Diabetes
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Pharmaceutical
French drug major Sanofi-Aventis (Euronext: SAN) has announced the top-line results of the Phase III GETGOAL-L-ASIA study assessing the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist, in combination with basal insulin, showing that its product significantly improved glycemic control. The study also confirmed that there are no specific safety concerns with lixisenatide in patients with type 2 diabetes. The drug is licensed from Danish firm Zealand Pharma. 1 October 2010
Pharmaceutical
UK-based GW Pharmaceuticals (GWP: AIM) has commenced the first of a program of Phase IIa exploratory clinical trials exploring its cannabinoids as potential treatments in the field of type 2 diabetes and metabolic syndrome. This study program follows promising preclinical research results and comprises at least three small-scale clinical trials evaluating various metabolic parameters. 1 October 2010
Pharmaceutical
Positive results from a randomized, double-blind Phase III clinical study of Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca's (LSE: AZN) dapagliflozin in adults with type 2 diabetes inadequately controlled on metformin therapy alone were presented last week at the 46th European Association for the Study of Diabetes (EASD) annual meeting held in Stockholm, Sweden. 26 September 2010
Pharmaceutical
GlaxoSmithKline (LSE: GSK) suffered a double dose of bad news yesterday, when the European Medicines Agency (EMEA) decided to withdraw the marketing approval of UK pharmaceutical giant's diabetes drug Avandia (rosiglitazone) on the grounds of much-publicized cardiac risks. Also, the US Food and Drug Administration issued a statement saying it would 'significantly restrict' the use of Avandia to those diabetics who cannot control their condition with alternative medicines, so stopping short of a total ban. 24 September 2010
Pharmaceutical
New Phase III data presented this week at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Stockholm, Sweden, found that German independent drug major Boehringer Ingelheim's investigational linagliptin therapy resulted in significant reductions in blood sugar as measured by hemoglobin A1c (HbA1c) when compared to placebo, both when added to sulfonylurea (SU) in inadequately controlled type 2 diabetes (T2D) patients, and when administered as monotherapy in T2D patients for whom metformin is inappropriate. 23 September 2010
Pharmaceutical
The continued uptake of key agents such as Merck & Co's Januvia (sitagliptin), Amylin/Eli Lilly's Byetta (exenatide) and Lilly/Amylin/Alkermes' Bydureon (a once-weekly version of exenatide) will drive the type 2 diabetes drug market to nearly double from $19 billion in 2009 to $36 billion in 2019 in the USA, France, Germany, Italy, Spain, UK and Japan, according to new research from advisory firm Decision Resources. 23 September 2010
Pharmaceutical
The European Association for the Study of Diabetes heard presentations on progress with Danish insulin major Novo Nordisk's (NVO.N) Victoza (liraglutide), UK-based AstraZeneca (LSE: AZN) and US firm Bristol-Myers's Squibb's (NYSE: BMY) investigational compound dapagliflozin and French drug major Sanofi-Aventis' (Euronext: SAN) lixisenatide. 21 September 2010
Biotechnology
The US Food and Drug Administration says it has begun a safety review of Japanese drug major Takeda Pharmaceutical's (TSE: 4502) diabetes type 2 drug Actos (pioglitazone), after receiving preliminary results from a long-term observational study funded by the company designed to evaluate the risk of bladder cancer associated with use of this drug. 20 September 2010
Pharmaceutical
Canada's Transition Therapeutics that a clinical study of gastrin analogue TT-223 in combination with an Eli Lilly (NYSE: LLY) proprietary GLP-1 analogue in patients with type 2 diabetes did not meet its efficacy endpoints. Given these findings, there will be no further development of TT-223. 20 September 2010
Pharmaceutical
The UK's National Institute for Health and Clinical Excellence (NICE), issued its Final Appraisal Determination (FAD) today, supporting the use of Danish insulin giant Novo Nordisk's Victoza (liraglutide) for patients with type 2 diabetes under the National Health Service. This is not a surprise as an earlier preliminary opinion from the NICE also favored approving the drug (The Pharma Letter June 15). 10 September 2010
Pharmaceutical
Santarus (Nasdaq: SNTS) has entered into a distribution and license agreement with fellow USA-based companies S2 Therapeutics and VeroScience granting Santarus exclusive rights to manufacture and commercialize Cycloset (bromocriptine mesylate) tablets in the USA. 10 September 2010
Pharmaceutical
Despite an expert panel of the UK Medicines and Healthcare products Regulatory Agency (MHRA) calling for its use to be suspended a couple of months ago, GlaxoSmithKline's (GSK: L) diabetes drug Avandia (rosiglitazone) is still available on the National Health Service, a BBC television program has revealed. The continued debate about the drug - along with criticism from the British Medical - Journal, caused GSK's shares to fall 1.5% yesterday to 12.49, even before the program was aired. 7 September 2010
Pharmaceutical
In contrast to previous reports, the risks of the composite endpoint of heart attack, heart failure, both, or death were the same - about 4% - for patients taking the diabetes drugs Avandia (rosiglitazone) from UK pharma giant GlaxoSmithKline (GSK: L) or Actos (pioglitazone) from Takeda (4502.TO), Japan's largest drugmaker, according to a study published in the American Heart Association journal Circulation: Cardiovascular Quality and Outcomes. 25 August 2010
Pharmaceutical
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a reminder for health care professionals about current advice for the use of rosiglitazone (UK drugs giant GlaxoSmithKline's Avandia, Avandamet) in the treatment of diabetes and has highlighted contraindications for the use of saquinavir. 11 August 2010
Pharmaceutical
US firm Targacept has acquired worldwide rights to fellow USA-based Cornerstone Therapeutics' nicotinic-receptor based patents and library of preclinical compounds that target the alpha-7 or other nicotinic receptors originally licensed to Cornerstone from the Feinstein Institute for Medical Research. 4 August 2010
Pharmaceutical
USA-based drugmaker MannKind received a boost last week when the US Food and Drug Administration accepted response to the complete response letter (CRL) issued by the agency on its inhaled insulin candidate, Afrezza (insulin human [rDNA origin]), which is being developed for treating type 1 and type 2 diabetes. 26 July 2010
Pharmaceutical
The European Medicines Agency (EMEA) announced yesterday that it is still reviewing GlaxoSmithKline's controversial diabetes drug Avandia (rosiglitazone), which has been linked to cardiovascular side effects - though recommended for continuation of marketing by a Food and Drug Administration advisory panel earlier this week (The Pharma Letter July 21). The EMEA said it will recommend whether or not the drug should stay on the market by September. 23 July 2010
Pharmaceutical
In a joint study, scientists from the USA-based Scripps Research Institute and the Dana-Farber Cancer Institute at Harvard University have uncovered a novel mechanism that dramatically increases insulin sensitivity and reduces the risk of developing type 2 diabetes and cardiovascular disease. 23 July 2010
Pharmaceutical
The US Food and Drug Administration yesterday informed UK drug giant GlaxoSmithKline), that the post-marketing trial known as TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation) relating to the firm's controversial diabetes drug Avandia (rosiglitazone) has been placed on partial clinical hold. 22 July 2010
Pharmaceutical
Pfizer, the world's largest drugmaker by sales, had another disappointment for its R&D efforts, announcing yesterday that, at the request of the US Food and Drug Administration, it has suspended the chronic low back pain and painful diabetic peripheral neuropathy studies in the clinical program for the investigational compound tanezumab. Investigation of the compound continues in some areas of high unmet medical need, including cancer pain. 20 July 2010
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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