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
“A clear signal from government that the UK remains a great place for life-sciences” is how Mike Thompson, chief executive of the British Association of the Pharmaceutical Industry (ABPI), responded to news of a £220 million ($283 million) investment in new technology in the sector. 3 October 2016
The National Institute for Health and Care Excellence (NICE), the medicines cost-effectiveness watchdog for England and Wales, plans to introduce the fees next year for pharma companies requesting appraisals of their drugs for use in Britain’s National Health Service, according to a report by The Sunday Times. 2 October 2016
The European Medicines Agency has appealed two interim orders by the President of the General Court of the European Union to suspend the release of documents requested by third parties under Regulation (EC) no 1049/2001, the so-called “Transparency Regulation.” 1 October 2016
Biotherapeutics company CSL Behring has received approval in Japan for its hemophilia B treatment Idelvion (coagulation Factor IX [recombinant], albumin fusion protein; albutrepenonacog alfa). 30 September 2016
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has highlighted the findings of a new report in calling for a global response to the problem of counterfeit medicines. 30 September 2016
The Russian Federal Antimonopoly Service (FAS) may cancel registration of certain imported drugs, which are presented in the Russian market, due to the pricing policy, which is implemented by their producers, according to an official spokesman for the agency, reports The Pharma Letter’s local correspondent. 30 September 2016
The National Institute for Health and Care Excellence (NICE) has published final guidance recommending German pharma major Bayer’s Xofigo (radium-223 dichloride) for a new indication in prostate cancer. 29 September 2016
Italian family-owned drugmaker Chiesi Farmaceutici has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its triple combination for chronic obstructive pulmonary disease (COPD). 29 September 2016
Swiss pharma giant Novartis’ Cosentyx (secukinumab) is to be made available on the National Health Service (NHS) in England and Wales to treat adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy. 29 September 2016
Ariad Pharmaceuticals says its partner Otsuka Pharmaceutical has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for Iclusig (ponatinib). 29 September 2016
The US Food and Drug Administration has approved Vertex Pharmaceuticals’ Orkambi (lumacaftor/ivacaftor) for use in children with cystic fibrosis (CF) ages six through 11 who have two copies of the F508del mutation. 29 September 2016
The use of generic medicines saves European health systems – and the taxpayers who fund them – 100 billion euros ($112 billion) per year, a new study has found. 28 September 2016
Australia’s Pharmaxis says that its Bronchitol, a dry-powder mannitol formulation, has been approved for marketing in Russia for the treatment of both pediatric and adult cystic fibrosis (CF) patients. 28 September 2016
The National Institute for Health and Care Excellence (NICE) has recommended Eylea (aflibercept) as a cost-effective first-line treatment option for adults with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) within final guidance, 28 September 2016
UK drugmaker Summit Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for ezutromid in the treatment of Duchenne muscular dystrophy. 28 September 2016
The government is encouraging feedback from Australia’s research and development community, businesses and industry groups and other stakeholders on the R&D Tax Incentive Review findings released today. 28 September 2016
Belgian drugmaker UCB and US biotech major Amgen have had their biologics license application (BLA) for romosozumab accepted by the US Food and Drug Administration (FDA). 27 September 2016
When testifying before US Congress last week, the chief executive of Netherlands-incorporated drugmaker Mylan told members that her company’s profits from the EpiPenAuto-Injector (epinephrine injection, USP) were 60% lower than they actually were. 27 September 2016
CEL-SCI Corp says it has received verbal notice from the US Food and Drug Administration that its Multikine (leukocyte interleukin injection) Phase III clinical trial in advanced primary head and neck cancer has been placed on clinical hold. 27 September 2016
As part of the US Obama Administration’s commitment to address the rising public health challenges caused by the national prescription opioids and heroin epidemic, Attorney General Loretta Lynch issued a memo this week announcing the department’s three-part prevention, enforcement and treatment strategy. 27 September 2016