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
Emerging US biopharma firm Mycovia Pharmaceuticals has shared top-line results from evaluating Vivjoa (oteseconazole) capsules in patients suffering from recurrent vulvovaginal candidiasis (RVVC). 23 June 2022
Just three months after Nutcracker Therapeutics’ announcement of receiving $167 million in Series C funding, three new leadership positions have been filled alongside the release of its oncology and disease-focused pipeline. 22 June 2022
Belgian biotech company Galapagos (Euronext: GLPG) announced that it will acquire Dutch cell therapy company CellPoint and AboundBio to boost access to next-generation cell therapies, for around $250 million. 22 June 2022
Biotech firm BeiGene said today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) for the company’s anti-PD-1 inhibitor, tislelizumab, in combination with chemotherapy as a first-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1. 22 June 2022
Sweden-based NorthX Biologics is expanding into cell therapy manufacturing at its existing GMP-facility, as well as in premises at the Karolinska University Hospital campus in Stockholm. 21 June 2022
Swiss drugmaker Basilea Pharmaceutica has announced that the sales of the antifungal Cresemba (isavuconazole) by its license partner Pfizer in the Asia Pacific region, exceeded the threshold triggering the first sales milestone payment for this region of $1.25 million. 20 June 2022
The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to discuss the case for approval of pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) resulted in a decisive negative vote of 9 to 3, noting that the evidence presented does not support a conclusion that pimavanserin is effective for the treatment of hallucinations and delusions in the ADP population. 18 June 2022
Cardio-renal diseases specialist Renibus Therapeutics has announced positive interim data from its lead clinical candidate, RBT-1, from its randomized, placebo-controlled Phase II trial. 17 June 2022
US clinical-stage biotech Scholar Rock today announced new data from the Phase II TOPAZ trial extension period evaluating patient outcomes after 24-months of treatment, which support sustained and continued improvement with apitegromab (SRK-015) for non-ambulatory patients with Types 2 and 3 SMA receiving a spinal muscular atrophy (SMN) therapy. 17 June 2022
Switzerland-headquartered biotech Addex Therapeutics today announced that it has terminated the Phase IIb/III study evaluating dipraglurant as a potential treatment for dyskinesia associated with Parkinson’s disease (PD-LID) due to the slow recruitment of patients. 17 June 2022
Shares in Akero Therapeutics ended the day up over a fifth on Thursday, after the firm announced a deal with Pfizer, including a $25 million equity investment. 17 June 2022
Iceland-based global pureplay biosimilars developer and manufacturer Alvotech announced that its ordinary shares and warrants will begin trading on the Nasdaq Stock Market on Thursday, June 16, under the new ticker symbols “ALVO” and “ALVOW”, respectively. 16 June 2022
Aqemia, a next-gen French pharmatech company leveraging artificial intelligence and quantum physics announced, today that it has entered a new research collaboration with pharma major Sanofi. 16 June 2022
US biotech company Exelixis and Sweden’s BioInvent have entered into an option and license agreement focused on the identification and development of novel antibodies for use in immune-oncology (I-O) therapeutics. 16 June 2022
Biotech BeiGene has announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months to January 20, 2023 for the supplementary new drug application (sNDA) submitted for Brukinsa as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 14 June 2022
RNAi therapeutics company Alnylam Pharmaceuticals today announced that the US Food and Drug Administration (FDA) approved Amvuttra (vutrisiran), an RNAi therapeutic administered via subcutaneous injection once every three months (quarterly) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. 14 June 2022
Danish vaccine developer Bavarian Nordic today announced that the European Health Emergency Preparedness and Response Authority (HERA) has ordered 110,000 doses of MVA-BN smallpox/monkeypox vaccine, which will be made available to European Union member states, Norway and Iceland in response to the current monkeypox outbreak. 14 June 2022
Amylyx Pharmaceuticals’ shares closed down 3.9% at $13.00 on Monday, despite announcing it has received the first regulatory approval for its Albrioza (sodium phenylbutyrate and ursodoxicoltaurine), from Health Canada, for the treatment of amyotrophic lateral sclerosis (ALS). 14 June 2022