2006, Biosimilars and Licensing - Drug Discovery Digest

NEW: The 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

OCTOBER 5, 2021

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: Biosimilars Are Delivering Higher Profits for Drug Distributors (press release) We’re offering special discounted pricing if you order before October 15, 2021! Section 4.4.

Pharmaceuticals

Pharmaceuticals Biosimilars Licensing Licensing

NEW: The 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

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! We also update sections that were introduced in recent editions, such as our estimates of wholesalers' profits from provider-administered biosimilar drugs.

Pharmaceuticals

Pharmaceuticals Biosimilars Licensing Licensing

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

Drug Channels

FEBRUARY 21, 2023

If you have any questions before purchasing a license to the report, please email me. Copyright © 2006-2023 Pembroke Consulting, Inc. The numbers indicate the report chapter that corresponds to, explains, and analyzes each channel flow. Click to Enlarge] Thank you for your interest in our work. d/b/a Drug Channels Institute.

Pharmacy

Pharmacy Specialty Pharmacies Licensing Licensing

Available for Preorder: The 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

SEPTEMBER 17, 2024

Review pricing/license options and place a preorder Download a free pre-publication report overview (including key industry trends, What's New in this edition, the Table of Contents, and a List of Exhibits) You can pay online with all major credit cards (Visa, MasterCard, American Express, and Discover) or via PayPal. All rights reserved.

Pharmaceuticals

Pharmaceuticals Licensing Licensing Drugs

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

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

Laboratories

Laboratories FDA Regulations Licensing

Available for Preorder: The 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

SEPTEMBER 12, 2023

The notable new material in this 2023-24 edition includes new data about commercial pricing and reimbursement for provider-administered biosimilars as well as updated, expanded, and reorganized data about pharmacy services administrative organizations and group purchasing organizations for small pharmacies and physician practices.

Pharmaceuticals

Pharmaceuticals Pharmacy Biosimilars Licensing

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Biosimilars

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

The Pharma Data

DECEMBER 21, 2020

Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Respir Med 2006 : 100 (7): 1139-51. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Eur Respir J.

Trials

Trials Production Clinical Trials Therapies

Decades Later, Congress Continues Debating the Preserve Access to Affordable Generics (and Biosimilars) Act; But will the Recent Jarkesy SCOTUS Decision Finally Put an End to the Insanity?

FDA Law Blog: Biosimilars

AUGUST 29, 2024

Shumsky — As readers of this blog know ( see, e.g. , here ), the Affordable Generics (and Biosimilars) Act has been floating around in Congress for the better part of two decades. The latest iteration of the Preserve Access to Affordable Generics and Biosimilars Act making its way through Congress is Senator Amy Klobuchar’s (D-MN) S.

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

Drug Channels

FEBRUARY 22, 2022

We also present a more unified outlook for specialty drugs, including specialty generics and biosimilars. If you have any questions before purchasing a license to the report, please email me. Copyright © 2006-2022 Pembroke Consulting, Inc. Download a free report overview for more details. Click to Enlarge].

Pharmacy

Pharmacy Specialty Pharmacies Biosimilars Licensing

NOW AVAILABLE: The 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

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! The exhibits appear in all license versions. The PowerPoint file option is available only with the purchase of a corporate license.)

Pharmaceuticals

Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars

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. 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.

FDA

FDA Science Biosimilars Regulations

“If You’ve Got Legitimate Suspenders, Don’t Have an Unconstitutional Belt:” Federalist Society Panel’s Take on Jarkesy and the Preserve Access to Affordable Generics and Biosimilars Act

FDA Law Blog: Biosimilars

DECEMBER 3, 2024

142, the Preserve Access to Affordable Generics and Biosimilars Act. Nevertheless, we are where we are at the moment and Congress is pressing on for passage of the Preserve Access to Affordable Generics and Biosimilars Act. Karst — On August 30, 2024, we posted on what was then the most recent version of S.

Drug Discovery Digest

NEW: The 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

NEW: The 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Trending Sources

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

Available for Preorder: The 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

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

Available for Preorder: The 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

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

Decades Later, Congress Continues Debating the Preserve Access to Affordable Generics (and Biosimilars) Act; But will the Recent Jarkesy SCOTUS Decision Finally Put an End to the Insanity?

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

NOW AVAILABLE: The 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

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

“If You’ve Got Legitimate Suspenders, Don’t Have an Unconstitutional Belt:” Federalist Society Panel’s Take on Jarkesy and the Preserve Access to Affordable Generics and Biosimilars Act

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