2005, Licensing and Pharmaceuticals - Drug Discovery Digest

Gepirone

New Drug Approvals

JUNE 11, 2025

2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] 5] History Gepirone was developed by Bristol-Myers Squibb in 1986, [5] but was out-licensed to Fabre-Kramer in 1993. 1] It is taken orally. [1] 1] It is taken orally. [1] The scientific article published in J.

FDA

FDA FDA Approval Treatment Clinical Trials

Burning Rock Announces an Exclusive in-Licensing of a Risk Stratification Test for Early Stage Lung-Cancer Patients from Oncocyte in China

The Pharma Data

DECEMBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”) today announced that it entered into an exclusive licensing agreement with Oncocyte Corporation (NYSE American: OCX) to bring DetermaRx , a risk stratification test for early stage lung cancer patients, to China. 3 Shi JF et al.,

Licensing

Licensing Licensing Pharmaceutical Companies Treatment

Seladelpar

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

FDA Licensing Licensing FDA Approval

Landiolol

New Drug Approvals

APRIL 19, 2025

0004]The synthesis of Landiolol 1 is disclosed in US 5013734 , JP 3302647 , CN 100506814 , JP 2539734 and Chemical & Pharmaceutical Bulletin 1992, 40 (6) 1462-1469. “Development of a highly cardioselective ultra short-acting beta-blocker, ONO-1101” Chemical & Pharmaceutical Bulletin. Baker JG (February 2005).

FDA

FDA Clinical Trials Treatment Trials

How nucleolar stress accelerates aging in mice

Drug Target Review

APRIL 9, 2024

In 2005, he joined CNIO to lead the Genomic Instability Group where he has been ever since. These compounds were later licensed to the pharmaceutical industry for clinical development. Oscar Fernandez-Capetillo did his PhD in the University of The Basque Country working with mouse models of autoimmunity with Dr Ana Zubiaga.

RNA

RNA Cell Biology Clinical Development DNA

Novartis presents new findings at ERS reinforcing the efficacy of.

The Pharma Data

SEPTEMBER 2, 2021

“Our presence at ERS this year reiterates our commitment to patients through the further development of first-in-class therapies like Enerzair Breezhaler, as well as by exploring the potential of digital health companions and the carbon footprint of our solutions,” said Dominic Brittain, Respiratory Global Program Head, Novartis Pharmaceuticals. “As

Licensing

Licensing Licensing Treatment Therapies

A Roadmap for Introducing Novel Excipients: How to Approach Excipient Qualification with the FDA

The Premier Consulting Blog

NOVEMBER 16, 2022

Although novel excipients can be a part of any new drug application (NDA) or biologics license application (BLA) development program, they seem to be more common with the 505(b)(2) pathway, since many companies use cutting-edge delivery technologies to solve issues associated with previously approved drugs. What is an excipient?

FDA

FDA Production Packaging Licensing

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

Pharmacopeia (USP) and the FDA – to clarify whether the “actual ‘shelf life’ of many pharmaceutical products might be considerably longer than the expiration date that appears on the manufacturer’s container.” And per the FDA, “extension of drug product expiration dating periods is strictly voluntary for pharmaceutical manufacturers.”

Science

Science FDA Production Packaging

China’s Clinical Trial Boom

Codon

APRIL 24, 2025

While China’s AI competitiveness may have blindsided the tech world, the pharmaceutical industry has already had quite a few “ DeepSeek Moments ” of its own. “Today, they’re just as likely to license a molecule from a Chinese company. Just a couple of years ago, this number was about 10 percent.

Clinical Trials

Clinical Trials Trials Pharmaceutical Companies Licensing

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

JUNE 16, 2023

Final Rule Stage Clean Water Act Section 401: Water Quality Certification 2040-AG12 August 2023 Clean Water Act (CWA) section 401 provides States and Tribes with a powerful tool to protect the quality of their waters from adverse impacts resulting from federally licensed or permitted projects. On September 14, 2018, the U.S.

Regulations

Regulations Compliance Production Science

Trospium chloride

New Drug Approvals

APRIL 27, 2025

15] :13 Madaus licensed the US rights to trospium chloride to Interneuron in 1999 and Interneuron ran clinical trials in the US to win FDA approval. [17] 26] Indevus had developed intellectual property around the extended release formulation which it licensed to Madaus for most of the world. [25] billion in 2004. [23] 12 (6): 815827.

FDA Approval

FDA Approval FDA Pharmacokinetics Licensing

How the Fifty States View Electronic Data as a “Product”

Drug & Device Law

JULY 31, 2023

The 2005 revisions to Article 2 excludes “information” from the definition of goods and also defines computer software as “information.” Alaska 2005), predicted that Alaska would follow the Third Restatement “defin[ition] of a product as ‘tangible personal property distributed commercially for use or consumption.” Id. Munhoven v.

Production

Production Trials International Government

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

Drug & Device Law

FEBRUARY 2, 2023

Novartis Pharmaceuticals Corp. , Wyeth , 2005 WL 544222, at *6 (N.D. March 4, 2005), rev’d on other grounds , 462 F.3d Luitpold Pharmaceuticals, Inc. , McNeil Consumer & Specialty Pharmaceuticals , 672 F.3d Bayer Healthcare Pharmaceuticals, Inc. , 2d 898, 909-10 (W.D. 2013); Massa v. Genentech Inc.

Production

Production FDA Approval Vaccine FDA

Unimpressed Learned Intermediaries Defeat Warning Causation

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.

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Drug Discovery Digest

Gepirone

Burning Rock Announces an Exclusive in-Licensing of a Risk Stratification Test for Early Stage Lung-Cancer Patients from Oncocyte in China

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Seladelpar

Landiolol

How nucleolar stress accelerates aging in mice

Novartis presents new findings at ERS reinforcing the efficacy of.

A Roadmap for Introducing Novel Excipients: How to Approach Excipient Qualification with the FDA

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

China’s Clinical Trial Boom

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Trospium chloride

How the Fifty States View Electronic Data as a “Product”

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

Unimpressed Learned Intermediaries Defeat Warning Causation

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