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
Much like a soccer player having to adapt his game when he goes to play in a different national league, pharma companies need a different approach to gaining regulatory approval and reimbursement in different major markets. 15 August 2016
British businesses and universities will have certainty over future funding and should continue to bid for competitive European Union funds while the UK remains a member of the European Union, ahead of leaving in the so-called ‘Brexit’ move following the referendum vote to leave, according to a government announcement on Saturday. 14 August 2016
The US Food and Drug Administration, with information received from the European Medicines Agency (EMA) and the French national medicines agency (ANSM), has completed a comprehensive review of safety information relevant to the investigational new drug BIA 10-2474 and the potential implications for related drugs under investigation in the USA. 12 August 2016
Endo International said today that, based on an August 11, 2016 discussion with the US Food and Drug Administration, the company has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for its opioid antagonist Opana ER without prejudice to re-filing. 12 August 2016
In Australia, product Information documents for US biotech major Amgen’s denosumab have been updated regarding the potential risk of QT interval prolongation associated with hypocalcemia. 12 August 2016
In draft guidance published today, Anglo-Swedish pharma major AstraZeneca’s Brilique (ticagrelor) has been recommended for National Health Service use by the medicines cost-effectiveness watchdog for England and Wales. 12 August 2016
NHS England has launched a 45-day public consultation on a proposed clinical commissioning policy for Pre-Exposure Prophylaxis (PrEP) for HIV. 11 August 2016
The US Food and Drug Administration (FDA) has created a model Drug Facts Label (DFL) to help drugmakers submit new drug applications for over-the-counter (OTD) versions of a drug that combats the effects of an opioid overdose. 11 August 2016
The US Food and Drug Administration (FDA) has granted Priority Review status to privately-held Marathon Pharmaceuticals’ investigational drug deflazacort for Duchenne Muscular Dystrophy (DMD). 11 August 2016
A European Medicines Agency (EMA) report on its adaptive pathways pilot fails to address concerns about how real world data can be used to draw reliable conclusions after drug approval, says Germany's Institute for Quality and Efficiency in Healthcare (IQWiG). 10 August 2016
Following a pre-planned interim analysis for MONARCH 2, an independent Data Monitoring Committee (DMC) recommended the study continue without modification as the interim efficacy criteria were not met, says US pharma major Eli Lilly. 10 August 2016
US specialty biotech group Heron Therapeutics says it has received US Food and Drug Administration approval for its Sustol (granisetron) extended-release injection. 10 August 2016
Canada’s Cardiome Pharma says that Xydalba (dalbavancin) has been approved by the European Medicines Agency for administration as a single, 30 minute, 1500mg infusion (three 500mg vials). 10 August 2016
Astellas Pharma has submitted a new drug application to the Ministry of Health, Labor and Welfare in Japan for extended-release tablets of quetiapine fumarate (FK949E) for the indication of improvement of depressive symptoms associated with bipolar disorder. 10 August 2016
The US Food and Drug Administration has given the nod for Japanese pharma major Eisai and US biotech Biogen to take their investigational oral beta-secretase cleaving enzyme (BACE) inhibitor E2609 into Phase III studies in Alzheimer’s. 10 August 2016
Japanese pharma major Takeda Pharmaceutical has expressed its disappointment at preliminary draft guidance from the National Institute for Health and Care Excellence (NICE) which does not recommend Adcetris (brentuximab vedotin) – a drug which is on the UK’s Cancer Drugs Fund (CDF) list. 10 August 2016
The US Food and Drug Administration granted accelerated approval to for pharma giant Merck & Co’s Keytruda (pembrolizumab) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. 9 August 2016
The UK's National Institute for Health and Care Excellence (NICE) has gone back on its initial view after publishing final draft guidance which recommends talimogene laherparepvec for advanced melanoma that has spread and cannot be surgically removed. 9 August 2016
The overwhelming majority of US patients’ groups opposing a Medicare Part B proposal to reduce drug expenditures got funding from the pharmaceutical industry, according to a new Public Citizen report. 9 August 2016