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Home » Authors » T.V. Padma

Articles by T.V. Padma

India continues to struggle with new drug research & development

Feb. 5, 2015
By T.V. Padma
HYDERABAD, India – India may have a proven track record developing generics, but it is limping far behind other countries in the discovery and development of new drugs, areas which call for entirely new skill sets and investments.
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EU regulator urges suspension of Indian CRO over data concerns

Feb. 4, 2015
By T.V. Padma
NEW DELHI, India – The EMA has recommended suspending the Hyderbad-based contract research organisation (CRO) GVK Biosciences on charges of data manipulation, a decision that once again shines a spotlight on the issue of Western drug firms outsourcing clinical trials to CROs to cut costs.
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EU regulator urges suspension of Indian CRO over data concerns

Jan. 29, 2015
By T.V. Padma
NEW DELHI, India – The EMA has recommended suspending the Hyderbad-based contract research organisation (CRO) GVK Biosciences on charges of data manipulation, a decision that once again shines a spotlight on the issue of Western drug firms outsourcing clinical trials to CROs to cut costs.
Read More

India approves HCV drug Sovaldi, rejects Gilead's patent filing

Jan. 21, 2015
By T.V. Padma
NEW DELHI – In twin developments, an Indian patent office rejected U.S.-based Gilead Sciences Inc.'s patent application for its blockbuster hepatitis C virus (HCV) drug Sovaldi (sofosbuvir), leaving the door open for low-cost generic versions of a drug that is currently out of reach of most Indian patients. However, the court also granted regulatory approval for the drug, making India the first Asian country to do so.
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India approves HCV drug Sovaldi, rejects Gilead's patent filing

Jan. 20, 2015
By T.V. Padma
NEW DELHI – In twin developments, an Indian patent office rejected U.S.-based Gilead Sciences Inc.'s patent application for its blockbuster hepatitis C virus (HCV) drug Sovaldi (sofosbuvir), leaving the door open for low-cost generic versions of a drug that is currently out of reach of most Indian patients.
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India continues controversial drug trade agreement, IP talks as patients protest

Dec. 31, 2014
By T.V. Padma
NEW DELHI – India's attempts to enter into a Regional Comprehensive Economic Partnership (RCEP) deal among 16 countries in Asia are likely to have a significant impact on the biopharma industry, but analysts are divided as to what that will be.
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India continues its controversial drug trade agreement, IP talks as patients protest

Dec. 30, 2014
By T.V. Padma
NEW DELHI – India’s attempts to enter a Regional Comprehensive Economic Partnership (RCEP) deal among 16 countries in Asia are likely to have a significant impact on the biopharma industry, but analysts are divided as to what that will be.
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New initiatives in India proposed to strengthen medical device industry

Dec. 29, 2014
By T.V. Padma

India's first compulsory license stands; Bayer loses Nexavar appeal

Dec. 24, 2014
By T.V. Padma
NEW DELHI – India's Supreme Court has dismissed German multinational Bayer AG's appeal against attempts to make and sell cheaper generic versions of its cancer drug, Nexavar (sorafenib tosylate), used to treat liver and rectal cancers.
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India's first compulsory license stands; Bayer loses Nexavar appeal

Dec. 23, 2014
By T.V. Padma
NEW DELHI – India's Supreme Court has dismissed German multinational Bayer AG's appeal against attempts to make and sell cheaper generic versions of its cancer drug, Nexavar (sorafenib tosylate), used to treat liver and rectal cancers.
Read More
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