Data used to approve some drugs are in doubt after software issue | Alnylam's rare-disease drug patisiran shows promise in midstage trial | New bone marrow cancer drug trial to be launched in 2015
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October 16, 2014
DIA Global SmartBrief
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Data used to approve some drugs are in doubt after software issue
A European Medicines Agency official said regulators would meet next week to discuss an apparent software glitch involving Thermo Fisher Scientific's Kinetica package for analyzing bioequivalence, which could put the reliability of clinical tests used to obtain approval for some drugs in doubt. Some drugs could have been approved while others may have been denied approval or were never filed because of incorrect data. The possible problem may extend to drugs filed for approval in the U.S., the EU and beyond, though the scale of the problem has not been determined. Reuters (10/13)
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Alnylam's rare-disease drug patisiran shows promise in midstage trial
Alnylam said its RNA interference-based drug patisiran obtained encouraging results in a Phase II trial involving patients with familial amyloid polyneuropathy. Trial data showed there was less deterioration in muscle, autonomic and sensory function among 19 patients who took patisiran for six months compared with patients who did not receive treatment. American City Business Journals/Boston/BioFlash blog/Mass High Tech (10/13)
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New bone marrow cancer drug trial to be launched in 2015
Imperial College London researchers will start a clinical trial of a new multiple myeloma drug designed to kill a key module in the cancer cell without toxic effects. The drug will also be tested on patients with other blood cancers, as well as those with ovarian and colon cancer. The research is funded by the NIH, the Medical Research Centre and Cancer Research UK. Yahoo/The Press Association (U.K.) (10/13)
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Device, drug regulatory agencies in Bulgaria, Sweden get new leaders
The Bulgarian Drug Agency has appointed Assena Stoimenova as its new executive director, while the Medical Products Agency in Sweden has tapped Catarina Andersson Forsman to serve as its director general. The European Medicines Agency said Stoimenova and Andersson Forsman became members of its management board on Sept. 30 and Oct. 1, respectively. Clinica (subscription required) (10/14)
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Asia Pacific
India may require divestments to approve Sun-Ranbaxy merger
Before Ranbaxy Laboratories and Sun Pharmaceuticals will be allowed to complete their proposed merger, they may need to sell parts of their businesses. The Competition Commission of India is expected to suggest the companies apply "structural remedies," including selling key drug segments, to secure its approval. Business Standard (India) (10/15)
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Sanofi unit kicks off Phase III trials of rotavirus vaccine in India
Phase III trials have begun in India to test the efficacy of Sanofi subsidiary Shantha Biotechnics' rotavirus vaccine in preventing severe diarrhea in children. The vaccine was designed to prevent rotavirus infections that cause gastroenteritis. Reuters (10/14)
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North America
Final FDA guidance distinguishes device recalls from market withdrawals
Guidance outlining requirements for differentiating medical device recalls from market withdrawals has been finalized by the FDA. Apparently taking industry feedback into account, the final guidance revises how the terms "correction" and "removal" are defined. Manufacturers also will no longer be required to report device corrections or removals to the FDA but rather must keep records of them for two years. Regulatory Focus (10/14)
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Pentamer begins crowdfunding effort to raise funds for Ebola vaccine
U.S. biopharmaceutical firm Pentamer Pharmaceuticals has launched a crowdfunding campaign to raise money for its Ebola vaccine candidate NoBola amid lack of interest from traditional investors. Pentamer will use the money for vaccine characterization and efficacy trials of NoBola, which is currently in preclinical stage. BioSpectrum Asia (10/15)
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CDC develops faster laboratory test for detecting enterovirus
The CDC has designed a quick test for identifying enterovirus D68, a rare respiratory virus which has sickened hundreds of children across the country. The test would deliver results in just a few days compared with several weeks for other tests. Increases in confirmed cases of the disease following the introduction of the test "will not reflect changes in real time or mean that the situation is getting worse," according to the agency. The Hill (10/14), Reuters (10/14)
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Adoption of biosimilars could cut overall drug costs
A report released last month by Evaluate found that per-patient revenue for the top 100 drugs has increased sevenfold since 2010. The report cited possible reasons, including high costs of drug development, greater interest in drugs that target rare and orphan diseases and a lack of competition. Biosimilars have the potential to bring down costs significantly, according to the report, but the FDA has been slow to issue guidelines. American City Business Journals/Boston/bioflash blog/Mass High Tech (10/14)
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-- H.G. Wells,
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