Pharma, Biotech and Generics Industry News | The Pharmaletter
WEBSep 17, 2024 · Pharma, Biotech and Generics Industry News | The Pharmaletter. Pharmaceutical. Greek pharma report lays bare industry’s impact. The Foundation for Economic and Industrial Research and Greek pharma trade group the Hellenic Association of Pharmaceutical Companies have presented two studies reflecting the industry’s importance.23 September 2024.
Long Grove Pharma set to be a new leader in specialized generics
WEBApr 22, 2022 · Long Grove Pharma set to be a new leader in specialized generics. Illinois, USA-based Long Grove Pharmaceuticals, founded in 2019 by strategic health care investor Water Street Healthcare Partners, will begin shipping its first products in mid-2022. Dedicated to bringing high-demand, high-quality health …
Kolon TissueGene cleared to resume US Phase III trial for Invossa
WEBApr 14, 2020 · The trial had been suspended due to product identity concerns, the company noted, adding that the firm’s US unit, Kolon TissueGene, has begun activities to resume the Phase III trial and reinitiate enrollment later this year. The clinical exploration was halted last May after Invossa’s cell line was found to have been mislabeled as ...
Pharma and Biotech Rare Diseases News | The Pharmaletter
WEBPhase III data on Quince Therapeutics’ EryDex. US rare diseases focused biotech Quince Therapeutics today announced the online publication of data in The Lancet Neurology from its Phase III ATTeST (Ataxia-Telangiectasia Trial with the EryDex SysTem clinical trial evaluating the safety and efficacy of its lead asset, EryDex. 15 August 2024.
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.
FDA Focus: The Sherley Amendment
WEBPharmaceutical. 10 November 2014. In the fourth of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks at the history of the FDA in the historic Shirley Amendment. Today, new applications for marketable drugs undergo a strict, lengthy, all-encompassing process of testing for safety and efficacy.
Theravance tanks as Phase IIb trial of izencitinib fails in ulcerative ...
WEBAug 24, 2021 · Ireland-incorporated drug developer Theravance Biopharma (Nasdaq: TBPH) saw its shares plummet 27.5% to $10.33 pre-market today, after it announced top-line results from its Phase IIb dose-finding induction study of izencitinib, an orally administered, gut-selective pan-Janus kinase (JAK) inhibitor in development for the treatment of ulcerative colitis.
China's Henlius bolsters alliance with India's Intas to launch ...
WEBBiotechnology. 30 October 2023. Indian drugmaker Intas Pharmaceuticals has inked an exclusive deal with Shanghai Henlius Biotech for the development and commercialization of serplulimab in Europe and India. Serplulimab, a recombinant humanized anti-PD-1 monoclonal antibody (MAb) injection, is the first monoclonal antibody developed by Henlius.
Pharma and Biotech News | The Pharmaletter
WEBSep 19, 2024 · Basilea Pharmaceutica announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) has awarded Basilea an Other Transaction Agreement (OTA), under OTA number 75A50124C00033. 20 September 2024. Biotechnology.
ESMO News - The Pharmaletter
WEBSep 16, 2024 · Survey shows varied views on impact of new cancer drugs. As the world’s leading cancer research professionals arrived at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona on Friday, they were given a reminder of some of the remaining challenges that lie ahead in their field. 13 September 2024.
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