Diabetes
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By Barbara Obstoj-Cardwell. Editor
Teva Pharmaceuticals’ announcement on Monday that it will voluntarily suspend sales, marketing and distribution of its Zecuity migraine relief product will likely have little impact on the company, analysts have said. 19 June 2016
Pharmaceutical
Shares in Denmark's Novo Nordisk fell almost 5% to a three-month low on Tuesday, as new trial data revealed its diabetes drug Victoza (liraglutide) was not as effective as Eli Lilly's Jardiance (empagliflozin) at reducing the risk of death from heart attacks and strokes. 15 June 2016
Pharmaceutical
Eli Lilly and Boehringer Ingelheim have revealed new trial data showing that SGLT2 inhibitor Jardiance (empagliflozin) significantly reduces the progression of kidney disease in patients with type 2 diabetes and established cardiovascular (CV) disease. 15 June 2016
Pharmaceutical
French drugmaker Sanofi (EPA: SAN) has presented the first real world data on the use of Toujeo (insulin glargine injection 300 Units/mL) at the 76th Scientific Sessions of the American Diabetes Association (ADA) in New Orleans. 15 June 2016
Biotechnology
Johnson & Johnson (NYSE: JNJ) subsidiary Janssen has announced results from a Phase II study showing glycemic improvements in patients with type 1 diabetes (T1DM) who were treated with its SGLT2 inhibitor Invokana (canagliflozin). But in the same week the US Food and Drug Administration (FDA) upped its safety warnings on the drug. 15 June 2016
Pharmaceutical
French pharma major Sanofi has announced that two late-stage Phase III trials of its LixiLan diabetes drugs have met their primary endpoints. 14 June 2016
Pharmaceutical
The global type 2 diabetes market is set to almost double from $31.2 billion in 2015 to $58.7 billion by 2025, representing a compound annual growth rate (CAGR) of 6.5%. 9 June 2016
Pharmaceutical
Positive findings from a Phase IIIa clinical trial for semaglutide, an investigational glucagon-like peptide-1 (GLP-1) analogue, demonstrated that treatment with semaglutide, administered once-weekly, significantly improved glycemic control compared to insulin glargine U100 in adults with type 2 diabetes. 28 May 2016
Generics
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval at its May meeting. 27 May 2016
Pharmaceutical
The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) yesterday recommended the approval of the New Drug Application (for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. 26 May 2016
Pharmaceutical
The National Institute for Health and Clinical Excellence (NICE), the medicines cost-effectiveness watchdog for England and Wales, has today published final guidance recommending three drugs for treating type 2 diabetes. 25 May 2016
Pharmaceutical
The US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) yesterday voted 16-0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes. 25 May 2016
Pharmaceutical
In a presentation to the investment community today, US pharma major Eli Lilly said it has the potential to launch 20 new products in the 10 years beginning in 2014 and extending through 2023. 24 May 2016
Pharmaceutical
Staffers at the US Food and Drug Administration (FDA) have questioned the efficacy of Sanofi’s experimental diabetes drug iGlarLixi. 24 May 2016
Pharmaceutical
A US Food and Drug Administration (FDA) advisory panel briefing document has questioned the effectiveness of IDegLira, Novo Nordisk’s insulin degludec (IDeg) Tresiba and liraglutide (Victoza) treatment for type 2 diabetes mellitus (T2DM). 23 May 2016
Biotechnology
Israel’s Oramed has announced positive top-line results from a Phase IIb study to test the safety and efficacy of its oral insulin capsule (ORMD-0801) in patients with type 2 diabetes. 19 May 2016
Biotechnology
A new UK company called Islexa has been created by the Cell and Gene Therapy Catapult (CGT) and University of Aberdeen to develop a novel technology to treat diabetes. 18 May 2016
Pharmaceutical
Serious, sometimes life-threatening and fatal cases of diabetic ketoacidosis (DKA) have been reported in patients on sodium glucose co-transporter 2 (SGLT2) inhibitors for type 1 and type 2 diabetes, warns medicines regulator Health Canada. 17 May 2016
Biotechnology
Stephen O’Hara is chief executive of OptiBiotix Health, a UK-based biotech which has been interesting big pharma recently with its Lactobacillus plantarum strain, a statin-free cholesterol pill. He spoke to the Pharma Letter... 4 May 2016
Pharmaceutical
Danish diabetes care giant Novo Nordisk (NOV: N) plans to meet the entire demand of Russia for insulin over next few years, according to Kenneth Mortensen, vice president of Novo Nordisk, who is the director of the Russian factory in Kaluga. 2 May 2016
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
Pharmaceutical
Anglo-Swedish drugmaker AstraZeneca beat analyst expectations with its third-quarter 2024 revenue and earnings figures. 12 November 2024
Biotechnology
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
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