UK and USA-based biotech F-star Therapeutics, an invoX company, has entered into another collaboration with Japan’s largest drugmaker Takeda. 5 July 2023
Shares of Amneal Pharmaceuticals fell 13.1% to $2.70 in choppy post-market trading, after the US drugmaker revealed that the US drugmaker revealed that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) regarding the New Drug Application (NDA) for IPX203 in the treatment of Parkinson’s disease. 5 July 2023
South Korean firm SK bioscience today revealed it has signed a Memorandum of Understanding (MOU) with the Government Pharmaceutical Organization (GPO), a state pharmaceutical enterprise in Thailand, to strengthen Thailand’s vaccine infrastructure. 5 July 2023
Genentech, the US biotech subsidiary of Swiss pharma giant Roche, plans to withdraw Gavreto (pralsetinib) from use in the USA for the treatment of a type of RET+ medullary thyroid cancer (MTC) as it was not feasible to pursue the drug for full approval, its partner Blueprint Medicines said on Friday. 3 July 2023
News coming out of Cure SMA meeting on new 36-month extension data from US biotech Scholar Rock’s Phase II TOPAZ clinical trial reinforces long-term substantial and sustained improvement of motor function in patients with non-ambulatory spinal muscular atrophy (SMA) treated with apitegromab. 3 July 2023
Industry analyst GlobalData has provided a downbeat analysis of prospects for BioXcel following claims of “bad clinical practice” related to the TRANQUILITY II study. 3 July 2023
French clinical-stage developer of immunotherapies Exeliom Biosciences today announced the completion of its 24 million-euro ($26 million) Series A financing to progress the clinical development of its therapeutic pipeline. 30 June 2023
Dublin, Ireland-headquartered protein specialist Prothena has published results from the Phase III VITAL trial in a journal of the American Society of Hematology (ASH). 30 June 2023
Canada-headquartered Aurinia Pharmaceuticals saw its shares leap more than 17% to $10.77 in pre-market trading, after it said that its board of directors has initiated an exploration of strategic alternatives. 30 June 2023
BioXcel has presented positive top-line results for TRANQUILITY II, a Phase III trial of BXCL501, its orally dissolving film formulation of dexmedetomidine under investigation for the acute treatment of Alzheimer’s disease-related agitation. 29 June 2023
Italy’s privately-held Italfarmaco Group has taken another pivotal step towards approval of its proprietary histone deacetylase (HDAC), givinostat, in Duchenne muscular dystrophy (DMD). 29 June 2023
US clinical stage biotech RenovoRx saw its shares leap 30% to $2.90 in pre-market activity, after it released positive interim Phase III data showing an 8-month improvement in progression-free survival (PFS) for patients on RenovoGem (intra-arterial administration of gemcitabine) in locally advanced pancreatic cancer. 29 June 2023
Traders have taken a downbeat view of Cognition Therapeutics’ prospects, with top-line results from a Phase II trial shaking confidence in the firm’s Alzheimer’s research. 29 June 2023
A new Pompe disease therapy has been approved by the European Medicines Agency, with Amicus Therapeutics picking up authorization for the enzyme stabilizer Opfolda (miglustat). 27 June 2023
Shares Avalo Therapeutics plummeted almost 89% to $0.50 by close of trading yesterday, after the US clinical-stage biotech released disappointing clinical trial results asthma candidate. 27 June 2023
US traded shares of Swiss biotech MoonLake Immunotherapeutics leapt almost 79% to $46.58 this morning, after the inflammatory diseases specialist announced positive top-line results from its global Phase II MIRA trial evaluating the efficacy and safety of the Nanobody sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS). 26 June 2023
A reminder has been issued of the potential of US biopharma 89bio’s pegozafermin to finally provide a solution in non-alcoholic steatohepatitis (NASH). 26 June 2023
Based on analysis of available information and input from a MEDACorp patent attorney, SVB Securities Research believes US pharma major AbbVie’s allegations that Brukinsa infringes on a recently granted patent (#11,672,803) are substantiative and could potentially result in damages to China-headquartered biotech BeiGene. 26 June 2023
UK cancer immunotherapy firm Immodulon has appointed Richard Couch as chief technology officer and Owen Vaughan as chief regulatory officer. 26 June 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