FDA Law Blog

MARCH 13, 2024

156(d)(l)(D) requires that a PTE application contain “a brief description of the activities undertaken by the applicant during the applicable regulatory review period with respect to the approved product and the significant dates applicable to such activities” In addition, 35 U.S.C. § How, pray tell, does this relate to PTEs you ask?

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The Pharma Data

DECEMBER 28, 2020

This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.” sales of brand products containing glucagon for injection, 1 mg, were approximately $306 million for the 12 months ended September 30, 2020.

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Drug Channels

MARCH 15, 2022

Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study Examines Consolidation and Vertical Integration of U.S. Prescription Market (press release) We’re offering special discounted pricing if you order before March 28, 2022.

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Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2.

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Pharmacy Checkers

MAY 22, 2020

There are many thousands of drugs approved for the U.S. market, so maybe some do disclose this information, but most do not. Janumet, a dual compound drug (two drugs – APIs – in one pill), contains the same API as Januvia, sitagliptin, and another API, metformin. The label just reads “Made in UK.”

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The Pharma Data

DECEMBER 4, 2021

The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. Currently, 1 in 11 generic prescriptions dispensed in the U.S.

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Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs.

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Drug Channels

FEBRUARY 23, 2021

Despite these responses, more than half of payers believe that cost containment strategies should not limit patients’ ability to receive access to appropriate care. For background, see Express Scripts + Prime Therapeutics: Our Four Takeaways From This Market Changing Deal. The battle for specialty drug margin rages on.

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The Pharma Data

JANUARY 17, 2021

The Company will continue to leverage its scientific expertise and operations in Europe and North America for product development and optimization while it plans to add significant commercial experience in the fields of manufacturing, distribution, marketing and sales. Drug Formulations and Delivery. About XPhyto Therapeutics Corp.

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Pharma in Brief

JANUARY 9, 2022

In 2020, the FC struck down the new price calculation contained in the amendments but upheld the other impugned amendments. The proposed amendments contain fee changes including the introduction of an excess claim fee for applications with over 20 claims.

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FDA Law Blog

JANUARY 11, 2022

Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. Hikma , the generic industry can have some hope. Koblitz — Since the August 2021 decision in GSK v. Teva from this case.

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FDA Law Blog

JANUARY 11, 2022

Teva , the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. Hikma , the generic industry can have some hope. Koblitz — Since the August 2021 decision in GSK v. Teva from this case.

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FDA Approval Production Branding Drugs 52

Pharmacy Checkers

NOVEMBER 21, 2019

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. There are 19,000 approved prescription drugs for marketing in the U.S. Of course, the faster a safe and effective medicine can come to market, the better.

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The Pharma Data

OCTOBER 14, 2020

About Mallinckrodt Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients.

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Druggist

MARCH 25, 2021

Do generic, and branded drugs produce exactly the same effect? . Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). In terms of prescribing, both contraceptives are regarded as the same drug. . Cerelle vs Cerazette: are they the same?

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XTalks

JUNE 16, 2023

There are currently no shortages of cancer drugs in Europe or other countries; however, last year, Germany was experiencing a critical shortage of the breast cancer drug tamoxifen. Medicines for Europe said the supply issues were evidence of the damaging effects of European cost-containment measures.

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The Pharma Data

JANUARY 27, 2021

The addition of in-house, scalable commercial drug manufacturing capability is expected to add significant value and optionality to XPhyto’s drug formulation business. In 2020, XPhyto reported significant advancements in four drug formulation development programs.

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Drugs Manufacturing Drug Delivery Production 52

The Pharma Data

DECEMBER 17, 2020

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches. Cautionary Note on Forward-Looking Statements. Source link.

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XTalks

AUGUST 2, 2023

Join us as we present an in-depth analysis of each company’s revenue, net income, R&D investments, core therapeutic areas, market presence and strategic collaborations. is a global pharmaceutical company, working across both developed and emerging markets. It contains the antiviral medications nirmatrelvir and ritonavir.

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The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. in December 2019; and. in December 2019; and.

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Pharmaceutical Technology

DECEMBER 4, 2022

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.

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XTalks

AUGUST 30, 2022

Strategic leaders know how to think critically and navigate through daily challenges that are bound to emerge in this competitive market. The pharmaceutical industry deals with threats such as product liability, cyberthreats, supply chain disruptions, competition from generic drugs and more. Transformational Leadership.

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Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Please check your email to download the Report.

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XTalks

SEPTEMBER 14, 2020

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. Drugs and Vaccines. billion in June.

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