China will loosen its grip on imported drugs that are unapproved in the country, according to the amended China's drug law that was approved at the ongoing 13th National People's Congress. 26 August 2019
Sir Andrew Dillon, the chief executive of the UK’s reimbursement agency, the National Institute for Health and Care Excellence (NICE), is to stand down next year. 23 August 2019
The European Commission has granted an extension of the indication for Fiasp (fast-acting insulin aspart), approving it for the treatment of diabetes in adolescents and children aged one year and above. 22 August 2019
The US Food and Drug Administration has granted priority review to a supplemental New Drug Application for Xtandi (enzalutamide) in metastatic hormone-sensitive prostate cancer. 22 August 2019
Pharma companies developing NASH treatments have responded to the most recent draft guidance for non-alcoholic steatohepatitis (NASH) with compensated cirrhosis, issued by the US Food and Drug Administration (FDA). 16 August 2019
Daiichi-Sankyo, GW Pharmaceuticals, Bayer, Proveca and Otsuka will be named in advertisements following breaches of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry. 13 August 2019
Immunovant, a Roivant company company focused on developing innovative therapies for patients living with debilitating autoimmune diseases, today announced the appointment of Robert Zeldin, as chief medical officer and W Bradford Middlekauff, as general counsel. 13 August 2019
Given in addition to stating therapy, US pharma giant Merck & Co’s Zetia/Vytorin (ezetimibe) has a preventive effect in patients with coronary heart disease (CHD) and coronary syndrome (ACS), according to Germany’s health cost watchdog the Institute for Quality and Efficiency in Health Care (IQWiG). 12 August 2019
China’s medicines regulator has put in place a set of new restrictions on oxycodone, as part of measures designed to combat drug addiction. 12 August 2019
The US Food and Drug Administration is announcing the availability of a draft guidance for industry titled, “Fabry Disease: Developing Drugs for Treatment." 9 August 2019
Japanese pharma major Astellas today announced that David Fryrear joined its Medical and Development (M&D) organization as senior vice president and head of the clinical and research quality assurance (CRQA) organization in June 2019. 6 August 2019
The European Medicines Agency (EMA) has told marketing authorization holders of medicines containing liposomal drug delivery systems to submit a variation to change the names of these medicines as soon as possible before the end of September. 2 August 2019
UK pharma major GlaxoSmithKline says it has completed its transaction with US giant Pfizer to combine their consumer healthcare businesses into a world-leading joint venture. 1 August 2019
The US regulator has sent a Form 483 warning to the India-based active pharmaceutical ingredient (API) producer Dr. Reddy’s Bollaram, regarding a number of deficiencies including a failure to respond to complaints about out-of-specification (OOS) results. 31 July 2019
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