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Lexeo to help launch spinout around RNA drugs for the heart

BioPharma Drive: Drug Pricing

Published June 24, 2025 Gwendolyn Wu Senior reporter post share post print email license Lexeo Therapeutics and two life sciences investors are working together to launch a startup to develop cardiac RNA therapies. © 2025 TechTarget, Inc. or its subsidiaries. All rights reserved.

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Private equity firms back PCI Pharma in bet on drug production

BioPharma Drive: Drug Pricing

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. PCI helps biopharmaceutical companies manufacture and package drug products used in clinical trials as well as commercially.

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The rise of GLP-1 drugs: Transforming weight loss treatment

BioPharma Drive: Drug Pricing

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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Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

FDA Law Blog: Biosimilars

Butler — In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database. By Sarah Wicks & Michelle L.

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Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Agency IQ

on June 20, 2023 and will apply starting January 1, 2025. These features should not be included on outer packaging or immediate packaging, if there is no outer packaging. Beginning January 1, 2025, the MHRA will be responsible for authorizing all medicines for the U.K. wide license: The requirements of the E.U.

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Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

The Premier Consulting Blog

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. Prescription Drug User Fee Rates for Fiscal Year 2025.

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Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

The following PDUFA dates were obtained from publicly available sources. Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER.

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