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Pharmaceutical
Swiss drug major Roche (ROG: SIX) said yesterday that it will return its development and marketing rights for CSG452, a SGLT2 inhibitor, discovered by its majority owned Japanese subsidiary Chugai Pharmaceuticals (TYO: 4519) and in development for type 2 diabetes. 6 July 2011
Pharmaceutical
In a flurry of Japanese drug approvals over the last few days (see also The Pharma Letters July 1 and 4), UK pharma giant GlaxoSmithKline (LSE: GSK) gained clearance for its rotavirus vaccine from Japan's Ministry of Health, Labor and Welfare (MHLW) for use in infants to prevent gastroenteritis caused by rotavirus. 4 July 2011
Pharmaceutical
Japan's second largest drug company, Astellas (TYO: 4503), yesterday revealed that it will sell its patent estate relating to diabetes treatments, a non-core business for the firm, to US investment fund Royalty Pharma, for $609 million, thus shedding a non-core asset acquired with its hard fought for $4 billion takeover last year of USA-based OSI Pharmaceuticals (The Pharma Letter May 17, 2010). 1 July 2011
Pharmaceutical
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommending approval of German independent drugmaker Boehringer Ingelheim and US partner Eli Lilly' (NYSE:LLY) linagliptin, 5mg, film-coated tablets (to be marketed under the trade name Tradjenta in Europe) for the treatment of adults with type 2 diabetes. Tradjenta recently gained Food and Drug Administration approval and roll out of the drug in the USA began earlier this month (The Pharma Letter June 16). 27 June 2011
Pharmaceutical
There was a batch of good news coming out of the American Diabetes Association (ADA) 71st annual scientific meeting taking place over the weekend in San Diego, California. This including positive results for type 2 diabetes products from Novo Nordisk, AstraZeneca, Bristol-Myers Squibb and Sanofi. 27 June 2011
Pharmaceutical
In what was excellent news for all three companies following rejections of the drug by US regulators, US drug major Eli Lilly (NYSE: LLY), along with partners with Amylin Pharmaceuticals (Nasdaq: AMLN) and Alkermes (Nasdaq: ALKS), announced yesterday that the European Commission has granted marketing authorization for their type 2 diabetes drug Bydureon (exenatide 2mg powder and solvent for prolonged release suspension for injection). 22 June 2011
Pharmaceutical
US drug developer Concert Pharmaceuticals says that it has achieved a $4 million milestone in its strategic alliance with UK pharma giant GlaxoSmithKline (LSE: GSK) for its HIV protease inhibitor (HIV-PI) development program, as part of a two-year old accord that could generate a total of up to $1 billion for the US firm (The Pharma Letter June 2, 2009). 21 June 2011
Pharmaceutical
German independent drug major Boehringer Ingelheim has signed an exclusive global licence and collaboration agreement with Denmark's Zealand Pharma (Nasdaq OMX: ZEAL) for the latter's dual-acting glucagon and GLP-1 receptor agonists for the treatment of patients with type-2 diabetes and patients with obesity which could cost it as much as 376 million euros ($539.9 million). Shares in the Danish firm leapt an initial 13% but settled 8.4% higher at 8.4 Danish kroner on the news. 17 June 2011
Pharmaceutical
The latest bad news for Japan's largest drugmaker, Takeda Pharmaceutical (TYO: 4502) came last night with a warning from the US Food and Drug Administration that its blockbuster diabetes drug Actos (pioglitazone) when used for more than one year may be associated with an increased risk of bladder cancer. 16 June 2011
Pharmaceutical
German independent drug major Boehringer Ingelheim and USA-based Eli Lilly (NYSE: LLY) announced yesterday that their new type 2 diabetes drug Tradjenta (linagliptin) is now available by prescription in pharmacies across the USA including Walgreens, CVS, Rite Aid and many leading chain and independent pharmacies. 16 June 2011
Pharmaceutical
