Diabetes
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Pharmaceutical
The US Food and Drug Administration has accepted for review French pharma major Sanofi’s New Drug Application for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), an investigational basal insulin, the company announced this morning. 8 July 2014
Pharmaceutical
Danish diabetes care giant Novo Nordisk's fixed-dose combination therapy insulin degludec/liraglutide (Xultophy, formerly known as IDegLira) is set to become the clinical gold-standard among FDCs used to treat patients with type 2 diabetes. 7 July 2014
Pharmaceutical
Japanese drug major Mitsubishi Tanabe Pharma has received approval to manufacture and market the SGLT2 inhibitor, Canaglu (canagliflozin hydrate) Japan, for the treatment of patients with type 2 diabetes mellitus. 4 July 2014
Pharmaceutical
In a much awaited decision, the US Food and Drug Administration on Friday approved MannKind Corp’s Afrezza (insulin human [rDNA origin]) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. The news on Friday sent the stock rocketing 80% to around $7.25. 30 June 2014
Pharmaceutical
At its end-June meetings, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended six new medicines for approval. 27 June 2014
Pharmaceutical
UK-based drug discovery firm ImmuPharma has extended its research capabilities by setting up its own research team within the Institut Europeen de Chimie et Biologie in Bordeaux (IECB), an international and interdisciplinary research team incubator. 27 June 2014
Biosimilars
The imminent patent expiration of French pharma major Sanofi’s Lantus (insulin glargine) has opened the door for Eli Lilly to increase its share of the diabetes treatment market, and the USA-based company has three big weapons in its pharmaceutical arsenal, says an analyst with research and consulting firm GlobalData. 26 June 2014
Pharmaceutical
The US Food and Drug Administration has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure drug olmesartan in diabetic patients. 25 June 2014
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has issued new final guidance recommending Invokana (canagliflozin), from US health care giant Johnson & Johnson’s (NYSE: JNJ) subsidiary Janssen-Cilag, for treating some people with type 2 diabetes. 25 June 2014
Pharmaceutical
New data for Danish diabetes care giant Novo Nordisk’s liraglutide 3mg from the Phase IIIa SCALET Obesity and Prediabetes trial were presented at the International Congress of Endocrinology (ICE) and the Endocrine Society's meeting (ENDO) on June 21, showing positive impact on cardiovascular risk markers and fewer people progressing to pre-diabetes compared with placebo in adults with obesity. 23 June 2014
Pharmaceutical
Danish diabetes care giant Novo Nordisk has launched its newest prefilled insulin delivery device Levemir FlexTouch (insulin detemir [rDNA origin] injection) in the USA. 19 June 2014
Pharmaceutical
The US subsidiary of German family-owned drugmaker Boehringer Ingelheim and pharma major Eli Lilly have resubmitted a New Drug Application for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for the treatment of adults with type 2 diabetes to the US Food and Drug Administration. 19 June 2014
Pharmaceutical
In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) now examined whether canagliflozin alone (monotherapy) or in combination with other blood-glucose lowering drugs offers an added benefit over the appropriate comparator therapy. 17 June 2014
Biosimilars
For the first time, US pharma major Eli Lilly and family-owned German major Boehringer Ingelheim presented data showing that LY2963016, the alliance's investigational new insulin glargine product, has a similar safety and efficacy profile to currently marketed insulin glargine (Lantus). 15 June 2014
Pharmaceutical
A new Phase IIIa study shows that IDegLira, the once-daily single injection combination of Danish diabetes care giant Novo Nordisk’s insulin degludec (IDeg) Tresiba and liraglutide (Victoza) for the treatment of adults with type 2 diabetes, maintained its glucose-lowering effect and safety profile for up to one year. 15 June 2014
Pharmaceutical
French pharma major Sanofi has released data from a pooled analysis, investigational therapy Toujeo (insulin glargine [rDNA origin] injection, 300U/mL), which consistently showed significantly fewer low blood sugar events at any time of day compared with its blockbuster diabetes drug Lantus (insulin glargine). 15 June 2014
Pharmaceutical
Patients enrolled in of four randomized Phase III studies who remained on Tanzeum/Eperzan (albiglutide), a once-weekly glucagon-like peptide (GLP-1) receptor agonist, continued to show blood glucose lowering at three years, consistent with results at the one year (52 week) primary endpoint, according to new data presented by UK pharma major GlaxoSmithKline at the American Diabetes Association (ADA) in San Francisco. 15 June 2014
Generics
Hepatitis C, diabetes and cancer are sustaining high pricing power through innovation according to Morningstar's June 2014 Healthcare Observer. 13 June 2014
Pharmaceutical
Largely attributable to the widespread adoption of insulin analogs, use of insulin among patients with type 2 diabetes increased from 10% in 2000 to 15% in 2010, and out-of-pocket expenditures per prescription increased from a median of $19 to $36, according to a study in the June 11 issue of the Journal of the American Medical Association (JAMA), a diabetes theme issue. 11 June 2014
Pharmaceutical
Up to 2022, Danish diabetes care giant Novo Nordisk expects to hire 6,000 new employees in Denmark, half of whom will work within research and development. The new jobs will have the derived effect of boosting employment by more than 15,000 jobs nationally. 11 June 2014
Biotechnology
The past year has been a very busy one for privately-held Dewpoint Therapeutics, a Boston firm founded in 2018 that focuses on the application of biomolecular condensate biology towards the development of a new generation of therapeutics to address diseases of high unmet need. 7 January 2025
Pharmaceutical
The type 1 diabetes (T1D) market across the seven major markets (7MM: USA, France, Germany, Italy, Spain, the UK, and Japan) is set to grow at a compound annual growth rate (CAGR) of 13.3% from $2.2 billion in 2023 to $9.9 billion in 2033. 2 January 2025
Generics
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
Generics
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
Novavax has agreed to sell its manufacturing plant in the Czech Republic to Novo Nordisk for $200 million. 6 December 2024
Pharmaceutical
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
Pharmaceutical
Eli Lilly has announced a $3 billion investment to expand its recently acquired manufacturing facility in Wisconsin, USA. 6 December 2024
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
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