Pharma, Biotech and Generics Industry News | The Pharmaletter
Jan 2, 2025 · Up to date news for the pharmaceutical and biotechnology industries - The Pharma Letter
Pharma USA 2025 - The Pharmaletter
A leading meeting for commercial, marketing, medical affairs, patient engagement, RWE, market access and patient leaders.
Second FDA approval for BeiGene’s Tevimbra in 2024
Dec 27, 2024 · The US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1), Sino-China biotech BeiGene.
Positive Phase III trials results with BMS’ Sotyktu
Dec 24, 2024 · US pharma major Bristol Myers Squibb has announced positive results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal Phase III trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in …
Pfizer unveils new China strategy with $1 billion investment
Nov 8, 2024 · Pfizer plans to invest $1 billion in China by 2030 to support innovation, diagnostics, and the biotech sector, aligning with China’s “Healthy China 2030” initiative. This includes an upgrade to its Beijing R&D center and plans to introduce 60 innovative drugs and indications in China. Pfizer joins other global pharma firms, like AstraZeneca and Eli Lilly, in expanding their presence amid ...
First ‘Breakthrough’ designation for datopotamab deruxtecan
Dec 9, 2024 · Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with disease progression on or after treatment with an EGFR-tyrosine kinase inhibitor (TKI) and platinum ...
Uncertain future for S1P receptor modulators in Crohn’s disease, …
Oct 11, 2024 · Pfizer (NYSE: PFE) is to present initial findings from its CULTIVATE study of its sphingosine-1-phosphate (S1P) receptor modulator Velsipity (etrasimod) in Crohn’s disease (CD) at United European Gastroenterology Week 2024. The results show only modest efficacy in endoscopic response and remission rates. With its in-class competitor Zeposia (ozanimod) also underperforming in trials, the ...
FDA generic drug science and research priorities for 2025
Nov 28, 2024 · The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). The FDA determined the priority initiatives in collaboration with industry and the public, including feedback received during the FY 2024 Generic Drug Science and Research Initiatives Public Workshop.
Relation’s $45 million upfront GSK collaboration all part of right ...
Dec 23, 2024 · Nine months out from landing an additional $35 million in seed funding, Relation has more news – a big pharma collaboration. The group has announced a $45 million upfront deal, including a $15 million equity investment with UK pharma group GSK.
NewAmsterdam leaps on positive trial results | The Pharmaletter
Dec 11, 2024 · Dutch clinical-stage drug developer NewAmsterdam Pharma saw its shares close up 41% at $26.19 yesterday on positive research results for its cholesterol lower obicetrapib.