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!

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Drug Channels

OCTOBER 11, 2022

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

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Drug Channels

SEPTEMBER 17, 2024

On October 8, 2024, Drug Channels Institute will release our 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. pharmaceutical distribution industry. Read on for more details. All rights reserved.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

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 ). Shumsky & Philip Won & Adrienne R. Gaulkin & Jeffrey N.

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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.

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FDA Law Blog: Biosimilars

AUGUST 29, 2024

That bill, addressing drug (and later biological product) patent settlement agreements (pejoratively referred to as “reverse payment agreements” by their opponents), was first introduced by Senator Herb Kohl (D-WI) in June 2006 as S. But like cockroaches, some pieces of legislation are resilient and never seem to die.

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National Drug & Alcohol Research Centre Blog

NOVEMBER 23, 2023

Ms Daisy Gibbs, Evaluation Officer, Burnet Institute; A/Prof Caitlin Hughes, Associate Professor in Criminology and Drug Policy, Centre for Crime Policy and Research, Flinders University; Dr Rachel Sutherland, Senior Research Fellow, NDARC How long have drug detection dogs been used, why were they introduced, and how common are they?

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Drug Target Review

FEBRUARY 28, 2024

These include engineering the cells to express cytokines that promote their maturation and/or differentiation, and engineering drug-resistant γδ T cells that can be combined with chemotherapies, which stress cancer cells but would otherwise also deplete the T-cell population. Kabelitz D, Serrano R, Kouakanou L, et al.

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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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The Pharma Data

DECEMBER 16, 2020

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. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc.

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Drug Channels

OCTOBER 13, 2020

Click here to download a free report overview (including the Table of Contents and a List of Exhibits) New Drug Channels Institute Study Examines Impact of COVID-19 on U.S. Drug Distribution Industry (press release) We’re offering special discounted pricing if you order before October 23, 2020! d/b/a Drug Channels Institute.

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Drug Channels

OCTOBER 10, 2023

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: U.S. we summarize the key provisions of the law that relate to prescription drugs. The exhibits appear in all license versions. d/b/a Drug Channels Institute.

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Drug Channels

SEPTEMBER 12, 2023

On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. If you have any questions before purchasing a license to the report, please email me ( afein@drugchannels.net ). Copyright © 2006-2023 Pembroke Consulting, Inc.

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The Pharma Data

NOVEMBER 22, 2020

In one of the largest heart failure clinical trials ever conducted, our novel mechanism drug candidate demonstrated positive efficacy in a diverse patient population with high unmet need and without an imbalance in the overall incidence of adverse events. SOUTH SAN FRANCISCO, Calif., Conference Call and Webcast Information.

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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.

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The Pharma Data

OCTOBER 19, 2020

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. About CNS Pharmaceuticals, Inc.

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The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. When Lucentis ® (Ranibizumab) received FDA approval in late June 2006, the new macular degeneration drug was celebrated as a major medical breakthrough.

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The Pharma Data

NOVEMBER 5, 2020

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. Prior to this, he held a position as a director of Analytical Chemistry in Drug Discovery at GlaxoSmithKline. from 1993 to 1995.

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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. NEW YORK–(BUSINESS WIRE)– Pfizer Inc. 2016;22(1):60.

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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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The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Respir Med 2006 : 100 (7): 1139-51.

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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.

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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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Drug Channels

MARCH 18, 2025

I am pleased to announce that Drug Channels Institutes new 2025 Economic Report on U.S. Download a free 30-page report overview including key industry trends, What's New in this edition, the Table of Contents, and a List of Exhibits Read the press release: HMP Globals Drug Channels Institute Releases 2025 Economic Report on U.S.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2024

—Each party that violates or assists in the violation of this section shall forfeit and pay to the United States a civil penalty sufficient to deter violations of this section, but in no event greater than 3 times the value received by the party that is reasonably attributable to the violation of this section.

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. Drug Discovery Today: Disease Models (2008). Link Production of the antimalarial drug precursor artemisinic acid in engineered yeast , by Ro D-K. Nature (2006).

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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.

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. Drug Discovery Today: Disease Models (2008). Link Production of the antimalarial drug precursor artemisinic acid in engineered yeast , by Ro D-K.

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Codon

FEBRUARY 23, 2025

By Kamal Nahas Scientists had no antiretroviral drugs when the AIDS crisis began in 1981. ” Gilead is already offering the drug at reduced prices in 120 low-income countries with high HIV burdens, including South Africa. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. million by 2004.

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Drug & Device Law

JULY 31, 2023

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. 18, 2012) (using Black’s Law Dictionary definition of “product” as “tangible personal property”); ABM Industries, Inc.

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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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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. 2006) (reversal concerned warning issues); Blackmon v. These are especially common in the field of drugs. Centocor, Inc. Hamilton , 372 S.W.3d

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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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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. Two other oldies but goodies are Plummer v.

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