Danish diabetes care giant Novo Nordisk just announced plans to expand its research and development (R&D) presence in the greater Boston, USA, metro area, creating one of its largest R&D hubs outside of Denmark. 2 March 2023
US immunotherapy specialist Dynavax Technologies announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for its Heplisav B (hepatitis B vaccine (recombinant), adjuvanted). 1 March 2023
The Radiation and Nuclear Countermeasures Program (RNCP) of the National Institute of Allergy and Infectious Diseases, part of the USA’s National Institutes of Health, has selected RedHill Biopharma’s opaganib for the nuclear medical countermeasures product development pipeline. 28 February 2023
Perrigo subsidiary HRA Pharma Rare Diseases has signed a partnership with Celnova Pharma to register and launch products in Argentina, Chile and Peru. 27 February 2023
UK-based Pharmanovia has expanded its neurology portfolio by acquiring certain rights to Sunosi (solriamfetol) from Axsome Therapeutics. 22 February 2023
In 2022, the European Medicines Agency (EMA) recommended 89 medicines for marketing authorization. Of these, 40 had a new active substance which had never been authorized in the European Union (EU) before. 16 February 2023
British oncology and central nervous system (CNS) specialist Astex Pharmaceuticals has inked a new collaboration deal with Cardiff University’s Medicines Discovery Institute (MDI). 13 February 2023
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions affecting blood vessels in the brain. 10 February 2023
The US Food and Drug Administration (FDA) has approved Eylea (aflibercept) as the first pharmacologic treatment for preterm infants with retinopathy of prematurity (ROP), a leading cause of childhood blindness worldwide, says US biotech Regeneron, which out-licensed the drug to German pharma major Bayer. 10 February 2023
Swiss rare disease company Santhera Pharmaceuticals has secured a final reimbursement agreement with the French authorities for its Leber's hereditary optic neuropathy (LHON) therapy Raxone (idebenone). 8 February 2023
The Hellenic Association of Pharmaceutical Companies (SfEE) has announced that representatives of patient associations, the medical, academic and scientific community, and the pharma sector submitted to the Prime Minister and the Minister for Health their joint proposals to pursue the national dialogue on the creation of a modern and effective National Action Plan against Caner. 6 February 2023
Indian drugmaker Sun Pharmaceutical Industries today announced the launch of Sezaby (phenobarbital sodium) in the USA for the treatment of neonatal seizures. 25 January 2023
Spanish drugmaker PharmaMar says that its licensing partner, Adium Pharma, has received full approval for commercialization of Zepzelca (lurbinectedin) by the Federal Commission for the Protection against Sanitary Risks of Mexico (COFEPRIS) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. 24 January 2023
The US Federal Trade Commission has asked a federal judge to hold “Pharma Bro” Martin Shkreli in contempt for failing to provide the FTC with information needed to determine whether he is violating a previous order by the judge that banned him from working in the pharmaceutical industry for life. 23 January 2023
Indian drugmaker Glenmark Pharmaceuticals today announced it is the first to launch in India a unique intravenous (IV) injection formulation, Akynzeo IV, a fixed dose combination of fosnetupitant and palonosetron for the prevention of chemotherapy-induced nausea and vomiting (CINV), under an exclusive licensing agreement with privately-held Swiss drugmaker Helsinn. 23 January 2023
Russia has slightly increased public procurements of drugs in recent months, according to recent statements by some leading local pharma analysts and Russian media reports. 21 January 2023
NeoPhore, a British immuno-oncology company specializing in the development of neoantigens, has raised $28.5 million in a series B financing round, with a $7.5 million extension. 19 January 2023
Poolbeg Pharma has announced the strategic expansion of POLB 001, an innovative targeted therapy which blocks the p38 MAP kinase, into oncology. 16 January 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