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Gepirone

New Drug Approvals

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. 2003 Jun;25(6):1618-33. 1] It is taken orally. [1] 1] It is taken orally. [1]

FDA 62
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Preliminary Findings from a Phase 2a Trial of Investigational COVID-19 Therapeutic Molnupiravir

The Pharma Data

Since licensed by Ridgeback all funds used for the development of EIDD-2801 by Ridgeback have been provided by Wayne and Wendy Holman and Merck. Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. About Ridgeback Biotherapeutics.

Trials 69
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BioArctic receives European patent for new antibodies targeting Alzheimer’s disease

The Pharma Data

The company was founded in 2003 based on innovative research from Uppsala University , Sweden. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market and out-licensing potential.

Disease 40
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Bridging science and technology: a biotech CEO’s perspective

Drug Target Review

As a business executive at IBM Research in New York, Dr Singh led the go-to-market for IBM Watson Genomics Analytics. In 2003, he was selected by EE Times as one of the top 13 most influential people in the semiconductor industry. He was also Vice President and Head of the Microbiome Division at Eagle Genomics Ltd, in Cambridge.

Science 52
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PREA and Fixed-Dose Combinations: When Things Get Complicated

The Premier Consulting Blog

The Pediatric Research Equity Act (PREA) was signed into law in 2003 to increase pediatric use information in product labeling and close knowledge gaps regarding the safety, efficacy, and appropriate dosing of drugs to treat children.

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Decades Later, Congress Continues Debating the Preserve Access to Affordable Generics (and Biosimilars) Act; But will the Recent Jarkesy SCOTUS Decision Finally Put an End to the Insanity?

FDA Law Blog: Biosimilars

3582 went nowhere; and many additional unsuccessful attempts to get a similar bill passed followed over the years. But like cockroaches, some pieces of legislation are resilient and never seem to die. 3) A covenant not to sue on any claim that the ANDA product or biosimilar biological product infringes a United States patent.

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Navigating Regulatory Hurdles in Drug Development

DrugBank

A well-known example is Merck’s rofecoxib , approved for pain relief in 1999 but withdrawn from the market in 2004 due to cardiovascular risks that were not sufficiently monitored during post-market surveillance. One of the most significant challenges in drug development is global regulatory variability.