hold due to a “higher than expected” number of deaths in patients treated with ifinatamab deruxtecan.

January 13, 2026

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3 min read

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Tristan Manalac

Illustration showing woman starting down curved path with markers toward goal marked by flag

Gene therapy

After Mortality-Marred Year, Sarepta Looks Ahead to Catalyst-Rich 2026

Jefferies analysts forecast a $1 billion market opportunity for each of Sarepta’s siRNA programs for facioscapulohumeral muscular dystrophy and myotonic dystrophy type 1.

January 13, 2026

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2 min read

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Tristan Manalac

Female hand showing thumbs up gesture on blue background, art collage. Positive hand sign. Fashion collage in the style of Thumbs up magazine. Contemporary art. Modern design.

Approvals

Sentynl, Fortress Bounce Back With FDA Approval for Rare Pediatric Disease

The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing facility.

January 13, 2026

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2 min read

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Tristan Manalac

Johnson & Johnson's business center in Switzerland

Manufacturing

J&J To Add 500 Jobs at New Plant, Doubling Down on North Carolina

Johnson & Johnson’s second facility in Wilson, North Carolina, is part of a $55 billion push to make all advanced medicines used in the U.S. domestically.

January 13, 2026

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2 min read

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Nick Paul Taylor

Policy

Acadia CEO Bands With Peers To Lobby Against MFN Drug Pricing for Small Biotech

Acadia Pharma’s Catherine Owen Adams has formed a group of small- to mid-cap biotechs to advocate against a ‘peanut butter blanket’ approach to drug pricing for small companies.

January 13, 2026

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3 min read

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Annalee Armstrong

Events

JPM26 Day 1: Obesity Front-and-Center, Q4 Sales Beats

Obesity took center stage on the first day of the 2026 J.P. Morgan Healthcare Conference, with industry frontrunners Eli Lilly and Novo Nordisk providing supply chain, regulatory and pricing updates.

January 13, 2026

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3 min read

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Tristan Manalac

South San Francisco, CA, USA - May 1, 2022: Exterior view of the Merck Researches Laboratories in South San Francisco, California. Merck & Co., Inc. is a global pharmaceutical company headquartered in Rahway, New Jersey. The company does business as Merck Sharp & Dohme (MSD) outside the United States and Canada.

Events

JPM26: Confident Merck Sees Growth Through Keytruda Loss of Exclusivity

Merck CEO Rob Davis expressed high confidence during the company’s J.P. Morgan presentation on Monday, revealing that the company is open to deals in the range of “multi tens of billions of dollars.”

January 13, 2026

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1 min read

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Heather McKenzie

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Deals

JPM26: Attendees Wonder, Where’s Our Big M&A Deal?

There hasn’t been a headline-stealing deal at J.P. Morgan yet. Nevertheless, the mood is positive amid green shoots and a flurry of dealmaking to end 2025.

January 13, 2026

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2 min read

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Annalee Armstrong