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
A landmark declaration to combat the growing threat of antimicrobial resistance (AMR) has been signed by all 193 United Nations member states at a high-level meeting at the UN headquarters in New York. 21 September 2016
Some more essential drugs to treat cancer, malaria and epilepsy have been brought under price revision and, in certain cases, price control by the Indian government. The move has not gone down well with pharmaceutical companies, reports The Pharma Letter’s India correspondent. 21 September 2016
The Russian Ministry of Health is changing the existing procedure for the launch of new drugs on the domestic market, with the aim to speed their withdrawal, according to recent statements by Veronika Skvortsova, Russia’s Minister of Health, reports The Pharma Letter’s local correspondent. 21 September 2016
On August 26, 2016, the US Food and Drug Administration (FDA) issued revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the USA and all of its territories. 21 September 2016
Whereas scores of new diabetes and non-diabetes endocrine drugs have been launched since the mid-1990s, and the demand for new therapies continues to grow, the development process for new diabetes and non-diabetes endocrine drugs is riskier compared to all drug development, according to results of a new study conducted by the Tufts Center for the Study of Drug Development. 21 September 2016
AstraZeneca today announced its decision to withdraw the Marketing Authorization Application (MAA) submitted to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2015 for cediranib in combination with platinum-based chemotherapy. 21 September 2016
The European Medicines Agency today issues a correction regarding the highlights of the September meeting of the Committee for Medicinal Products for Human Use (CHMP), which were originally published on Friday, September 15, and have now been re-published with a correction. 21 September 2016
A pledge to defeat antimicrobial resistance (AMR) has been signed by many of pharma’s biggest companies during an event hosted as part of the United Nations (UN) General Assembly high-level meeting. 20 September 2016
Alnylam Pharmaceuticals is expanding its global footprint with the opening of a new development and commercial hub in Maidenhead, UK, with a multi-million pound investment. 20 September 2016
German pharma major Bayer has received US Food and Drug Administration (FDA) approval for Kyleena (levonorgestrel-releasing intrauterine system) 19.5mg, a progestin-containing intrauterine system (IUS), to prevent pregnancy for up to five years. 19 September 2016
The US Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). 19 September 2016
US biotech Viamet Pharmaceuticals has been granted qualified infectious disease product (QIDP) designation by the US Food and Drug Administration (FDA) for VT-1598, a novel candidate for the oral treatment of coccidioidomycosis, or Valley Fever. 19 September 2016
Biosimilar medicines provide a tremendous opportunity for governments throughout Europe to increase patient access to treatment with modern biologic therapies while at the same time supporting the sustainability of healthcare budgets. 19 September 2016
The US Department of Health and Human Services (HHS) has issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information. 19 September 2016
Commenting on the release last week of the Biosimilar User Fee Act (II) performance goals letter, trade group Pharmaceutical Research and Manufacturers of America (PhRMA) president and chief executive Stephen Ubl welcomed the move, saying: "The Biosimilar User Fee Act (BsUFA) is critical to supporting the US Food and Drug Administration (FDA) in its core mission of protecting public health.” 19 September 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines for approval at its September meeting. Among these were: 17 September 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended three cancer medicines for approval at its September meeting. 16 September 2016
Figures showing a steep rise in the amount of public money spent on prescription drugs in Japan have led to warnings that increasing prices could soon drain state resources entirely. 16 September 2016
The UK Department of Health received 51 formal responses from a variety of organizations including the pharmaceutical industry, patient groups, National Health Service bodies and charities, in response to its consultation on changes to the statutory scheme to control the prices of branded medicines. 16 September 2016