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
The Food and Drug Administration has approved Relistor (methylnaltrexone bromide) tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. 20 July 2016
Shares in Canadian drugmaker Valeant took an upturn on Wednesday with the news that a US Food and Drug Administration advisory committee had voted unanimously in favor of approving Siliq (brodalumab) for adult patients with moderate-to-severe plaque psoriasis. 20 July 2016
The pharmaceutical market in Vietnam will expand in value from $3.5 billion in 2015 to an estimated $6.6 billion by 2020, registering a compound annual growth rate of 13.8%, a new report shows. 20 July 2016
Free movement of people across Europe has been ‘hugely beneficial’ to science and research in the United Kingdom and must be allowed to continue, a government committee has heard. 20 July 2016
In our weekly expert view piece, Darren Cooper, director of industry solutions at Stibo Systems examines the implications and potential benefits of the Indentification and Medicinal Products (IDMP) standards. 19 July 2016
AstraZeneca today announced that the European Commission has approved its Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 European Union member countries plus Iceland, Liechtenstein and Norway. 19 July 2016
UK pharma major GlaxoSmithKline has received approval for its cervical cancer vaccine Cervarix from the Chinese Food and Drug Administration. 19 July 2016
Eisai and US partner Arena Pharmaceuticals have received US Food and Drug Administration approval of the New Drug Application for obesity drug Belviq XR (lorcaserin HCl) CIV extended-release 20mg tablets. 19 July 2016
The US Food and Drug Administration has approved the use of Berinert (esterase inhibitor [human]), CSL Behring’s therapy for treating hereditary angioedema (HAE) attacks, for use in pediatric patients. 19 July 2016
Bristol-Myers Squibb today announced that both the US Food and Drug Administration and European Medicines Agency have accepted marketing applications to expand the use of Opdivo (nivolumab) for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). 18 July 2016
US generic drugmaker ANI Pharmaceuticals today revealed that it has received approval from the US Food and Drug Administration of the Abbreviated New Drug Application for nilutamide tablets. 18 July 2016
The UK government remains tight-lipped on whether a new Life Sciences Minister will be appointed to replace George Freeman MP, who was moved to a different department last week. 18 July 2016
Briefing documents prepared for a US Food and Drug Administration advisory committee have raised concerns on a potential suicide risk involving Siliq (brodalumab), a psoriasis treatment being developed by Canada’s Valeant Pharmaceuticals. 18 July 2016
Merck KGaA today said that the European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) of the investigational product cladribine tablets for the treatment of relapsing-remitting multiple sclerosis (MS). 18 July 2016
Pharmaceutical companies are making it exorbitantly expensive to vaccinate vulnerable children, the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) warned today. 18 July 2016
Ensuring better access to drugs and improved health care innovation should be top of the agenda at an annual meeting of Canada's Premiers this week, according to industry group the Canadian Pharmacists Association (CPhA). 18 July 2016
South Korean drug developer Samsung Bioepis has had its marketing authorization application (MAA) for a biosimilar candidate referencing big-selling arthritis drug Humira (adalimumab) accepted for review by the European Medicines Agency. 18 July 2016
The Treat and Reduce Obesity Act aims to improve access to weight management therapy. Over the last few years, obesity has become the hot button issue that legislators can set their sights on and pass meaningful legislation on without ruffling too many feathers, writes Dr Nicolas Davies in her monthly exclusive FDA Blog for The Pharma Letter. 18 July 2016
The Irish Medicines Verification Organization (IMVO) is a new organization being established by a range of stakeholders across the medicines supply chain in Ireland to set up and manage a national repository of the unique identifiers that will be included on the packaging of most medicines placed on the market from February 2019. 18 July 2016
The King of Spain, Felipe VI, last week received members of the pharma trade group Farmaindustria in an official audience at the Palace, when the monarch got to directly learn about the activity of a sector gathered by 180 companies, in which national and international big, medium and small size enterprises share a common space. 18 July 2016