Latest News in the pharma Industry

Policy & Regulation

EMA Recommends Discontinuation of Vimpat Syrup

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

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

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

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

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

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

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

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

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

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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FDA Urged to Revise Regulations on Generic Drug Labelling

FDA Urged to Revise Regulations on Generic Drug Labelling

2 Sep 2011

FDA currently prevents generic drug makers to update labels even if they are made aware of an unstated risk to the consumer, as they must remain identical to the original brand-name product.

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Roche’s Tarceva Receives European Approval

Roche’s Tarceva Receives European Approval

2 Sep 2011

This approval will enable the use of Tarceva as a first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR (epidermal growth factor receptor) activating mutations.

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