Diabetes
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Pharmaceutical
Patients with both type 1 diabetes and chronic kidney disease (CKD) have an increased risk of adverse outcomes. Despite aggressive treatment, many patients with type 1 diabetes and overt nephropathy develop end-stage renal disease (ESRD) and/or succumb to a premature death. The competing risks of death and ESRD may confound the estimates of risk for each outcome. 22 February 2011
Pharmaceutical
Danish insulin giant Novo Nordisk says it has received a subpoena from the office of the US Attorney for the District of Massachusetts calling for the production of documents regarding potential criminal offences relating to the company's marketing and promotion practices for its diabetes treatments NovoLog (insulin aspart [rDNA origin] injection), Levemir (insulin detemir [rDNA origin] injection) and Victoza (liraglutide). 16 February 2011
Pharmaceutical
Researchers at the Children's Hospital Boston in the USA have discovered a mechanism for normalizing blood sugar that does not involve insulin and could offer a new therapeutic approach to both kinds of diabetes. 16 February 2011
Pharmaceutical
Strong diabetes growth will not be enough to stop the cardiovascular and metabolic market from declining, according to independent market analyst Datamonitor. 10 February 2011
Pharmaceutical
More and more Western pharmaceutical producers are considering establishing their production capacities in Uzbekistan, the former Soviet state, located in Central Asia. 9 February 2011
Pharmaceutical
The Brazil government will provide free medicine for diabetes and hypertension to Brazilians, starting from mid-February, the country's new President Dilma Rousseff announced last week, according to the Xinhau news agency. 7 February 2011
Pharmaceutical
French drug major Sanofi-Aventis (Euronext: SAN) announced that the GetGoal-X Phase III study of lixisenatide, a once-daily GLP-1 receptor agonist licensed from Denmark's Zealand Pharma (OMX: ZEAL), achieved its primary endpoint of non-inferiority in HbA1c reduction from baseline, compared with exenatide (Eli Lilly and Amylin's Byetta) twice-daily. 3 February 2011
Pharmaceutical
French drugmaker Ipsen (Euronext: IPN) suffered a significant setback yesterday, when Swiss major Roche (ROG: VX) informed the group of its decision to return rights to the diabetes drug candidate taspoglutide to Ipsen. The drug was touted as having a sales potential of $2 billion a year, and the news saw Ipsen's share fall as much as 4%. 3 February 2011
Pharmaceutical
New research has been published indicating that patients suffering from a painful complication of diabetes may experience a significant improvement in their pain as measured by a pain intensity scale when using an investigational pain medication. 31 January 2011
Pharmaceutical
Shares of US drugmaker MannKind (Nasdaq: MNKD) plunged nearly 50% to $5.21 on Wednesday, after the company revealed that US approval of its inhalation powder for hyperglycemia, Afrezza, could not be approved at this time. 21 January 2011
Pharmaceutical
Danish insulin giant Novo Nordisk (NVO: N) revealed this morning that Judge Avern Cohn of the US District Court for the Eastern District of Michigan issued an adverse ruling in a patent litigation case regarding Novo Nordisk's US Patent No 6,677,358 relating to its type 2 diabetes drug Prandin (repaglinide). The company intends to appeal this ruling and is evaluating its best options for doing so. 20 January 2011
Pharmaceutical
In an announcement to the London Stock Exchange yesterday, pharma giant GlaxoSmithKline (LSE: GSK) revealed that it expects to take a legal charge for the fourth quarter of 2010 of a record-breaking 2.2 billion ($3.49 billion) - equal to an after tax cost of 1.8 billion). The news saw GSK's shares fall 2% in afternoon trading yesterday, before closing the day down 1.6% at 12.05. 18 January 2011
Pharmaceutical
French drug major Sanofi-Aventis (Euronext: SAN) has cleared one hurdle in its quest to acquire US biotech firm Genzyme (Nasdaq: GENZ), with the European Commission yesterday approving the deal on competition grounds. 13 January 2011
Pharmaceutical
Germany's largest independent pharmaceutical firm Boehringer Ingelheim and US drug major Eli Lilly (NYSE: LLY) yesterday announced a global agreement to jointly develop and commercialize a portfolio of anti-diabetic compounds currently in mid- and late-stage development for the fast-growing diabetes market. 12 January 2011
Pharmaceutical
Japanese drug major Astellas Pharma (TSE: 4503) says that it has engaged Citigroup Global Markets to conduct, in conjunction with executive management, a review of the company's strategic alternatives with regard to its Prosidion subsidiary, which was acquired as part of Astellas' $4 billion purchase of USA-based OSI Pharmaceuticals last year (The Pharma Letter May 4, 2010). 11 January 2011
Pharmaceutical
US FDA delays AstraZeneca's vandetanib NDA for three months; combo diabetes drug Kombiglyze launched
Anglo-Swedish drug major AstraZeneca (LSE: ANZ) announced last Friday that the US Food and Drug Administration has extended by three months the time to complete its review of the New Drug Application for the firm's metastatic medullary thyroid cancer (MTC) drug candidate vandetanib. 10 January 2011
Pharmaceutical
The US Food and Drug Administration disappointed two US drugmakers last week as it wannounced that it needs more time to assess MannKind Corp's (Nasdaq: MNKD) New Drug Application for Afrezza (insulin human [rDNA origin]) inhalation powder and issued a complete response letter (CRL) for Cephalon's (Nasdaq: CEPH) Nuvigil (armodafinil) NDA. 4 January 2011
Pharmaceutical
In a deal that will cost it $57.5 million, Danish insulin giant Novo Nordisk (NYSE: NVO) has entered into an exclusive agreement to develop and commercialize oral formulations of its insulins, which have the potential of treating diabetes, using USA-based Emisphere's (OTC BB: EMIS) Eligen technology. It also entered into a technology accord with Ireland's Merrion Pharmaceuticals. 22 December 2010
Generics
Japan's largest drugmaker, Takeda Pharmaceutical (TYO: 4502), and its US subsidiary have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications for generic Actos (pioglitazone HCl), ACTOplus met (pioglitazone HCl and metformin HCl) and duetact (pioglitazone HCl and glimepiride). Takeda filed the law suits to enforce several patents that expire in 2016 relating to these antidiabetic drugs. 22 December 2010
Pharmaceutical
US drug giant Merck & Co (NYSE: MRK) says it has entered into a definitive agreement under which it will acquire SmartCells, a private company developing a glucose responsive insulin formulation for the treatment of diabetes mellitus, that could eventually earn the latter more than $500 million. 3 December 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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