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
Israel’s Teva Pharmaceutical Industries (NYSE TEVA) today announced it has obtained approval from the European Commission for an indication extension for its leukemia drug. 21 November 2016
The Russian pharmaceutical market is one of the fastest growing in the world, and this overview describes the main regulatory trends, associated legal risks and opportunities for pharma manufacturers in 2016-2017 in Russia. 21 November 2016
Dynavax common stock plunged last Monday after receiving a complete response letter from the FDA regarding its approval application for Heplisav-B hepatitis vaccine. 20 November 2016
The US Food and Drug Administration’s Center for Biologics Evaluation and Research has approved expanding the indication for FluLaval Quadrivalent (Influenza Vaccine) to include use in children six months and older. 19 November 2016
US biotech firm Spectrum Pharmaceuticals has revealed in a filing with the Security and Exchange Commission that it has received a Complete Response Letter from the US Food and Drug Administration relating its investigational bladder cancer treatment. 18 November 2016
The US Food and Drug Administration has granted Fast Track designation for the development of the beta secretase cleaving enzyme (BACE) inhibitor E2609. 18 November 2016
Janssen Biotech has filed a Biologics License Application (BLA) with the US Food and Drug Administration approval of its investigational anti-interleukin-23 monoclonal antibody. 17 November 2016
The US Food and Drug Administration approved a new treatment for women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. 17 November 2016
Biosimilars of top-selling biological drugs are coming closer to the market, and such competition to Swiss pharma major Roche’s (ROG: SIX) blockbuster cancer drug Avastin (bevacizumab) – with 2015 sales of 6.68 billion Swiss francs ($7.67 billion) - is no exception. 17 November 2016
The European Medicines Agency has granted its PRIority MEdicines (PRIME) designation to SAGE-547 for the treatment of postpartum depression (PPD). 17 November 2016
The National Institute of Health and Care Excellence (NICE) has recommended the use of Swiss pharma giant Roche’s cancer drug Perjeta (pertuzumab) on the National Health Service (NHS) in England and Wales. 17 November 2016
More than 75% of treatments in the UK’s Cancer Drugs Fund (CDF) which have been reappraised by the National Institute for Health and Care Excellence (NICE) have received positive recommendations for routine use in the NHS. 17 November 2016
Resources dedicated to creating medicines to meet the unique needs of children have grown steadily since legislation guiding pediatric drug development was enacted in the USA two decades ago, and the outlook for still greater development looks promising, according to a new analysis. 16 November 2016
The European Medicines Agency, in cooperation with the European Commission and the Member States of the European Union, is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. 15 November 2016
Speculation is rife about what Donald Trump’s election win means for pharma and health care in the USA, but what of its potential impact on the industry in Europe? Novasecta’s Salma Ajraoui analyzes the issue. 15 November 2016
The French company developing ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, saw its shares plunge 23.8% to 13.31 euros this morning after it announced a negative development for its lead product candidate. 15 November 2016
Shares in US clinical-stage biopharma firm Dynavax Technologies took a 63% nosedive in Monday morning’s trading after bad news on its hepatitis B vaccine. 14 November 2016
With the coming of the 25th“World Diabetes Day,” R&D Based Pharmaceutical Association Committee of China Association of Enterprises with Foreign Investment (RDPAC) released Faces of Innovation: Meeting the Challenge of Diabetes today in Beijing. 14 November 2016
Russian drugmaker Biocad has announced that it has successfully completed registration of a generic of glatiramer acetate, a drug for the treatment of multiple sclerosis, reports The Pharma Letter’s local correspondent. 14 November 2016