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Pharmaceutical
Among a batch of recommendations resulting in meetings last week from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) was one for US drug major Eli Lilly's (NYSE: LLY) erectile dysfunction drug Cialis (tadalafil), for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in the European Union. 24 September 2012
Pharmaceutical
The worldwide insulin market was worth nearly $12.48 billion in 2011 and is expected to reach USD almost $32.35 billion in 2018, growing at a compound annual growth rate (CAGR) of 12% from 2011 to 2018, according to a new market report published by Transparency Market Research. 20 September 2012
Biotechnology
The overall global market for translational regenerative medicine will reach a value of $1.4 billion in 2012. That revenue forecast and others appear in Translational Regenerative Medicine Market Prospects 2012-2022, published by Visiongain, a business information provider based in the UK. 12 September 2012
Generics
Ireland headquartered Shire (LSE: SHP), NASDAQ: SHPG) says that its lead regenerative medicine product, Dermagraft (human fibroblast-derived dermal substitute) has received approval from medicines regulator Health Canada as a class IV medical device for the treatment of diabetic foot ulcers (DFUs), a complication of diabetes. 6 September 2012
Pharmaceutical
New data revealed yesterday by Swiss drug major Novartis (NOVN: VX) showed that Lucentis (ranibizumab) has demonstrated improvement in visual acuity achieved with individualized treatment after one year is maintained for up to three years on average in patients with visual impairment due to diabetic macular edema (VI-DME), with fewer injections in years two and three compared to the first year and no additional or new safety risks identified. 6 September 2012
Biotechnology
Specialist physicians surveyed in the USA and Europe are generally opposed to pharmacy-level automatic substitution of branded biologics for biosimilars, according to the findings of BioTrends Research, a unit of advisory firm Decision Resources. 5 September 2012
Pharmaceutical
Danish insulin giant Novo Nordisk (NOV: N) revealed on Friday that its ultra-long-acting insulin degludec has passed the review by Japan's Ministry of Health, Labor and Welfare (MHLW) advisory committee. The remaining step in the regulatory process will now be an official approval from the MHLW. 3 September 2012
Generics
The Food and Drug Administration is withdrawing approval of 27 Abbreviated New Drug Applications (ANDAs) held by Indian drugmaker Ranbaxy Laboratories (AB: BO). The drugs are no longer marketed, and Ranbaxy has requested that the approval of the applications be withdrawn. Ranbaxy's shares rose 4.1% to 534.50 rupees by close of trading yesterday. 23 August 2012
Pharmaceutical
Coverage of injectable type 2 diabetes therapies by public programs for pharmaceutical assistance in Brazil is limited to regular and NPH (neutral protamine Hagedorn) insulin and does not include any insulin analogues or Glucagon-like peptide 1 (GLP-1) analogues, notes a new report from health care advisory firm Decision Resources. 22 August 2012
Pharmaceutical
German family-owned drug major Boehringer Ingelheim and US partner and Eli Lilly (NYSE: LLY) said on Friday that the US Food and Drug Administration has approved a supplemental New Drug Application for Tradjenta (linagliptin) tablets for use as add-on therapy to insulin. 20 August 2012
Generics
The US subsidiary of Ranbaxy Laboratories (AB: BO), India's largest drugmaker, has launched authorized generic pioglitazone hydrochloride tablets in the US market, under an agreement with the local subsidiary of originator Japanese drug major Takeda Pharmaceuticals (TYO: 4502), which markets the type 2 diabetes drug as Actos, which generated total annualized US sales of $2.7 billion, according to IMS Health data for the 12 months to June. 20 August 2012
Generics
US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) says it has filed suit against the US Food and Drug Administration challenging the agency's decision regarding Watson's entitlement to shared exclusivity for its copy version of Japanese drug major Takeda Pharmaceutical's (TYO: 4502) blockbuster type 2 diabetes drug Actos (pioglitazone hydrochloride 15mg, 30mg and 45mg tablets). 16 August 2012
Pharmaceutical
USA-based Unigene Laboratories (OTCBB: UGNE) and privately-held Danish firm Nordic Bioscience have selected their lead compound for type 2 diabetes under the companies' established Joint Development Vehicle (JDV). 16 August 2012
Pharmaceutical
Diabetes prescriptions in England have for the first time topped the 40 million level in year, a rise of nearly 50% on six years ago, Health and Social Care Information Centre (HSCIC) figures show. The net cost of diabetes drugs also rose by just under 50%in the same period, according to Prescribing for Diabetes in England: 2005/06 to 2011/12. 15 August 2012
Biotechnology
Anglo-Swedish drug major AstraZeneca (LSE: AZN) said yesterday that, following Bristol-Myers Squibb's (NYSE: BMY) completion of the acquisition of Amylin Pharmaceuticals (The Pharma Letter July 2), it has made an initial payment of about $3.2 billion to Amylin, now a wholly-owned subsidiary of B-MS. The move also resulted in US drug major Eli Lilly (NYSE: LLY) to revise its guidance as a result of early payment of financial obligations to Amylin. 10 August 2012
Pharmaceutical
Denmark's Novo Nordisk, the world's largest insulin producer, this morning posted financial results for the second quarter of 2012, showing that earnings before interest and tax (EBIT) rose to 7.65 billion Danish kroner ($1.27 billion), a leap of 45% compared with 5.27 billion kroner in the like quarter year ago and beating an average 6.65 billion kroner forecast in a Reuters poll of analysts. The company's shares rose 5.2% to 975.50 kroner in early trading. 9 August 2012
Pharmaceutical
Researchers at Washington University School of Medicine in St Louis, USA, have identified a potential target for treating diabetes and obesity. Studying mice, they found that when the target protein was disabled, the animals became more sensitive to insulin and were less likely to get fat even when they ate a high-fat diet that caused their littermates to become obese. The findings are published on-line in the journal Cell Metabolism. 5 August 2012
Pharmaceutical
UK-based Diabetology Limited and Mumbai, India-based USV Limited, which has a leadership position in the Indian oral anti-diabetic market, have entered into a licence agreement to complete the development and commercialization of Diabetology's oral insulin for the Indian market. 1 August 2012
Pharmaceutical
San Diego, USA-based CoDa Therapeutics says that it raised an additional $20 million from RusnanoMedInvest (RMI), a subsidiary of Russia's RusNano, in a second close of its Series B financing round. 30 July 2012
Pharmaceutical
Independent German drug major Boehringer Ingelheim and US partner Eli Lilly (NYSE: LLY) received Marketing Authorisation from the European Commission for Jentadueto, which combines the DPP-4 inhibitor linagliptin and metformin in a single tablet, which the coma]panes say will provide a new, single-tablet treatment option, taken twice-daily, for adults with type 2 diabetes. 26 July 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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