Category Archives: Global
By Jill Wechsler | Published: September 24, 2014
Although biopharmaceutical companies and regulatory authorities have made considerable progress in establishing policies for bringing biosimilars to market, key differences and gaps in requirements for testing and documenting product similarity still characterize the European Union, the U.S. and other regions. The EU’s European Medicines Agency (EMA) has set the regulatory pace, with 18 products approved since 2006, […]
By Pharm Exec | Published: September 18, 2014
By Casey McDonald. GSK will weigh in on non-communicable diseases (NCDs) in Africa with a £1m contribution and a commitment of internal R&D expertise supporting researchers from South African institutions, the company announced this month.
By Guest Blogger | Published: September 17, 2014
Biopharmaceutical manufacturing is following the general pharmaceutical market trend toward global expansion. BioPlan Associates’ 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production identifies the markets best poised to profit from the internationalization of the outsourcing, finding that emerging markets such as China and India are among top potential destinations for both US and Western […]
By Pharm Exec | Published: September 16, 2014
Merck’s Keytruda, recently approved in the US to treat patients with advanced melanoma that have stopped responding to other cancer therapies, will soon face strong competition from Bristol-Myers Squibb’s (BMS) Opdivo, an analyst from research and consulting firm GlobalData has reported.
By Pharm Exec | Published: September 15, 2014
The European Federation of Pharmaceutical Industries and Associations’ new medicines verification system will put an end to the re-sale of stolen and counterfeit drugs in the European supply chain, the organisation claims. The European Stakeholder Model (ESM) reportedly offers a cost-effective technological solution using anti-tampering device together with 2D barcoding to verify the authenticity of medicinal products. Because of loopholes […]