Intas plans to join U.S. biosimilar market | Bayer plans major R&D investment | Despite obstacles, Merck bets on Russian growth
June 23, 2015
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Intas plans to join U.S. biosimilar market
Mumbai-based Intas Pharmaceuticals is seeking to introduce its first biosimilar in the U.S. within the next year. The company's version of filgratsim is on the market in Europe, and its biosimilar of Lucentis is sold in India. The Economic Times (India) (6/21)
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Bayer plans major R&D investment
Bayer has announced that it will spend more than $4.5 billion in research and development this year, with $2.5 billion of that amount devoted to its new blood thinner Xarelto. Bayer spent about $4 billion last year on R&D. Reuters (6/19)
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Despite obstacles, Merck bets on Russian growth
Merck plans to increase its workforce in Russia from 220 to more than 300 by the end of the year and hopes to beat its 2014 mark of $167 million in Russian sales. The company is confident that it can weather Russia's high inflation rates as well as possible Western sanctions. To meet demands for greater domestic drug production, Merck is partnering with Russia's largest drug manufacturer, Pharmstandard. The Moscow Times (6/18)
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Asia Pacific
Asia-Pacific bioscience market grew 11% in 2014, survey says
The Asia-Pacific bioscience market grew by 11% last year, reaching $193.46 billion, according to a BioSpectrum survey that included China, India, Australia, South Korea, Malaysia, Singapore and Taiwan. China and India lead the market, representing more than three-quarters of 2014 revenue from publicly listed companies. BioSpectrum Asia (6/22)
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India moves to strengthen drug inspections
India's Central Drug Standards Control Organization plans to add 147 inspectors by the end of the year to ensure that drugmakers are meeting internationally recognized Good Manufacturing Practices. The CDSCO has also conducted a number of workshops to increase the expertise of its inspection staff and maintain the quality of pharmaceutical exports. (India) (6/22)
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North America
243 charged in $712M Medicare, Medicaid fraud sweep
An eight-year, nationwide health care fraud crackdown resulted in 243 people being charged Thursday in connection with $712 million in alleged false Medicare and Medicaid claims, the Department of Justice announced. Forty-six licensed medical professionals were arrested in the health care fraud sweep, which is said to be the largest in the Justice Department's history. Miami remains a fraud hot spot, with 73 defendants charged with filing nearly $263 million in false Medicare claims. Arrests were also made in Brooklyn, N.Y., Los Angeles, Tampa, Fla., New Orleans, Detroit, Houston, Dallas and McAllen, Texas. The Washington Post (tiered subscription model) (6/18), Reuters (6/18), The Associated Press (6/18)
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FDA confiscates illegal drugs, devices offered online
online pharmaceuticals
(JAY DIRECTO/Getty Images)
The FDA confiscated unapproved drugs and medical devices being sold online at international mail facilities in New York, Miami and Chicago as part of Interpol's International Internet Week of Action combating the online sale of counterfeit medical products. The FDA sent warning letters and seized items from more than 1,050 websites. Unapproved products seized include dermal fillers, colon care products and drugs claiming to be generics of such FDA-approved drugs as Valium, Truvada and Advair. Reuters (6/18)
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Final guidance: Generics should be physically similar to originals
New guidance from the FDA calls for generic drugs to be of a similar shape and size to the originals, as well as their tablet coating, surface area, weight and disintegration time. New generics submitted using an abbreviated drug application are subject to the guidance. Regulatory Focus (6/18)
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Appeals court rules against Teva in patent case
The U.S. Court of Appeals for the Federal Circuit once again ruled to invalidate Teva Pharmaceutical Industries' patent for its Copaxone treatment for patients with multiple sclerosis. The court was asked by the Supreme Court to reconsider a previous ruling to invalidate the patent. The ruling, which was announced Thursday, opens opportunities for drugmakers to release a generic version. Reuters (6/18)
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447 experimental therapies are in pancreatic cancer pipeline
The development pipeline for pancreatic cancer includes 447 potential therapies in active development, and about a quarter have gone past Phase I studies, according to a report from GBI Research. Only 4% are in late-stage trials. While small molecules remain the major area of research, "drug developers are seeking novel approaches to pancreatic cancer treatment that differ from the present market," analyst Joshua Libberton said. BioSpectrum Asia (6/18)
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