Pharma, Biotech and Generics Industry News | The Pharmaletter
WEBGenerics. 13 September 2024 The protection of intellectual property (IP) rights of foreign pharmaceutical companies in Russia remains complex situation, according to recent statements by Konstantin Panurovsky, legal director of AstraZeneca’s Russian subsidiary, reports The Pharma Letter’s local correspondent. Pharmaceutical.
BRIEF— FDA slaps clinical hold on Rx-to-OTC switch for Cialis
WEBThe US Food and Drug Administration has informed French pharma major Sanofi that its planned Actual Use Trial (AUT) to support the Rx-to-OTC switch for Cialis (tadalafil) has been placed on clinical hold due to matters surrounding the protocol design.
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 …
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 …
AstraZeneca in-licenses lung cancer candidate from Allorion
WEBPharmaceutical. 3 January 2024. China and USA-based Allorion Therapeutics has entered into an exclusive option and global license agreement with UK pharma major AstraZeneca (LSE: AZN). The deal is for the development and commercialization of a novel epidermal growth factor receptor (EGFR) L858R mutated allosteric inhibitor, as a potential new ...
Pharmaceutical Industry News | The Pharmaletter
WEBSep 5, 2024 · MHRA finds no evidence to support a link between GLP-1s and suicidal thoughts. MHRA has concluded that the available evidence does not establish a causal relationship between glucagon-like peptide-1 (GLP-1) receptor agonists and suicidal behavior, suicidal ideation, self-injury and depression. 4 September 2024. 12 …
US FDA accepts Nova Lab’s filing for mercaptopurine in childhood …
WEB4 December 2013. Privately-held UK drugmaker Nova Laboratories says the US Food and Drug Administration has accepted a New Drug Application for childhood acute lymphoblastic leukemia (ALL) drug that is marketed in the European Union as Xaluprine (mercaptopurine). A liquid formulation of mercaptopurine, the product has …
Nucleome Therapeutics | Biotechnology - The Pharmaletter
WEBNucleome’s cell type-specific platform creates high resolution 3D genome structure maps and enables variant functional validation at scale in primary cell types, enabling the discovery and development of novel, better and safer drugs.
Synergy Pharmaceuticals | Biotechnology - The Pharmaletter
WEBUSA-based biopharma group Synergy Pharmaceuticals (Nasdaq: SGYP) is a biopharmaceutical company dedicated to developing new drugs to treat patients with gastrointestinal disorders and diseases. Based in New York, Synergy is led by a seasoned team of scientists, clinicians and executives with extensive experience in the biopharmaceutical industry.
PharmaMar amends licensing deal for Yondelis | The Pharmaletter
WEBPharmaceutical. 26 August 2019. Spanish drugmaker PharmaMar (MC: PHM) has entered into a new licensing agreement with Janssen Products, a unit of US health care giant Johnson & Johnson (NYSE: JNJ), for cancer drug Yondelis (trabectedin), which replaces the 2001 Licensing Agreement entered into by …