Drug Patent Watch

MARCH 18, 2025

Exploring the Russian Pharma Industry: Key Players and Innovations As we continue to navigate the complexities of the global pharmaceutical landscape, it's essential to stay informed about emerging markets and trends. billion by 2025, with a compound annual growth rate (CAGR) of 10.5%. billion by 2025, with a CAGR of 10.5%.

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FDA Law Blog: Biosimilars

JULY 13, 2025

Snow — On July 7, 2025, President Trump, via Executive Order (“EO”), issued a presidential memorandum and accompanying fact sheet directing major changes in federal civilian hiring, including extending the federal civilian hiring freeze through October 15, 2025. By Charles D.

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FDA Law Blog: Biosimilars

MARCH 12, 2025

The American Conference Institutes 21st Annual Paragraph IV Disputes is scheduled to take place from April 29-30, 2025 at The Altman Building in New York, NY. PTOs PTAB, the FTC, and the FDA, to tackle the critical legal, regulatory, and business issues shaping pharmaceutical patent litigation.

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Drug Patent Watch

DECEMBER 10, 2024

Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. As patents for these biologics expire, the market for biosimilars is expanding rapidly, with significant implications for manufacturing technologies.

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BioPharma Drive: Drug Pricing

JULY 22, 2025

Published July 22, 2025 By BioPharma Dive staff post share post print email license Daniel Tadevosyan via Getty Images Today, a brief rundown of news involving Replimune Group and Johnson & Johnson, as well as updates from Omega Funds, iTeos Therapeutics and Roche that you may have missed. and European life sciences companies.

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BioPharma Drive: Drug Pricing

JULY 22, 2025

Published July 22, 2025 • Updated 2 hours ago Delilah Alvarado Staff Reporter post share post print email license A sign bearing Sanofi's logo sits outside the company's U.S. JHVE Photo via Getty Images Dive Brief: French pharmaceutical giant Sanofi said Tuesday it will pay $1.15 headquarters in Bridgewater, New Jersey.

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Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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FDA Law Blog: Biosimilars

SEPTEMBER 11, 2024

One specific kind of nitrosamines called N-nitrosamine drug substance-related impurities, or NDSRIs, are especially vexing to FDA and to industry because they mimic the structure of the specific active pharmaceutical ingredients (API), making them difficult to detect. The revisions due in 2025 include testing for NDSRIs.

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FDA Law Blog: Biosimilars

SEPTEMBER 25, 2024

Throughout his illustrious career, Al has been engaged with Hatch-Waxman, even authoring one of the earliest papers providing an account of the law: “ Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness? ” In his new book, “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer,” which will be released (..)

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The Pharma Data

MAY 18, 2021

Kundl, Austria further strengthens production for oral antibiotics while facility in Palafolls, Spain expands for sterile active pharmaceutical ingredients. Sterile API production is planned to transfer from Kundl to the new facility at Palafolls in 2025. About Sandoz.

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FDA Law Blog: Biosimilars

JUNE 29, 2025

Gibbs — The Federal Food, Drug, and Cosmetic Act (FD&C Act) has very different regulatory regimes for pharmaceutical products than devices. This raises a separate question: where is the FY 2024 report, given that we are more than halfway through FY 2025? By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N.

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Agency IQ

MAY 3, 2024

voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U.

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Agency IQ

SEPTEMBER 1, 2023

pharmaceutical law ceased to apply to the U.K. The Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. centralized procedure until 2025, when the Windsor Framework takes effect.

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FDA Law Blog: Biosimilars

JUNE 7, 2023

to transfer their patented pharmaceutical products to Medicare beneficiaries, for public use” at a government-dictated price that is a fraction of the drug’s value. First, Merck characterizes the program as a “ per se taking” without just compensation under the Fifth Amendment, because manufacturers are “force[d]. Complaint at 2.

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FDA Law Blog: Biosimilars

JULY 15, 2025

For example, in 2016, CMS explained that, “[g]iven the continually changing pharmaceutical marketplace, we will continue to allow manufacturers the flexibility to determine the fair market value of a service when evaluating whether the service fee is bona fide or not.”

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BioPharma Drive: Drug Pricing

JULY 21, 2025

After the fierce competition between Humira (adalimumab) biosimilars, manufacturers are keeping a close eye on adoption dynamics for biosimilars of Johnson & Johnson’s autoimmune drug, Stelara (ustekinumab). What is the impact of vertical integration, the IRA and other factors on biosimilar adoption?

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Agency IQ

JULY 8, 2024

and the E.C.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year. state pharmaceutical assistance programs).

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Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

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Agency IQ

AUGUST 2, 2024

All clinical trials still ongoing must transition to the Clinical Trials Regulation by January 31, 2025 to ensure continuity. Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L.

