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Pharmaceutical
Privately-held Xcovery Holdings, an oncology-focused pharma company, has announced that the US Food and Drug Administration (FDA) has approved Ensacove (ensartinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). 19 December 2024
Biotechnology
Privately-held biotech Ottimo Pharma today announces the completion of a Series A financing round of over $140 million. 19 December 2024
Biotechnology
Safi Biotherapeutics, a specialist in stem-cell derived red blood cell products, has received Rare Pediatric Disease designation and Orphan Drug designation from the US regulator. 19 December 2024
Biotechnology
BioAge Labs today announced a multi-year research collaboration with Swiss pharma giant Novartis, with the news pushing the US biotech’s shares up 6.1% to $4.35 by early afternoon. 18 December 2024
Pharmaceutical
Marking its second deal this month alone, Novo Nordisk has entered into a multi-year collaboration with Massachusetts, USA-based Photys Therapeutics to develop novel proximity-based therapeutics for a cardiometabolic disease target. 18 December 2024
Biotechnology
Cara Therapeutics and Tvardi Therapeutics have announced a definitive agreement to merge, creating a new entity under the Tvardi name. 18 December 2024
Pharmaceutical
SiteOne Therapeutics has announced the completion of a $100 million series C financing, led by Novo Holdings, with participation from OrbiMed, Wellington Management, Mission BioCapital, and others. 18 December 2024
Biotechnology
Flagship Pioneering-founded genome engineering biotech Tessera Therapeutics today announced an investment of up to $50 million from the Bill & Melinda Gates Foundation to develop curative, globally accessible in vivo genetic therapies for sickle cell disease. 18 December 2024
Biotechnology
San Francisco-based Indapta Therapeutics, a privately held start-up developing next-generation cell therapies, has raised $22.5 million in a new financing round. The firm raised over $50 million in series A funding in 2022. 18 December 2024
Biotechnology
French CNS specialist Theranexus saw its shares leap more than 34% to 0.65 euros as it revealed a license and supply agreement with Exeltis to commercialize TX01, its novel formulation of a compound already approved in the indication for the treatment of rare neurological diseases. 18 December 2024
Biotechnology
Shares in US biopharma Viridian Therapeutics shot up by 21% on Monday. 17 December 2024
Biotechnology
US antivirals giant Gilead Sciences today revealed it has entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets with Californian biotech Terray Therapeutics. 17 December 2024
Pharmaceutical
Swedish biotech company Inify Laboratories has raised approximately 135 million kroner ($12.3 million) through a private placement, supporting a planned expansion into the UK. 16 December 2024
Biotechnology
Dewpoint Therapeutics and ConcertAI have announced the first phase of their translational oncology partnership, aligned around the former company's latest drug candidate, DPTX3186. 16 December 2024
Biotechnology
Bicycle Therapeutics, a UK-headquartered pharma company developing a new class of therapeutics based on its proprietary bicyclic peptide technology, closed a third lower on Friday. 16 December 2024
Biotechnology
In a filing with the US financial regulator, German mRNA specialist BioNTech has noted the lifting of a partial clinical hold on its PRESERVE-003 trial. 16 December 2024
Biotechnology
VectorY Therapeutics, a Netherlands-based biotech focused on neurodegenerative diseases, has appointed Jim Scibetta as chief executive officer. 16 December 2024
Biotechnology
Sino-American biotech BeiGene has announced it has entered into a global licensing agreement with China’s CSPC Zhongqi Pharmaceutical Technology for SYH2039, a novel methionine adenosyltransferase 2A (MAT2A)-inhibitor being explored for solid tumors. 13 December 2024
Pharmaceutical
US biotech Corcept Therapeutics has reported positive results from the Phase IV CATALYST study of Korlym (mifepristone) in people with hypercortisolism and difficult-to-control type 2 diabetes. 13 December 2024
Biotechnology
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. 13 December 2024
Biotechnology
US clinical-stage biotech Kymera Therapeutics today announced the appointment of Jeremy Chadwick as its chief operating officer (COO). 22 May 2023
Pharmaceutical
