2006, Biosimilars and Regulations - Drug Discovery Digest

The Booming Biosimilar Market of 2020

Drug Channels

OCTOBER 6, 2020

The biosimilar market is finally beginning to fulfill its promise. The latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products. As I predicted last year, newer biosimilars are being adopted quickly, and their prices are declining rapidly.

Biosimilars

Biosimilars Marketing Regulations FDA

The Booming Biosimilar Market of 2020 (rerun)

Drug Channels

DECEMBER 17, 2020

Conveniently for HHS, ASPE's analysis stopped before the biosimilar boom began. The biosimilar market is finally beginning to fulfill its promise. The latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products. As you will see below, Dr. Gottlieb was right.

Biosimilars

Biosimilars Marketing Regulations FDA

FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations

FDA Law Blog: Biosimilars

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Regulations

Regulations FDA Doctors Government

Available for Preorder: The 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Copyright © 2006-2022 Pembroke Consulting, Inc.

Pharmacy

Pharmacy Specialty Pharmacies Biosimilars Licensing

Informa Connect’s Trade and Channel Strategies

Drug Channels

OCTOBER 23, 2023

With regulation and policy changes, specifically surrounding the DCSCA, IRA and serialization, the loss of exclusivity wave, adoption of low-WAC products affecting GTN and the rise of alternative distribution models, there has never been a more important time for industry to unite. Copyright © 2006-2023 Pembroke Consulting, Inc.

Pharmacy

Available for Preorder: The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more. Copyright © 2006-2023 Pembroke Consulting, Inc.

Pharmacy

Pharmacy Specialty Pharmacies Licensing Licensing

From the Porcine to the Ridiculous: Veterinary Drugmaker Sues FDA for Alleged APA Violations

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.

FDA

FDA FDA Approval International Production

New Sandoz Board of Directors appointed

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.

Science

Science Doctors Government Compliance

FDA Phones a Friend: Joint Statement with CMS Eschews CLIA Modernization and Supports FDA Oversight of LDTs

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).

FDA

FDA Laboratories Regulations Compliance

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

Laboratories

Laboratories FDA Regulations Licensing

WORLD’S LARGEST BROWSABLE RESOURCE LINKING RARE PROTEIN-CODING GENETIC VARIANTS TO HUMAN HEALTH AND DISEASE

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.

Disease

Disease Government Clinical Trials Research

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

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.

Trials

Trials Production Clinical Trials Government

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

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.

FDA

FDA Science Biosimilars Regulations

Drug Discovery Digest

The Booming Biosimilar Market of 2020

The Booming Biosimilar Market of 2020 (rerun)

Trending Sources

FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations

Available for Preorder: The 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

Informa Connect’s Trade and Channel Strategies

Available for Preorder: The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

From the Porcine to the Ridiculous: Veterinary Drugmaker Sues FDA for Alleged APA Violations

New Sandoz Board of Directors appointed

FDA Phones a Friend: Joint Statement with CMS Eschews CLIA Modernization and Supports FDA Oversight of LDTs

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

WORLD’S LARGEST BROWSABLE RESOURCE LINKING RARE PROTEIN-CODING GENETIC VARIANTS TO HUMAN HEALTH AND DISEASE

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

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