Following discussions with the US regulator, Texan drugmaker Lexicon Pharmaceuticals now plans to resubmit a New Drug Application (NDA) for sotagliflozin. 12 March 2024
US clinical-stage biotech IDRx today announced that it has strengthened its leadership team with the appointments of Tim Clackson, as chief executive and Brad Dahms as chief financial officer and chief business officer. 12 March 2024
A final report for KarXT (xanomeline tartrate/trospium chloride) has been published by influential US pricing watchdog The Institute for Clinical and Economic Review (ICER). 12 March 2024
US immunology specialist Acelyrin came up with positive trial results for izokibep, which last year failed to meet a study endpoint for the treatment of moderate-to-severe hidradenitis suppurativa (HS). 12 March 2024
Shanghai-based CARsgen Therapeutics has announced that zevorcabtagene autoleucel (CT053), or zevor-cel, its autologous CAR T-cell developed for multiple myeloma, has been approved by China’s National Medical Products Administration (NMPA). 11 March 2024
The ACTION3 Phase III trial of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) was successful in the pre-specified interim analysis of the proteinuria (efficacy) endpoint from the trial’s first 72 randomized patients, Melbourne, Australia-based Dimerix Limited revealed today. 11 March 2024
US retinal disease specialist Apellis Pharmaceuticals today announced that Dr Philip Ferrone will join the company as chief medical retina advisor, effective March 18. 11 March 2024
Shares of Switzerland-based MoonLake Immunotherapeutics were up 10.5% at $50.38 in pre-market activity today, after its Sunday R&D update on its Nanobody sonelokimab. 11 March 2024
Sino-American biotech BeiGene on March 8 disclosed in stock exchange announcement that it has filed patent infringement suits under the Hatch-Waxman Act against the US subsidiary of Swiss firm Sandoz and separately against Indian-owned companies MSN Pharmaceuticals and MSN Laboratories Private in the US District Court for the District of New Jersey. 9 March 2024
Singapore-based TauRx Pharmaceuticals, which is seeking treatments for Alzheimer’s and related neurodegenerative diseases, presented the 24-month data from its Phase III LUCIDITY trial of hydromethylthionine mesylate (HMTM). 8 March 2024
The US Food and Drug Administration granted accelerated approval for Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. 8 March 2024
In a filing with the US Securities and Exchange Commission (SEC), Boundless Bio has revealed its intention for an initial public offering (IPO). 7 March 2024
UK-based Ellipses Pharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its selective RET inhibitor EP0031/A400 for the potential treatment of RET-fusion positive non-small cell lung cancer (NSCLC). 7 March 2024
Trevi Therapeutics has announced significant milestones in its clinical programs for Haduvio (nalbuphine), an investigational therapy aimed at treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). 4 October 2024
Paris-based asset manager Kurma Partners has raised 140 million euros ($154 million), successfully completing the first closing of Biofund IV 4 October 2024
Singapore’s Agency for Science, Technology and Research (A*STAR) and US biotech incubator Flagship Pioneering have agree to collaborate on advancing health and sustainability outcomes in Singapore and the broader Asia Pacific region. 4 October 2024
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 October 2024
Caliway Biopharmaceuticals has successfully completed its initial public offering, raising NT$6.4 billion ($206 million), the largest IPO in Taiwan's biotech industry to date. 3 October 2024
US clinical-stage biotech Arcus Biosciences has entered into a clinical trial collaboration with AstraZeneca on renal cancer treatments. 3 October 2024
PeptiDream says that its wholly-owned PDRadiopharma subsidiary has entered into a strategic partnership with French nuclear medicines firm Curium. 3 October 2024
Shares of UK drug developer Hemogenyx Pharmaceuticals rose as much as 9% and closed up 5.9% at 1.70 pence yesterday on the news of a further investment from Prevail Partners. 3 October 2024
UK-based biotech Resolution Therapeutics has announced the completion of a £63.5 million ($76.8 million) series B financing round led by Syncona. 3 October 2024
Liquidia Corporation and Pharmosa Biopharm have amended the current exclusive licensing agreement for the development and commercialization of L606. 3 October 2024
Timing can be crucial in biotech, and any company that can help optimize radiopharmaceuticals to fight cancer is likely to a hot property right now, given the recent popularity of the field among investors and drugmakers. 2 October 2024
UK-based biotech LoQus23 Therapeutics has closed a £35 million ($43 million) series A financing round, led by Forbion, with support from SV Health Investors' Dementia Discovery Fund and Novartis Venture Fund. 2 October 2024
Privately-held UK biotech Curve Therapeutics today announced the further strengthening of its leadership team with the appointments of Andre Hoekema as chairman of the board and Cora Griffin as head of business development. 2 October 2024
NK:IO, a London startup developing a cell therapy for treating solid tumors, has announced the appointment of a permant chief executive and the finalization of a seed funding round. 2 October 2024
Spanish epigenetics firm Oryzon Genomics has announced the receipt of the official meeting minutes from a recent End-of-Phase II meeting for vafidemstat in borderline personality disorder (BPD) with the US Food and Drug Administration (FDA). 2 October 2024
Halda Therapeutics, a US biotech company advancing cancer treatments, announced the appointment of Christian Schade as president and chief executive. 1 October 2024