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
Israeli drugmaker Teva Pharmaceutical Industries has suffered a serious blow to its plans to launch a generic version of Mylan’s EpiPen (epinephrine) auto-injector in the US. 3 March 2016
The US Food and Drug Administration has approved Odefsey (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. 2 March 2016
“We are outraged that the Minister of Health has today confirmed NZ$30 million [~$20 million] of PHARMAC’s budget was not reinvested in medicines in 2015. PHARMAC’s gross underfunding has left New Zealanders missing out on innovative medicines,” said Graeme Jarvis, general manager of Medicines New Zealand. 2 March 2016
Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a new indication for Merck & Co’s heart drug Ezetrol (ezetimibe). 2 March 2016
Novo Nordisk has presented new data showing that, on average, in the UK, daily administration of Xultophy (insulin degludec/liraglutide; IDegLira), costs less in total and was more effective compared to the separate injections of liraglutide added to basal insulin or compared to basal-bolus regimens. 2 March 2016
Janssen says it is extremely disappointed with the UK’s drugs cost watchdog the National Institute for Health and Care Excellence’s (NICE) initial response regarding its Imbruvica (ibrutinib) which was released this morning. 2 March 2016
Swedish rare disease specialist Swedish Orphan Biovitrum (Sobi) has upgraded its financial outlook for 2016 after receiving positive feedback on hemophilia B drug Alprolix (coagulation Factor IX [recombinant], Fc fusion protein). 1 March 2016
Bayer’s blockbuster ophthalmic drug Eylea (aflibercept) has already undergone several early benefit assessments according to the Act on the Reform of the Market for Medicinal Products (AMNOG) for other therapeutic indications. 1 March 2016
The US Food and Drug Administration has announced actions to provide important information about the risks of using German pharma major Bayer’s birth control implant Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. 1 March 2016
In our weekly expert view piece Robert Blank, senior consultant at Alliance Life Sciences examines the role of social media in pharmaceutical pricing practices. 1 March 2016
The Chinese Food and Drug Administration (CFDA) now requires all imported drugs to comply with the newest version of the China Pharmacopoeia (CP) released in 2015, reports The Pharma Letter’s local correspondent Wang Fangqing. Previously, such a requirement only targeted drugs manufactured inside mainland China. 29 February 2016
AbbVie says that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for the use of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets). 29 February 2016
US Senator Ted Cruz wants to change the way the Food and Drug Administration approves drugs. Indeed, the introduction of his “Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act” has sparked hot debate, says Dr Nicola Davies in her monthly FDA Blog for The Pharma Letter. 29 February 2016
Even as Asia appears to be struggling to come into its own with biosimilar drugs, India seems to be offering a better market to drugmakers chasing the over $1 billion global biosimilar industry in regulated markets, reports The Pharma Letter’s India correspondent. 29 February 2016
For almost four decades Europe's major pharma companies have worked in a competitive but integrated environment but there are now fears that Britain's role could come to an end if it leaves the EU. 29 February 2016
The Japanese Ministry of Health, Labor and Welfare has granted Orphan Drug designation to drug major Takeda Pharmaceutical’s ixazomib (MLN9708), an investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma. 27 February 2016
US biotech firm Genentech, a subsidiary of Swiss pharma giant Roche, has received approval from the US Food and Drug Administration for Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment. 27 February 2016
A private member’s bill that would help doctors in the UK try innovative treatments on patients has moved forward another step in the Parliamentary process. 26 February 2016
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines, two of which were Orphan designated, for marketing authorization at its February 2016 meeting. 26 February 2016
Patient access to cancer medicines in the UK will be significantly hampered under the reformed Cancer Drug Fund (CDF), according to the Association of the British Pharmaceutical Industry (ABPI). 26 February 2016