From October 19, 2020, developers of human or veterinary medicines should use the European Medicines Agency’s IRIS Regulatory & Scientific Information Management Platform to request scientific advice. 12 October 2020
Indian drugmaker Glenmark Pharmaceuticals today announced results of its “FAITH” combination trial with antivirals umifenovir and favipiravir for the treatment of moderate hospitalized COVID-19 patients. 9 October 2020
The UK’s Health Secretary, Matt Hancock, announced on Monday at Conservative Party conference that the Medicines and Healthcare products Regulatory Agency (MHRA) will join Project Orbis, an initiative led by the USA’s Food and Drug Administration Oncology Center of Excellence. 6 October 2020
Responding to South Africa and India’s proposal to waive provisions of the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement that protect intellectual property rights, for the prevention, containment and treatment of COVID-19, Anna Marriott, Oxfam’s health policy lead said: 4 October 2020
Portuguese pharma company BIAL and Swedish contract development and manufacturing organisation (CDMO), Recipharm (STO: RECI-B), have have expanded a long term agreement for the global manufacturing and supply of opicapone. 1 October 2020
US microbiome company Vedanta Biosciences today announced it has been awarded funding of $7.4 million, with the potential for up to an additional $69.5 million, from the Biomedical Advanced Research and Development Authority (BARDA) to advance clinical development of VE303 for high-risk Clostridioides difficile infection(CDI). 30 September 2020
Danish diabetes care giant Novo Nordisk has signed up the major Chinese supplier CR Sanjiu to sell its growth hormone therapy Norditropin (somatropin) Nordilet injection in mainland China. 25 September 2020
Monte Rosa Therapeutics, a company originally formed as a spinout from Cancer Research UK-funded drug discovery research at The Institute of Cancer Research, London, in collaboration with Versant Ventures’ drug discovery engine Ridgeline Therapeutics, has closed a $96 million Series B financing from investors to support the further development of its drug pipeline. 24 September 2020
The European Union Falsified Medicines Directive (FMD) legislation, introduced to prevent fake medicines, has also brought about the standardization of medicinal product identification and common 2D barcodes on all prescription medicinal packs. 24 September 2020
Johnson & Johnson today announced the launch of its large-scale, pivotal, multi-country Phase III trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen companies. 23 September 2020
Having completed its review of results from the RECOVERY study arm that involved the use of the corticosteroid medicine dexamethasone in the treatment of patients with COVID-19 admitted to hospital, the European Medicines Agency’s human medicines committee (CHMP) has concluded that dexamethasone can be considered a treatment option for patients who require oxygen therapy (from supplemental oxygen to mechanical ventilation). 19 September 2020
French drugmaker Sanofi and its partner GlaxoSmithKline have finalized and signed an advanced purchase agreement with the European Commission (EC) for the supply of up to 300 million doses of a COVID-19 vaccine, once the product is approved. 18 September 2020
The US regulator has granted Breakthrough Therapy designation to Sanofi’s Dupixent (dupilumab) in eosinophilic esophagitis (EoE), based on positive results from Part A of a Phase III trial. 14 September 2020
The UK’s reimbursement agency has provided a positive decision on AstraZeneca’s Tagrisso (osimertinib) for certain people with locally-advanced or metastatic non-small cell lung cancer (NSCLC). 11 September 2020
The European Commission today announced that it will support with 4 million euros ($4.7 million) a new research project, SUPPORT-E, that will coordinate efforts to determine if COVID-19 convalescent plasma transfusion – using plasma from patients who recovered from the disease - is an effective and safe treatment. 11 September 2020
The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Landsteiner Scientific pharmaceutical company have announced an agreement for the supply of 32 million doses of the Russian Sputnik V COVID-19 vaccine to Mexico (25% of population). 9 September 2020
California’s Exelixis has partnered with Swiss firm NBE-Therapeutics to discover and develop multiple antibody-drug conjugates (ADCs) in oncology. 8 September 2020
Tokyo’s Eisai is to acquire the Japanese rights to Parkinson's disease treatment Equfina (safinamide mesilate) from Meiji Seika Pharma. 7 September 2020
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