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
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
Amicus Therapeutics says that the National Institute for Health and Care Excellence (NICE) has issued draft ‘Highly Specialized Technologies’ guidance recommending its Galafold (migalastat) for the treatment of Fabry disease. 19 October 2016
Roche’s subsidiary Genentech has received approval for the US Food and Drug Administration for Tecentriq (atezolizumab) for the treatment of certain people with metastatic non-small cell lung cancer (NSCLC). 19 October 2016
The Italian subsidiary of South Africa’s Aspen Pharmacare has challenged the findings of the Italian Competition Authority (ICA) of an alleged antitrust violation by Aspen and its related group companies. 19 October 2016
Uppsala University and Swiss pharma giant Novartis lead a new public-private research project "Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER)" under the Innovative Medicines Initiative (IMI), which was launched this month. 19 October 2016
The UK’s National Institute of Biological Standards and Control (NIBSC) and the National Institute of Food and Drug Safety Evaluation (NIFDS) from the Republic of Korea have signed a memorandum of understanding (MoU) paving the way for closer cooperation on promoting and evolving standardization of biological medicines and diagnostics, and for maintaining excellence in technical expertise and knowledge. 19 October 2016
The Italian Competition Authority (ICA) imposed a fine of more than 5 million euros ($5.5 million) on South Africa-based drugmaker Aspen Pharmacare for infringing article 102a of the Treaty on the Functioning of the European Union. 18 October 2016
Ireland-headquartered Shire has been granted EU marketing authorization for pancreatic cancer drug Onivyde (pegylated liposomal hydrochloride trihydrate), it has been announced 18 October 2016
AstraZeneca today announced that the US Food and Drug Administration has accepted a complete re-submission of a New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9). 18 October 2016
In our weekly expert view piece, Rohit Malpani, director of policy and analysis for Mèdecins Sans Frontiéres Access Campaign, discusses the UN Secretary General's High-Level Panel report on Access to Medicines and looks at the responsibilities it places on industry. 17 October 2016
PTC Therapeutics announced today that, at the end of last week, the US Food and Drug Administration’s Office of Drug Evaluation I (ODE-I) denied the company's first appeal of the refuse to file letter issued by the FDA's Division of Neurological Products (DNP) on February 22, 2016 regarding PTC's New Drug Application for Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). 17 October 2016
Prices for cheap drugs from the list of vital medicines may significantly increase in Russia this year due to a recent decision by the Russian government to refrain from further state regulation of prices for drugs from this segment. 17 October 2016
Ukraine’s pharmaceutical trade association APRaD, in cooperation with organizations representing international pharmaceutical manufacturers and business in general such as US-Ukraine Business Council, Association of International Pharmaceutical Manufacturers AIMP Ukraine and Indian Pharmaceutical Manufacturer’s Association (IPMA), has signed a letter concerning actions of law enforcement in the Ukraine pharmaceutical market. 17 October 2016
The pharmaceutical industry based in Spain will invest around 200 million euros ($220 million) over the next two years in order to adapt its production lines thus incorporating the technical requirements of the new system for the unitary verification of medicines. 17 October 2016
US pharma major Bristol-Myers Squibb saw its shares fall nearly 10% to $50.04 last Monday to a near two year low, on the news that its best-selling cancer immunotherapy drug Opdivo had failed to beat placebo in a head to head trial, the results of which were presented in Denmark over the weekend at the ESMO 2016 Congress. 15 October 2016
The US Food and Drug Administration and representatives from the generic drug industry have reached an agreement in principle on proposed recommendations for the first reauthorization of the generic drug user fee program. 15 October 2016
Canada’s Valeant Pharmaceuticals International on Friday announced that the company's Patient Access and Pricing Committee has made decisions regarding price changes of products in the company's neurology, gastrointestinal (GI) and urology portfolios. 15 October 2016
The Netherlands Medicines Evaluation Board (MEB) wants manufacturers of over-the-counter medicinal products to list the shelf life after opening on the packaging. 15 October 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five new branded medicines for approval at its October 10-13 meeting. 14 October 2016
Potentially anticompetitive practices in the pharmaceutical industry are among topics to be discussed at a global meeting on competition next week in Geneva, Switzerland, being held under the auspices of the United Nations Conference on Trade and Development (UNCTAD). 14 October 2016
The UK’s National Institute for Health and Care Excellence (NICE) has proposed changes to the way it appraises new treatments that could see patients benefiting from the most cost effective treatments nearly three months faster than is currently the case. 14 October 2016