Embrace the eCTD and stay ahead
As one door closes, businesses must look for their next opening. Today, the traditional strongholds of the pharmaceutical industry, the US and Europe, are witnessing a downturn in growth to around 6% a year. This is the result not only of problems in the broader economy, but also the loss of marketing exclusivity by products in a number of major therapeutic categories; lower contributions from new products because of increased scrutiny of their value; and slower take-up by doctors and healthcare systems.
FDA Announces Measures to Improve Generic Drug Access
The Food and Drug Administration (FDA) im March 2004 announced that it will provide more information to the public to help generic drug applicants determine if they are eligible for 180-day marketing exclusivity for their products. This period of marketing exclusivity is generally provided to the first generic drug that challenges a patent for the innovator product.
Targeted Therapy Cancer Brands - High growth market will see eight new blockbusters by 2017
Targeted therapies are the top selling class of cancer drug, reaching sales of nearly $15 billion in the seven major pharmaceutical markets in 2007. The high growth of this therapy class makes it attractive to drug developers, resulting in 10 new entrants to the market since 2005. More drugs are likely to gain approval in the near future, contributing to a rapidly changing competitive landscape.
A RARE HERB OF MADHYA PRADESH HAVING PIVOTAL IMPORTANCE IN FOLK REMEDIES
Kotlaiya is an important medicinal plant of the ancient system of healing. It is type of kantkāri, a medicinal plant widely used in Āyurveda in the treatment of respiratory diseases. It has been described as white variety of kantkārī. The present paper reviews the pharmacognosy, phytochemistry and traditional uses of the herb.
Multiple Sclerosis - Tysabri to prevail despite safety setbacks
Spurred by uptake of Biogen Idec and Elan's Tysabri (natalizumab) and continued revenue growth for the three beta-interferon brands and Teva's Copaxone (glatiramer acetate), the seven major multiple sclerosis market value increased 15.1% from 2006 to $5.3 billion in 2007.
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Regulatory Affairs Support for EU and USA
In collaboration with Regulanet network of regulatory affairs consultants throughout Europe and USA, we keep daily contacts and communication with National Agencies for Medicines and Medical Devices. Beside regulatory we also maintain understanding of the business, scientific and technical background of products.
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