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
More than 20 tumor types are being treated with one or more of the 70 new cancer treatments that have been launched in the past five years, with the sustained surge in innovative therapies driving the global oncology market to $107 billion in 2015. 2 June 2016
The European Commission has announced the adoption of two reasoned opinions calling the end of the export restriction systems implemented in Portugal and Slovakia. 1 June 2016
US biotech Amicus Therapeutics has received approval from the European Commission for Galafold (migalastat) as a treatment for patients diagnosed with Fabry disease and who have an amenable mutation. 1 June 2016
Teva Pharmaceutical Industries has been asked to provide more information on its New Drug Application for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease (HD) by the US Food and Drug Administration. 1 June 2016
The government of Ukraine is completing preparations for the de-regulation of the national pharmaceutical market, which involves easing access of Western drug imports to the market. 1 June 2016
The Russian government will start to limit the participation of foreign drugs in the public procurement and state tenders since the second half of the current year, according to recent statements of Arkady Dvorkovich, Russia’s Deputy Prime Minister. 1 June 2016
UK medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has asked Janssen, to set out a case for including its leukemia drug Imbruvica (ibrutinib) in the Cancer Drugs Fund (CDF). 1 June 2016
The European Commission has granted marketing authorization in the European Union for Flixabi, an infliximab biosimilar referencing Remicade, Johnson & Johnson and Merck & Co's Remicade (infliximab). 31 May 2016
Trade group AusBiotech’s 2016 Biotechnology Industry Position Survey of industry chief executives confirms biotechnology continues to be front and center of Australia’s post-mining boom economic transition. 31 May 2016
The US Food and Drug Administration Advisory Committee has voted against accelerated approval for eteplirsen, a drug designed to combat Duchenne muscular dystrophy (DMD). The drug was put up for accelerated approval under the FDA Safety and Innovation Act (FDASIA), but the committee found insufficient grounds for approval, noted Dr Nicola Davies in her monthly exclusive FDA Blog for The Pharma Letter. 31 May 2016
The US Food and Drug Administration on Friday approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). 31 May 2016
The Drugs Controller General India (DCGI) has granted limited approval for manufacturing and marketing of stem cell based biological product Stempeucel for the treatment of Buerger's disease. 31 May 2016
The US Food and Drug Administration has granted accelerated approval to liver disease drug Ocaliva (obeticholic acid), the lead product of US biopharma Intercept. 31 May 2016
The European Commission has approved Strimvelis, the first ex-vivo stem cell gene therapy to treat patients with a very rare disease called ADA-SCID (severe combined immunodeficiency due to adenosine deaminase deficiency). 31 May 2016
The cost of medicines in Ukraine is the lowest in Europe, but still Ukrainians cannot afford them due to low income, according to experts of Spanish non-governmental organization CivioFoundation. 31 May 2016
At its Annual Assembly last week, Spanish trade group Farmaindustria gave the green light to the amendment of the Code of Practice by which all companies adhered to it will inform healthcare professionals that transfers of value made from January 1, 2017 (to be disclosed in 2018) derived from their collaboration as far as education, scientific-professional meetings and services provision will be disclosed in an individual manner. 31 May 2016
Minerva Neurosciences saw its shares make massive gains on Thursday following the release of positive results from a couple of mid-stage clinical trials. 31 May 2016