Diabetes
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Pharmaceutical
Denmark's Novo Nordisk (NOV: N), the world's largest insulin maker, says that the US Food and Drug Administration has told the company that an FDA Advisory Committee meeting is tentatively scheduled to be held on November 8, 2012 to discuss the New Drug Applications for the ultra-long-acting insulin Tresiba (insulin degludec) and insulin combination analogue Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes. 19 July 2012
Pharmaceutical
The majority of type 2 diabetes patients in Brazil and Mexico rely heavily or entirely on government-sponsored medical programs to cover their treatment costs. However, most public health care programs in Mexico do not provide coverage for DPP-IV inhibitors, and public coverage for these drugs in Brazil is nonexistent, notes a new report from Decision Resources. 19 July 2012
Pharmaceutical
The critical role of a receptor called c-Kit in the development and function of insulin-producing beta cells, has been identified by scientists from Western University in London, Canada, and the Children's Health Research Institute, an Institute within the Lawson Health Research Institute, making it an exciting therapeutic target for the management of diabetes. 18 July 2012
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) says that positive data from the Phase III Harmony 8 study and from the event driven meta-analysis for assessment of cardiovascular safety conducted across the albiglutide clinical program are the final elements required to complete the clinical registration package for its type 2 diabetes drug candidate. 12 July 2012
Biotechnology
German biotech firm Evotec AG (EVT: TecDAX) has licensed to Janssen Pharmaceuticals, a unit of US health care giant Johnson & Johnson (NYSE: JNJ), a portfolio of small molecules and biologics designed to trigger the regeneration of insulin-producing beta cells. 10 July 2012
Pharmaceutical
The widely used diabetes drug metformin comes with a rather unexpected and alluring side effect: it encourages the growth of new neurons in the brain. The study reported in the July 6 issue of Cell Stem Cell also finds that those neural effects of the drug also make mice smarter. 8 July 2012
Pharmaceutical
Russia's ChemRar Hi-Tech Centre, a pharmaceutical investment and R&D group, said yesterday that global drugs behemoth Pfizer (NYSE: PFE) has granted exclusive development and marketing rights to SatRx for its DPP(1)-IVi compound, PF-00734200. 6 July 2012
Pharmaceutical
Japanese drugmakers Otsuka Pharmaceutical (TYO: 4578) and Kyowa Hakko Kirin (TYO: 4151) have entered into an agreement to pursue a strategic alliance in the fields of diabetes and oncology. 3 July 2012
Biotechnology
Having rejected a media reported $22 a share offer from the company earlier this year, US biotech firm Amylin (Nasdaq: AMLN) has now accepted a cash $31 per share takeover bid from the same drug major, Bristol-Myers Squibb (NYSE: MBY), it was announced late last Friday. B-MS has been seeking to enhance its product portfolio to replace its top selling drug, Plavix (clopidogrel; co-marketing with originator France's Sanofi), which is now facing generic competition. 2 July 2012
Pharmaceutical
US health care giant Johnson & Johnson's (NYSE: JNJ) European subsidiary Janssen-Cilag International NV (Janssen) has submitted a Marketing Authorisation Application to the European Medicines Agency for the use of canagliflozin, an investigational, oral, once-daily sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of adult patients with type 2 diabetes. 27 June 2012
Generics
French drug major Sanofi (Euronext: SAN) and the Joslin Diabetes Center, a teaching and research affiliate of Harvard Medical School, USA, have entered a new collaboration to promote the development of new drugs for the treatment of diabetes and related disorders. 20 June 2012
Pharmaceutical
Danish insulin giant Novo Nordisk (NOV: N) is partnering with the US charitable organization JDRF to discover and develop novel immunotherapies to prevent, treat, and help cure the disease. The collaboration between JDRF and Novo Nordisk will focus on research originating from academia and biotechnology companies, as well as from internal research projects at Novo Nordisk. 14 June 2012
Biotechnology
Rhythm raises $25 million to fund diabetes and obesity drugs development 14 June 2012
Pharmaceutical
Non-insulin dependent (type 2) diabetes accounts for 90% of all diagnosed cases of diabetes. The leading non-insulin antidiabetic Actos (pioglitazone, from Takeda and Eli Lilly) will lose its patent exclusivity in August 2012, offering significant market opportunities for competing generics, according to a new from Global Information. 13 June 2012
Pharmaceutical
Ongoing news from the American Diabetes Association meeting in Philadelphia (see also The Pharma Letter June 11) provided updates on French drug major Sanofi's (Euronext: SAN) already marketed diabetes drug Lantus (insulin glargine) and Eli Lilly (NYSE: LLY) and German independent drugmaker Boehringer Ingelheim's LY2605541. 13 June 2012
Pharmaceutical
French drug major Sanofi (Euronext: SAN), has submitted a marketing authorization application for lixisenatide (the proposed trade name in Europe is Lyxumia) to Japan's Ministry of Health, Labor and Welfare. Lixisenatide is a once-daily investigational GLP-1 agonist, invented by Denmark's Zealand Pharma (Nasdaq OMX Copenhagen: ZEAL) and licensed to Sanofi for the treatment of type 2 diabetes. 11 June 2012
Pharmaceutical
The weekend saw a flood of new data on diabetes drug candidates and currently approved treatments presented at the 72nd Annual Scientific Sessions of the American Diabetes Association (ADA) in Philadelphia, highlights of some of which follow. 11 June 2012
Pharmaceutical
The US Food and Drug Administration has extended the regulatory review period for the ultra-long-acting insulins degludec and insulin degludec/insulin aspart for the treatment of type 1 and type 2 diabetes, under development by Denmark's Novo Nordisk (NOV: N). 8 June 2012
Biotechnology
Genzyme, a subsidiary of French drug major Sanofi (Euronext: SAN) today reported top-line results from the Phase III TOWER study (n=1169) showing that once-daily treatment with teriflunomide (proposed trade name Aubagio) 1mg produced a statistically significant reduction in annualized relapse rate (36.3%, p<0.0001) and risk of sustained accumulation of disability (31.5%, p=0.0442) as measured by EDSS in patients with relapsing forms of multiple sclerosis. 1 June 2012
Pharmaceutical
Although the death toll is relatively low for people who suffer from traumatic brain injury (TBI), it can have severe, life-long consequences for brain function. TBI can impair a patient's mental abilities, impact memory and behavior, and lead to dramatic personality changes. And long-term medical treatment carries a high economic cost. 30 May 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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