Drug Channels

OCTOBER 10, 2023

I am pleased to announce our new 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. we analyze the IRA’s likely consequences for wholesalers and the overall pharmaceutical business. In Subsection 6.5.1.,

Pharmaceuticals 40

Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40

Drug Channels

SEPTEMBER 12, 2023

On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. pharmaceutical distribution industry. If you have any questions before purchasing a license to the report, please email me ( afein@drugchannels.net ). d/b/a Drug Channels Institute.

Pharmaceuticals 40

Pharmaceuticals Pharmacy Biosimilars Licensing 40

The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. We will now rapidly move to initiate our Phase 2 trial of Berubicin for adults with GBM and expect to begin enrolling patients in the first quarter of next year,” commented John Climaco , CEO of CNS Pharmaceuticals. About CNS Pharmaceuticals, Inc.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

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] 2007.05.007.

FDA 62

FDA Licensing Licensing FDA Approval 62

Drug Channels

OCTOBER 19, 2020

Channel Strategy for First Medical Product – A Look at Channel Considerations for Pharmacy vs. Medical Plus – Tailored Track Options Based on Company Size : Emerging/Small Companies – Infrastructure Set-Up, License Procurement and 3PL Contracting Mid-Large Companies – How Do I Think About My Portfolio Differently Based on Product Type?

Science 52

Science Specialty Pharmacies Pharmacy Licensing 52

The Pharma Data

OCTOBER 6, 2021

licensed the compound series in 2015, and is continuing to advance the compound into clinical development. Since 2006, Johnson & Johnson has donated more than 1.7 1] This research builds on Johnson & Johnson’s work to advance science against emerging and entrenched global public health threats. Janssen Pharmaceutica, N.V.

Virus 52

Virus Clinical Development Science Disease 52

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

Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources. and the E.C.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

FDA 40

FDA Science Biosimilars Regulations 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.

Regulations 40

Regulations Compliance Production Science 40

Drug Channels

MARCH 18, 2025

Pharmacies and PBMs, Examining $683 Billion Market Review pricing/license options and download the full 2025 report Order before March 31, 2025 to receive special discounted pricing! Note: All license versions include exhibits within the text.) 2006-2025 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company.

Pharmacy 52

Pharmacy Specialty Pharmacies Licensing Licensing 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2024

For those of us who study the patent system and in particular the pharmaceutical industry and its use of patents, this raises the question of whether the Preserve Access [Act] is even relevant anymore.” A lot has happened since then of course. In particular, the Supreme Court has weighed in fairly definitively in its 2013 decision in FTC v.

Biosimilars 80

Biosimilars Licensing Licensing Production 80

Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). and the E.C.

Regulations 40

Regulations FDA Science Production 40

Codon

FEBRUARY 23, 2025

In 2024, the pharmaceutical company Gilead announced that a single injection of lenacapavir protected 96 to 100 percent of recipients from HIV for up to six months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. If a permanent freeze goes into effect, researchers estimate there could be 8.7

Clinical Trials 70

Clinical Trials Virus Vaccine DNA 70

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 Trials International Government 52

Drug & Device Law

FEBRUARY 20, 2023

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. 2006), app. As a result, appellee was prohibited by federal law from employing either of these [alternatives]. 2d 397 (6th Cir.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

FEBRUARY 2, 2023

Novartis Pharmaceuticals Corp. , 2006) (reversal concerned warning issues); Blackmon v. Luitpold Pharmaceuticals, Inc. , McNeil Consumer & Specialty Pharmaceuticals , 672 F.3d Bayer Healthcare Pharmaceuticals, Inc. , None of these cases engaged in case-by-case analysis of the plaintiffs’ design defect claims.

Production 59

Production FDA Approval Vaccine FDA 59

Drug & Device Law

JUNE 2, 2022

This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v. Plan B, which utilizes the progestin levonorgestrel that is also used in a number of oral contraceptives, received FDA approval for over-the-counter use in 2006. the state action would be preempted.

FDA Approval 127

FDA Approval Pharmacy FDA Drugs 127

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 692, 694 (5th Cir.

Testimonials 59

Testimonials Doctors Production Laboratories 59