FDA Law Blog: Biosimilars

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

The company asserts that carbadox residues fall below dangerous levels before the products hit consumers’ plates, and that the Agency’s anti-carbadox bias and failure to follow the mandated regulatory procedures violated the “the FDCA, FDA’s regulations, the APA, and due process.” Carbadox has had a tortured approval history.

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The Pharma Data

MAY 15, 2023

Before joining Solvias Group, Karen held various senior leadership roles at Novartis, including global head investor relations from 2000 to 2006, head M&A and Executive Committee member, as well as site head for the Vaccines & Diagnostics division between 2006 and 2011.

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The Pharma Data

JULY 8, 2021

UK Biobank recruited 500,000 people aged between 40-69 years in 2006-2010 from across the UK. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp.

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The Pharma Data

DECEMBER 21, 2020

Furthermore, Amgen’s research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Respir Med 2006 : 100 (7): 1139-51. Amgen’s business may be impacted by government investigations, litigation and product liability claims.

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Agency IQ

JULY 28, 2023

A big legislative question about PAHPA Reauthorization : The Pandemic and All-Hazards Preparedness Act (PAHPA) was originally passed in 2006. October 1, 2023 [link] Regulations Expected to be Published in Q3These are taken from the most recent version of the White House’s Unified Agenda.

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Drug Patent Watch

JANUARY 13, 2025

Biosimilars have emerged as a game-changing force, promising to revolutionize patient access to life-saving biologics while simultaneously reducing healthcare costs. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 billion by 2025, growing at a CAGR of 34.2%

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