Drug Patent Watch

JANUARY 7, 2025

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. Public Awareness Campaigns Encourage government-sponsored public awareness campaigns about the safety and efficacy of generic drugs. “2021 Generic Drug & Biosimilars Access & Savings in the U.S.

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FDA Law Blog: Biosimilars

JUNE 1, 2025

stating that he would advise President Trump to ban pharmaceutical advertising on TV. In addition to his letter to FDA, Senator Durbin has introduced bipartisan legislation aimed at addressing deceptive advertising practices by the pharmaceutical industry. Department of Health and Human Services Secretary, Robert F. Kennedy Jr.,

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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. One area that's gaining attention is the development of biosimilars.

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FDA Law Blog: Biosimilars

JULY 13, 2025

Fiscal Discipline & Deregulation Framed as a strategy to enhance fiscal accountability, the initiative is part of the administration’s purported broader goals to control taxpayer spending, streamline government, and reverse the last administration’s federal job growth.

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FDA Law Blog: Biosimilars

MAY 15, 2025

Against the backdrop of increasing uncertainty and change in the drug pricing landscape, this hybrid event brings together experts working in or with the pharmaceutical and biotechnology industries to share best practices and discuss the cross-functional impacts of the ever-changing government and state drug pricing landscape on commercialization, (..)

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DrugBank

OCTOBER 4, 2024

Deal Structuring Deal structuring in pharmaceutical M&A requires a balance of financial, legal, and strategic considerations. Intellectual Property Valuation Valuing intellectual property (IP) assets is a critical component of pharmaceutical M&A, as these assets often represent a significant portion of a company's value.

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

Karst — If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. VANDA PHARMACEUTICALS, INC. VANDA PHARMACEUTICALS, INC. 24-270 VANDA PHARMACEUTICALS, INC. 23-5200 (D.C.

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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept. Eylea ® is a trademark of Bayer AG and in the US of Regeneron Pharmaceuticals, Inc.

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FDA Law Blog: Biosimilars

JUNE 12, 2024

HP&M) seeks to add an experienced attorney (7+ years) to our government discount program and price reporting practice. Hyman, Phelps & McNamara, P.C. (HP&M) Our firm culture is collaborative, and the subject matter is intellectually stimulating. Strong verbal and writing skills are required.

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Drug Channels

JULY 11, 2022

President and CEO, National Pharmaceutical Council Julie Ritchie Wagner, Senior Assistant General Counsel, Head of Global Ethics, Compliance, and Enforcement Legal Policy, PhRMA Joel White, Founder and President, Horizon Government Affairs Charlene Keller Fullmer, Assistant U.S. O’Brien, Pharm.

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Federal Court Orders Puerto Rico Pharmaceutical Distributor to Pay $12 Million in Connection with Alleged Failure to Report Suspicious Orders of Pharmaceutical Drugs and Other Controlled Substance Violations, Nov. The government asserted additional allegations that are outside our scope. 6, 2023 ( DOJ Press Release ).

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The Pharma Data

MAY 31, 2022

Sandoz, a global leader in generic and biosimilar medicines, today announced the launch of a new global initiative called ‘Act4Biosimilars’ to help address health inequity and inequality worldwide. Biosimilars match their respective reference medicine in terms of quality, safety and efficacy.

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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. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label.

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The Pharma Data

OCTOBER 27, 2020

Commenting on his appointment, Parag Agarwal said, “Dr Reddy’s is driven by its purpose, high governance standards, a robust strategy and strong leadership. Reddy’s”) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

With over 26 years of dedicated service to the pharmaceutical and medical device industries, Ms. Walsh has garnered acclaim for her passionate efforts in assisting companies with preventing or responding to government investigations, conducting internal investigations to ensure compliance, and defending against DOJ prosecutions.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

Walsh, with over 26 years of experience in providing counsel to the pharmaceutical and medical device industries, will provide invaluable insights into global advertising and promotion regulations.

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FDA Law Blog: Biosimilars

APRIL 4, 2023

The South Korean government has recently announced its plan to provide support for the growth of the nation’s biohealth industry, aiming to establish it as a significant and strategic sector in the nation, similar to the semiconductor industry.

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FDA Law Blog: Biosimilars

MAY 30, 2024

Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. Novartis Pharmaceuticals v.

