Drug Channels

OCTOBER 11, 2022

Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022! pharmaceutical distribution industry. If you would like to pay by corporate purchase order or check, please email Tamra Feldman.

Biosimilars 74

Biosimilars Hospitals Pharmaceutical Manufacturing Documentation 74

Outsourcing Pharma

JULY 24, 2024

Data integrity is a paramount concern for pharmaceutical manufacturers, particularly as they navigate the complexities of modern production with legacy equipment.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Biosimilars 52

Drug Channels

JULY 23, 2024

It’s time for Drug Channels ’ annual update on pricing at the largest pharmaceutical manufacturers. Insulin has been the first to deflate—and the Humira biosimilar market may be next. You can find links to each company’s data below. See the second chart below.

Drug Pricing 52

Drug Pricing Pharmaceutical Manufacturing Biosimilars 52

FDA Law Blog: Biosimilars

JUNE 24, 2024

The event, titled “New and Improved – AMCP Format for Formulary Submissions v5.0,” aims to educate pharmaceutical manufacturers and other healthcare stakeholders on the latest updates and best practices in dossier development.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

Express Pharma

NOVEMBER 18, 2024

The PMEC segment will highlight companies such as ACG, Cadmach Machinery, Fette India, and Parle Global Technologies, showcasing pharmaceutical manufacturing equipment. The event will feature prominent exhibitors, including Dr Reddy’s Laboratories, Biocon, Glenmark Lifesciences, Hetero Labs Limited, and Lupin, among others.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing Biosimilars 52

FDA Law Blog: Biosimilars

JUNE 27, 2023

Mr. Karst, a co-author of the FDA Law Blog, provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. This is an achievement that only around 5% of WWL-listed practitioners were accorded in 2023.

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Drug Development Pharmaceutical Manufacturing 81

FDA Law Blog: Biosimilars

AUGUST 14, 2024

Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers.

Drug Pricing 59

Drug Pricing Pharmaceutical Manufacturing 59

Drug Channels

OCTOBER 10, 2023

Drug Distribution Industry Gaining from Anti-Obesity Drugs and Provider-Administered Biosimilars (press release) We’re offering special discounted pricing if you order before October 20, 2023! pharmaceutical distribution industry. and Section 6.4.3. A new Section 6.2.2.

Specialty Pharmacies 40

Specialty Pharmacies Biosimilars Pharmaceutical Manufacturing Documentation 40

Quality Matters

JANUARY 23, 2023

Advanced manufacturing technologies The legislation also calls for HHS to support development and implementation of advanced and continuous pharmaceutical manufacturing technologies through creation of national centers of excellence. Such products include small molecule medicines, biologics and biosimilars.

Generic Medicine 52

Generic Medicine Pharmaceutical Manufacturing Biosimilars Communication 52

Express Pharma

AUGUST 13, 2024

Sustainability in the pharmaceutical sector is becoming increasingly critical. With growing awareness of the environmental impact of pharmaceutical manufacturing—such as pollution from toxic discharges—companies must adopt more sustainable practices. billion green loan to fund its purchase of Viatris’ biosimilars business.

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Pharmaceutical Manufacturing Packaging Biosimilars Pharmaceutical Companies 64

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

She also provides consulting services for state licenses, as well as regulatory due diligence concerning licensing requirements, primarily for pharmaceutical manufacturers, wholesale distributers, and pharmacies. Sara is conveniently able to be a client’s one-stop point of contact for licensing needs.

Controlled Substances 45

Controlled Substances Documentation Pharmaceutical Manufacturing Communication 45

FDA Law Blog: Biosimilars

MARCH 6, 2024

Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Drug Development Pharmaceutical Companies Pharmaceutical Companies 59

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. In United Therapeutics Corporation v.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Hospitals 59

FDA Law Blog: Biosimilars

APRIL 16, 2024

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

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Dosage Drug Pricing Pharmaceutical Manufacturing 59

FDA Law Blog: Biosimilars

OCTOBER 4, 2023

The court did not make much of Plaintiff’s argument that a manufacturer cannot terminate its participation in Medicare for close to two years, see Motion at 8; Complaint at 27-28, potentially dismissing it as a mere administrative matter. Standing The Defendants questioned, and the court reviewed, Plaintiffs’ standing.

Drug Pricing 59

Drug Pricing Pharmaceutical Manufacturing Immunity Immunization 59

FDA Law Blog: Biosimilars

JULY 18, 2023

FDA issued 72 CGMP-related warning letters to pharmaceutical manufacturing sites, and over two-thirds of those went to makers of non-application products. Again, the effects of the PHE lingered in this area, as FDA targeted hand sanitizer manufacturers with 31 of those 72 letters.

Pharmaceutical Manufacturing 52

Pharmaceutical Manufacturing 52

PharmaShots

FEBRUARY 27, 2023

Addepalli Veeranjaneyulu and Shubhadeep Debabrata Sinha introduced the session by describing the function of PV in the safety profiles of biosimilars. There was also discussion of the PV difficulties related to structure, nomenclature/ product name, manufacturing, and manufacturing variation challenges.

Biosimilars 40

Biosimilars Diabetes Packaging Hospitals 40

Safe Biologics

MARCH 10, 2025

Dr. Christina Beato: Lowering Interchangeable Biosimilar Standards Risks Patient Health, Physician Confidence On January 17th, the Albuquerque Journal published an op-ed by Dr. Christina Beato, former Assistant Secretary for Health and Human Services (HHS) on the topic of interchangeable biosimilar standards.

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Biosimilars Independent Pharmacies Drug Pricing Vaccines 130