More and more drug developers turn to organizations with large genetic datasets and patient information to speed up and increase the success rate of their trials. 23 May 2018
UK pharma major GlaxoSmithKline has received approval from the US Food and Drug Administration (FDA) for the use of Arnuity Ellipta (fluticasone furoate), a once-daily inhaled corticosteroid (ICS) medicine for the maintenance treatment of asthma in children from five to 11 years. 22 May 2018
The Japanese arm of UK-based HIV specialist ViiV Healthcare has appointed a new president and general manager, the company’s former European marketing boss Dustin Haines. 22 May 2018
USA-based Harmony Biosciences today announced that it has received Breakthrough Therapy and Fast Track designations for its investigational product, pitolisant, from the US Food and Drug Administration. 21 May 2018
AstraZeneca has submitted a supplemental new drug application (sNDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Forxiga (dapagliflozin), a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). 21 May 2018
Daiichi Sankyo's Lixiana (edoxaban) has announced positive results from the ENGAGE AF-TIMI 48 trial, with the drug reducing the likelihood of intercranial haemorrhage (ICH) among patients suffering from atrial fibrillation (AF). 18 May 2018
Pharma major Janssen has announced that it is stopping the screening, randomization and dosing of atabecestat (JNJ-54861911), which is in Phase IIb/III EARLY study in late-onset preclinical stage Alzheimer’s disease and in a Phase II long-term safety study. 18 May 2018
Akari chief executive David Horn Solomon has resigned following allegations of financial impropriety related to the personal use of a company credit card. 14 May 2018
Canadian drugmaker Innomar Strategies, a division of US drug wholesaler AmerisourceBergen, has acquired the regulatory consulting firm Therapeutic Products (TPIreg). 14 May 2018
Healthcare investors, as well as the pharma industry, will be looking for direction today as US President Donald Trump gives a highly anticipated speech about drug prices. 11 May 2018
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the European Commission’s proposal for a Regulation on health technology assessment (HTA). 10 May 2018
Following US Food and Drug Administration approval last month of its rare disease therapy Crysvita (burosumab), Ultragenyx Pharmaceutical and Japan’s Kyowa Hakko Kirin have announced the therapy is already available in US pharmacies. 8 May 2018
Japan’s Astellas Pharma says that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for the use of mirabegron in combination with the muscarinic antagonist solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. 8 May 2018
Japanese companies Daiichi Sankyo and The Chemo-Sero-Therapeutic Research Institute – known as Kaketsuken – have announced the termination of their cooperative sales agreements for the influenza hemagglutinin vaccine Kaketsuken and the recombinant adsorbed hepatitis B vaccine, Bimmugen. 8 May 2018
Swiss drugmaker Vifor Pharma says that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for its Veltassa (patiromer), for the treatment of hyperkalemia, with or without food. 8 May 2018
Stockholm-based NeuroVive Pharmaceutical is to partner with TRACK-TBI, a network of US-based traumatic brain injury (TBI) clinicians and researchers, to “create synergies, share know-how and leverage resources,” to further clinical progress against the condition. 3 May 2018
US-based Trevena and China’s Jiangsu Nhwa Pharmaceutical have agreed a deal to develop and sell Trevena’s investigational product oliceridine, which is currently under review by the US Food and Drug Administration. 2 May 2018
The US Food and Drug Administration (FDA) has approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph nodes, following complete resection. 1 May 2018
University Medical Center Groningen (UMCG) and SHINE Europe have secured a 10.5 million euro ($11 million) grant to advance European production of terbium isotopes for cancer treatments. 17 October 2024
Gan & Lee Pharmaceuticals as reported that its three investigational drugs - GZR18, GZR4, and GZR101 - achieved positive results in Phase II diabetes trials. 17 October 2024
A new group of British Members of Parliament (MPs) and peers have written to the Chancellor urging her to protect and promote the UK’s world-leading life sciences sector in the government's first Budget, due on October 30. 17 October 2024
The US Food and Drug Administration (FDA) has updated the US label for French pharma major Sanofi’s Flublok (Influenza Vaccine) to include data from a new safety study involving pregnant women. 17 October 2024
Chengdu Baiyu Pharmaceutical yesterday announced that it has entered into an exclusive license agreement with Swiss pharma giant Novartis for a small molecule anti-tumor asset. 17 October 2024
Shionogi has announced new data at IDWeek 2024 from PROVE (Retrospective Cefiderocol Chart Review), the largest global real-world evidence study of Fetroja/Fetcroja (cefiderocol), an innovative siderophore cephalosporin. 17 October 2024
Sanofi has entered into an agreement with Orano Med, a subsidiary of the Orano Group, to advance the development of radioligand therapies for rare cancers. 17 October 2024
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