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 trade group PhRMA has said that new government data on the cost of prescription drugs paints a ‘misleading picture’ about the Medicare Part D program because it fails to include discounts and rebates negotiated directly with manufacturers. 19 August 2016
Australia’s Pharmaceutical Benefits Scheme Committee has recommended the listing of Brenzys as a biosimilar of originator brand etanercept (Enbrel) on a cost minimization basis with Enbrel for all adult indications – rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and chronic plaque psoriasis. 19 August 2016
Many orphan drugs on the US market today are used to treat common, non-orphan conditions, and that’s making them more expensive for patients and the health care system, according to a new report from America’s Health Insurance Plans (AHIP). 19 August 2016
The National Institute for Health and Care Excellence (NICE) has said in draft guidance published today that German pharma major Bayer’s liver cancer drug Nexavar (sorafenib) – which is currently available on the Cancer Drugs Fund (CDF) – is not value for money. 19 August 2016
The makers of two cholesterol-lowering drugs have responded to a report which said that their products were not cost-effective and called for their US price to be cut by at least 68%. 18 August 2016
Israeli generics giant Teva Pharmaceutical Industries says that the European Commission has granted marketing authorization for Cinqaero (reslizumab) in the 28 countries of the European Union in addition to Norway, Liechtenstein and Iceland. 18 August 2016
Removing cancer drug Afinitor (everolimus) from the UK’s revamped Cancer Drugs Fund (CDF) will prevent women with advanced breast cancer from accessing medicine that could significantly slow the progression of their disease, Swiss pharma giant Novartix has said. 18 August 2016
A supplemental Biologics License Application (sBLA) has been submitted to the US Food and Drug Administration (FDA) for the use of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who received at least one prior therapy. 18 August 2016
The National Institute for Health and Care Excellence (NICE) has issued second draft guidance which recommends US pharma giant Pfizer’s Xalkori (crizotinib) for some people with lung cancer. 18 August 2016
A ‘huge blow to patients’ and the realization of ‘our worst fears' about the re-launched Cancer Drugs Fund (CDF) is how one charity has reacted to the recommended discontinuation of oncology treatments in England. 18 August 2016
At a time when the inability of UK patients to access certain potentially lifesaving cancer drugs has come under fire, one company executive has praised the stance taken by the British government on a treatment of advanced renal cell carcinoma (RCC). 17 August 2016
The price of a new group of cholesterol-lowering drugs is too high and should be cut by at least 68% to represent good value for the US health care system, according to a new article published in the Journal of the American Medical Association (JAMA). 17 August 2016
Falling stock markets, political uncertainty and continued global economic weakness all contributed to a mixed first half for the pharma and medtech industries, according to a new report. 17 August 2016
The Directorate General of Foreign Trade in India has laid down the conditions for import and export of human biological samples for commercial purposes recently. 17 August 2016
The US Food and Drug Administration (FDA) has granted esketamine, an investigational antidepressant medication, Breakthrough Therapy Designation for the treatment of major depressive disorder with imminent risk for suicide. 16 August 2016
Politically unaccountable groups, having their own agendas, should not be dictating the practice of medicine in the form of guidelines to be required by Medicare, states the Association of American Physicians and Surgeons (AAPS) in comments it submitted on Saturday (August 13) to the Centers for Medicare & Medicaid Services (CMS) on its proposed new regulation. 16 August 2016
A report on why UK cancer patients are missing out on drugs available elsewhere is ‘too simplistic’ in attributing the problem to failed negotiations with pharma companies, according to the Association of the British Pharmaceuticals Industry (ABPI). 15 August 2016
National health spending in the USA in June 2016 was 5.2% higher than in June 2015, totaling $3.36 trillion (seasonally adjusted annual rate). 15 August 2016
The European Medicines Agency has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), titled “Product- or population-specific considerations II: Biological medicinal products.” 15 August 2016