Articles by Rich Whitworth - BioPharm International



Articles by Rich Whitworth

Funding to Drive Nanoscale Technology for Healthcare

Sep 20, 2011

The UK?s Technology Strategy Board has partnered with the Engineering and Physical Sciences Research Council (EPSRC) to invest as mush as £9 million ($14.2 million) in grant funding with the aim of bringing proof-of-concept ideas to pilot technology demonstration for healthcare.

EMA to Apply New Electronic Submission Validation Criteria

Sep 6, 2011

EMA announced in a press release that a new version of the validation criteria for electronic applications for human medicines comes into effect on Sept. 1, 2011. The new criteria (version 3.1) have been agreed with the regulatory authorities in European Union member states and will be applied to all electronic common technical document (eCTD) sequences received starting September 1.

EMA, FDA Say Future Joint API Inspections Likely

Aug 16, 2011

EMA has concluded in a recent report that a pilot program investigating the mutual benefits of joint international inspections of API manufacturing facilities has been a success. The collaboration between the EMA, a number of European member states, FDA, and Australia?s Therapeutic Goods Administration (TGA) sought to increase international regulatory information-sharing to enhance global drug quality and safety by building on API GMP standards.

EMA Welcomes New Directive on Falsified Medicines

Jul 12, 2011

The European Medicines Agency (EMA) has responded positively to a new directive published in the Official Journal of the European Union addressing concerns over increases in falsified medicines in the supply chain. The directive comes into effect on July 21, 2011, and EMA will be working closely with its partners and the European Commission (EC) on implementation over the next 18 months. Member states will have to begin applying the measures beginning January 2013.

EMA Stakeholder Forum On Pharmacovigilance

Jul 5, 2011

EMA has held a second forum regarding the implementation of new pharmacovigilance legislation, which gave stakeholders the opportunity to discuss their expectations on various aspects of the new legislation?s execution. The forum, held on June 17, 2011, was attended by a wide cross-section of participants from industry, patient, and consumer representatives, as well as those from the EMA and national authorities, and represented a clear effort to guarantee timely input from all stakeholders during the implementation process.

Independent Expert Advises EMA on Benefit/Risk Communication

Jun 7, 2011

An independent report released by the European Medicines Agency on May 31, 2011, highlighted a number of recommendations to aid the agency in its communication of the benefits and risks of medicines. The report was the conclusion to a one-year project conducted by Frederic Bouder, PhD, at the behest of EMA, aiming to provide detailed, evidence-based input by analyzing the expectations and attitudes of the agency?s stakeholders toward communication on medicines.

Teva Snatches Cephalon from Valeant

May 10, 2011

Israel-based Teva Pharmaceuticals Industries has sealed a deal to acquire Cephalon for $6.8 billion. In a press release issued on May 2, 2011, Teva explained that it will pay $81.50 cash per share in a transaction that is expected to be completed in the third quarter of 2011. The companies' combined portfolio will include more than 20 branded products and represent approximately $7 billion in sales.

Warner Chilcott to Axe 500 European Jobs

May 3, 2011

Warner Chilcott, a specialty pharmaceutical company with headquarters in Dublin, announced its plans to restructure in a press release on Apr. 18, 2011, which places 500 Western European jobs on the line. The decision came after a strategic review of operations following the loss of Actonel's patent exclusivity in late 2010. Accounting for approximately 70% of the company's Western European revenues, Actonel (risedronate sodium) is a monthly, oral medication for the prevention and treatment of ostioporosis.



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