BioSpace News Archive

Rare diseases

IRA Leaves Orphan Drugs Stranded Even as Regulators Promise Progress

The Inflation Reduction Act includes an exemption for orphan drugs for a single indication, but experts say this is far from sufficient to maintain momentum in the rare disease space.

June 23, 2025

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7 min read

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Heather McKenzie

©Vertex Pharmaceuticals Incorporated. All Rights Reserved.

Diabetes

Vertex’s Cell Therapy Could Be ‘Functional Cure’ for Diabetes, but Market Prospects Uncertain

While BMO Capital Markets said that zimislecel is “highly encouraging” for type 1 diabetes, questions regarding its target population and Vertex’s execution hang over the cell therapy’s commercial potential.

June 23, 2025

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2 min read

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Tristan Manalac

Corporate headquarters of Novo Nordisk in Denmark

Obesity

Novo Leans on CagriSema’s Safety as Amycretin Moves Forward to Phase III

After consistently failing to meet investor expectations, Novo Nordisk touted a safety profile for CagriSema in line with the GLP1-RA class, while reporting mid-stage data for its GLP1- and amylin-targeting drug amycretin that raised dosing questions.

June 23, 2025

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2 min read

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Tristan Manalac

Depression

Compass Plots Path to FDA With ‘Meaningful’ Phase III Data for Psilocybin Drug in Depression

Although the company withheld detailed findings from the study of treatment-resistant depression, analysts at Stifel called COMP360’s efficacy “more than good enough” for registrational purposes.

June 23, 2025

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2 min read

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Tristan Manalac

Refusal to contact. Barrier to negotiations. Division, separation. Protagonist, antagonist, minions. Mediation and conflict resolution.

Vaccines

Experts Say Axed ACIP Members’ Conflicts of Interest Are ‘a Red Herring’

In advance of this week’s CDC vaccine advisory meeting, HHS Secretary Robert F. Kennedy Jr. restacked the committee, claiming problematic industry ties within the previous group. Experts say ACIP had long navigated COIs appropriately and that the new appointees risk the apolitical nature of membership.

June 23, 2025

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4 min read

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Dan Samorodnitsky

leader crossed forbidden line, leadership vector concept, finish line and winner

Cancer

Exelixis Beats Bayer in Colorectal Cancer as Zanzalintinib Delivers ‘First Pivotal Success’

In combination with Roche’s PD-L1 blocker Tecentriq, zanzalintinib bested Bayer’s Stivarga. Exelixis is positioning the drug candidate as a successor to cabozantinib, which is set to lose patent exclusivity in 2030.

June 23, 2025

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2 min read

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Tristan Manalac

Isometric Breaking the Wall. An alternative Solution to the Problem. Businessman Solved Problem, New Solution, Success and Leadership. Breakthrough. Business concept.

Weight Loss

Lilly Takes Victory Lap on Oral Weight Loss Drug as Analysts Spot Safety Crack

While Eli Lilly brushed off concerns about gastrointestinal side effects for oral weight loss candidate orforglipron, analysts from William Blair worried that adverse events are not tapering off as expected.

June 23, 2025

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5 min read

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Annalee Armstrong

A group of people sitting before microphones at a table on a stage

Government

Acting CDER Head Becomes Latest in String of FDA Leaders to Leave Agency

Jacqueline Corrigan-Curay, who stepped into the role as the agency’s top drug regulator in January, is departing in July, according to an email sent to agency staff.

June 23, 2025

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1 min read

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Dan Samorodnitsky

Press Releases

[Latest] Global Alzheimer’s Drug Market Size/Share Worth USD 19.3 Billion by 2034 at a 13.03% CAGR: Custom Market Insights (Analysis, Outlook, Leaders, Report, Trends, Forecast, Segmentation, Growth Rate, Value, SWOT Analysis)

June 23, 2025

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24 min read

Press Releases

Thermo Fisher Scientific Awarded $94.5 Million U.S. Government Contract to Supply the Navy with Advanced Radiation Detection Systems

June 23, 2025

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2 min read