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 European Commission has approved Orencia (abatacept) intravenous (IV) infusion and subcutaneous (SC) injection, in combination with methotrexate (MTX), for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. 6 September 2016
Trade group AusBiotech chief executive Glenn Cross says the proposed cut to the Research & Development (R&D) Tax Incentive included in the Omnibus Savings Bill, which recently entered Parliament, risks Australia’s competitive advantage in the life sciences. 6 September 2016
Despite government reassurances that British businesses and universities will have certainty over future research funding in the face of Brexit, concerns are coming forward that cessation of European Union funding – particularly under the Horizon 2020 scheme - will impact R&D activities in the UK. 6 September 2016
The National Institute for Health and Care Excellence (NICE) has today issued final draft guidance, repeating its negative view on Swiss pharma giant Roche’s Cotellic (cobimetinib) with vemurafenib (Zelboraf, also from Roche) for a type of advanced skin cancer. 5 September 2016
More than 2,000 medicine brands treating common conditions will drop in price for millions of Australians from next month – some by as much as 50% or more – with the Turnbull government delivering a win-win for consumers and taxpayers. 5 September 2016
The Food and Drug Administration's Center for Biologics Evaluation and Research has cancelled the scheduled November 16, 2016, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Biologics License Application (BLA) for Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted]). 5 September 2016
Novo Nordisk announced on Friday that the US Food and Drug Administration has extended the regulatory review period for IDegLira, the fixed-ratio combination of insulin degludec (Tresiba) and liraglutide (Victoza) in adults with type 2 diabetes. 5 September 2016
The German Institute for Quality and Efficiency in Health Care (IQWiG) has published a report which suggests that on formal or methodological grounds, respectively, no additional benefit has been proven for Halaven (eribulin) versus established comparator therapies - as defined by the Federal Joint Committee (G-BA) - for the treatment of unresectable advanced or metastatic liposarcomas. 5 September 2016
Lung cancer is the leading cause of cancer death among men and women in the USA, and each year, tens of thousands of Americans are diagnosed with the most common form, non-small cell lung cancer (NSCLC). 5 September 2016
US Democratic presidential nominee Hillary Clinton is offering a plan to protect Americans from unjustified price hikes in lifesaving treatments that have long been on the market. 3 September 2016
In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether patients treated for multiple myeloma with the monoclonal antibody Empliciti (elotuzumab) in combination with lenalidomide (Revlimid) and dexamethasone who have received one previous treatment benefit from this new combination. 3 September 2016
The US government is to back Japanese pharma major Takeda in its bid to develop a vaccine against the Zika virus by providing funding of up to $312 million, it has been announced. 2 September 2016
The US Food and Drug Administration has granted Fast Track designation for biotech major Biogen’s aducanumab, its investigational treatment for early Alzheimer’s disease (AD). 2 September 2016
The US Food and Drug Administration has approved biotech major Amgen’s supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab). 2 September 2016
The National Institute for Health and Care Excellence has today issued draft final guidance recommending German pharma major Bayer’s Xofigo (radium-223 dichloride) as an option for treating prostate cancer, reversing an earlier decision not to back the drug. 2 September 2016
Canada is experiencing a growing number of opioid overdoses and deaths across the country, and days such as the International Overdose Awareness Day are bringing needed attention to this crisis. 1 September 2016
Amidst concerns about death and overdose risks from narcotic painkillers taken with certain antianxiety or sedative drugs, the US Food and Drug Administration has issued a strong “Boxed Warning” of combination usage. 1 September 2016