Latest News in the pharma Industry
Policy & Regulation
EMA Recommends Restricting Use of Multaq
23 Sep 2011
Due to an increased risk of liver, lung and cardiovascular adverse events, Multaq should only be prescribed after alternative treatment options have been considered.
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EMA Starts Review of Orlistat-containing Medicines
23 Sep 2011
The EMA is reviewing relevant data on the risk of hepatotoxicity of orlistat-containing medicines and will issue an opinion on whether or not the marketing authorisations should be revoked, suspended or changed.
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EMA Recommends Discontinuation of Vimpat Syrup
23 Sep 2011
The recommendation follows the voluntary recall of Vimpat 15mg/ml syrup on 15 September 2011. The recall was initiated because of a quality defect in some batches leading to uneven distribution of the active substance lacosamide in the syrup.
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NIH to Facilitate License Agreements of Medical Technologies
21 Sep 2011
NIH is reducing both the cost and paperwork requirements for start-up companies to obtain an exclusive option agreement to license the extensive patents and patent applications from research laboratories.
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FDA Probes into GlaxoSmithKline's Zofran
21 Sep 2011
The investigation is focused around active ingredient ondansetron. It is feared that the ingredient could cause QT interval prolongation, potentially leading to abnormal heart rhythms.
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FDA Grants Orphan Drug Designation to Avedro's VibeX
19 Sep 2011
The FDA has granted orphan drug designation to Avedro's VibeX solution for use with its KXL System for corneal cross-linking to treat keratoconus.
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EU Approves Marketing Authorisation for Zytiga
8 Sep 2011
The approval comes after an accelerated regulatory review process by the European Medicines Agency (EMA) and a positive CHMP opinion.
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India's Pharmacy Council to Regulate Sale of Un-prescribed Drugs by Pharmacists
8 Sep 2011
With this move, the number of drugs sold over the counter (OTC) in pharmacies may come down in the near future.
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Healthcare Reform May Have Larger Impact on Pharma than Expected
7 Sep 2011
A report says the post-2016 U.S. pharmaceutical industry revenue impact of the Affordable Care Act will be 20 percent, which is larger the 3 percent estimates that were widely circulated before.
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Novartis Drug Gains EU Approval to Treat Pancreatic Neuroendocrine Tumours
6 Sep 2011
The European Commission has approved Afinitor? (everolimus) tablets for the treatment of neuroendocrine tumors of pancreatic origin in adults with progressive disease.
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FDA Issues Draft Guidance to Industry on Tablet Scoring
6 Sep 2011
The FDA has issued a draft of guidance to the pharmaceutical industry on Tablet Scoring: Nomenclature, Labelling, and Data for Evaluation.
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FDA Grants Fast-track Designation to Aicuris Human Cytomegalovirus Drug
5 Sep 2011
The US FDA has granted fast track status to AiCuris' HCMV drug Letermovir.
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