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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. The complaint characterizes this as political deception that conscripts companies to legitimize government extortion. Complaint at 2. Complaint at 3.

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FDA Law Blog: Biosimilars

MARCH 5, 2024

According to the court, AstraZeneca’s “desire” or even “expectation” to sell its drugs to the Government at the higher prices it once enjoyed does not create a protected property interest.” The court reasoned that no one is entitled to sell to the Government at prices the Government will not agree to pay.

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The Pharma Data

MARCH 5, 2021

At the Kundl site, Novartis is a pioneer and has decades of experience in pharmaceutical production of proteins and in more recent years of nucleic acids. “We feel it is our responsibility to do everything in our power to help and we are pleased to announce our collaboration with CureVac.

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FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

Her expertise includes preparation and maintenance of licensing documentation, communications with state boards and government agencies, conducting research, and the preparation of associated licensing documentation and applications.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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FDA Law Blog: Biosimilars

MARCH 24, 2024

The 340B statute is silent about delivery and distribution of pharmaceuticals by pharmacies to patients even though pharmacies are essential and a legally required part of the drug distribution chain. Code Ann. § 23-92-604(c)(1), (2) (Act 1103). McClain , No. 22-3675, 2024 U.S. LEXIS 5840 (8th Cir. 2024) at 13 (“Decision”). Decision at 8-9.

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FDA Law Blog: Biosimilars

JUNE 7, 2023

Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in the pharmaceutical, device, and biologics space that benefit from reimbursements from Federal health care programs. They are entitled to receive one third of any claw back, which can result in multi-million-dollar awards.

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FDA Law Blog: Biosimilars

OCTOBER 4, 2023

According to the court, the Constitution guarantees no right to conduct business with the government, so the consequences of that participation can be “conditioned by regulation” without being considered unconstitutional. Standing The Defendants questioned, and the court reviewed, Plaintiffs’ standing. See Order at 15, 21.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

Hyman Phelps & McNamara received the following honors: Tier 1 FDA: Pharmaceutical Tier 1 FDA: Medical Device Additionally, eight professionals are included in LMG’s coverage: Robert A. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C. Dormer (Hall of Fame), Jeffrey N. Gibbs (Hall of Fame), John A. Gilbert , Gail H.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

Government—was that, despite having missed the statutory 60-day filing deadline, the patent was granted a PTE due to a change in the law created by Section 37 of the Leahy-Smith America Invents Act (“AIA”) ( Pub. Taiho Pharmaceutical Co., The way that matter ended up—after touching all three branches of the U.S.

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FDA Law Blog: Biosimilars

JUNE 26, 2023

Chamber of Commerce (complaint here ), in New Jersey by Bristol Myers Squibb (complaint here ), and in Texas by Pharmaceutical Research and Manufacturers of America (PhRMA) and others (complaint here ). Since then, complaints have been filed in federal court in Ohio by the U.S.

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Agency IQ

AUGUST 2, 2024

For various reasons, that currently seems unlikely, but it is perhaps more likely that Congress will pass a short-term continuing resolution to fund the federal government for a few months, as it often does. In addition, FDA’s Congressionally appropriated funding runs out at midnight on September 30, requiring Congress to pass a new budget.

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FDA Law Blog: Biosimilars

JULY 24, 2023

Koblitz — Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. After suing each other in patent litigation and Avadel’s suit against FDA challenging the Agency’s authority to compel patent certifications, it’s Jazz’s turn to sue FDA.

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Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

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Agency IQ

JULY 8, 2024

The court’s decision on June 28 is going to cause a frantic re-evaluation at every regulatory agency in the federal government and in every court in the country. We’re about to find out. Read AgencyIQ’s analysis of the Loper Bright decision ] Unified Agenda: What regulations is the FDA expecting to release through the end of the year?

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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. from the E.U. on February 1, 2020 started a year-long transition period; The E.U.

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The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. ALEXION PHARMACEUTICALS, INC. ALEXION PHARMACEUTICALS, INC. Initiated Phase 3 program for CAEL-101 in AL amyloidosis in collaboration with Caelum Biosciences. Raised full year guidance, driven by increased revenue guidance of $350 million. BOSTON –(BUSINESS WIRE)–Oct.

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