Article Listing - Teva sales for full-year 2000 reach $1.75 billion as Copaxone forges ahead
Japanese launches of subcutaneous injection forms of Pralia and Enbrel, and of Acofide
11 June 2013
Among a bunch of Japanese drug launches in the past couple of days, Daiichi Sankyo (TYO: 4568) announced the debut of the osteoporosis treatment Pralia (denosumab, genetic recombinant) subcutaneous injection 60mg syringe, which was approved in Japan for manufacture and marketing on March 25, 2013, and placed on National Health Insurance drug price list, May 24.
Canada announces new medical marijuana regulations
11 June 2013
Canada's Health Minister Leona Aglukkaq has announced new regulations that will change the way Canadians access marijuana for medical purposes. The new Marijuana for Medical Purposes Regulations (MMPR) will be published in the Canada Gazette on June 19, 2013.
Negative FDA news for AVEO's tivozanib and Dynavax' hep B vaccine
11 June 2013
US biotech firm AVEO Oncology (Nasdaq: AVEO) says that it has received a complete response letter from the US Food and Drug Administration saying that the FDA will not approve in its present form the New Drug Application for the company's investigational agent tivozanib for the treatment of patients with advanced renal cell carcinoma (RCC).
Elan board unreservedly rejects Royalty's increased tender offer
11 June 2013
Ireland-based drugmaker Elan Corp (NYSE: ELN) says that its board of directors, after careful review and consideration and with the assistance of its executive management team as well as outside financial and legal advisors, has rejected the revised bid from privately held investment firm Royalty Pharma to acquire all of the shares of Elan for $13.00 plus up to an additional $2.50 per share in contingent value rights (CVR; The Pharma Letter June 10).
Emerging targeted therapies offer advantages over currently-used platinum-resistant ovarian cancer drugs
11 June 2013
The effect of an emerging therapy on key efficacy endpoints, including time to disease progression and overall survival, has the most influence over surveyed US and European oncologists' prescribing decisions for platinum-resistant advanced ovarian cancer, according to a new report from health care advisory firm Decision Resources.
Zambon to acquire UK respiratory specialist Profile Pharma
10 June 2013
Family-owned Italian drugmaker Zambon has taken a significant step to grow in the respiratory therapy area, with the planned acquisition of UK-based Profile Pharma from present owner the Philips Group. Financial details of this transaction will not be disclosed.
Licensing deals between Xenon and Isis for XEN701, and Access and AMAG for MuGard
10 June 2013
USA-based Isis Pharmaceuticals (Nasdaq: ISIS) revealed that privately-held Canadian firm Xenon Pharmaceuticals has exercised its option to an exclusive worldwide license to XEN701, an antisense drug discovered in a collaboration between Isis and Xenon.
Alliance Boots and Walgreens expansion into China an "obvious next step," says EIU analyst
10 June 2013
Following the news that Alliance Boots and the USA's Walgreen, which initially took a 45% stake in the UK-based retailer and pharmaceutical wholesaler for $6.7 billion, with an option to buy the remainder (The Pharma Letter June 20, 2012), plan to expand into China, Ana Nicholls, healthcare analyst at The Economist Intelligence Unit, commented: "China is the obvious next step for Boots and Walgreen, now that they dominate the US and European markets.
EMA initiates consultation on guideline on biosimilars containing biotechnology-derived proteins
10 June 2013
The European Medicines Agency today (June 10) released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance for a six-month public consultation. The document lays down the non-clinical and clinical requirements for marketing authorization of a biosimilar claiming to be similar to a biological product already marketed.
Irish Medicines Board drawing up list of generic drugs to help reduce costs
10 June 2013
In Ireland, drugs to treat medical conditions such as high cholesterol, blood pressure and stomach ulcers will be the first to be subjected to new generic substitution regulations in a bid to bring down costs, reports the Irish Independent newspaper.
- US Supreme Court says patent settlement can "sometimes" be illegal
- InSite Vision joins Merck & Co and Pfizer in patent infringement law suit against
- Highlights of EHA meeting: Novartis' Jakavi; Bristol-Myers and AbbVie's elotuzumab; Janssen's ibrutinib
- Daiichi Sankyo files for Japanese approval of Prasugrel
- Osteoporosis drug bazedoxifene stops growth of breast cancer cells, even in resistant tumors
