The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. About CNS Pharmaceuticals, Inc.

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FDA Approval FDA Pharmaceuticals Clinical Trials 52

Drug Channels

MARCH 15, 2022

Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study Examines Consolidation and Vertical Integration of U.S. drug pricing, reimbursement, and dispensing system. Copyright © 2006-2022 Pembroke Consulting, Inc.

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Pharmacy Specialty Pharmacies Licensing Licensing 98

The Pharma Data

OCTOBER 19, 2020

20, 2020 /PRNewswire/ — CNS PHARMACEUTICALS AG , Inc. manufacturer, Pharmaceutics International, Inc. (“Pii”), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Treatment 52

Drug Channels

OCTOBER 19, 2020

Drug Channels readers will save $300 off the standard rate when they use code GJE973 and register prior to October 30th.*. Drug Channels readers will save $300 off the standard rate when they use code GJE973 and register prior to October 30th.*. Drug Channels, or any of its employees. d/b/a Drug Channels Institute.

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Specialty Pharmacies Science Pharmacy Licensing 52

The Pharma Data

OCTOBER 6, 2021

In 2013, Janssen collaborated with Professor Johan Neyts and Suzanne Kaptein at the KU Leuven Rega Institute and Patrick Chaltin at Centre for Drug Design and Discovery (CD3), as well as their respective teams, to identify a compound series capable of inhibiting the virus in lab-grown cells and animals. Janssen Pharmaceutica, N.V.

Virus 52

Virus Clinical Development Science Disease 52

Agency IQ

AUGUST 2, 2024

Happy 40 th Birthday, generic drugs: September 24 will mark the 40 th anniversary of the 1984 signing of the Hatch-Waxman Act, which created a formal pathway for the approval of generic drugs. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election.

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FDA Science Regulations Biosimilars 40

The Pharma Data

NOVEMBER 5, 2020

X4 Pharmaceuticals – Art Taveras was named CSO of Cambridge, Mass.-based Prior to that, Taveras was vice president of Small Molecule Drug Discovery and CMC Development at Biogen Idec, and Alantos Pharmaceuticals, which was acquired by Amgen in 2007. Most recently, Holland served as Global Head of licensing at Lonza AG.

Analytical Chemistry 40

Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

New Drug Approvals

SEPTEMBER 8, 2024

1] [2] [3] The compound was licensed from Janssen Pharmaceutica NV. [4] 2007.05.007 Drug Discovery, Johnson and Johnson Pharmaceutical Research and Development, LLC, 8 Clarke Drive, Cranbury, NJ 08512, USA Scheme 1. Seladelpar cas 851528-79-5 C 21 H 23 F 3 O 5 S, 444.47 1] It is used as the lysine dihydrate salt. [1]

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FDA Licensing Licensing FDA Approval 62

Agency IQ

JULY 12, 2024

A closer look at the seven new proposed regulations Stage of Rulemaking Title Estimated Publication Synopsis Proposed Rule Amendments to the Current Good Manufacturing Practice Regulations for Drug Products February 2025 FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

JUNE 16, 2023

Following the EPA’s January 4, 2006, publication of a final rule that revised 40 CFR part 16 to comply with federal mandates associated with the Privacy Act (5 U.S.C. EPA then conducted a residual risk and technology review on July 27, 2006 (71 FR 42724). This action will address Louisiana Environmental Action Network v.

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Regulations Compliance Production Science 40

Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

FDA 40

FDA Science Biosimilars Regulations 40

Drug & Device Law

JULY 31, 2023

Medicis Pharmaceutical Corp. , 2006 WL 2595944, at *23 (N.D. 11, 2006) (same), aff’d in pertinent part , 291 F. 2006) (video game “clearly qualifies as an ‘artistic work’ entitled to First Amendment protection”). 2006), aff’d , 279 F. Paddock Pool Construction Co. , 2d 968, 972 (Ariz. 3d 944, 949 (Ariz. 40 (2d Cir.

Production 52

Production International Trials Government 52

Drug & Device Law

JUNE 2, 2022

This has been more than us saying, in essence, that drug and device companies should get to do whatever they want without liability or that any preemption argument should carry the day. This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v. 472 (2013). (See

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FDA Approval Pharmacy FDA Drugs 127

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. That means that prescribers can make risk/benefit analyses to determine what prescription drugs or medical devices their patients need. That “common and widely known side effect” of many “chemotherapy drugs,” id. Bayer HealthCare Pharmaceuticals, Inc. ,

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

FEBRUARY 20, 2023

Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one. Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations.

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FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

FEBRUARY 2, 2023

The Texas Supreme Court had recognized comment k’s applicability “particularly to the medical field and unavoidably unsafe products like prescription drugs.” Block Drug Co. Novartis Pharmaceuticals Corp. , 2006) (reversal concerned warning issues); Blackmon v. Luitpold Pharmaceuticals, Inc. , Centocor, Inc.

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Production FDA Approval Vaccine FDA 59