Having filed submissions in the USA, Canada and Europe, Danish diabetes giant Novo Nordisk has now set its sights on Japan as it seeks to gain approval for semaglutide, a glucagon-like peptide-1 (GLP-1) analogue administrated once-weekly, for the treatment of adults with type 2 diabetes. 28 February 2017
The US Food and Drug Administration has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2 diabetes. 28 February 2017
USA-based Evoke Pharma said yesterday that it has received a letter from the Food and Drug Administration exempting its late stage product, Gimoti from a Human Factors (HF) validation study requirement prior to submission of a New Drug Application (NDA). 16 February 2017
A study involving Australian biotech firm CSL Limited has prevented the progression of Diabetic Kidney Disease (DKD) in laboratory studies of type 2 diabetes. 13 February 2017
At its meeting this week, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency concluded a safety review and started two new ones. 10 February 2017
An update to its label means US pharma major Eli Lilly’s diabetes drug Trulicity (dulaglutide) is the first and only glucagon-like peptide-1 (GLP-1) receptor agonist that can be used in combination with mealtime insulin or basal insulin. 9 February 2017
Express Scripts, the USA’s largest pharmacy benefits management firm, has put the blame for rising prices of medicines in the USA at the door of drugmakers. 6 February 2017
Intarcia Therapeutics says the US Food and Drug Administration has accepted for active review its New Drug Application (NDA) for ITCA 650 (exenatide), an investigational therapy for the treatment of type 2 diabetes (T2D). 6 February 2017
The rationale and design of a pivotal investigational study on the potential beneficial effects of the diabetes drug Invokana (canagliflozin) on kidney disease progression have been published. 2 February 2017
Teva Pharmaceutical Industries says that it is seeking approval to market the generic version of Victoza (liraglutide) injection, in the USA. 2 February 2017
Novo Nordisk has warned of slower sales and profits growth in 2017, along with presenting fourth-quarter and full-year financial results for 2016. 2 February 2017
US drugmaker MannKind Corp today announced the launch of a new titration pack containing 60 – 4 unit cartridges, 60 – 8 unit cartridges and 60 – 12 unit cartridges of Afrezza (insulin human) inhalation powder. 1 February 2017
Diabetes specialist Novo Nordisk will invest £115 million ($145 million) in a new Oxford-based research facility, in what will be described as a vote of confidence in the UK’s intellectual capital and medical research infrastructure. 30 January 2017
Adocia has announced that American drugmaker Eli Lilly has terminated an agreement to develop and commercialize the fast-acting insulin treatment BioChaperone Lispro. 27 January 2017
French pharma major Sanofi has received marketing authorization in Europe for its diabetes therapy Suliqua, known as Soliqua in the USA. 18 January 2017
Irish life sciences company Malin Corp says it has acquired a 33% shareholding of Wren Therapeutics, a newly-created biotechnology company based in Cambridge, UK. 17 January 2017
The European Commission has granted marketing authorization for Fiasp (fast-acting insulin aspart for the treatment of diabetes in adults. 10 January 2017
Viatris has disclosed that its oral finished-dose manufacturing facility in Indore, India, is subject to regulatory action from the US regulator, after an inspection earlier this year. 24 December 2024
The US Food and Drug Administration (FDA) revealed on Monday that it has approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter. 24 December 2024
US pharma major Eli Lilly has recently announced a £279 million ($365.5 million) investment in the UK at the International Investment Summit in London. 19 December 2024
The Egyptian Drug Authority has approved EVA Pharma's insulin glargine injection, marking a significant milestone in its collaboration with US pharma major Eli Lilly. 18 December 2024
The European Commission has approved unconditionally, under the EU Merger Regulation, the proposed acquisition of contract development and manufacture organization (CDMO) Catalent (NYSE: MCTLT) by Denmark’s Novo Holdings. 7 December 2024
Novo Nordisk will reduce the US list prices of two insulin products, Tresiba (insulin degludec) and Fiasp (insulin aspart), by over 70% from 2026. 6 December 2024
Danish diabetes and obesity giant Novo Nordisk has announced plans to invest 2.9 billion Danish kroner ($410 million) to establish a cutting-edge quality control laboratory in Hillerød, Denmark. 6 December 2024
Dutch privately held Amarna Therapeutics, which specializes in transformative gene therapies, has entered into a strategic collaboration with Sweden-based NorthX Biologics, a leading biologics manufacturing partner. 4 December 2024
The China-based subsidiary of French pharma major Sanofi revealed it has signed a memorandum of cooperation with Beijing Municipal Bureau of Economy and Information Technology and Beijing Economic and Technological Development Zone today to invest approximately 1 billion euros ($1.05 billion) to establish a new manufacturing base. 3 December 2024
Hua Medicine has announced promising new clinical findings for its glucokinase activator dorzagliatin, presented at the China BioMed Innovation and Investment Conference. 2 December 2024
Australia’s Department of Health and Aged Care has developed a new API (application programming interface) for the efficient distribution of the monthly Pharmaceutical Benefits Scheme (PBS) schedule data. 2 December 2024
Privately-held UK firm Quell Therapeutics, which positions itself as a pioneer in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, has announced that AstraZeneca has selected a candidate to progress in the type 1 diabetes (T1D) Treg cell therapy program. 18 November 2024
French pharma major Sanofi today announced an investment of 40 million euros ($42.4 million) in its Lyon Gerland bioproduction site, consolidating its role as a strategic platform dedicated to immunology. 15 November 2024
Privately-held Montanan firm Microbion has announced promising findings from its Phase II study of pravibismane, a topical treatment aimed at addressing diabetic foot ulcer infections (DFI). 14 November 2024
While sky high expectations for Eli Lilly’s tirzepatide have not yet been realized, more positive data add to a growing sense that the future could be as bright as imagined. 14 November 2024
Germany’s Merck KGaA was trading 5% lower as Thursday’s trading day neared its end, after the company announced its third-quarter financial results and outlook for the rest of the year. 14 November 2024
French biotech DiogenX, which is focused on regenerating insulin-producing beta cells for the treatment of diabetes, today announces the appointment of Dr Klara Owen as chief medical officer. 12 November 2024