Swiss contract development and manufacturing organization (CDMO) Lonza announced today that its chief executive, Pierre-Alain Ruffieux, will leave the company at the end of September by mutual agreement. 18 September 2023
Final guidance from the UK’s health technology assessor recommends that the country’s national healthcare provider fund Jakavi (ruxolitinib) in polycythaemia vera (PV). 14 September 2023
The Johnson & Johnson subsidiary Janssen has submitted a Marketing Authorization Application to the European Medicines Agency seeking approval of erdafitinib for the treatment of patients with locally-advanced or metastatic urothelial cancer with susceptible pan-fibroblast growth factor receptor (FGFR) alterations. 8 September 2023
Cardiology specialist Corteria Pharmaceuticals has raised $71 million in a series A financing co-led by American investor OrbiMed and EU-based Jeito Capital. 7 September 2023
Women’s health company Organon has appointed Juan Camilo Arjona Ferreira as chief medical officer and Charlotte Owens as head of medical affairs and outcomes research. 6 September 2023
Swiss rare disease specialist Relief Therapeutics has entered into a new exclusive licensing agreement with Acer Therapeutics for Olpruva (sodium phenylbutyrate). 31 August 2023
The US Food and Drug Administration (FDA) has issued a final guidance for industry titled Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drugs and Biological Products. 31 August 2023
German infectious disease specialist AiCuris Anti-infective Cures has received a milestone payment of around $32.5 million from partner Merck & Co after a new US approval for Prevymis (letermovir). 23 August 2023
The US Food and Drug Administration (FDA) has accepted Swedish firm Calliditas Therapeutics’ submission for the supplemental New Drug Application (sNDA) and granted Priority Review for the full approval of Tarpeyo (budesonide) for the treatment of IgA nephropathy (IgAN). 18 August 2023
US legislators have proposed two new bills that aim to bolster the Vaccine Injury Compensation Program and help vaccines gain the general public's acceptance, the first being the Vaccine Injury Compensation Modernization Act and the second The Vaccine Access Improvement Act. 15 August 2023
Germany’s Ketabon GmbH, a joint venture between HMNC Brain Health and Develco Pharma, today announced today top-line results from its Phase II KET01-02 Ketabon study with lead asset KET01. 14 August 2023
Shares of Japanese drugmaker Daiichi Sankyo (TYO: 4568) moved up almost 2% to 4,279 yen today, as it revealed a decision to close its Japanese research and development (R&D) subsidiary, Daiichi Sankyo RD Novare, headquartered in Edogawa-ku, Tokyo. 7 August 2023
Danish vaccine developer Bavarian Nordic says that the US Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the US Department of Health and Human Services, has placed a new order valued at $120 million, primarily covering the manufacturing of new bulk product for the company’s Imvanex (marketed as Jynneos in the USA) smallpox/monkeypox vaccine. 4 August 2023
Taiho Pharmaceutical, a subsidiary of Japanese drugmaker Otsuka, says that its partner, privately-held French drugmaker Servier, has received approval from the European Commission, of Lonsurf (trifluridine/tipiracil) in combination with bevacizumab. 2 August 2023
The German economic development agency, Germany Trade and Invest (GTAI), has released a new podcast looking at recent developments in the life sciences industry in the country. 1 August 2023
C4X Discovery (C4XD) has sold its remaining rights to the oral Orexin-1 receptor antagonist, C4X_3256, to fellow British firm Indivior, for $20 million. 1 August 2023
Last Thursday, the US Food and Drug Administration (FDA) approved Ervebo, a vaccine for the prevention of Ebola virus disease caused by Zaire ebolavirus in individuals 12 months through 17 years of age. 29 July 2023
Syros Pharmaceuticals shares fell 5.7% after-hours trading on Friday, after it revealed that US pharma giant Pfizer will terminate a license deal between the companies related to the development of novel therapies for two blood disorders. 25 July 2023
The World Health Organization (WHO) is seeking to align its biowaiver policy with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guide. 21 July 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