The US subsidiary of Belgian pharmaceutical manufacturer UCB SA (Euronext Brussels: UCB) last week pleaded guilty to the off-label promotion of its epilepsy drug Keppra (levetiracetam) and will pay more than $34 million to resolve criminal and civil liability arising out of its illegal conduct, the Department of Justice announced. 13 June 2011
Pharmaceutical
Sales of blockbuster diabetes drug Actos (pioglitazone), from Japan's leading drugmaker Takeda Pharmaceuticals (TYO: 4502), have been suspended in France by the regulatory agency, the Afssaps, on concerns about bladder cancer risks, albeit slight. 10 June 2011
Pharmaceutical
It was a good news day for US drug major Eli Lilly (NYSE: LLY) yesterday, as the firm received approval for new labeling for its Humalog (insulin lispro injection [rDNA origin]), and the US District Court for the Southern District of California ruled in Lilly's favor, vacating a temporary restraining order and denying a request by Amylin Pharmaceuticals (Nasdaq: AMLN) for a preliminary injunction that sought to impose restrictions on the Lilly Diabetes sales force and other relief. Amylin recently filed litigation involving the two companies' diabetes collaboration agreement (The Pharma Letter May 27). 9 June 2011
Biotechnology
Asterand (LSE: ATD), a provider of human tissue and cell-based services to pharmaceutical and biotechnology companies, has acquired an exclusive license on a worldwide basis from fellow UK-based, privately-held Capsant Neurotechnologies and the introduction of isletOrganDOT, a novel 3-D cell based assay platform for evaluating therapeutic compounds for diabetes. Financial terms were not revealed. 9 June 2011
Pharmaceutical
Tianyin Pharmaceutical (NYSE Amex: TPI), a China-based pharmaceutical company that specializes in patented biopharmaceutical medicine, modernized traditional Chinese medicine, branded generics and other pharmaceuticals, says it has received a production license for its anti-diabetic drug Gliclazide Tablets (80mg formulation) from China's State Food and Drug Administration (SFDA). 2 June 2011
Pharmaceutical
French drug major Sanofi (Euronext: SAN) announced today that new results from a Phase III study showed that the investigational product Lyxumia (lixisenatide), when used as an add-on therapy to basal insulin (in association with or without metformin), achieved its primary efficacy endpoint of significantly reducing HbA1c versus placebo for patients with type 2 diabetes without significantly increasing their risk of hypoglycemia. 1 June 2011
Pharmaceutical
In an initial win for US biotech firm Amylin Pharmaceuticals (Nasdaq: AMLN), the US District Court for the Southern District of California has issued a temporary restraining order (TRO) against drug major Eli Lilly (NYSE: LLY) relating to its litigation with respect to the two companies diabetes collaboration agreement established in 2002. 27 May 2011
Pharmaceutical
As part of a US Food and Drug Administration re-assessment of UK drug giant GlaxoSmithKline's troubled type 2 diabetes agent Avandia (rosiglitazone), the drug will be removed from US market pharmacy shelves in November and will only be available through a special program for those patients who need to continue with the therapy. 20 May 2011
Pharmaceutical
Expensive new cancer drugs treating increasing numbers of patients could drive cancer drug spending by as much as 15% a year through 2013. At this accelerated rate, oncology drugs will likely rise to the second or third largest trend-driving category by 2015, following only diabetes and central nervous system (CNS) treatments, according to the newly-released 2011 Medco Drug Trend Report which tracks utilization and spending. 19 May 2011
Pharmaceutical
San Diego, USA-based Amylin Pharmaceuticals (Nasdaq: AMLN) has filed a law suit against drug major Eli Lilly (NYSE: LLY) in the US District Court for the Southern District of California, alleging that Lilly is engaging in anticompetitive activity and breaching its strategic alliance agreements with Amylin to maximize commercialization of exenatide. 17 May 2011
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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