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 National Institute for Health and Care Excellence (NICE) has published draft guidance not recommending Kadcyla (trastuzumab emtansine), a breast cancer drug currently available through the UK’s Cancer Drugs Fund (CDF). 29 December 2016
Russian President Vladimir Putin was told on a visit to Biocad, one of the country’s leading biotech companies, that the quality of Russia's research and development (R&D) and manufacturing meant it could “absolutely compete with foreign counterparts” in the pharmaceutical industry. 28 December 2016
Seattle Genetics has revealed receipt of a notice from the US Food and Drug Administration that a clinical hold or partial clinical hold has been placed on several early stage trials. 28 December 2016
The US Food and Drug Administration has approved Adynovate (antihemophilic Factor [recombinant], PEGylated), an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, in pediatric patients under 12 years of age. 28 December 2016
The US Food and Drug Administration has approved Spinraza (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. 27 December 2016
China-based vaccines developer Sinovac Biotech (Nasdaq: SVA) responded to a recent report regarding the allegations raised in a research report by Geoinvesting. 23 December 2016
Aerie Pharmaceuticals today revealed that the manufacturing line related to its glaucoma treatment Rhopressa (netarsudil ophthalmic solution) will not be ready in time for pre-approval inspection by the Food and Drug Administration. 23 December 2016
Following the Colombian Ministry of Health’s recent decision to lower the price of its cancer drug Glivec/Gleevec (imatinib), Swiss pharma giant Novartis has advised The Pharma Letter that it proposes to take action. 23 December 2016
Belgian biopharma firm TiGenix has submitted its responses to the European Medicines Agency's (EMA) day 120 list of questions for Cx601, its lead product candidate being developed for complex perianal fistulas in Crohn's disease. 23 December 2016
The UK’s National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of Otezla (apremilast). 22 December 2016
The price of Swiss pharma giant Novartis’ cancer drug Glivec/Gleevec (imatinib) will now be 44% lower in Colombia than previously, the country’s health authorities have decided. 22 December 2016
The US Senate’s Special Committee on Aging has published a damning report on pharma companies’ manipulation of loopholes in the system so they can raise prices of off-patent drugs massively. 22 December 2016
Fresh from its decision to intervene over the price of the multi-indication cancer drug Opdivo (nivolumab), the Japanese government has unveiled new plans to reduce the cost of health care. 21 December 2016
Translating bold campaign trail claims of “repeal and replace” into legislative action can often be challenging with any established bill, let alone one as complex as the Affordable Care Act (ACA). 21 December 2016
Sweeping changes are afoot at India's Health Ministry to encourage innovation in the pharmaceutical sector and to ensure speedier approvals for conducting medical research, reports The Pharma Letter's India correspondent. 21 December 2016
The European Commission (EC) has authorized the extension of the label for all metformin-containing products for all metformin-containing products for the treatment of type 2 diabetes. 21 December 2016
What more does pharma and biotech know now about the implications of Brexit six months after the UK population voted to leave the European Union? 19 December 2016
The US Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. 19 December 2016