Article Listing - Japam's Daiichi Sankyo quietly expanding in the USA as others downsize
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.
Arthritis drug disappointment: will fostamatinib's failure force pharma back to the drawing board?
10 June 2013
Recent news of fostamatinib's latest failure to meet clinical endpoints marks yet another blow to an already weakened rheumatoid arthritis (RA) therapeutics pipeline, and may drive manufacturers to investigate fresh approaches to drug development, says an analyst with research and consulting firm GlobalData.
Regulatory briefs: Sanofi's Fluzone; Roche' RoActemra; Takeda's Rienso
10 June 2013
French pharma major Sanofi (Euronext: SAN) today (June 10) announced that the US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for Fluzone Quadrivalent vaccine or use in children six months of age and older, adolescents, and adults. Fluzone Quadrivalent vaccine includes two A strains and two B strains for protection against influenza disease. The Fluzone Quadrivalent vaccine will be available to health care providers in the USA for the 2013-2014 influenza season in prefilled syringes and single-dose vials for intramuscular administration.
New Zealand to fund AstraZeneca's Brilinta for acute coronary syndromes
10 June 2013
New Zealand's Pharmaceutical Management Agency, PHARMAC, says it has reached an agreement with the local subsidiary of Anglo-Swedish drug major AstraZeneca (LSE: AZN) to fund the company's antiplatelet agent ticagrelor (Brilinta).
AstraZeneca to pay up to $1.15 billion to acquire Pearl Therapeutics
10 June 2013
In a further "strategic" bolt-on acquisition for Anglo-Swedish drug major AstraZeneca (LSE: AZN) in less than a month, the company revealed this morning (June 10) that it has entered into a definitive agreement to buy Pearl Therapeutics, a privately held company based in Redwood City, California, focused on the development of inhaled small-molecule therapeutics for respiratory disease, for a total cost of up to $1.15 billion.
Royalty Pharma hikes offer for Elan to $13 a share, plus CVR of up to $2.50
10 June 2013
Ireland-based Elan Corp (NYSE: ELN) saw its shares to 5.3% to $13.35 by mid morning last Friday (June 7), when hostile bidder Royalty Pharma said that it was increasing its offer for the Irish company) to $13.00 per share in cash plus a contingent value right (CVR) worth up to $2.50 per share, up from the earlier May raised offer of $12.50, that Elan's board rejected as grossly inadequate, but considerably higher than the original $11 proposed in February (The Pharma Letters passim).
Gilead gains FDA priority review for hep C candidate sofosbuvir; new data on Boehringer's faldaprevir
10 June 2013
US biotech firm Gilead Sciences (Nasdaq: GILD) revealed on Friday (June 7) that the US Food and Drug Administration has granted priority review to the company's New Drug Application for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection.
EU Pharma leaders call for right balance between health care budget and economic growth objectives
10 June 2013
The Executive Committee of the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing RD based drugmakers, met in Paris, France, last week, for discussions focused on how the industry can best respond to the financial crisis in a spirit of partnership with European governments, while striking the right balance between the objectives of securing rapid patient access to innovative medicines, controlling public health expenditure and preserving a stable, predictable and attractive environment for research and manufacturing investments.
- FDA probes two deaths possibly linked to Lilly's antipsychotic Zyprexa Relprevv
- US Supreme Court says patent settlement can "sometimes" be illegal
- Negative US patent ruling for Novo Nordisk on Prandin
- Daiichi Sankyo files for Japanese approval of Prasugrel
- Osteoporosis drug bazedoxifene stops growth of breast cancer cells, even in resistant tumors
