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Policy & Regulation - Intellectual Property
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US court invalidates Lilly's Gemzar method-of-use patent
30 July 2010
A US appeals court has upheld a previous ruling invalidating Lilly's method-of-use patent for its anticancer, Gemzar (gemcitabine HCl for injection). The ruling is expected to clear the path for the entry of cut-price generic versions of Gemzar ...
US judge sets August hearing on Sanofi-Aventis' bid to halt Lovenox generic
28 July 2010
A US federal judge has decided to hold a hearing on 17 August relating to Sanofi-Aventis 's lawsuit, which "seeks a temporary restraining order and a preliminary injunction requiring [the US] FDA to withdraw its approval" of the ANDA for Sandoz ...
FDA approval of generic Lovenox sparks debate and lawsuit
27 July 2010
The US FDA approval of the first generic version of Sanofi-Aventis's Lovenox (enoxaparin sodium) to Novartis ' generics arm Sandoz, which uses technology from Momenta Pharmaceuticals , has caused a buzz because the agency has treated the application ...
Suspected fake drugs on the rise in the EU
27 July 2010
Medicines that are suspected of infringing intellectual property rights (IPRs) are making up a larger proportion of goods detained by EU customs officials, according to the latest statistics from the European Commission. EU customs authorities ...
FDA turns down NicOx's lead drug naproxcinod for osteoarthritis
23 July 2010
NicOx 's lead drug candidate, the anti-inflammatory agent naproxcinod, has been turned down by the FDA for the treatment of osteoarthritis. The agency has required the company to conduct further studies, including a long-term safety study, if it ...
 
Rare diseases in the Middle East: prospects for CROs
28 July 2010
The treatment of rare diseases in Europe has been significantly enhanced by the EU's Orphan Drug Regulation and by raised levels of public awareness, thanks largely to the activities of interest ...
Simplifying dose regimens - new clarity in patenting procedures
13 July 2010
Recent legislative changes and court rulings have resulted in a simpler and more coherent approach to the patenting of new dosage regimens in Europe. Mark Chacksfield looks at the history of the ...
Are we near a telehealth tipping point?
30 June 2010
Telehealth is the use of IT to diagnose, treat and/or monitor a patient in a different physical location from the expert providing the care. At present, it is only targeted towards a segment of acute ...
 
Interview: Croatia's state insurer changes its role to raise efficiency
19 July 2010
Croatia's HZZO main responsibilities include setting drug prices, selecting reimbursable products and reimbursement. The institute uses France, Italy and Slovenia as reference countries for setting ...
Connexios: Harnessing the Indian cost advantage in network biology
01 June 2010
Imagine if a start-up company could afford to hire enough high-calibre scientists to spend years creating a detailed map of a broad and complex pathology like metabolic disease, incorporating large ...
European generics industry throws its weight behind IMPACT
08 April 2010
The emergence of counterfeit medicines in the European Union and indeed globally is a serious problem for the pharmaceutical industry. Generally counterfeiters target high-value products that are ...
 
AstraZeneca judgement changes the rules for dominant companies
07 July 2010
On 1 July 2010 the EU General Court handed down its judgement in the long-running saga of AstraZeneca's proton pump inhibitor anti-ulcer product Losec (omeprazole). Although dealing with events that happened almost two decades ago, the case – ...
Commentary: Japanese concessions could pave the way to EU trade pact
07 May 2010
The high-level summit between Japan and the EU in Tokyo last week produced little in the way of substantive progress, at least according to a reading of the publicly released material from the meeting. There was a general agreement to talk some ...
Editorial: ECJ ruling a blow for advertising regulations but safeguards MS autonomy
28 April 2010
Public health authorities now have the green light to offer financial incentives to doctors for prescribing lower-cost drugs, thanks to a European Court of Justice ruling on EU advertising legislation. This seems rather bizarre given that the same ...
 
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