The Pharma Data

JULY 15, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About Biogen.

Disease 52

Disease Biosimilars Government Treatment 52

Drug Channels

DECEMBER 1, 2020

Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. Speaking of next year, Drug Channels Institute will host an exclusive live webinar, Drug Channels Outlook 2021 , on December 18, 2020, from 12:00 p.m. to 1:15 p.m. Click here to learn more and sign up. d/b/a Drug Channels Institute.

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Pharmacy Drugs Vaccine Pharmaceuticals 40

Agency IQ

AUGUST 2, 2024

September 30, 2024 PDUFA Novel Approaches to Development of Cell and Gene Therapy Convene a public meeting to solicit input on methods and approaches (e.g., use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

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FDA Science Regulations Biosimilars 40

The Pharma Data

JULY 8, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About Biogen.

Disease 52

Disease Clinical Trials Government Research 52

The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. Amgen Inflammation Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs.

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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. That would leave 19% of staff affected by furloughs. We’ll be most interested to see how FDA plans to handle these risk control measures in a way to reduce the risk of drug shortages.

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FDA Science Biosimilars Regulations 40

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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FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

This time, however, the program, which has helped incentivize the development of dozens of pediatric rare disease therapies since 2012, was not renewed. The authors suggested that the developers of such therapies would receive a priority review voucher that they can sell to manufacturers of blockbuster drugs. See Table 1.

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