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 our weekly expert view piece, Elisabethann Wright, partner at international law firm Hogan Lovells, outlines some of the potential risks if British voters opt to exit the European Union (EU). 21 June 2016
Multinational pharmaceutical companies last week called for South Korea's government to help build a so-called "National Bio Cluster," proposed by a local business lobby group to foster the bio industry as a new growth engine, reports China’s state news agency Xinhua. 21 June 2016
Transfers of value made by pharmaceutical companies involving the expenses incurred in relation to healthcare professionals and healthcare organizations are to be made public for the first time by the end of June as part of a European-wide initiative to enforce stricter self-regulation of the industry and boost transparency, the Cyprus Association of Research and Development Pharmaceutical Companies (KEFEA). 21 June 2016
Groups representing Europe’s pharma, biotech and generics companies have welcomed the European Commission’s staging of a workshop on the uptake of biosimilars. 20 June 2016
Mitsubishi Tanabe Pharma today revealed that a New Drug Application has been submitted to the US Food and Drug Administration for edaravone (MCI-186) for the treatment of amyotrophic lateral sclerosis (ALS), a rapidly progressive neurological disease. 20 June 2016
China’s State Council has formally authorized a pilot for a new drug marketing authorization holder (MAH) system for 10 of its 23 provinces. 20 June 2016
The Ukraine Association of Pharmaceutical Research and Development (APRaD) has called its disclosure of information on transfers of value to health care professionals and organizations made in the country’s pharma industry in 2015 a step forward for transparency. 20 June 2016
Access to affordable biosimilars is around the corner in India, with the government looking to release guidelines after nearly two years of consultations with the pharma industry and the Central Drugs Standard Control Organization (CDSCO), reports The Pharma Letter’s India correspondent. 20 June 2016
Leading global drugmakers operating in the Russian market have called on the country’s government to ease the current conditions for conducting clinical trials of their drugs in Russia, according to recent statements from the press-service of the Russian Ministry of Health. 20 June 2016
By Barbara Obstoj-Cardwell. Editor
Teva Pharmaceuticals’ announcement on Monday that it will voluntarily suspend sales, marketing and distribution of its Zecuity migraine relief product will likely have little impact on the company, analysts have said. 19 June 2016
Medicines for Europe, the trade group representing the continent’s generics and biosimilars industry, has said it will work with health ministers to ensure swift implementation of calls for greater pharma competition which were made in the council of the European Union this week. 17 June 2016
USA-base Ariad Pharmaceuticals today announced the initiation of a New Drug Application submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the US Food and Drug Administration. 17 June 2016
Roche has received approval from the European Commission for Gazyvaro (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance in people with follicular lymphoma. 17 June 2016
The National Institute for Health and Care Excellence (NICE) has recommended the combination therapy of Opdivo (nivolumab) + Yervoy (ipilimumab), both drugs from US pharma major Bristol-Myers Squibb, to treat National Health Service patients with advanced skin cancer. 17 June 2016
The National Institute for Health and Care Excellence (NICE) has said it will not be able to recommend Orkambi (lumacaftor-ivacaftor) from US drugmaker Vertex Pharmaceuticals for treating cystic fibrosis. 17 June 2016
Netherlands-headquartered independent drugmaker Norgine has received approval from the Dutch Ministry of Health for the reimbursement of Xifaxan 550 (rifaximin-α 550mg) in hepatic encephalopathy (HE). 16 June 2016
The National Institute for Health and Care Excellence (NICE) has today published draft guidance on Cotellic (cobimetinib) with Zelboraf (vemurafenib) for a type of advanced skin cancer. 16 June 2016
The National Pharmaceutical Pricing Authority (NPPA) in India has taken action against major drug firms for not registering their products on the online database Integrated Pharmaceutical Database Management System. 16 June 2016
The US Senate Judiciary Committee introduced new legislation Tuesday, aimed at countering the growing issue of rising prescription drug prices in the USA and anti-competitive moves by pharmaceutical companies to delay lower-priced generic competition from entering the market. 15 June 2016