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Agency IQ

MARCH 29, 2024

Perhaps the most significant pharmaceutical news anticipated for April: the vote on the pharmaceutical legislation revision. This will include a number of conferences, webinars, and training sessions, as well as a long-awaited EMA workshop on psychedelics.

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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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Agency IQ

MAY 31, 2024

Program Agency Deadline Survey: EU4Health Annual Work Program 2025 European Commission 6/10/2024 Survey: Real4Reg survey on real-world data Real4Reg/EMA 6/14/2024 Survey: EMA Communication perception EMA 6/21/2024 Survey: E.U. These include, but are not limited to, calls for applicants, expressions of interest and surveys.

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Agency IQ

OCTOBER 27, 2023

Comment periods for EMA documents (such as concept, reflection, and guidance papers) generally stay open for at least six months, though these timelines can vary drastically. policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected through Q1 2024.

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Agency IQ

JULY 8, 2024

The European Council held its first public debate of the proposed pharmaceutical legislation last week. Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Now it is up to the Council to provide their position.

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The Pharma Data

FEBRUARY 8, 2021

Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% price, patients switching to Toujeo ® and biosimilar glargine competition. Pharmaceuticals business operating income. Specialty Care.

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The Pharma Data

FEBRUARY 4, 2021

Pharmaceuticals. Fourth-quarter 2020 Pharmaceutical sales increased 2.4% Fourth-quarter 2020 Pharmaceutical sales increased 2.4% In 2020, Pharmaceuticals sales increased 3.1% price, patients switching to Toujeo ® and biosimilar glargine competition. Pharmaceuticals business operating income. Specialty Care.

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FDA Law Blog: Biosimilars

JUNE 10, 2025

23,711 (June 4, 2025). 23,483 (June 3, 2025). Public comments must be submitted electronically or postmarked on or before July 3, 2025. Public comments must be submitted electronically or postmarked on or before July 3, 2025. 23,477 (June 3, 2025). DEA published the original Special Surveillance in May 1999.

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Agency IQ

DECEMBER 1, 2023

If all changes are accepted, the date of application is set to be January 1, 2025. Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. Expected Action Description of action Original Deadline Pharmaceuticals – changes to marketing authorisations (review of EU rules) [E.U.]

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The Pharma Data

MAY 4, 2021

Even excluding the growth provided from BNT162b2, our revenues grew 8% operationally, which aligns with our stated goal of delivering at least a 6% compound annual growth rate through 2025. In April 2021, Pfizer announced that it has acquired Amplyx Pharmaceuticals, Inc. CAPITAL ALLOCATION.

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FDA Law Blog: Biosimilars

JUNE 8, 2025

Amneal , the FTC sent another spate of “warning letters” on May 21, 2025 to Novartis, Amphastar Pharmaceuticals, Mylan Specialty, Covis Pharma, and three Teva entities. Well, the FTC is back at it—again without the help of FDA. Armed with the Federal Circuit opinion in Teva v.

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FDA Law Blog: Biosimilars

MAY 13, 2025

Wasserstein We are still parsing through the May 12 Executive Order (EO), Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients and impacts this may have on the pharmaceutical industry. Weve blogged about Most-Favored-Nation (MFN) drug pricing and how the new EO goes well beyond the 2020 order and questions we have.

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Drug Channels

FEBRUARY 4, 2025

ICYMI, the largest three pharmaceutical wholesalersCardinal Health, Cencora, and McKessonare using vertical integration to build significant market positions in businesses beyond drug distribution. In the video clip below, I review the vertical integration status of the largest three pharmaceutical wholesalers, illustrated in the chart below.

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Drug Channels

APRIL 3, 2025

Click here to see the original post from February 2025. ICYMI, the largest three pharmaceutical wholesalersCardinal Health, Cencora, and McKessonare using vertical integration to build significant market positions in businesses beyond drug distribution. This video was excerpted from my recent Drug Channels Outlook 2025 webinar.

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FDA Law Blog: Biosimilars

JANUARY 16, 2025

Hyman, Phelps & McNamara PC, (HPM), which will mark its 45thAnniversary on March 17, 2025, is pleased to announce that it is increasing its directors, counsel, and associates as it starts the year. Richardson has been promoted to Director. Kalie is the quintessential HPM lawyer.

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FDA Law Blog: Biosimilars

MAY 7, 2025

On April 14, 2025, the Seventh Circuit overturned the criminal conviction of Mark Sorensen, the owner of a durable medical equipment (DME) distributor, who had been found guilty of violating the AKS.

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FDA Law Blog: Biosimilars

MAY 26, 2025

The political battle went into gear on January 28, 2025, with an Executive Order titled Protecting Children from Chemical and Surgical Mutilation. The EO and DOJ memo were followed by a May 1, 2025 announcement of a report from the U.S. The gray box at the top of the document at this link shows the change in position.

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