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
US Representative Jan Schakowsky and US Senators Sherrod Brown and John McCain have introduced legislation aimed at helping to lower prices of life-saving drugs and save taxpayers billions of dollars over the next 10 years. 24 June 2016
The UK subsidiary of Japanese drug major Astellas Pharma has been suspended as a member of the Association of the British Pharmaceutical Industry (ABPI) with effect from June 24, 2016. 24 June 2016
The UK has spoken. The Referendum on Thursday, which saw a massive turnout of over 70%, resulted in a vote to leave the European Union. A total of 51.9%, or 17,410,742 people voted to Leave, compared with 48.1%, or 16,141,241people who voted Remain. 24 June 2016
The Indian government has withdrawn a Bill introduced in 2013 to amend the existing Drugs and Cosmetics Act, promising to ‘comprehensively review’ regulations to suit new science and research methods. 23 June 2016
The US Food and Drug Administration has granted Breakthrough Therapy designation for US biotech firm Incyte’s Jakafi (ruxolitinib) for the treatment of patients with acute graft-versus-host disease (GVHD). 23 June 2016
US biotech giant Gilead Sciences has received European Commission marketing authorization for the once-daily single tablet regimen (STR) Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide). 23 June 2016
Italian CNS-focused drug developer Newron Pharmaceuticals’ key value driver is safinamide (branded Xadago), a once daily oral add-on therapy for all stages of Parkinson's disease with a unique dual mechanism of action. 23 June 2016
Updated guidance by the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) states that AstraZeneca’s (LSE: AZN) FluMist Quadrivalent nasal vaccine should not be used in any setting. 23 June 2016
The US Food and Drug Administration has announced the approval of a supplemental New Drug Application (sNDA) modifying the risk evaluation mitigation strategy (REMS) for Sabril (vigabatrin) from Danish CNS drug specialist Lundbeck. 23 June 2016
England’s medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has today published final draft guidance that does not recommend US biotech firm Celgene’s Vidaza (azacitidine) to treat some people with acute myeloid leukemia (AML). 23 June 2016
New Zealand’s Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal involving Praxbind (idarucizumab) and Pradaxa (dabigatran). 23 June 2016
In Australia, the Annual Charge Exemption (ACE) scheme replaced the Therapeutic Goods Administration’s (TGA) low value turnover scheme on July 1, 2015, and companies wishing to claim the exemption for pre-revenue entries must do so between July 1 and 22, 2016. 23 June 2016
The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined in an early benefit assessment whether AstraZeneca’s Tagrisso (osimertinib) offers an added benefit for lung cancer patients in comparison with the appropriate comparator therapy. 22 June 2016
The US trade association representing pharmacy benefit managers has said that new bipartisan legislation will bring generic drugs to market sooner. 22 June 2016
The US Food and Drug Administration is coming under increasing pressure from other government authorities to review and provide clarity on off-label promotion regulations, as recent settlement agreements with pharmaceutical companies appear to give these companies license to extend previous working definitions of “scientific exchange” as allowed by law, notes Dr Nicola Davies in her monthly exclusive FDA Blog for The Pharma Letter. 22 June 2016
US not-for-profit body the Institute for Clinical and Economic Review (ICER) has posted a draft scoping document that will inform a report on drug therapies for treatment of non-small cell lung cancer (NSCLC). 22 June 2016
The National Institute for Health and Care Excellence (NICE), the medicines cost-effectiveness for England and Wales, has today published final guidance which recommends UK pharma major GlaxoSmithKline’s Benlysta (belimumab) for treating systemic lupus erythematosus. 22 June 2016
The National Institute for Health and Care Excellence (NICE), the medicines cost-effectiveness for England and Wales, has today published final guidance recommending that five drugs to treat four different conditions should be routinely funded by the National Health Service. 22 June 2016
The US Food and Drug Administration has approved OPKO Health’s Rayaldee (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30ng/mL. 21 June 2016
Mundipharma International today announced that Penthrox (low dose methoxyflurane) has been granted marketing authorization in France for the emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain. 21 June 2016