Armed with a pile of cash from its enormous successes with both a COVID-19 vaccine and antiviral treatment, US pharma giant Pfizer today announced the largest M&A deal so far this year in the biopharma sector. 10 May 2022
Swiss biotech Idorsia’s shares were up 1.4% at 13.71 francs by early afternoon today, having initially dropped to 13.26 francs, despite announcing disappointing Phase IIa results for its ACT-539313, a selective orexin-1 receptor antagonist. 10 May 2022
Denmark-based vaccine developer Bavarian Nordic saw its share drop more than 9% to 120.55 kroner by close of trading today on news that Johnson & Johnson subsidiary Janssen had terminated certain collaboration and license agreements. 9 May 2022
Swiss antibody-drug conjugate specialist ADC Therapeutics today announced that Chris Martin has stepped down as chief executive of the company. 9 May 2022
Shares of German biotech BioNTech were up 2.3% at $139.83 in pre-market New York trading, as the company reported financial results for the three months ended March 31, 2022. 9 May 2022
Myovant Sciences and Pfizer on Friday announced today that the US Food and Drug Administration has extended the review period for the supplemental New Drug Application (sNDA) for Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) for the management of moderate to severe pain associated with endometriosis. 9 May 2022
Enthera Pharmaceuticals, a privately-held Italian biotech developing biologics for selected autoimmune conditions based on the discovery of an apoptosis pathway, has named Aled Williams chief executive. 6 May 2022
Sino-American biotech BeiGene has announced that the China National Medical Products Administration (NMPA) has granted conditional approval of Blincyto (blinatumomab) for injection for the treatment of pediatric patients with relapsed or refractory (R/R) CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL). 6 May 2022
Privately-held Dutch biotech Byondis has entered into a license and collaboration and a supply agreement with medac GmbH, a privately owned pharmaceutical company based in Germany. 5 May 2022
Singapore-based Juniper Biologics and privately-held Swiss drugmaker Helsinn Group have signed an exclusive license agreement to develop and commercialize infigratinib (INN) in Australia, New Zealand, Southeast Asia and certain markets in the Middle East and Africa . 4 May 2022
US biotech companies Dragonfly Therapeutics and Gilead Sciences have announced a collaboration designed to advance a number of Dragonfly's novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation indications. 3 May 2022
Chinese biotech Hutchmed on Monday announced that the US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for surufatinib for the treatment of pancreatic (pNETs) and extra-pancreatic (non-pancreatic, epNETs) neuroendocrine tumors (NETs). 3 May 2022
Central nervous system (CNS) specialist Axsome Therapeutics expects to receive a complete response letter (CRL) from the FDA due to the recently revealed chemistry, manufacturing, and control (CMS) issues identified during the FDA’s review of its new drug application for AXS-07 (rizatriptan and meloxicam), for the acute treatment of migraines. 29 April 2022
Canada-based biotech Zymeworks late yesterday confirmed it has received an unsolicited, non-binding proposal from All Blue Falcons FZE (ABF) and its affiliates to purchase the company for $10.50 per share in cash, or some $773 million in total. 29 April 2022
The US Food and Drug Administration (FDA) approved Vivjoa (oteseconazole) capsules, an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential. 28 April 2022
Outlook Therapeutics recently submitted a Biologics License Application to the US Food and Drug Administration for ONS-5010 (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wAMD). 28 April 2022
Chinese start-up Xbiome, an AI-based microbiome drug development company, has acquired the clinical-stage M201 program from Californian firm Assembly Biosciences. 27 April 2022
The China National Medical Products Administration (NMPA) has recently granted breakthrough therapy (BTD) designation to China’s Innovent Biologic’s IBI310 in combination with Tyvyt (sintilimab) to treat patients with recurrent or metastatic cervical cancer. 27 April 2022
UK-based Mundipharma and US drug developer Cidara Therapeutics have presented data from the Phase III ReSTORE clinical trial of rezafungin in the treatment of candidemia and/or invasive candidiasis at the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). 27 April 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