The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
The US Food and Drug Administration (FDA) on Friday approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 28 September 2024
Shionogi said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD). 27 September 2024
China’s National Medical Products Administration (NMPA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD). 27 September 2024
A US Food and Drug Administration advisory committee meeting has recommended restricting the use of PD-1 inhibitors, in a move which could affect blockbuster products such as Bristol Myers Squibb's Opdivo (nivolumab) and Merck & Co's Keytruda (pembrolizumab). 27 September 2024
The US Food and Drug Administration yesterday approved pharma major Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. 27 September 2024
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
US biotech Emergent BioSolutions revealed it has secured approximately $400 million in orders in 2024 and 2025 associated with its vaccinia, smallpox and mpox product portfolio. 26 September 2024
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja (leniolisib), from Netherlands-based Pharming. 26 September 2024
The UK government has released a position paper outlining its vision for Framework Programme 10 (FP10), a successor to Horizon Europe, the EU's flagship research collaboration program. 26 September 2024
Shanghai-based Junshi Biosciences has announced that the European Commission has approved Loqtorzi (toripalimab) for two cancer indications. 26 September 2024
Amgen yesterday revealed that Tepezza (teprotumumab [genetical recombination]) has been approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan. 25 September 2024
Eli Lilly's Kisunla has been approved in Japan for early symptomatic Alzheimer's disease, following its US approval in July 2024. Administered via IV infusion, it targets patients with mild cognitive impairment and dementia linked to amyloid pathology. Kisunla aims to slow cognitive and functional decline in AD patients 25 September 2024
Healthcare plan provider Centivo has raised $75 million in equity and debt financing to support its goal of offering affordable care to employees and their families. 25 September 2024
President Biden has said the USA will commit at least $500 million to support African countries in battling the ongoing mpox outbreak in Central and Eastern Africa. 25 September 2024
People affected Niemann-Pick disease, a rare and fatal genetic disorder, have waited a lifetime for an effective medicine. Now, in the space of a week, the US regulator has approved two. 25 September 2024
The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Otsuka’s (TYO: 4578) Lupkynis (voclosporin) for the treatment of lupus nephritis (LN), an inflammation of the kidneys caused by systemic lupus erythematosus (SLE), an autoimmune disease 24 September 2024
CSL Vifor today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical marketing authorization approval for Veltassa (patiromer). 24 September 2024
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
In its dossier assessment published in early July 2016, the German Institute for Quality and Efficiency in Health Care (IQWiG) determined an indication of a minor added benefit of ticagrelor, Anglo-Swedish pharma major AstraZeneca’s Brilinta, in comparison with the administration of low-dose acetylsalicylic acid (ASA) alone. 16 September 2016
The Asia-Pacific gastric cancer market is set to grow from its 2015 value of $1.3 billion to $2.7 billion by 2022, predicts a report from GBI Research. 16 September 2016
The Russian Ministry of Health is considering changing the conditions of tendering for the public procurement of high-priced drugs and vaccines, according to recent statements of an official spokesman of Veronika Skvortsova, Russia’s Minister of Health. 15 September 2016
Shares in Canada-based specialty pharma company Aralez Pharmaceuticals were up more than 9% on Thursday lunchtime after the US Food and Drug Administration approved once-daily Yosprala (aspirin/omeprazole). 15 September 2016
The European Commission has approved under the EU Merger Regulation the acquisition of Anda Distribution of the USA by Teva Pharmaceutical Industries (NYSE: TEVA) of Israel. 15 September 2016
The United Nations (UN) Secretary-General’s High Level Panel (HLP) on Access to Medicines has published a series of recommendations on research and development (R&D) of health technologies and ensuring everyone can benefit from vital therapies. 15 September 2016
Cancer and other patients in Australia could potentially have access to some new medicines two years earlier than at present under changes to the regulation of medicines and medical devices announced today by the Turnbull government. 15 September 2016
Japanese pharma major Eisai has received approval from the European Commission for anticancer agent Kisplyx (lenvatinib) in combination with everolimus (Novartis' Afinitor) for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy. 15 September 2016
GlaxoSmithKline edged up 1.48% to 1,620 pence by close of trading on Tuesday, after the company released encouraging results from a Phase III study of its investigational shingles vaccine Shingrix yesterday. 15 September 2016
The US Food and Drug Administration will require additional time to complete its review of the New Drug Application for telotristat etiprate, an oral drug for the treatment of carcinoid syndrome, the drug’s developer Lexicon Pharmaceuticals revealed yesterday. 15 September 2016
The UK’s National Institute for Health and Care Excellence (NICE) has today published draft guidance that does not recommend Swiss pharma giant Roche’s Gazyvaro/Gazyva (obinutuzumab) with bendamustine for treating some people with follicular lymphoma – a type of non-Hodgkin’s lymphoma. 14 September 2016
A new US Government Accountability Office (GAO) report finds that prices for generic drugs in Medicare Part D fell 59% from the first quarter of 2010 to the second quarter of 2015. 14 September 2016
The US Food and Drug Administration has granted approval for Ireland-headquartered Shire’s Cuvitru (immune globulin subcutaneous [human], 20% solution) in adult and pediatric patients two years of age and older. 14 September 2016
The UK’s Department of Health has announced a record £816 million ($1.08 billion) investment into biomedical research in a move welcomed by the Association of the British Pharmaceutical Industry (ABPI). 14 September 2016
In our weekly expert view piece, pharmacovigilance team leader at Berlin-based CRO, KCR, examines the increasing benefits of post-authorization studies and the collection of real-world data. 14 September 2016
French drugmaker Ipsen revealed today that the European Commission has approved Cabometyx (cabozantinib) tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. 14 September 2016
Australia’s Turnbull government has today introduced important legislation to ensure security and law and order is maintained, as the Coalition leads the way in allowing for the cultivation of a safe, legal and reliable local supply of cannabis for medicinal products. 14 September 2016
Santhera Pharmaceuticals was trading more than 3% higher on Tuesday afternoon after new Phase III data was published on Raxone (idebenone) on inspiratory function in patients with Duchenne muscular dystrophy (DMD), just days after the granting of orphan drug designation for the same treatment in Australia. 13 September 2016
Documents on the smoking cessation product Chantix (varenicline) which will be considered by a US Food and Drug Administration (FDA) advisory committee on Wednesday have questioned the validity of data provided by Pfizer. 13 September 2016