BioPharma Drive: Drug Pricing

JULY 10, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., Kennedy Jr.

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BioPharma Drive: Drug Pricing

JULY 10, 2025

Published July 10, 2025 Ben Fidler Senior Editor post share post print email license Soleno Therapeutics on July 10, 2025 announced preliminary sales for its new Prader-Willi Syndrome drug Vykat. By Jonathan Gardner • Updated April 9, 2025 Keep up with the story.

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BioPharma Drive: Drug Pricing

JULY 14, 2025

Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Bain Capital, Kohlberg and Mubadala joined to invest in biopharmaceutical CDMO PCI Pharma on July 14, 2025.

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BioPharma Drive: Drug Pricing

JULY 2, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Organon drug for endometriosis falls short in mid-stage study Company executives had seen the drug as a potential multi-billion dollar opportunity in women’s health.

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BioPharma Drive: Drug Pricing

JULY 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Merck to buy Verona and its lung drug in $10B deal The New Jersey-based pharma has inked one of the biggest deals of the year in pursuit of a promising new way to treat COPD.

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BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. On June 26, 2025, the company announced the replacement of longtime CEO Hervé Hoppenot with Bill Meury. Track funding rounds here.

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BioPharma Drive: Drug Pricing

JUNE 27, 2025

Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. On June 26, 2025, the Food and Drug Administration eased some of the medicines' reporting requirements. Abecma and J&J’s Carvykti are used for multiple myeloma.

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Perficient: Drug Development

JUNE 30, 2025

Earlier this year, we published 5 Leading Digital Trends Shaping Wealth Management in 2025 , outlining the macro shifts redefining the industry. The dialogue offered a clear view into where the wealth and asset management industry is headed and how firms are beginning to act on the trends shaping 2025.

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

By Ned Pagliarulo, Jacob Bell and Julia Himmel • Updated June 17, 2025 Spencer Platt via Getty Images Facing ‘uncertainty on steroids,’ biotech dealmakers tread more cautiously Experts say market turmoil has made it harder for buyers and sellers to agree on price, which can be an especially imposing obstacle to large acquisitions.

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The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. i] United States Federal Register.

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LifeSciVC

JANUARY 16, 2024

Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Join the club.

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Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? Top-line data from the Phase IIb study is expected at the beginning of 2025. The third project in clinical phase, IRL757, is in Phase I and is being developed for the treatment of apathy.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. This study is planned to start in late 2024 and conclude in late 2025.

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Agency IQ

JULY 22, 2024

Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). AgencyIQ provides a status update for regulated industry.

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BioPharma Drive: Drug Pricing

JULY 15, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Cancer drugmaker LaNova to sell to China’s Sino Biopharm Sino Biopharmaceuticals plans to pay up to $950.9 Merck paid LaNova $588 million in upfront cash to license LM-299.

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Agency IQ

JULY 22, 2024

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Novel drug products are defined as products that have never been approved for any indication.

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest. Priority B List.

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Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. EMA has now published a report on the workshop; read on for AgencyIQ’s analysis.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Codon

SEPTEMBER 29, 2024

2025 While the broader life sciences community had pivoted towards working on traditional mechanistic interpretations of biology, one graduate student still believed there was something to be learned using the models of life so celebrated previously. The 2025 genetic network paper fit that bill exactly.

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Agency IQ

JUNE 21, 2024

Modeled on the Operation Warp Speed vaccine development communications approach, the pilot aims to test out a rapid communications approach for accelerating rare disease drug development.

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

Published June 23, 2025 Delilah Alvarado Staff Reporter post share post print email license A micrograph image of influenza A virus. By Ben Fidler and Gwendolyn Wu • Updated June 19, 2025 Retrieved from Vinay Prasad on May 08, 2025 Biotech is guessing how Vinay Prasad might change the FDA. Influenza A virus" [Micrograph].

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Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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BioPharma Drive: Drug Pricing

JUNE 30, 2025

Published June 30, 2025 Jonathan Gardner Senior Reporter post share post print email license Moderna announced results from an influenza vaccine clinical trial on June 30, 2025. Jyong Biotech priced only the second biotech IPO since mid-February, although both of those offerings raised $20 million or less in total proceeds.

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BioPharma Drive: Drug Pricing

JUNE 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Sponsored The golden era of GLP-1 drugs: How will it impact medicine and society? By Ned Pagliarulo • June 4, 2025 Keep up with the story.

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BioPharma Drive: Drug Pricing

JUNE 5, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from FDA’s AI tool ‘Elsa’ is here, and the industry has questions The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool’s rollout.

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BioPharma Drive: Drug Pricing

JULY 18, 2025

Published July 18, 2025 Delilah Alvarado Staff Reporter post share post print email license Food and Drug Administration Commissioner Martin Makary speaks on stage during The Semafor 2025 World Economy Summit on April 24, 2025 in Washington, DC. By Jacob Bell • July 1, 2025 Keep up with the story.

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

Published June 23, 2025 Ned Pagliarulo Lead Editor post share post print email license A sign for the Food and Drug Administration is seen outside of the agency's headquarters on July 20, 2020 in White Oak, Maryland. Track funding rounds here.

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Codon

APRIL 24, 2025

About one-fourth of all clinical trials and early drug development now happens in China. “Today, they’re just as likely to license a molecule from a Chinese company. regulators hoping to speed up drug development, too. ” Asimov Press (2025). Those reforms could hold lessons for U.S.

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Drug Target Review

APRIL 11, 2025

Drug development is hampered by high costs, long timelines and a low probability of success and complex therapies exacerbate these challenges. Even excluding repositioned drugs, which could benefit from pre-existing toxicology and clinical data, a significant increase in PoS is still observed. This is an AI-generated image.

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Drug Target Review

MARCH 13, 2025

Planning the journey from data to deliverables The future of AI-enabled drug development benefits from the continued advancement of multimodality and clinical genomics, with a focus on integration, efficiency and personalisation to transform both care and R&D.

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New Drug Approvals

APRIL 21, 2025

6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] 2] Acoramidis was authorized for medical use in the European Union in February 2025. [2] 2] [3] Names During development, acoramidis was known as AG10 (the Alhamadsheh-Graef molecule 10). [20]

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Codon

MAY 29, 2025

The way we typically prepare white beans completely deactivates the mild toxin that could otherwise cause food poisoning, the highly venomous cone snail that produced that shell was long gone by the time you picked it up, and Botox has been safe to inject by licensed healthcare professionals since FDA approval in 1991. Cite: Whiteman, N.

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