Diabetes
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Pharmaceutical
Independent German drug major Boehringer Ingelheim and US partner Eli Lilly (NYSE: LLY) have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending approval of their diabetes drug Jentadueto, which combines the DPP-4 inhibitor, linagliptin (the active ingredient in Trajenta) and metformin in a single tablet. 28 May 2012
Pharmaceutical
French drug major Sanofi (Euronext: SAN) revealed this morning that it has inaugurated a new assembling and packaging line to produce its pre-filled insulin injection pen Lantus (insulin glargine) SoloSTAR at its Beijing, China, plant. 28 May 2012
Pharmaceutical
Japan's largest drugmaker, Takeda Pharmaceuticals (TYO: 4502), says its European subsidiary has received confirmation of the acceptance of the submission of a Marketing Authorization Application from the European Medicines Agency for alogliptin, a selective dipeptidyl peptidase IV inhibitor (DPP-4i) for the treatment of type 2 diabetes. 24 May 2012
Pharmaceutical
Denmark-based global insulin giant Novo Nordisk (NOV: N) says that the US Food and Drug Administration has approved Levemir (insulin detemir [rDNA origin] injection) for use in children aged two to five years with type 1 diabetes. 23 May 2012
Pharmaceutical
USA-based Ventac Partners and the Guangzhou Institute of Biomedicine and Health, Chinese Academy of Sciences (GIBH) have announced the creation of CASiGEN Pharma, with the aim of bringing new treatments for diabetes and other metabolic disorders to the global market. 21 May 2012
Pharmaceutical
Janssen Pharmaceuticals, a unit of health care major Johnson & Johnson yesterday announced the results of an investigational Phase III study suggesting that Nucynta ER (tapentadol) extended-release tablets were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful diabetic peripheral neuropathy (DPN). Results of the study were presented at the 31st Annual Scientific Meeting of the American Pain Society being held May 16-19 in Honolulu, Hawaii. 18 May 2012
Pharmaceutical
An international team of scientists say that they have a deeper understanding of why diabetics suffer from increased pain and temperature sensitivity, which may lead to new treatment for those side effects of diabetes. Their report appeared in the journal Nature Medicine, May 13. 14 May 2012
Pharmaceutical
The Pharmaceutical Management Agency of New Zealand, PHARMAC, is seeking feedback on a proposal to fund NovoMix 30 FlexPen and NovoSeven RT and to amend the listing for Glucagen Hypokit from July 1, 2012 through a provisional agreement with the supplier, NovoNordisk Pharmaceuticals, the local subsidiary of Danish insulin giant Novo Nordisk (NOV: N). 2 May 2012
Pharmaceutical
A combination of two diabetes drugs, metformin and rosiglitazone (the active ingredient of GlaxoSmithKline's Avandia, now virtually withdrawn from the market because of safety concerns), was more effective in treating youth with recent-onset type 2 diabetes than metformin alone, a study funded by the National Institutes of Health (NIH) has found. Adding an intensive lifestyle intervention to metformin provided no more benefit than metformin therapy alone. 30 April 2012
Pharmaceutical
Danish insulin giant Novo Nordisk (NOV: N) reported first-quarter 2012 results last Friday, with a 13% rise in sales to 17.8 billion Danish kroner ($3.16 billion; up 10% in local currencies), boosted by its operations in North American, where revenues grew 21%, and international operations (ie, excluding North America and Europe, up 24%. 30 April 2012
Pharmaceutical
Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) says it has received a complete response letter from the US Food and Drug Administration regarding New Drug Applications (NDAs) for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone (Actos). Takeda has previously received a CRL for the product and refilled its submission last year (The Pharma Letter July 27, 2011). 26 April 2012
Pharmaceutical
Across OECD countries some 83 million people suffer from diabetes and, on current trends, that will rise to almost 100 million by 2030. Like other chronic diseases, diabetes reduces employment opportunities and earnings. In addition, diabetics are prone to depression, making it difficult to follow treatment guidelines. 25 April 2012
Pharmaceutical
Danish diabetes specialist Novo Nordisk (NOV: N) says that its investigational ultra-long-acting insulin degludec showed a significant reduction in the rates of nocturnal hypoglycemia by 25%, compared to insulin glargine, according to two studies featured in the prestigious medical journal The Lancet. 23 April 2012
Biotechnology
There was a batch of good news for several drugmakers coming out of the discussion meetings last week of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), but also delivered a negative for Amsterdam Molecular. 22 April 2012
Generics
US drugmaker Depomed (Nasdaq: DEPO) says that it has completed a Type B pre-New Drug Application meeting with the US Food and Drug Administration regarding the results of the three Phase III clinical trials of Serada (extended-release gabapentin tablets), Depomed's investigational gastric-retentive, extended-release formulation of gabapentin for menopausal hot flashes. Based on the results of the meeting with the FDA, Depomed intends to prepare and file a new drug application with the FDA in the second half of 2012. 20 April 2012
Generics
The US Supreme Court yesterday reversed the US Court of Appeals for the Federal Circuit's April 2010 decision that dismissed Caraco Pharmaceutical's claim to change Danish insulin giant Novo Nordisk's (NOV: N) patent submissions regarding the combination use of Prandin (repaglinide) and metformin for the treatment of type 2 diabetes. 18 April 2012
Pharmaceutical
As part of an official Danish state visit to Kenya, global insulin giant Novo Nordisk (NOV: N) last week officially launched a program to make insulin and diabetes care more accessible to poor populations. 15 April 2012
Pharmaceutical
The development of new diabetes medications are now more-commonly the result of deals between companies, a new study by pharmaceutical intelligence expert GBI Research has revealed. 15 April 2012
Pharmaceutical
Although the drug metformin is considered the gold standard in the management of type 2 diabetes, a study by a group of French researchers published in this week's PLoS Medicine suggests that the long-term benefits of this drug compared with the risks are not clearly established - an important finding given that currently, thousands of people around the world are regularly taking metformin to help control their blood sugar levels in the belief that it also has long-lasting health benefits. 11 April 2012
Pharmaceutical
The US Food and Drug Administration has approved an update to the product label for Victoza (liraglutide [rDNA] injection), from Danish insulin giant Novo Nordisk (NVO: N), to include data showing superior blood sugar control and weight reduction when compared to Januvia (sitagliptin) from US drug major Merck & Co (NYSE: MRK). 10 April 2012
Pharmaceutical
Denmark’s Novo Nordisk and Valo Health today announced they have entered into an expanded agreement to discover and develop novel treatments for obesity, type 2 diabetes, and cardiovascular disease based on Valo’s extensive human dataset and computation powered by artificial intelligence (AI). 8 January 2025
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
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