Along with providing a program update on GTX-102 for the treatment of Angelman syndrome (AS), Ultragenyx Pharmaceuticals today announced it will acquire GeneTx Biotherapies, its partner on the candidate. 19 July 2022
US biopharma firm Apellis Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review designation for the intravitreal pegcetacoplan New Drug Application (NDA). 19 July 2022
The UK’s National Institute for Health and Care Excellence (NICE) has issued guidance that recommends Imcivree (setmelanotide) as an option for treating hyperphagia and obesity and controlling hunger caused by pro-opiomelanocortin (POMC) deficiency, including proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency in people six years of age and over. 18 July 2022
Swiss biopharma company Relief Therapeutics today announced that its collaboration partner, Acer Therapeutics for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs), has resubmitted its New Drug Application (NDA) for ACER-001 to the US Food and Drug Administration (FDA). 18 July 2022
The European Commission (EC) has granted conditional marketing authorization for Kinpeygo (budesonide) for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. 16 July 2022
Clene Nanomedicine, a part of Clene Inc, has reported significantly improved survival in amyotrophic lateral sclerosis (ALS) patients initially treated with CNM-Au8 compared to initially randomized placebo treated participants during the long-term open-label extension of its RESCUE-ALS trial 15 July 2022
Sino-American biotech firm BeiGene today announced that the US Food and Drug Administration (FDA) has deferred action on the Biologics License Application (BLA) for tislelizumab as a second-line (2L) treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). 14 July 2022
A firm developing a novel vaccine technology, which could offer safer and more effective protection against infectious diseases, has appointed a new chief executive officer. 13 July 2022
California, USA-based biotech Epic Bio, which is developing ultracompact therapies to modulate gene expression in vivo, today announced its launch and Series A financing of $55 million. 12 July 2022
The US Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DoD), announced that it has secured 3.2 million doses of Novavax’ COVID-19 vaccine (NVX-CoV2373). 12 July 2022
US drugmaker La Jolla Pharmaceuticals Company saw its shares rocket 81.7% to $6.16 in early trading, after it was revealed that it has received a takeover approach from Innoviva. 11 July 2022
In a filing with the US Securities and Exchange Commission, Legend Biotech revealed it had notified the US Food and Drug Administration (FDA) that it has terminated its Phase I clinical trial under the Investigational New Drug (IND) application for LB1901, the US biotech’s investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of adults with relapsed or refractory T-cell lymphoma. 11 July 2022
US biotech Alector saw its shares dip 2.8% to $11.16 in morning trading, after it revealed n a filing with the Securities and Exchange Commission that its licensing partner AbbVie was pulling of a collaboration on Alzheimer’s disease. 8 July 2022
US biopharma company Intercept Pharmaceuticals yesterday announced positive top-line results from a new interim analysis of its ongoing pivotal Phase III REGENERATE trial of obeticholic acid (OCA) in patients with liver fibrosis due to non-alcoholic steatohepatitis (NASH). 8 July 2022
Sino-American company Brii Biosciences announced the commercial launch of the amubarvimab/romlusevimab (previously BRII-196/BRII-198) combination, a long-acting COVID-19 neutralizing antibody therapy, in China. 8 July 2022
Swedish Orphan Biovitrum, also known as Sobi, today announced an exclusive license agreement with Swiss firm ADC Therapeutics to develop and commercialize loncastuximab tesirine for use in hematology and other indications of large unmet medical need in Europe and most international markets. 8 July 2022
US oncology biotech CytomX Therapeutics’ shares were down more than 25% at $1.47 in pre-market trading, after the company revealed that the latest clinical data on its praluzatamab ravtansine did not support further development alone. 7 July 2022
USA-based immuno-oncology company Portage Biotech has signed an agreement to acquire Tarus Therapeutics, a private company developing adenosine receptor antagonists. 7 July 2022
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