The US Food and Drug Administration (FDA) has granted approval of Balfaxar (prothrombin complex concentrate, human-lans) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. 26 July 2023
Swiss clinical-stage biotech AC Immune today announced the appointment of Nuno Mendonca as its new chief medical officer of the neurodegenerative diseases specialist. 26 July 2023
Shares in Stoke Therapeutics have fallen by a third after the company announced what it described as “positive new safety and efficacy data” from its early stage trial program for STK-001. 26 July 2023
Kodiak Sciences lost 47% of its stock market value on Monday after presenting top-line results from three Phase III studies of tarcocimab tedromer, an antibody biopolymer conjugate. 25 July 2023
Japanese pharma major Astellas Pharma today announced a research collaboration and license agreement with Kanagawa-based biotech firm PeptiDream to discover novel protein degraders for two targets selected by Astellas. 25 July 2023
Shares of Denmark-based vaccine developer Bavarian Nordic plummeted 21% to 148.80 Danish kroner yesterday, after it said it was discontinuing its RSV program. 25 July 2023
The US Food and Drug Administration (FDA) has approved Ycanth (cantharidin), a drug/device for the topical treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. 25 July 2023
Ireland-headquartered Horizon Therapeutics’ shares were barely changed in morning trading today, despite the company announcing after hours on Friday that its Phase II clinical trial evaluating daxdilimab for the treatment of systemic lupus erythematosus (SLE) did not show a statistically-significant separation between daxdilimab and placebo on the primary endpoint. 24 July 2023
Bicara Therapeutics, a biotech start-up founded in 2021 with the goal of developing dual-action biologics, has appointed David Raben as chief medical officer. 24 July 2023
US antibody-drug conjugates (ADCs) developer ImmunoGen today announced a multi-target license and option agreement to research novel, first-in-class ADCs with Canadian privately-held firm ImmunoBiochem Corp. 24 July 2023
The US Food and Drug Administration (FDA) has approved Cyfendus (anthrax vaccine adsorbed, adjuvanted), previously known as AV7909, developed by US biotech Emergent BioSolutions, whose shares closed up 8% on the news. 24 July 2023
San Diego, USA-based Turnstone Biologics has announced the pricing of its upsized initial public offering of 6,666,667 shares of common stock at a price to the public of $12.00 per share. 24 July 2023
Switzerland-headquartered ADC Therapeutics has announced that it plans to discontinue the Phase II LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). 22 July 2023
Privately-held Recludix Pharma has agreed a deal with French pharma major Sanofi to develop and commercialize oral small molecule STAT6 (signal transducer and activator of transcription 6) inhibitors for immunological and inflammatory (I&I) diseases. 21 July 2023
Polish clinical-stage biotech Molecure (WSE: MOC) revealed that it has successfully closed a secondary public offering (SPO) and entered into subscription agreements for all 2,776,000 H shares offered by way of private placement, within the authorized capital. 21 July 2023
Announcing a range of cost-cutting measures, the chief executive of Swiss biotech Idorsia has said it will take “longer than originally planned” for Quviviq (daridorexant) to become a commercial success. 21 July 2023
Boston, USA-based biotech start-up Jnana Therapeutics has appointed Dr George Vratsanos as its chief medical officer and head of research and development. 20 July 2023
A new analysis of clinical research into selinexor suggests it could be an effective maintenance therapy for certain people with endometrial cancer. 19 July 2023
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