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
US-based specialty pharma company Insys Therapeutics has received US Food and Drug Administration (approval for its cannabis-derived drug Syndros. 6 July 2016
The European Commission (EC) has granted marketing authorization for Zinbryta (daclizumab) to treat adults with relapsing forms of multiple sclerosis (RMS). 6 July 2016
After listening to what New Zealanders had to say, the country’s Pharmaceutical Management Agency PHARMAC said today that it has changed the way it makes decisions - the most significant change to its decision making in its 23 year history. 6 July 2016
Russian pharmaceutical companies plan to significantly increase the volume of investments in the conduct of clinical trials of their drugs over the next few years, according to recent statements of drugmakers. 5 July 2016
The National Institute for Health and Care Excellence (NICE), has today issued draft guidance for the use of Opdivo (nivolumab) for previously treated advanced renal cell carcinoma in adults, saying it does not recommend this Bristol-Myers Squibb drug for this kidney cancer indication. 5 July 2016
Bial said today that its Ongentys (opicapone) for the treatment of adult Parkinson´s disease patients with motor fluctuations was approved by the European Commission. 5 July 2016
AbbVie’s Humira (adalimumab) has today received approval from the European Medicines Agency as the first and only biologic medicine authorized for patients with certain types of non-infectious uveitis, an inflammatory, painful eye condition that can lead to blindness. 5 July 2016
French pharma major Sanofi and US biotech firm Regeneron Pharmaceuticals have received Japanese approval for Praluent (alirocumab) to treat uncontrolled low-density lipoprotein (LDL) cholesterol, in certain patients with hypercholesterolemia at high cardiovascular risk. 5 July 2016
The German Institute for Quality and Efficiency in Health Care (IQWiG) assessed the added benefit of ticagrelor for patients with acute coronary syndrome already in 2011 in its very first dossier assessment, just after the Act on the Reform of the Market for Medicinal Products (AMNOG) had come into force. 5 July 2016
The European Medicines Agency today said it has concluded its second inquiry within the framework of its infringement procedure against Swiss pharma giant Roche. 4 July 2016
Daiichi Sankyo and Belgian drugmaker UCB today announced the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted approval for Vimpat (lacosamide). 4 July 2016
The US not-for-profit organization the Institute for Clinical and Economic Review (ICER) has posted a draft scoping document which will inform a report on drug therapies for treatment of relapsing-remitting multiple sclerosis (RRMS). 4 July 2016
The National Institute for Health and Care Excellence (NICE) has recommended privately-held Switzerland-headquartered drugmaker Ferring Pharmaceuticals’ Firmagon (degarelix) for a group of men with advanced hormone-dependent prostate cancer – those with spinal metastases. 1 July 2016
US pharma major AbbVie says that the US Food and Drug Administration has approved Humira (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. 1 July 2016
Ampio Pharmaceuticals today announced disappointing results of the Ampion PIVOT clinical trial as well as a comprehensive analysis that integrates trial data from three single injection studies that will be presented to the Food and Drug Administration. 30 June 2016
Medicines regulator Health Canada published final regulations in the Canada Gazette, Part II requiring mandatory reporting by industry of drug shortages and discontinuances of sales. Health Canada is on track to implement these regulations, which will be supported by a new third party reporting website, by spring 2017. 30 June 2016
Earlier this week, iPR Pharmaceuticals, the owner of NDA 021366 for Crestor (rosuvastatin calcium) and Anglo-Swedish pharma major AstraZeneca (LSE: AZN), which markets the cholesterol drug, filed a Complaint a in the US District Court for the District of Columbia seeking to block the US Food and Drug Administration’s approval of Abbreviated New Drug Applications (ANDAs) for generic Crestor tablets. 30 June 2016
Stronger warnings are needed on drugs that can cause patients to lose control of their behavior, leading to pathological gambling, hypersexuality, and compulsive shopping or eating, Public Citizen said in a petition to the US Food and Drug Administration. 29 June 2016
US pharma company AbbVie said today that the US Food and Drug Administration has granted a fourth Breakthrough Therapy designation (BTD) for Imbruvica (ibrutinib) as a potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. 29 June 2016