New Drug Approvals

JULY 25, 2025

11] [21] [22] In October 2023, the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Agamree, intended for the treatment of Duchenne muscular dystrophy. [2] This article incorporates text from this source, which is in the public domain.

FDA

New Drug Approvals

MAY 8, 2025

This article incorporates text from this source, which is in the public domain. This article incorporates text from this source, which is in the public domain. ^ “U.S. 4] Participants had a median of three prior lines of therapy, with 93% having two or more prior lines. [4] 27 January 2023. . 27 January 2023. 12 (5): 80.

FDA Approval

Drug Target Review

JULY 29, 2025

Kyle notes that “clinical trials face costly delays, inefficient resource allocation, and even standstill or stalling of trials, ultimately resulting in the failure to bring crucial treatments to market.” Jennifer has been a licensed CPA (California) since July 2014. Available from: [link]

Clinical Trials

BioPharma Drive: Drug Pricing

JUNE 11, 2025

Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer. In a research note on Wednesday, RBC Capital Markets analyst Leonid Timashev estimated peak yearly sales of the drug could reach nearly $640 million.

FDA

BioPharma Drive: Drug Pricing

JULY 28, 2025

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Clinical Trials

BioPharma Drive: Drug Pricing

JUNE 26, 2025

Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease.

Disease

New Drug Approvals

APRIL 18, 2025

This article incorporates text from this source, which is in the public domain. ^ “Novel Drug Approvals for 2024” U.S. Article ] Yogi A, Kashimada K: Current and future perspectives on clinical management of classic 21-hydroxylase deficiency. Food and Drug Administration (FDA) (Press release). 1 October 2024.

FDA

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.,

Vaccine

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. Until Vykat came along, though, no drug therapies were specifically approved to curb the all-consuming hunger that hallmarks the condition.

Drugs

BioPharma Drive: Drug Pricing

JULY 18, 2025

Published July 18, 2025 • Updated 3 hours ago Ned Pagliarulo Lead Editor post share post print email license The U.S. Alamy The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive.

Therapies

BioPharma Drive: Drug Pricing

JULY 30, 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 News roundup Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval The Hong Kong-based CSPC will receive $120 million from Madrigal under the deal.

Drugs

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.

Clinical Trials

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. “We and sold [Karuna],” wrote RBC Capital Markets analyst Brian Abrahams, in a note to clients. Sign up A valid email address is required. Please select at least one newsletter.

Therapies

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. Dive Insight: Since the FDA’s approval of Novartis’ Kymriah for leukemia in 2017, six more CAR-T therapies have reached market.

Therapies

BioPharma Drive: Drug Pricing

JULY 28, 2025

Fragmented approaches – whether through retail or oversized specialty hub models, or limited alternative solutions that lack true integration – simply cannot deliver the efficiency, control, and customization that market-defining brands need. You can unsubscribe at anytime.

Specialty Pharmacies

BioPharma Drive: Drug Pricing

AUGUST 11, 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 Regulatory uncertainty and access challenges changing go-to-market models, DTC, and DTP Published Aug.

Marketing

Drug Patent Watch

FEBRUARY 3, 2021

This article was originally published by Ioana Gherghescu and Begoña Delgado-Charro in Pharmaceutics 2021, 13(1) under a Creative Commons Attribution License. Abstract Biosimilar medicines expand the biotherapeutic market and improve….

Biosimilars

BioPharma Drive: Drug Pricing

JULY 22, 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 News roundup Replimune drug rejected by FDA; Omega raises $647M biotech fund The FDA raised issues that Replimune said hadn’t come up in meetings previously.

FDA

BioPharma Drive: Drug Pricing

JULY 22, 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 // Vaccines Sanofi to acquire vaccine biotech in billion-dollar deal The French pharma will pay $1.15 You can unsubscribe at anytime.

Vaccine

Drug Patent Watch

JANUARY 21, 2021

This article was first published by Elinevan Overbeeke, Sissel Michelsen, Mondher Toumi, Hilde Stevens, Mark Trusheim, Isabelle Huys, and StevenSimoens in Drug Discovery Today under a Creative Commons License. Highlights….

