Rare diseases company Amryt has announced that The Lancet Diabetes & Endocrinology has published full results of a global Phase III trial that compared Mycapssa (oral octreotide capsules) to long-acting injectable somatostatin receptor ligands for maintenance of biochemical response in patients with acromegaly. 4 January 2022
Merck & Co, known as MSD outside the USA and Canada, and Ridgeback Biotherapeutics have announced that Japan’s Ministry of Health, Labor and Welfare has granted Special Approval for Emergency in Japan for molnupiravir, an investigational oral antiviral medicine, for infectious disease caused by SARS-CoV-2. 29 December 2021
Israel-based Oramed Pharmaceuticals says that its subsidiary, Oravax Medical, has signed a cooperation and purchase agreement with Vietnam-based Tan Thanh Holdings Investment to pre-purchase Oravax’ oral COVID-19 vaccine, currently in development. 29 December 2021
A new licensing agreement between Durect Corporation and Innocoll Biotherapeutics grants the latter exclusive development and commercialization rights to Posimir (bupivacaine). 23 December 2021
The US Food and Drug Administration has approved German drug major Bayer’s Xarelto (rivaroxaban) as tablets and an oral suspension to treat venous thromboembolism (VTE), or blood clots that form in the veins, and reduce the risk of VTE recurring in pediatric patients from birth to younger than 18 years who have received at least five days of injectable or intravenous treatment for blood clots. 21 December 2021
Switzerland-based Essential Pharma, which is focused on maintaining access to mature, well-established prescription pharmaceutical products across multiple therapeutic areas, has acquired two new assets from Novartis. 16 December 2021
Japan’s Sumitomo Dainippon Pharma today announced that the Phase III WIZARD 201G study of investigational cancer vaccine DSP-7888 (adegramotide/nelatimotide) in patients with recurrent or progressive glioblastoma (GBM) will terminate following its second interim analysis after determining there is a low probability of meeting the primary endpoint of overall survival (OS) at the final analysis. 15 December 2021
French ophthalmology company Nicox has appointed Doug Hubatsch as chief scientific officer, leading non-clinical and clinical development activities. 13 December 2021
Japanese drug major Sumitomo Dainippon Pharma says that the US Patent and Trademark Office (USPTO) has decided that all of the claims in the method of use patent related to the proprietary atypical antipsychotic agent, Latuda (lurasidone HCl tablets), are unpatentable in the Inter Partes Review (IPR) proceeding whose petition was filed with the USPTO by USA-based Slayback Pharma. 10 December 2021
Swiss specialty drugmaker Covis Pharma has appointed Raghav Chari as chief innovation officer and Nicolas Verbeke as senior VP, Europe & International. 7 December 2021
Chinese drugmaker Hengrui is about to file a new drug application (NDA) in China for approval of the ophthalmic treatment SHR8058 (perfluorohexyloctane), an eye drop for lowering intraocular pressure (IOP) developed by the German biotech Novaliq, which in 2019 sold its China rights to Hengrui. 1 December 2021
UK pharma major GlaxoSmithKline today announced that Dr Phil Dormitzer will join the company as global head of vaccines R&D on December 3, 2021. 30 November 2021
The US Food and Drug Administration (FDA) has issued a draft guidance for drugmakers relating to the use of real-world evidence (RWE). 30 November 2021
Earlier this month, Novartis agreed to sell 53.3 million (around 33%) bearer shares of fellow Swiss pharma giant Roche in a bilateral transaction to Roche for a total consideration of $20.7 billion. 26 November 2021
Danish diabetes care giant Novo Nordisk says it has received the results from the Volume Based Procurement (VBP) tender for insulin in China. 26 November 2021
UK pharma major AstraZeneca will today formally unveil The Discovery Centre (DISC) in Cambridge, UK – a state-of-the-art research and development (R&D) facility designed to the world’s highest environmental standards and accommodating over 2,200 research scientists. 23 November 2021
In the week that the company has announced that it will start selling its Vaxzevria COVID-19 vaccine for profit in the world’s wealthier countries, AstraZeneca has stressed that poorer nations have been receiving their share. 16 November 2021
An anxiously awaited nomination for the future Commissioner of the US Food and Drug Administration was announced in Friday by US President Joe Biden, who named former head of the regulatory agency, Dr Robert Califf, as his choice for the post. 13 November 2021
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