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European regulators prepare for advanced therapies

Roche's Actemra faces further delay in US for RA

Friday 5 December 2008

The US approval of Roche's novel biological rheumatoid arthritis drug Actemra (tocilizumab) has been further delayed after the FDA requested that Roche submit a risk evaluation and mitigation strategy (REMS) plan as well as additional preclinical studies.

Latest News

Pancreatic enzyme products should warn of pig virus risks, US panel says

Labelling for Solvay's Creon (pancrelipase delayed-release) and other pancreatic enzyme products (PEPs) that are approved as drugs should warn about the potential human risks from swine viruses, a US FDA advisory panel unanimously recommended on December 2nd.
Thursday 4 December 2008

Philippines implements new cheaper medicines law

The Philippines has now finalised the implementing rules and regulations for the cheaper medicines legislation it passed earlier this year after lengthy debate. The rules clarify how the new law should be applied in practice and there is no change to its basic provisions.
Thursday 4 December 2008

Evotec collaborates with Novartis on drug discovery

Evotec is to receive more than $28 million through a drug discovery collaboration with Novartis for novel small molecule therapies. Under the three-year deal, Evotec will develop the molecules up to preclinical development and then Novartis will take them through clinical development to commercialisation.
Thursday 4 December 2008

High prices restrict access to drugs in low-income countries

The availability of essential medicines for public healthcare in low-income countries is very limited and patients have to buy drugs in the private sector at far higher prices, despite such countries'pharma spending accounting for 20–60% of healthcare budgets.
Thursday 4 December 2008

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Features & Analysis

Ian Schofield - Analyst Editorial: Shaking the antitrust stick

The European Commission has finally presented its preliminary report on why competition is not working as it should in the EU pharmaceutical sector. Is it an indictment of widespread anticompetitive activity by originator companies, or simply a compendium of figures and selective quotations that fails to address the real issues affecting access to medicines?
Editorial - December 2008

Stock Tracker Scrip Pharma and Biotech Stock Tracker - October 2008

In Scrip's Stock Tracker for October, US reporter Christopher Spillane reviews the impact of recent political intervention and global turmoil on both the capital markets in general and the 15 biopharmaceuticals stocks followed in this monthly feature.
Stock Tracker - October 2008

Market Insights What Obama's victory means for pharma

The new US President will push to get more Americans covered by health insurance, which should mean more unit sales of pharmaceuticals. But he also will attack drug pricing, so that higher volume may not equal higher profits, reports Daniel B Moskowitz
Market Insight - 21 November 2008

Ian Schofield - Analyst EU experts assess the role of biocides in antibiotic resistance

Could washing the dishes or applying make-up be contributing to the rise in antibiotic resistance? This is the worrying prospect raised by an advisory committee to the European Commission...
Ian Schofield - 14 November 2008

More Analysis

Blog

MicroRNA – a technology to rival RNAi?

One of the hot topics in drug discovery at the moment is microRNA (miRNA). MicroRNAs are short pieces of single-stranded RNA, about 21-23 bases long, that bind to matching sequences of messenger RNA, thereby rendering them double-stranded and inhibiting the production of the corresponding protein.
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Posted 01/12/2008 15:43:18 PM
by Dr Peter Charlish,
Analyst

Sir Alan Sugar's firm targets messages to doctors' waiting rooms

Doctors waiting rooms full of nervous patients are soulless places, but their mood may soon be lightened in the UK by digital screens displaying health messages from Amscreen Healthcare, a new digital signage company from the well-known serial UK entrepreneur and TV personality, Sir Alan Sugar.
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Posted 01/12/2008 10:55:31 AM
by John Davis,
Managing Editor

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