BioSpace News Archive

Cem Zorlular is CEO of Er-Kim, a specialty pharmaceutical company that serves as a regional affiliate to small and large pharma and biotech companies to commercialize their medicines in markets that fall outside of the U.S. and Western Europe.

factory of the pharmaceutical industry. pills on the conveyor

Manufacturing

After Phase III Win, Lilly Promises to Manufacture Weight-Loss Pill in US

President Donald Trump in February threatened top pharma leaders, including Eli Lilly CEO David Ricks, with tariffs unless they reshore their manufacturing operations.

April 21, 2025

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2 min read

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Tristan Manalac

Immunology and inflammation

Following Rejection, FDA Okays Sanofi/Regeneron’s Dupixent for Chronic Hives

Dupixent, which was rejected by the FDA for chronic spontaneous urticaria in October 2023, is now approved as the first new targeted therapy for the indication in more than 10 years.

April 21, 2025

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2 min read

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Tristan Manalac

Concept business people work with modern laptop. Double exposure. Meeting room in office building background

FDA

Banning Industry From FDA Adcomms Won’t ‘Move the Needle Much’ in Makary, RFK’s Fight Against COIs

FDA Commissioner Marty Makary last week announced a directive that would limit industry participation in the agency’s advisory committees. But not only do company reps serve only as non-voting members, a 1997 law actually requires industry involvement.

April 21, 2025

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5 min read

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Heather McKenzie

command failed. Business team walk in a line following faulty orders vector

Layoffs

Tempest Cuts 80% of Staff While Considering Strategic Alternatives

California-based Tempest Therapeutics is laying off 21 of its 26 full-time employees. The cuts come while the biotech is exploring strategic alternatives, including a merger or acquisition, as it tries to move its investigational PPARα antagonist into late-stage development.

April 21, 2025

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1 min read

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Angela Gabriel

The concept of environmental protection. Earth in hands on a beige background. Earth Day. Collage

Opinion

Regulatory and Economic Turmoil Is More Familiar in Other Countries

Disruptive conditions are typical in non-Western markets. The U.S. industry, thrown into a period of significant change as the Trump administration overhauls HHS and considers implementing tariffs, could learn a thing or two by looking overseas.

April 21, 2025

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5 min read

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Cem Zorlular

FDA

Makary Discusses Expedited Rare Disease Approvals Pathway, ‘Public Distrust’ in New Interview

In an interview with former Fox News journalist Megyn Kelly, FDA Commissioner Marty Makary introduced a new mechanism-driven pathway that could be leveraged by rare disease therapies while saying that autism could potentially be driven by certain environmental factors.

April 21, 2025

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2 min read

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Tristan Manalac

Press Releases

Neurotech Appoints Beth Marsh as Chief Commercial Officer

April 21, 2025

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8 min read

Press Releases

ATEC Launches PTP™ Corpectomy, The Next Evolution of Lateral Approach Surgery