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 US pharma giant Pfizer’s Xalkori (crizotinib) for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC), the company revealed today. 31 August 2016
PHARMAC has made decisions to award the Zoladex brand of cancer drug goserelin Sole Subsidized Supply in the community and Hospital Supply Status in District Health Board hospitals and to apply reference pricing to leuprorelin (Eligard and Lucrin) in the community. 31 August 2016
Sandoz has received US Food and Drug Administration approval for Erelzi (etanercept-szzs) for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA). 31 August 2016
In India, 33 drugs supplied to various government hospitals and stores in Arunachal Pradesh were found to be of sub-standard quality during laboratory tests. 30 August 2016
Although the performance and procedural goals for the sixth iteration of the US Prescription Drug User Fee Act (PDUFA) were laid out last month, pharmaceutical companies, including Anglo-Swedish AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the program from fiscal years 2018 through 2022. 30 August 2016
To push India into top five pharmaceutical innovation hubs by 2020 and establish global presence by launching one out of every five-10 drugs discovered in India at a global level, the government is preparing for multi-billion dollar investment with 50% public funding through its public private partnership (PPP) model to enhance innovation capability, a new study reveals. 30 August 2016
Mylan has said it will launch the first generic to EpiPen Auto-Injector (epinephrine injection, USP) at a list price of $300 per generic EpiPen two-pack carton. 29 August 2016
Bernstein analyst Tim Anderson and team wonder if Pfizer winning the bidding war for Medivation with its $14 billion offer (announced last Monday) is “something to be proud of,” reported Barron’s magazine. 28 August 2016
The Russian Federal Anti-Monopoly Service (FAS) has started investigations regarding the recent detection of a cartel in the Russian pharmaceutical market, which was created by some leading local drugmakers and global majors operating in the Russian market, according to press-service of the FAS, reports The Pharma Letter’s local correspondent. 26 August 2016
The Ministry of Health of Ukraine has officially approved the conduct of clinical trials of drugs imported to the country – the initiative that has long been lobbied by global pharmaceutical majors, operating in the country. 26 August 2016
Eisai today said that the anticancer agent Treakisym (bendamustine hydrochloride) for Injection 100mg been approved in Japan for an additional indication of chronic lymphocytic leukemia. 26 August 2016
Japanese drugmaker Chugai Pharmaceutical has received approval for an additional indication of its cancer drug Xeloda (capecitabine) in Japan. 26 August 2016
Medicines regulator Health Canada has issued a warning to healthcare professionals on the potential hepatoxicity of Revolade (eltrombopag), a thrombopoietin receptor agonist. 26 August 2016
NICE, the medicines cost-effectiveness watchdog for England and Wales, has issued an updated guideline recommending the use of Esmya (ulipristal acetate 5mg), up to four courses, as first-line treatment for patients presenting with heavy menstrual bleeding and uterine fibroids 3cm or more in diameter. 26 August 2016
Netherlands-based generics major Mylan and Indian drugmaker Biocon have had their regulatory submission for a trastuzumab biosimilar accepted by the European Medicines Agency (EMA). 25 August 2016
Mylan today announced it is taking immediate action to further enhance access to EpiPen (epinephrine) Auto-Injector by expanding already existing programs in recognition of those patients who are facing the burden of higher out-of-pocket costs. 25 August 2016
The Food and Drug Administration has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for Parsabiv (etelcalcetide), a potential treatment for secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. 25 August 2016