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 UK Competition and Markets Authority (CMA) today issued a statement of objections to the pharmaceutical company Merck Sharp & Dohme (MSD). 23 May 2017
Swiss pharma giant Roche has received US Food and Drug Administration approval for Actemra (tocilizumab), the first ever treatment for adult patients with the autoimmune condition giant cell arteritis (GCA). 23 May 2017
Taking in and making use of key findings from conferences can be a difficult task but industry veteran Shawn Manning, managing director of investment banking firm Outcome Capital, came away from this month’s BioTrinity 2017 in the UK with some important learnings on the life sciences sector at present. 22 May 2017
The policy of putting Russian drug manufacturers before foreign firms was one of many issues discussed during the Adam Smith Institute’s Russian Pharmaceutical Forum last week. 22 May 2017
Positive top-line results from an additional Phase III clinical trial of tolvaptan in adult patients with autosomal dominant polycystic kidney disease (ADPKD) have been released. 22 May 2017
The European Medicines Agency has recommended changes to prescribing information for the antibiotic vancomycin to ensure appropriate use in the treatment of serious infections caused by Gram-positive bacteria. 22 May 2017
Among major pharmaceutical news stories last week were Johnson & Johnson’s upbeat presentation on its R&D pipeline at an investors review day, as well as the announcement that Amgen was filing a Biological License application for its new migraine drug, more data on Shire’s rare disease candidate lanadelumab and Ionis’ inotersen. 21 May 2017
Following the May meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) it was announced that three new marketing authorizations could not be recommended. 20 May 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued positive recommendations for six new medicines at its May meeting. 19 May 2017
Swedish biotech firm Hansa Medical has been accepted onto the European Medicines Agency’s Priority Medicines (PRIME) scheme for lead candidate IdeS, an enzyme being developed to facilitate successful kidney transplantation. 19 May 2017
Astellas Pharma says its partner, MSD KK, the Japanese subsidiary of US pharma giant Merck & Co, has submitted an application for marketing approval of a combination drug of the DPP-4 inhibitor Januvia (sitagliptin) phosphate hydrate and the SGLT2 inhibitor Suglat (ipragliflozin L-proline) for the treatment of type-2 diabetes in Japan. 19 May 2017
Biotech giant Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for erenumab, a treatment designed to prevent migraine by blocking the calcitonin gene-related peptide (CGRP) receptor. 19 May 2017
Prices for drugs from low and middle-priced segments of the Russian market may increase significantly this year, due to plans of the government to change the scheme of pricing for such categories of drugs, starting from January 1, 2018, reports The Pharma Letter’s local correspondent. 19 May 2017
Typically, when the US Food and Drug Administration approves an expansion of the indication for a drug, it means that additional clinical data have shown the drug can safely and effectively treat patient populations other than those for which it was originally intended. 19 May 2017
Major drug makers in India are in a soup. It is not just the US Food and Drug Administration that is cracking the whip given its three-fold increase in scrutiny of pharma units, the National Pharmaceutical Pricing Authority (NPPA) has issued ‘show cause’ notices to 67 drug companies for introducing certain new brands without price approval, reports The Pharma Letter’s India correspondent. 18 May 2017
The Association of the British Pharmaceutical Industry (ABPI), the trade group representing the UK’s pharma sector, has praised parts of the manifestos proposed by Labour, the Liberal Democrats and the Conservatives. 18 May 2017
Russia may be faced with a shortage of drugs in the future, due to the forthcoming transition to a new system of drug labeling that may lead to huge interruption in medicines supplies to the country. 18 May 2017
Shares in USA-based Concert Pharmaceuticals dropped 10% before rallying slightly, as stockholders learned the company’s clinical trial into hair loss candidate CTP-543 has been put on hold by the US Food and Drug Administration. 18 May 2017