The European Commission (EC) has granted marketing authorization to ADV7103 (potassium citrate/potassium hydrogen carbonate), proposed trade name Sibnayal, for the treatment of distal renal tubular acidosis (dRTA), says French biotech Advicenne. 4 May 2021
Legend Biotech, a clinical stage CAR-T immuno-oncology biotech being spun out of Hong Kong-listed GenScript Biotech, revealed on Friday that a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) seeking approval of ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed and/or refractory multiple myeloma. 1 May 2021
Swedish biotech Calliditas Therapeutics says that the US Food and Drug Administration has accepted its New Drug Application for Nefecon (budesonide) for priority review as a treatment for IgA nephropathy (IgAN). 28 April 2021
Privately-held Pyxis Oncology has announced the targets of its three antibody-drug conjugate (ADC) candidates along with additional details and preclinical data supporting the potential of its ADC platform. 27 April 2021
USA-based LogicBio Therapeutics has announced a strategic collaboration and option agreement with China-based CANbridge Pharmaceuticals leveraging LogicBio’s gene editing and gene delivery platforms. 27 April 2021
Krakow, Poland-based oncology specialist Ryvu Therapeutics today announced that Vatnak Vat-Ho has joined the company as chief business officer. 26 April 2021
Anavo Therapeutics, a Netherlands-based company that is aiming to unlock the full therapeutic potential of human phosphatase biology, debuted today with a 20 million euros (~$24 million) seed financing from M Ventures, INKEF, Taiho Ventures, and Bioqube Ventures. 22 April 2021
Global non-profit partnership CARB-X is funding privately-held UK company Phico Therapeutics to develop a new intravenous engineered bacteriophage drug to treat ventilator-associated pneumonia caused by Pseudomonas aeruginosa. 19 April 2021
California, USA-based biotech BioAge Labs has entered into an exclusive worldwide license agreement with Amgen to develop and commercialize Amgen’s clinical-stage APJ agonist, BGE-105 previously (named AMG 986 by Amgen) to ameliorate muscle aging. 15 April 2021
US biotech Tango Therapeutics has signed a deal with BCTG Acquisition, a special-purpose acquisition company, or SPAC, sponsored by San Diego's Boxer Capital, to go public through a reverse merger. 14 April 2021
London-listed blood disease specialist Hemogenyx Pharmaceuticals (LSE: HEMO) has provided an update on the development of its lead product candidate, a CDX bispecific antibody. 14 April 2021
US biotech Ventus Therapeutics today announced a $100 million Series B financing led by RA Capital Management, with the proceeds to be used to advance its pipeline of small-molecule medicines against traditionally undruggable targets. 8 April 2021
UK biotech Artios Pharma Limited (Artios) has entered into a global research collaboration with Swiss pharma giant Novartis to discover and validate next generation DNA damage response (DDR) targets to enhance Novartis’s Radioligand Therapies (RLT). 7 April 2021
Shares of US biotech Cidera Therapeutics were up nearly 11% at $2.95 6% pre-market on Monday, as it revealed an exclusive worldwide license and collaboration with Janssen Pharmaceuticals. 6 April 2021
The US Food and Drug Administration has approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients six to 17 years of age. 6 April 2021
Fortress Biotech partner company Journey Medical today announced that it has entered into a definitive agreement to acquire Qbrexza (glycopyrronium) in the USA from Dermira, a wholly-owned subsidiary of Eli Lilly. 1 April 2021
UK-based biopharma firm Hemogenyx Pharmaceuticals has issued an update on negotiations regarding the future development of its leading product candidate CDX bispecific antibody (CDX) for the treatment of acute myeloid leukemia (AML). 1 April 2021
Epitopea, a UK and Canada-based cancer immunotherapeutics company, has partnered with nucleic acid delivery specialist Genevant Sciences to develop new RNA-based therapies targeting proprietary tumor antigens. 20 December 2024
US biotech Assembly Biosciences has announced an equity investment of $20.1 million by Gilead Sciences to purchase additional common stock in the company and an amendment to their collaboration to advance the research and development of novel antiviral therapies with $10 million in accelerated funding. 20 December 2024
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