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
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
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
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
Cara Therapeutics and Tvardi Therapeutics have announced a definitive agreement to merge, creating a new entity under the Tvardi name. 18 December 2024
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
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
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
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
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
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
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
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
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
VectorY Therapeutics, a Netherlands-based biotech focused on neurodegenerative diseases, has appointed Jim Scibetta as chief executive officer. 16 December 2024
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
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
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
The US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for Neffy (epinephrine nasal spray) in the treatment of allergic reactions (Type I), including anaphylaxis for adults and children ≥30 kg. 21 September 2023
Precision medicine specialist Rezo Therapeutics has appointed Nadir Mahmood as chief executive officer, replacing co-founder Nevan Krogan, who has held the role on an interim basis. 20 September 2023
The past year has been one of ups and downs for Blueprint Medicines Corporation, a US precision medicines company developing therapies for people with cancer and blood disorders. 20 September 2023
Japanese biopharma firm PeptiDream saw its share rise almost 5% to 1,714 yen, after it revealed a potentially lucrative licensing deal with US biotech Genentech. 20 September 2023
Privately-held genome-scale drug discovery company Orionis Biosciences today revealed a multi-year collaboration with Genentech, the US biotech subsidiary of Swiss pharm giant Roche, to discover novel small molecule medicines for challenging targets in major disease areas, including oncology and neurodegeneration. 20 September 2023
Swiss pharma firm Acino has acquired M8 Pharmaceuticals, a specialty biopharmaceutical company focused on licensing, marketing, and distributing innovative and established medicines in Mexico and Brazil. 20 September 2023
Gene therapy company Orchard Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for OTL-200 in metachromatic leukodystrophy (MLD) under Priority Review. 20 September 2023
A shortening cash runaway and a lack of near-term “value creation prospects” have forced some difficult decisions for Californian cancer firm Kinnate Biopharma. 20 September 2023
With medical research into molecular glues on the rise, research from Harvard University is finding its way into the local biotech scene. 19 September 2023
Sino-American biotech BeiGene today announced that it has entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize Tevimbra (tislelizumab). 19 September 2023
Korean biotech 1ST Biotherapeutics has announced a clinical trial collaboration and supply agreement with US pharma giant Merck & Co. 19 September 2023
A cancer drug under development by Cellectar Biosciences, a company based in New Jersey, USA, has been awarded an expedited review framework from the European Medicines Agency. 19 September 2023
Swiss biotech ImmunOs Therapeutics today announced the appointment of Dr Constanze Guenther as senior vice president, CMC and technical development. 19 September 2023
Leading Indian drugmaker Sun Pharmaceutical Industries has entered into a license agreement with US privately-held biopharma Pharmazz to commercialize a first-in-class innovative drug, Tyvalzi (sovateltide) in India. 18 September 2023
A novel antibody developed by Anthos Therapeutics, a cardiovascular specialist founded by Blackstone Life Sciences, has performed well in a Phase II trial. 18 September 2023
Citing resource constraints for the decision, the US Food and Drug Administration (FDA) says requires additional time to complete the Priority Review of Iovance Biotherapies’ Biologics License Application (BLA) for lifileucel. 18 September 2023
UK-based lifecycle management and pharma manufacturing company Pharmanovia today announced the expansion of its neurology portfolio with the acquisition of 11 central nervous system (CNS) brands from French pharma major Sanofi. 18 September 2023
Germany-based mRNA specialist CureVac, in collaboration with UK pharma major GSK, recently announced the advancement of its multivalent valent, modified seasonal influenza mRNA vaccine candidate into Phase II clinical trials. 15 September 2023
A new US biotech, Arialys Therapeutics, which is pioneering new therapeutics for autoimmune neuropsychiatry, has announced the closing of $58 million in seed financing. 15 September 2023