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
The German Institute for Quality and Efficiency in Health Care (IQWiG) has said that, in an early benefit assessment investigating whether palbociclib offers advantages for patients over the appropriate comparator therapies in advanced breast cancer, the drug’s disadvantages predominate in certain patients. 4 March 2017
Three major trade federations representing pharmaceutical companies in Europe have welcomed the findings reached by a European Commission (EC) study into off-label use of pharmaceutical products. 3 March 2017
The UK’s Competition and Markets Authority (CMA) today alleged that Concordia and Actavis UK signed illegal agreements which enabled high prices for a life-saving drug to be prolonged. 3 March 2017
The USA and the European Union have completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 US-EU Mutual Recognition Agreement. 3 March 2017
New medicine prices in the European Union have risen over the past few decades, to the point of being unaffordable for many EU citizens and threatening the sustainability of national health care systems, say Members of the European Parliament (MEPs) in a resolution voted on Thursday. 2 March 2017
The National Institute for Health and Care Excellence (NICE) says it is now at the half-way point of its requested review of drugs, approved and still available only through the old Cancer Drugs Fund (CDF). 2 March 2017
The National Institute for Health and Care Excellence (NICE) has approved Ocaliva (obeticholic acid) for routine use by the National Health Service (NHS) in England, Wales and Northern Ireland. 2 March 2017
Tuesday night, President Donald Trump gave his joint address to the nation. In it, he suggested that the US Food and Drug Administration prevents a host of new medications and medical devices from hitting the market. 2 March 2017
The New Drug Application (NDA) for enasidenib (AG-221/CC-90007) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation has been accepted by the US Food and Drug Administration. 2 March 2017
Eye disease specialist Aerie Pharmaceuticals has resubmitted its New Drug Application for Rhopressa (netarsudil ophthalmic solution) to the US Food and Drug Administration. 2 March 2017
Danish allergy immunotherapy specialists ALK-Abelló today announced it has received FDA approval for its house dust mite sublingual allergy immunotherapy (SLIT) tablet. 2 March 2017
Erbitux (cetuximab) is closer to being available on the UK’s National Health Service (UK) as an option for RAS wild type metastatic colorectal cancer (mCRC). 2 March 2017
US Senators Cory Booker (Democrat, New Jersey), Bernie Sanders (Independent, Vermont) and Bob Casey (Dem, Pennsylvania) introduced legislation Tuesday to lower the skyrocketing cost of prescription drugs by allowing Americans to import safe, low-cost medicine from Canada. 1 March 2017
The European Medicines Agency has granted access to its Priority Medicines (PRIME) scheme for givosiran (ALN-AS1), an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the treatment of acute hepatic porphyrias. 1 March 2017
Shares in Lexicon Pharmaceuticals rose more than 5% in pre-market trading, following the announcement that the Texan biopharmaceutical company had received FDA approval for its carcinoid syndrome diarrhea treatment. 1 March 2017
Health plans partnering with Express Scripts are delivering high-quality, affordable pharmacy care to millions of individuals enrolled in government-sponsored programs, but this record is at risk without decisive action to advance additional pro-patient and pro-payer policy changes, according to new research. 1 March 2017
Having filed submissions in the USA, Canada and Europe, Danish diabetes giant Novo Nordisk has now set its sights on Japan as it seeks to gain approval for semaglutide, a glucagon-like peptide-1 (GLP-1) analogue administrated once-weekly, for the treatment of adults with type 2 diabetes. 28 February 2017
The National Institute for Health and Care Excellence (NICE) today published draft guidance which does not recommend Keytruda (pembrolizumab) for untreated PD-L1-positive metastatic lung cancer. 28 February 2017
The US FDA has accepted for Priority Review the Biologics License Application (BLA) for avelumab, as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on or after platinum-based therapy. 28 February 2017