Japanese companies Chugai and TwoCells have announced the termination of their collaboration for the investigational regenerative cellular medicine for knee chondrogenesis gMSC 1. 13 April 2023
The US Food and Drug Administration issued a draft guidance, “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making 6 April 2023
The UK's National Institute for Health and Care Excellence (NICE) has issued preliminary guidance which does not recommend Cabometyx (cabozantinib) for a specific use in thyroid cancer. 5 April 2023
Gaetan Leblay has been named vice president, customer and digital strategy for Europe, the Middle East and Africa at the Johnson & Johnson subsidiary Janssen. 30 March 2023
Germany’s Evotec has extended and expanded a strategic partnership with US pharma major Bristol Myers Squibb in neurodegeneration that was originally signed in 2016. 28 March 2023
USA-based Cyclerion Therapeutics has announced corporate updates including advances in its zagociguat (formerly CY6463) mitochondrial disease program. 24 March 2023
A new immunology company, NImmune Biopharma, has been launched to develop omilancor, NIM-1324, and the entire LANCL portfolio, which it has bought from Landos Biopharma. 24 March 2023
Psychiatric and neurologic condition specialist Karuna Therapeutics has announced a public stock offering, with the goal of raising $400 million. 21 March 2023
The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). 20 March 2023
Danish drugmaker Pharmacosmos has announced the launch of its intravenous iron deficiency anemia medicine MonoVer (ferric derisomaltose) in Japan. 17 March 2023
UK-based Pharmanovia has expanded its endocrinology portfolio with a licensing agreement for Ghryvelin (macimorelin), a new medicine used for diagnosing adult growth hormone deficiency (AGHD) from US biopharma Aeterna Zentaris. 16 March 2023
Industry analyst Future Market Insights has forecast that the global market for psychedelic medicines, which it estimates to be currently worth $3.1 billion, will be worth over $14 billion by 2033. 14 March 2023
Japanese pharma majors Takeda and Shionogi will each receive about 130 million yen ($9.7 million) from the Japanese GHIT Fund to invest in malaria drugs development, according to a GHIT announcement issued on March 13. 14 March 2023
Spanish drugmaker PharmaMar says it has received the Temporary Authorization for the commercialization of Zepzelca (lurbinectedin) by the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy without central nervous system (CNS) metastases. 10 March 2023
The trade group for UK-based drugmakers, the Association of the British Pharmaceutical Industry (ABPI), has appointed vice president Susan Rienow to the role of president. 9 March 2023
The US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) investigating a potential new indication to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes. 8 March 2023
Japanese pharma company Alfresa has entered into a licensing deal with K Pharma to develop and commercialize ropinirole in Japan for the treatment of amyotrophic lateral sclerosis (ALS). 3 March 2023
The US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). 2 March 2023
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