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Pharmaceutical
Following a positive European Medicines Agency advisory committee recommendation two is months ago, Independent German drugmaker Boehringer Ingelheim and partner US major Eli Lilly (NYSE: LLY) yesterday received marketing authorization from the European Commission for Trajenta (linagliptin) 5mg film-coated tablets for the treatment of adults with type 2 diabetes. 26 August 2011
Pharmaceutical
Diabetes prescriptions now account for 8.4 per of the entire National Health Service net bill for primary care drugs in England, a new report from The NHS Information Centre shows today. The percentage increase in the total cost of prescriptions for the condition was four times that in prescription cost overall between 2005/6 and 2010/11 - taking the cost of diabetes prescribing to 725 million ($1.2 billion) in 2010/11. 24 August 2011
Pharmaceutical
KalVista Pharmaceuticals launched with 8 million funding to develop drugs for diabetic macular edema
With backing from life sciences investors Novo A/S and SV Life Sciences, KalVista Pharmaceuticals, a new ophthalmology company with a focus on diabetic macular edema (DME) and based in Southampton, UK, has raised 8 million ($13.3 million) in a series A financing round. 24 August 2011
Pharmaceutical
US drugmakers Santarus (Nasdaq: SNTS) and Depomed (Nasdaq: DEPO) have entered into a new commercialization agreement for type 2 diabetes treatment Glumetza (metformin hydrochloride extended release tablets) under which Santarus will assume broad commercial, manufacturing and regulatory responsibilities to replace a promotion agreement that the companies entered into in July 2008. 23 August 2011
Pharmaceutical
Most surveyed physicians in Europe expect to increase Rxing of GLP-1 analogues and DPP-IV inhibitors
Almost all surveyed physicians in each of the top European Union countries (France, Germany, Italy, Spain and the UK) currently prescribe GLP-1 analogues and DPP-IV inhibitors for the treatment of type 2 diabetes, according to a new study from advisory firm Decision Resources. 18 August 2011
Pharmaceutical
Findings from a new study published on-line in the Journal of Medical Economics suggest that, in the USA, adherence to oral anti-diabetic medications is improved for Medicare Part D beneficiaries who receive their medication via mail service. 14 August 2011
Pharmaceutical
US drugmakers Amylin Pharmaceuticals (Nasdaq: AMLN), Eli Lilly (NYSE: LLY) and Alkermes (Nasdaq: ALKS) said yesterday that the US Food and Drug Administration has acknowledged their resubmission of the New Drug Application for the type 2 diabetes drug candidate Bydureon (exenatide extended-release for injectable suspension), and has assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012. 12 August 2011
Pharmaceutical
Type 2 diabetes patients, who face higher risk of cardiovascular disease, often take a combination of medications designed to lower their low-density lipoprotein (LDL) or "bad" cholesterol and triglyceride levels while raising their high-density lipoprotein (HDL) or "good" cholesterol because doctors long have thought that taken together, the drugs offer protection from heart attacks and improve survival. 11 August 2011
Pharmaceutical
New York, USA-based Intercept Pharmaceuticals has entered into a worldwide ex-USA and Japan agreement with privately-owned French drugmaker Laboratoires Servier for the discovery and development of novel TGR5 agonists for the treatment of type 2 diabetes and other metabolic indications. The collaboration will leverage Intercept's drug discovery platform based on its proprietary bile acid analogue chemistry and expertise targeting TGR5 and other bile receptors. 10 August 2011
Pharmaceutical
Danish insulin giant Novo Nordisk (NVO: N) posted first-half 2011 sales of 31.69 billion Danish kroner ($6.11 billion), a rise 9% (+11% in local currencies), driven by strong performances from the firm's latest diabetes drug offering Victoza (liraglutide) and modern insulins NovoRapid and Levemir (insulin detemir). 4 August 2011
Pharmaceutical
Given the suspension of use in France and Germany and ongoing deliberations at the US Food and and Drug Administration and European Medicines Agency on cancer risk concerns (The Pharma Letters passim), use of Japanese drug major Takeda's (TYO: 4502) blockbuster type 2 diabetes drug Actos (pioglitazone) will continue to decrease, but most expect to increase their prescribing of DPP-IV inhibitors and GLP-1 agonists, according to a new report available on companiesandmarkets.com. 1 August 2011
Biotechnology
US biotech Amylin Pharmaceuticals (Nasdaq: AMLN), drug major Eli Lilly (NYSE: LLY) and partner Alkermes (Nasdaq: ALKS) yesterday submitted their reply to a complete response letter issued in October 2010 by the US Food and Drug Administration regarding their investigation type 2 diabetes drug Bydureon (exenatide extended-release for injectable suspension). 29 July 2011
Pharmaceutical
Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) says it has resubmitted two New Drug Applications to the US Food and Drug Administration for alogliptin and the fixed-dose combination therapy alogliptin and the firm's currently marketed type 2 diabetes drug Actos (pioglitazone). 27 July 2011
Generics
Backed by factors like patent expiration of drugs and aging population, the US generics market will expand at a compound annual growth rate (CAGR) of 10% during 2010-2013, says a new report from market analysts RNCOS. 23 July 2011
Pharmaceutical
Yesterday saw a batch of recommendations from the European Medicines Agency's advisory body, including on: Takeda's (TYO: 4502) Actos (pioglitazone) and other brands with the same active ingredient; GlaxoSmithKline's (LSE: GSK) flu vaccine Pandemrix and Pfizer's (NYSE: PFE) smoking cessation product Champix (varenicline). 22 July 2011
Generics
US pharma giant Merck & Co (NYSE: MRK) has signed a framework agreement with leading Chinese drugmaker Simcere Pharmaceuticals (NYSE: SCR) to establish a joint venture focused on serving China's rapidly expanding health care needs by providing significantly improved access to quality medicines in major therapeutic areas. Setting up of the JV is subject to satisfying certain agreed to closing conditions. 22 July 2011
Pharmaceutical
The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee yesterday voted to not recommend approval of Anglo-Swedish drug major AstraZeneca (LSE: AN) and US partner Bristol-Myers Squibb's (NYSE: BMY) New Drug Application for their investigational type 2 diabetes drug dapagliflozin. 20 July 2011
Pharmaceutical
Ahead of an advisory panel meeting scheduled for tomorrow (July 19) to discuss US drug major Bristol-Myers Squibb (NYSE; BMY) and Anglo-Swedish AstraZeneca's (LSE: AZN) New Drug Application for their diabetes drug candidate dapagliflozin, the US Food and Drug Administration issued briefing papers suggesting that, while it is seen to be effective, the drug may increase the risk of bladder and breast cancer. 18 July 2011
Pharmaceutical
Following a recent positive recommendation from the European Medicine Agency's advisory panel, Bristol-Myers Squibb today announced that the European Commission has approved US drug major Bristol-Myers Squibb's (NYSE: BMY) Yervoy (ipilimumab) for the treatment of adult patients with previously-treated advanced melanoma (The Pharma Letter May 23). 15 July 2011
Pharmaceutical
Amylin Pharmaceuticals (Nasdaq: AMLN), Eli Lilly (NYSE: LLY) and Alkermes (Nasdaq: ALKS) have announced results from a thorough QT (tQT) study that assessed the potential of their type 2 diabetes drug candidate Bydureon (exenatide extended release) to increase the QT interval across a wide range of plasma concentrations. 11 July 2011
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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