British respiratory company Synairgen is presenting full data from the Phase III SPRINTER trial of its COVID-19 therapy SNG001 at the annual meeting of the American Thoracic Society (ATS 2022). 17 May 2022
French ophthalmology company Nicox has announced a new governance structure, with a separation of the functions of chief executive and chairman of the board. 16 May 2022
Japan’s Astellas Pharma has provided a preview of the research it intends to present during the 2022 American Society of Clinical Oncology (ASCO) annual meeting in early June. 13 May 2022
German cerebrovascular specialist Vasopharm has announced a statistically-significant result from post hoc analyses of its clinical trial program for ronopterin. 10 May 2022
The US Food and Drug Administration has released two draft guidances for industry focused on the development of drugs to treat Crohn’s disease (CD) and ulcerative colitis (UC). 30 April 2022
The European Commission has granted marketing authorization to Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adult hemodialysis patients from Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics. 28 April 2022
Glenmark Pharmaceuticals has launched a novel diabetes med in India, a fixed-dose combination of the widely-used DPP4 inhibitor teneligliptin, together with pioglitazone. 25 April 2022
Health Canada has granted Marketing Authorization for the expanded use of Vertex Pharmaceuticals’ Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages six through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 21 April 2022
Nagoya, Japan-based RaQualia Pharma has received approval of its new drug application (NDA) in China for its acid-related gastrointestinal disease treatment tegoprazan, a potassium competitive acid blocker (P-CAB). 14 April 2022
Switzerland-based Myovant Sciences and US pharma giant Pfizer have announced an update on 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. 13 April 2022
Privately-owned pharma company Galen has acquired the rights to Provocholine 100mg Powder for nebuliser solution (methacholine chloride) - manufactured by Methapharm Specialty Pharmaceuticals of Canada - to exclusively distribute and commercialize in the UK. 12 April 2022
Swedish immunology company InDex Pharmaceuticals today announced that after more than seven years as chief executive, Peter Zerhouni has decided to leave his position. 11 April 2022
The European Medicines Agency has announced that general, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorization holders are increasing by 0.3% and 5.3% as of April 1, 2022, to reflect the inflation rate adjustments of 2020 and 2021, respectively. 5 April 2022
Vifor Pharma has announced full results from its Phase-IIIb DIAMOND trial showing that Veltassa (patiromer) allowed patients to achieve long-term potassium control, reduced the risk of recurrent hyperkalemia and prolonged optimized and guideline recommended renin-angiotensin aldosterone system inhibitor (RAASi) therapy. 4 April 2022
ViiV Healthcare, the specialist HIV company majority owned by GSK, today announced the presentation of new real-world evidence and implementation data showing the effectiveness, adherence, and quality-of-life improvement of Apretude (cabotegravir long-acting (CAB LA)) for HIV pre-exposure prophylaxis (PrEP). 16 October 2024
Jaguar Health today announced the US launch of Gelclair, the only Food and Drug Administration (FDA)-approved mucoadhesive on the market indicated for the management of pain caused by oral mucositis 16 October 2024
Netherlands-based life sciences venture capital firm Forbion has raised more than 2 billion euros ($2.2 billion) across its two newest funds. 16 October 2024
The American Lung Association Research Institute has announced a $22 million research investment in 2024, marking one of the largest lung health research programs in the USA. 16 October 2024
US pharma major Eli Lilly has announced a strategic collaboration with two UK government departments and the devolved nations to tackle significant population health challenges, including exploring new models to better care for people living with obesity. 16 October 2024
TenNor Therapeutics, a Suzhou-based clinical-stage biotech company, has announced the initial closing of a series E financing round, raising over 300 million yuan ($41 million). 16 October 2024
Switzerland-based Novocure saw its shares rise 10% yesterday and leap a further 24% to $22.05 pre-market, after the company received a new US regulatory approval for its key product Optune Lua. 16 October 2024
Shares of Spanish drugmaker PharmaMar leapt more than 28% to 63.70 euros today, after it announced positive clinical trial findings for its combo lung cancer treatment, under development with USA-based Jazz Pharmaceuticals, which rose 4.2%. 15 October 2024
Novartis has discontinued an early Phase II trial of LTP001 in idiopathic pulmonary fibrosis (IPF). The company confirmed that the decision was not related to safety, with no issues emerging in the study. 15 October 2024
US pharma major Eli Lilly has announced plans to invest around 1.5 billion renminbi ($206 million) into expanding its manufacturing facility in Suzhou, China. 15 October 2024
Spanish dermatology specialist Almirall (BME: ALM) has announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole. 15 October 2024
French biopharma company Inventiva has announced financing of immediately 94.1 million euros ($103 million) and up to 348 million euros, subject to satisfaction of specified conditions. 15 October 2024
India's Central Drugs Standard Control Organization (CDSCO) has provided a favorable recommendation for its novel antibiotic Miqnaf (nafithromycin) discovered and developed for the treatment of community-acquired bacterial pneumonia (CABP) in adults. 14 October 2024
The Danish Medicines Council (Medicinrådet), responsible for evaluating and recommending new treatments for Denmark’s healthcare system, is facing a significant increase in processing times. 14 October 2024
The South African Health Products Regulatory Authority (SAHPRA) and the Australian Therapeutic Goods Administration (TGA) have signed a Memorandum of Understanding (MoU), which will strengthen collaboration between the two health product regulators. 14 October 2024
California-based AI company Suki has raised $70 million in new funding to accelerate the growth of its AI-powered voice solutions in healthcare. 11 October 2024
Pfizer is to present initial findings from its CULTIVATE study of its sphingosine-1-phosphate (S1P) receptor modulator Velsipity (etrasimod) in Crohn’s disease (CD) at United European Gastroenterology Week 2024. 11 October 2024
Switzerland-based KeyBioscience and US pharma major Eli Lilly have agreed to extend their collaboration on the development of dual amylin calcitonin receptor agonists (DACRA), a new class of potential treatments for obesity and related disorders. 11 October 2024