Pharma, Biotech and Generics Industry News | The Pharmaletter
WEBGenerics. 2 September 2024 German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. Generics.
Fasenra approved in the USA for EGPA
WEB1 day ago · AstraZeneca’s (LSE: AZN) Fasenra (benralizumab) has been approved in the USA for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA, the UK pharma major announced today.. EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal. The approval by the US Food and Drug Administration (FDA ...
Pharma and Biotech News | The Pharmaletter
WEBSep 9, 2024 · Report shows cost decrease for dependency-forming medicines in England. The cost of prescribed dependency-forming medicines has decreased by £410 million ($539.6 million) since 2015/16, according to newly released data from the UK’s National Health Service (NHS). 6 September 2024. Biotechnology.
Pharmaceutical Industry News | The Pharmaletter
WEBSep 2, 2024 · US pricing watchdog says Rytelo is too expensive. The Institute for Clinical and Economic Review (ICER) has published its final evidence report evaluating the clinical effectiveness and value of Rytelo (imetelstat), raising concerns about the drug's net health benefits and its high cost. 23 August 2024. 25 August 2024.
FDA drug regulation and approval news | The Pharmaletter
WEBSep 12, 2024 · FDA grants tentative approval of Yutrepia. The US Food and Drug Administration (FDA) has granted tentative approval of Liquidia Corp’s Yutrepia (treprostinil) inhalation powder to treat adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). 21 August 2024.
Biotech Industry News | The Pharmaletter
WEBSep 3, 2024 · The Cell and Gene Therapy Catapult (CGT Catapult) has highlighted what it regards as the UK's potential to lead the global cell and gene therapy sector. 5 September 2024. Gene therapy company Genprex (Nasdaq: GNPX) has announced plans to transfer its diabetes program and related assets into a new, wholly-owned subsidiary. 5 …
week to August 30, 2024 - The Pharma Letter
WEBSep 1, 2024 · Regulatory news last week included European Commission approval for Swiss drugmaker Basilea’s antibacterial Cresemba, triggering a milestone payment from partner Pfizer. On the research front, Neurocrine Biosciences released mixed results from a Phase II study of its NBI-1117568 as a treatment for schizophrenia. Also, Alnylam Pharmaceuticals reported new Phase III data on its vutrisiran in ...
Special Reports - The Pharma Letter
WEBJun 17, 2020 · Our latest Special Report is a review of key factors impeding progress of US biosimilar adoption written by Helen Ji, an associate at Schiff Hardin LLP, Rekha Hanu, executive director and chief IP counsel at Akorn Pharmaceuticals and Christine Simmon, SVP for policy and strategic alliances at the Association for Accessible Medicines. 4 …
Pharma and Biotech Regulatory News | The Pharmaletter
WEBAug 23, 2024 · BioNTech resumes Phase I trial after FDA lifts partial hold. BioNTech (Nasdaq: BNTX) and MediLink Therapeutics have resumed recruitment for their Phase I trial of BNT326/YL202, following the US Food and Drug Administration's decision to lift a partial clinical hold. 19 August 2024. Biotechnology.
Pharms and Biotech Asia Pacific News | The Pharmaletter
WEBAug 20, 2024 · Organon KK, a Japan subsidiary of Organon & Co, announced that the primary endpoint was achieved in a domestic Phase III clinical trial evaluating the efficacy and safety of OG-8276A 6 September 2024