Articles by Stephanie Sutton - BioPharm International

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Articles by Stephanie Sutton

European Commission Consults on Pharmacovigilance

Sep 20, 2011

The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission?s 2010 amended pharmacovigilance legislation.

Pfizer Completes Tender Offer For Icagen

Sep 13, 2011

Pfizer has completed its cash tender offer for the biopharmaceutical company Icagen (Durham, North Carolina) after extending its initial deadline twice. The tender offer of $6 per share was originally scheduled to expire on Aug. 31, 2011, but had to be extended on both Sept. 1 and Sept. 2 after insufficient shares were tendered.

Bayer Joins TB Battle

Aug 23, 2011

Bayer Healthcare has pledged its support to a Tuberculosis (TB) partnership by providing 620,000 tablets of the antibiotic moxifloxacin to the World Health Organization (WHO), which will make the tablets available to China?s national TB program. In particular, the medicine will be used to fight multidrug-resistant TB.

Pfizer's $50-Million Drug-Discovery Partnership

Aug 16, 2011

Pfizer has partnered with the University of California?s San Diego Health Sciences (UCSD) in a drug-discovery collaboration that could see Pfizer invest up to $50 million over the next five years in the development of new therapies. The partnership will leverage UCSD?s expertise in neurosciences, cancer, inflammation, metabolism, clinical pharmacology, HIV, and pain.

BMS to Acquire Amira for $325 Million

Aug 2, 2011

Bristol-Myers Squibb (BMS) has signed an agreement to acquire Amira Pharmaceuticals, a small-molecule company with a focus on treatments for inflammatory and fibrotic diseases for $325 million. The amount will be paid upfront, but there is potential for additional milestone payments up to $150 million. The acquisition represents BMS?s entrance into the fibrotic diseases area, which the company says is an area of high unmet need.

EMA Improves the Readability of Packaging Leaflets

Aug 2, 2011

The European Medicines Agency has updated the template for package leaflets to make the information easier for patients to understand. Leaflets will now include less rigid language and new sections that provide greater information about a drug?s benefits. There will also be more information about the medicine?s use in children to comply with the requirements of pediatric regulation.

EMA Plans Public Access to Side-Effects Data

Jul 19, 2011

The European Medicines Agency (EMA) has detailed plans for granting public access to information concerning the potential side effects of medicines. Members of the public will be able to access data in the EudraVigilance database-EMA?s central repository for reports of suspected adverse reactions related to authorized medicines in the European Economic Area, as well as those being studied in clinical trials.

FDA Withdraws Approval for Roche's Avastin

Jul 12, 2011

An FDA panel has voted unanimously to withdraw approval for Roche?s Avastin for use in the treatment of metastatic breast cancer because there is not enough data to support the conclusion that the benefits outweigh the risks. The fate of Avastin in this indication now lies in the hands of FDA Commissioner Margaret Hamburg, who will make the final decision after the period for public comments closes at the end of July. Roche will also have the opportunity to submit its final summary on the matter.

The Status of Pharma R&D

Jul 5, 2011

Data has highlighted the pharma industry's high rate of Phase III drug terminations and significantly reduced research and development (R&D) spending. According with Thomson Reuters, 2008?2010 saw more than double the number of Phase III terminations compared to 2005?2007, while pharmaceutical R&D spend, in general, hit a three-year low in 2010. The information has been published in the 2011 edition of the Pharmaceutical R&D Factbook, compiled by Thomson Reuters? CMR International unit. A press statement from Thomson Reuters also added that the clinical trials dropout rate is at ?unsustainable levels.?

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