Pharma, Biotech and Generics Industry News | The Pharmaletter
WEB11 September 2024 NewCo, a relatively new business model that involves a joint venture (JV) between a biotech and a group of investors to bring the biotech’s promising assets to the global market, is gaining popularity among Chinese biotechs, who traditionally rely on out-licensing deals to capitalize assets, s. More Insights >.
Pharmaceutical Industry News | The Pharmaletter
WEBSep 5, 2024 · FDA snubs Vanda Pharma's NDA for tradipitant in gastroparesis. Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024.
Ignis Therapeutics and STADA partner on apomorphine in China
WEB18 March 2022. China’s Ignis Therapeutics and Germany’s STADA Arzneimittel’s (SAZ: Xetra) Britannia Pharmaceuticals UK affiliate today jointly announced the signing of an exclusive licensing agreement under which Ignis Therapeutics will develop and commercialize subcutaneous apomorphine for Parkinson's …
CP Pharmaceuticals - The Pharmaletter
WEB6 July 1999. 2 September 1998. More CP Pharmaceuticals news >. Sign up to receive email updates. Join industry leaders for a daily roundup of biotech & pharma news. The Pharma Letter. 39-43 Putney High Street, Putney. London, SW15 1SP. United Kingdom.
Pharma M&A news | The Pharmaletter
WEBAug 23, 2024 · The Pharma Letter M&A roundup - August 2024. Plenty of money changed hands in pharmaceutical M&A terms in August, albeit big pharma companies were largely not involved. 3 September 2024.
BRIEF-Dr Reddy's receives FDA warning over complaints
WEBJul 31, 2019 · The US regulator has sent a Form 483 warning to the India-based active pharmaceutical ingredient (API) producer Dr Reddy’s Bollaram, regarding a number of deficiencies including a failure to respond to complaints about out-of-specification (OOS) results. The US FDA says three complaints were received, related to microbiological failures. In addition, the regulator said customers have ...
Pharma News and Insights Podcast | The Pharmaletter
WEBJul 17, 2023 · The Pharma Letter Podcast — Episode 22 — A new way to innovate, from Flagship Pioneering. Flagship Pioneering has had an outsized impact on the sector, launching a spate of successful biotechs, including Moderna Therapeutics. Now, with Pioneering Medicines, the group hopes to shake things up again. 20 April 2023.
BRIEF—FDA approves first new estrogen in USA in over half century
WEBApr 16, 2021 · BRIEF—FDA approves first new estrogen in USA in over half century. The US Food and Drug Administration has approved the New Drug Application (NDA) for the novel combined oral contraceptive Nextstellis (3mg drospirenone (DRSP) and 14.2mg of estetrol (E4) tablets). Australia-based Mayne Pharma anticipates the commercial launch of Nextstellis by ...
The intersection of regulatory and patent exclusivities for the life ...
WEBJul 3, 2020 · An Expert View from Jonathan Roses (pictured, left), counsel, Wolf, Greenfield & Sacks, and Toby Simpson, partner, Hoffmann Eitle, exploring legal differences between the two major jurisdictions of the USA and Europe that …
Hodgkin's lymphoma market to suffer with Adcetris patent expiry, …
WEBAug 19, 2020 · Adcetris (brentuximab vedotin) is the market-leading drug in the world’s 7MM (the USA, France, Germany, Italy, Spain, the UK and Japan) markets and the main contributor to the market growth in Hodgkin’s lymphoma (HL) over the recent years. Adcetris is being jointly developed and marketed by Japanese drugmaker Takeda (TYO: 4502) and US ...