The US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee does not appear to sold on Intercept Pharmaceuticals’ obeticholic acid (OCA) in pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis (NASH). 22 May 2023
Biotechnology
The US Food and Drug Administration on Friday approved Vyjuvek (beremagene geperpavec-svdt), a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients six months and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. 22 May 2023
Biotechnology
Neurocrine Biosciences has announced that the complete study results from its Phase III KINECT-HD study of valbenazine in chorea associated with Huntington's disease (HD) has been published in The Lancet Neurology online edition and will appear in the June 2023 print issue. 19 May 2023
Biotechnology
The US Food and Drug Administration (FDA) has eased the partial clinical hold on AOC 1001, allowing Avidity Biosciences, the drug’s developer, to double the number of participants in the MARINA Open-Label Extension (MARINA-OLE) study receiving 4 mg/kg of AOC 1001. 18 May 2023
Biotechnology
UK-based Senisca, a biotech company developing RNA-based therapeutics to reverse cellular senescence and target age-related disease, has announced an expansion of its leadership team. 18 May 2023
Pharmaceutical
USA-based ophthalmic diseases specialist EyePoint Pharmaceuticals saw its share leap 15.4% to $7.40 in pre-market trading today, as it announced a definitive agreement for the sale of Yutiq (fluocinolone acetonide intravitreal implant) 0.18mg to Alimera Sciences. 18 May 2023
Pharmaceutical
Shares of US drug developer Intercept Pharmaceuticals closed down 14.7% at $13.83 yesterday, after the US Food and Drug Administration released briefing document ahead of the FDA’s Gastrointestinal Drugs Advisory Committee. 18 May 2023
Biotechnology
Not-for-profit UK medical research organization LifeArc and techbio company PrecisionLife have announced a strategic R&D collaboration to accelerate the discovery and development of targeted treatments for amyotrophic lateral sclerosis (ALS), a disease also known as motor neurone disease. 17 May 2023
Biotechnology
Shares in Australian immunotherapy specialist Immutep are up 15% after news of a positive clinical trial result in lung cancer. 17 May 2023
Biotechnology
Californian genetic medicine company Scribe Therapeutics has lined up another deal with a pharma major to out-license its technologies. 17 May 2023
Biotechnology
Some positive data from Coya Therapeutics lifted the US biotech’s shares 10% in normal trading and a further 6.4% to $6.20 in after-hours activity on Tuesday. 17 May 2023
Biotechnology
Boundless Bio, a US precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) for oncogene amplified cancers, has announced the closing of a $100 million Series C financing. 16 May 2023
Pharmaceutical
Dermavant Sciences, an immuno-dermatology-focused subsidiary of Switzerland-based Roivant Sciences, today announced positive results from ADORING 1, the second of two double-blind, randomized, vehicle-controlled Phase III studies to evaluate the efficacy and safety of topical Vtama (tapinarof) cream. 16 May 2023
Biotechnology
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biological License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985), under development by Dutch clinical-stage biotech Byondis. 16 May 2023
Biotechnology
Another well-funded clinical-stage start-up has emerged in the thriving biotech hub around Boston, Massachusetts. 16 May 2023
Biotechnology
Californian companies Gilead Sciences and Arcus Biosciences have expanded a previously-announced research collaboration focused on oncology to include therapies for the treatment of inflammatory diseases. 15 May 2023
Biotechnology
UK-based RNA delivery and therapeutics company SiSaf has announced that SIS-101-ADO, its siRNA therapeutic for patients with autosomal dominant osteopetrosis type 2 (ADO2), has been granted orphan drug designation by the US Food and Drug Administration (FDA). 15 May 2023
Biotechnology
Privately-held US precision medicines company Frontier Medicines Corporation has appointed Dr Andrew Krivoshik as chief medical officer. 13 May 2023
Biotechnology
Pan Cancer T, a spin-off from The Netherlands’ Erasmus Medical Center focused on the discovery and development of next-generation TCR-T therapies against solid tumors, has a new boss. 12 May 2023
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