Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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Therapies Virus DNA Clinical Trials 135

Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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The Pharma Data

NOVEMBER 20, 2020

Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. Related Articles: Zokinvy (lonafarnib) FDA Approval History. SOURCE Eiger BioPharmaceuticals, Inc. . Posted: November 2020. Source link.

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FDA Approval FDA Clinical Trials Disease 52

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

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Agency IQ

SEPTEMBER 29, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

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Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

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Drug Target Review

APRIL 11, 2025

Carlos specialises in helping pharmaceutical and biotechnology companies develop their in- and out-licensing strategies, with additional expertise and experience in portfolio assessment and prioritisation, drug candidate valuation, valuation and related services. Using clinical genomics and AI in drug development to elevate success.

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Clinical Development Drugs Pharmaceuticals Clinical Trials 97

Drug Target Review

MARCH 13, 2025

This article, along with other insightful analyses, will be featured in our upcoming report, Beyond the Lab – Artificial Intelligence, launching on 21st March 2025. He also develops and presents customised training programmes (both live and virtual) for companies seeking to improve their in- and out-licensing processes.

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Drug Development Science Clinical Trials FDA 59

Drug Target Review

FEBRUARY 11, 2025

Carlos specialises in helping pharmaceutical and biotechnology companies develop their in- and out-licensing strategies, with additional expertise and experience in portfolio assessment and prioritisation, drug candidate valuation, valuation and related services. Clinical bioinformatics desiderata for Molecular Tumor Boards.

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Drug Development Bioinformatics Drugs Small Molecule 59

Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence.

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Testimonials Drugs FDA Vaccine 105

Drug & Device Law

MAY 19, 2023

Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal. A draft of this article is now available on SSRN.

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