Therapies

Agency IQ

AUGUST 4, 2023

This past week, the MHRA provided guidance on labeling of medicines destined for Northern Ireland, with provisions to ensure that medicines only move into Northern Ireland market and don’t re-enter E.U. The European centralized marketing authorization procedure is no longer a valid medicines approval pathway for the U.K. member states.

Packaging

Agency IQ

JANUARY 4, 2024

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. KAROLINE MATHYS is the head of the new sector.

Marketing

Perficient: Drug Development

JULY 24, 2025

Who, even out of curiosity, has asked a question to generate an image, refine ideas, or seek answers in one of the many artificial intelligence applications on the market? Now, parallel to this conversation, there are numerous myths about the arrival and use of artificial intelligence, some of which we will address in this article.

Licensing

Agency IQ

JUNE 2, 2023

What we expect to be talking about in June: Supply chain information: Under the FDORA legislation, holders of Biologics License Applications are required to submit a one-time report to the FDA on June 25, 2023 regarding which of their biologic products are available for sale or have been withdrawn from the market.

FDA

BioPharma Drive: Drug Pricing

JUNE 23, 2025

The black and gray market risks Ben warned about the proliferation of counterfeit GLP-1 drugs in unregulated markets, posing significant dangers to patients who might unknowingly use ineffective or harmful products. You can unsubscribe at anytime. The balance is complex, as obesity carries its own serious health risks.

Treatment

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

That clause excludes those ingredients that were first marketed as drug ingredients. MKP) asserting that “NMN is excluded from the dietary supplement definition under [FDC Act § 201(ff)(3)(B)(ii)] and may not be marketed as or in a dietary supplement.”

Production

Agency IQ

MAY 28, 2024

This draft framework – which will come into force alongside the future medical device regulations – proposes four market access routes that have the potential to recognize the decision-making of four “comparable regulator countries,” but only for certain device and diagnostics types. law as the Medical Devices Regulation 2002 (UK MDR 2002).

International

Agency IQ

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. both pre- and post-market. New roadmap sets out U.K.

Regulations

Perficient: Drug Development

SEPTEMBER 11, 2023

If you read my last article, the big deal with headless , you know that the big deal is performance. Experience Edge accelerates content delivery but does not support Sitecore Analytics or Marketing features. Read my article on making sense of search options in Sitecore for more details.

Licensing

Agency IQ

SEPTEMBER 29, 2023

The intent is to create a single market for data, establish common European data spaces, and allow the companies that generate the data to keep control and maintain trade secrets. market regardless of the location of the business. The Act would apply to manufacturers of connected products and related services on the E.U.

Regulations

Agency IQ

AUGUST 25, 2023

The FDA states that “certain text in the reference product labeling related to condition(s) of use for the reference product that are not licensed for the biosimilar product would generally not be included in the biosimilar product labeling.” Featuring previous research by Rachel Coe.

Biosimilars

Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. market more quickly. The procedure is available for E.U.

International

Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. Compass has studied psylocibin for PTSD in an open-label, Phase 2 setting.

FDA

Agency IQ

JANUARY 12, 2024

The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect fees from companies that submit marketing applications to the agency for certain human drug and biological products. According to Downey, the timeline of pre-license inspections for biologics can create challenges. modernization efforts.

FDA

Agency IQ

SEPTEMBER 22, 2023

The FDA-required labeling is the drug labeling that is submitted by the sponsor and reviewed and approved by the FDA as part of the drug’s marketing application (including a New Drug Application, Abbreviated NDA, or a Biologics License Application) – and includes prescribing information (PI).

FDA

Perficient: Drug Development

JUNE 15, 2023

New test automation technologies are entering the market as the scope expands. The market was previously dominated by proprietary tools like selenium. However, new open-source tools are now leading the market. Playwright is one of many Test Automation Frameworks available in the market. What is Playwright? The Apache 2.0

Marketing

Perficient: Drug Development

FEBRUARY 14, 2024

But there’s one more type of training your healthcare content strategists and marketers need that you’re (probably) not doing: healthcare writing training. The skills that often are part of successful digital marketing in other areas of commerce don’t always translate exactly to healthcare marketing. And it’s not you.

Engineering