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Generics
Denmark-based insulin giant Novo Nordisk (NOV: N) says that the US Court of Appeals for the Federal Circuit partially affirmed a 2011 District Court decision, with a two to one ruling that a claim in a company patent related to the use of repaglinide (trade name Prandin) in combination with metformin for the treatment of type 2 diabetes was invalid. This decision favors approval and launch of a generic repaglinide product. 19 June 2013
Pharmaceutical
Canada's Transition Therapeutics (TSX: TTH) announced this morning (June 17) that US drug major Eli Lilly (NYSE: LLY) has exercised its option to assume all development and commercialization rights to type 2 diabetes drug candidate TT-401, under their original deal signed in 2010 (The Pharma Letter March 4, 2010). In conjunction with this assumption of rights, Transition will receive a $7 million milestone payment. 17 June 2013
Biotechnology
Anglo-Swedish drug major AstraZeneca's (LSE: AZN) US biologics R&D subsidiary MedImmune has entered into an exclusive agreement with US venture capital backed NGM Biopharmaceuticals to discover, develop and commercialize novel therapeutics from NGM's enteroendocrine cell (EEC) program for the treatment of type 2 diabetes and obesity. 17 June 2013
Pharmaceutical
Danish Insulin giant Novo Nordisk (NOV: N) presented data further supporting the safety of Victoza (liraglutide [rDNA origin] injection) at a scientific workshop in the US arranged by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Cancer Institute (NCI). 14 June 2013
Pharmaceutical
The American Diabetes Association is asking all pharmaceutical companies involved in the development or marketing of incretin-based medications, used to lower blood glucose levels, to make patient-level data on their products available for an independent review that could help settle the question of whether such therapies contribute to the development of pancreatitis or pancreatic cancer. 12 June 2013
Pharmaceutical
A joint advisory committee to the US Food and Drug Administration (FDA) voted to continue to make UK pharma giant GlaxoSmithKline's (LSE: GSK) diabetes drug Avandia (rosiglitazone) available to appropriate patients with the majority of the 26 panel members voting to either modify (13) or remove (7) the Risk Evaluation and Mitigation Strategy (REMS) program in place. Remaining members voted to continue the REMS (5) or withdraw (1) Avandia from the US market. 7 June 2013
Pharmaceutical
Indian drugmaker Zydus Cadila today (June 5) made a breakthrough in its research efforts with Lipaglyn (saroglitazar), a novel drug targeted at treating diabetic dyslipidemia or hypertriglyceridemia in type 2 diabetes, not controlled by statins alone, gaining approval for launch in India by the Drug Controller General of India (DCGI). 6 June 2013
Pharmaceutical
UK biopharma company GW Pharmaceuticals (AIM: GWP), which is developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced financial results half year ended March 31, 2013, showing that total revenue £12.9 million ($19.6 million) compared to £11.1 million in first-half 2012. 5 June 2013
Pharmaceutical
Danish insulin giant Novo Nordisk (NOV: N) said today (May 31) that it has submitted a marketing authorization application to the European Medicines Agency for the approval of IDegLira, the combination product of insulin degludec (Tresiba, the once-daily new-generation basal insulin analogue, with an ultra-long duration of action, and liraglutide (Victoza, the once-daily human GLP-1 analogue. IDegLira has been developed for the treatment of people with type 2 diabetes. 31 May 2013
Pharmaceutical
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) today (May 30) issued a Final Appraisal Determination (FAD) for drug majors Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca's (LSE: AZN), first-in-class type 2 diabetes medicine Forxiga (dapagliflozin)., recommending use of the drug as a treatment option for adults with type 2 diabetes as dual therapy in combination with metformin, and in combination with insulin with or without other oral antidiabetic drugs. 30 May 2013
Biotechnology
Japanese drug major Mitsubishi Tanabe Pharma (TYO: 4508) said yesterday (May 27) that it has submitted an application for the manufacturing and marketing approval of TA-7284 (canagliflozin), a sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of patients with type 2 diabetes, to the Japanese Ministry of Health, Labor and Welfare. 28 May 2013
Pharmaceutical
Danish insulin giant Novo Nordisk (NOV: N) has released headline results from a 56-week double-blind Phase IIIa clinical trial investigating the potential of liraglutide, the active ingredient of its type 2 diabetes agent Victoza, to induce and maintain weight loss in people without diabetes who are obese or overweight with co-morbidities such as pre-diabetes, hypertension and dyslipidemia. 24 May 2013
Pharmaceutical
The US Food and Drug Administration yesterday (May 23) announced that it is allowing marketing of the Cobas Integra 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals, a product from Swiss drug major Roche (ROG: SIX). This is the first HbA1c test that the FDA has allowed to be marketed for this use. 24 May 2013
Pharmaceutical
Results of the INTERVAL study were published on line in The Lancet today (May 23) and for the first time demonstrated the feasibility of setting and achieving individualized treatment targets in elderly patients with type 2 diabetes. 23 May 2013
Pharmaceutical
Japanese drug major Takeda's (TYO: 4502) recently announced positive late-stage results for new type 2 diabetes drug, fasiglifam, has prompted excitement within the industry and raised hopes of reviving Takeda's diabetes treatment business, following last year's patent expiration of hit product Actos (pioglitazone). But as drugs continue to improve without the addressing the biggest unmet needs of the current therapy landscape, an analyst with research and consulting firm GlobalData asks, are we entering an era without blockbuster diabetes drugs? 23 May 2013
Pharmaceutical
Under the rules of the German Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute for Quality and Efficiency in Health Care (IQWiG) has now assessed additional information to studies for two drugs, US pharma behemoth Pfizer's (NYSE: PFE) Xalkori (crizotinib) and Drug major Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca's (LSE: AZN) Onglyza/Komboglyze (saxagliptin). 14 May 2013
Biotechnology
USA-based Unigene Laboratories (PINK: UGNE) has entered into an equity transfer and exclusive license agreement with Nordic Bioscience, involving three proprietary metabolic peptide analogs for type 2 diabetes, osteoarthritis and osteoporosis developed as part of a joint development vehicle (JDV) established by both companies in October 2011. 10 May 2013
Pharmaceutical
A new report by Visiongain predicts the world market for diabetes medications will reach $55.3bn in 2017. The antidiabetic medicines industry generated $35.6 billion in 2012, and its revenues will show strong growth to 2023. That sales forecast and others appear in Diabetes Treatments: World Drug Market 2013-2023. 8 May 2013
Pharmaceutical
French drug major Sanofi (Euronext: SAN) is considering expanding its presence in Ukraine this year, amid the ongoing growth of the local pharmaceutical market. 7 May 2013
Biotechnology
US pharma major Bristol-Myers Squibb (NYSE: BMY) says that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Sustiva (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5kg. 6 May 2013
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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