2007, FDA Approval and Licensing - Drug Discovery Digest

2007

FDA Approval

Licensing

International Women’s Day: Female life science leaders

Drug Discovery World

MARCH 7, 2023

Linda Powers, CEO, Northwest Biotherapeutics Powers has served as the Chairman of NW Bio since 2007, and as CEO since 2011. She has over 15 years’ experience in corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual property licensing.

International

International Science Pharmaceuticals DNA

FDA More Selective About Convening Advisory Committee Panels During Pandemic | 2021-01-18

The Pharma Data

JANUARY 18, 2021

FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving the panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based based research firm.

FDA

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Seladelpar

New Drug Approvals

SEPTEMBER 8, 2024

1] [2] [3] The compound was licensed from Janssen Pharmaceutica NV. [4] 4] Seladelpar was approved for medical use in the United States in August 2024. [1] 1] [2] [3] The compound was licensed from Janssen Pharmaceutica NV. [4] 4] Seladelpar was approved for medical use in the United States in August 2024. [1]

FDA

FDA Licensing Licensing FDA Approval

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

Vaccine

Vaccine FDA Approval FDA Disease

Cell and gene therapy – where is the innovation?

Drug Discovery World

SEPTEMBER 16, 2022

The UK also benefits from expedited pathways to development and adoption of novel medicines through the Innovative Licensing and Access Pathway, co-developed by the Medicines and Healthcare Products Regulatory Agency (MHRA), NICE and the Scottish Medicines Consortium (SMC).?- Neelam Patel, CEO of London cluster organisation, MedCity. .

Therapies

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Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

The FDA first proposed a rule on “Prescription Drug Labeling: Medication Guide Requirements” in 1995 , which was finalized in 1998. However, over the last decade the FDA and other stakeholders have acknowledged that there are opportunities for improvement. After all, companies already have FDA-approved labels.

FDA

FDA FDA Approval Production Regulations

Mifepristone Manufacturer Wins First Round in West Virginia

Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. In GenBioPro, Inc.

FDA Approval

FDA Approval Pharmacy FDA Production

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. 124 (2007), which would also be knocked out by Dobbs if it sticks.

FDA Approval

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Comment K, Presumptions, and Medical Device Design Defects Under Texas Law

Drug & Device Law

FEBRUARY 2, 2023

2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil v. Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. 2d 898, 909-10 (W.D.

Production

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NPP, DCC, And FDA-Regulated Medical Products

Drug & Device Law

MAY 26, 2023

A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use.

Regulations

Regulations Production FDA FDA Approval

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. In Bruesewitz v. Wyeth LLC , 562 U.S. at 237-38. Wyeth Laboratories, Inc. , 2d 397 (6th Cir. 2d at 401.

FDA

FDA FDA Approval Testimonials Vaccine

International Women’s Day: Female life science leaders

FDA More Selective About Convening Advisory Committee Panels During Pandemic | 2021-01-18

Trending Sources

Seladelpar

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

Cell and gene therapy – where is the innovation?

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Mifepristone Manufacturer Wins First Round in West Virginia

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Comment K, Presumptions, and Medical Device Design Defects Under Texas Law

NPP, DCC, And FDA-Regulated Medical Products

The FDA and Feasible Alternative Designs

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