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
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 granted marketing authorization for Brineura (cerliponase alfa), the first treatment approved in the European Union for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency. 1 June 2017
Joe Jimenez, the chief executive of Swiss pharma giant Novartis and chairman-elect of US trade group PhRMA, has said that he expects Donald Trump’s administration to come back with proposals on making prescription drugs more affordable for Americans within three months. 1 June 2017
Breakthrough Therapy designation has been granted by the US Food and Drug Administration for givosiran (ALN-AS1), an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the prophylaxis of attacks in patients with acute hepatic porphyria (AHP). 1 June 2017
Ohio is to become the second US state to sue the pharmaceutical industry over its role in the opioid epidemic currently facing America, after Mississippi. 1 June 2017
The US Food and Drug Administration has approved the Biologics License Application for Rebinyn (nonacog beta pegol; N9-GP) for the treatment of adults and children with hemophilia B. 1 June 2017
French biotech firm Nicox saw its shares rise 18% to 12.55 euros by late-afternoon trading today, after the company announced it has received its first drug approval from the US Food and Drug Administration. 31 May 2017
The National Institute of Health and Care Excellence (NICE) has issued a positive Final Evaluation Determination (FED) recommending Cerdelga (eliglustat) as a first-line treatment for adult patients with type 1 Gaucher disease, a very rare and inherited genetic condition which can be life-threatening in severe cases. 31 May 2017
The Cystic Fibrosis Engagement Network, a project of the Alliance for Patient Access, today released a new white paper, “Making Treatment Accessible for Cystic Fibrosis Patients.” 31 May 2017
The European Commission has granted approval for Trumenba (meningococcal group B vaccine) for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older. 31 May 2017
Sandoz, a division of Swiss pharma giant Novartis, has had its proposed adalimumab and infliximab biosimilars accepted for regulatory review by the European Medicines Agency (EMA). 31 May 2017
Several drugmakers have simultaneously received US Food and Drug Administration approval for copycat versions of Strattera (atomoxetine), a treatment for attention-deficit/hyperactivity disorder in pediatric and adult patients. 31 May 2017
In a report likely to please French and Scandinavian readers and have the opposite effect on Italians and Spaniards, the cities hoping to host the new headquarters of the European Medicines Agency (EMA) have been ranked by the financial services firm KPMG. 30 May 2017
Partnerships between UK and European Union medical researchers have increased the value of research, benefiting patients across Europe, according to a report published today (May 30). 30 May 2017
Women’s health specialist Mithra has received a Marketing Authorization (MA) for the commercialization of Tibelia (tibolone), a generic version of Livial, in France. 30 May 2017
TaiGen Biotechnology has submitted a new drug application (NDA) for the intravenous formulation of Taigexyn (nemonoxacin) to the China Food and Drug Administration (CFDA). 30 May 2017
Switzerland’s medicines regulator has released its annual report, noting that regulatory approval was granted for more than 40 innovative medicinal products last year, with 99% of applications completed on schedule. 30 May 2017
Indian drugmaker Glenmark Pharmaceuticals has received final approval from the US Food and Drug Administration for its generic nebivolol product. 30 May 2017
The National Institute for Health and Care Excellence (NICE) has recommended Keytruda (pembrolizumab) for inclusion in the UK’s Cancer Drugs Fund (CDF) as the first immunotherapy for a specific population of previously untreated metastatic non-small-cell lung cancer (NSCLC). 30 May 2017
The USA’s new Food and Drug Administration Commissioner Scott Gottlieb was in the hot seat last week to defend President Donald Trump's budget plan to the House of Representatives appropriations subcommittee. 30 May 2017
South Africa’s Aspen Pharmacare has entered into a memorandum of understanding (MoU) has been concluded between Aspen’s Russian business and the Vladivostok Far Eastern Federal University (FEFU). 30 May 2017