Category Archives: Manufacturing

J.P. Morgan: Pharma's Agenda for 2014

Presenters at the 32nd annual J.P. Morgan Healthcare Conference talked up value-based pricing, emerging market strategies, complex generics and new technology, from bedside devices and genetic sequencers to first-in-class mechanisms of action. Company executives honed in on their chosen therapeutic areas and made the case for aggressive spending in R&D to bring the next generation […]
Also posted in Biotech, Corporate Responsibility, Deals, Emerging Markets, Europe, Events, FDA, Gene therapy, Global, IP, leadership, Legal, Market Access, Orphan Drugs, People, pricing, R&D, Regulatory, Safety, Sales, Strategy, Technology | Tagged , , , , , , , , , , , , , , , , , | Leave a comment

GSK Invests in UK Manufacturing

GlaxoSmithKline (GSK) will invest £200 million ($327 million) to expand its manufacturing facilities in Ware, Hertfordshire and Worthing, Sussex in the United Kingdom and establish a new manufacturing innovation facility. The investment is in addition to a £500 million ($818 million) investment that GSK made in March 2012, which included a commitment to build a […]
Also posted in Europe, Global | Tagged , , , | Leave a comment

The Little Orphan That Could: How Alexion is Going Global

Since the initial FDA approval of its flagship orphan drug Soliris in 2007, Alexion Pharmaceuticals has done well for itself as a small biotech firm that focuses on ultra-rare disease. So well in fact, that instead of partnering, the company has taken global expansion into its own hands. Apart from a pipeline that includes asfotase […]
Also posted in Biotech, Global, Market Access, Orphan Drugs, Strategy, Supply Chain | Tagged , , , , , , , , | Leave a comment

Congress Clarifies Drug Compounding, Tracking Policies

Public outrage over deaths from contaminated injectables produced by large compounding pharmacies, along with rising concerns about counterfeit and unauthorized drugs entering the U.S. market, managed to lift the stalemate on Capitol Hill long enough to generate agreement on reform legislation. After months of public hearings and negotiations, Democrat and Republican leaders of the House […]
Also posted in FDA, Legal, Regulatory, Safety, Strategy, Supply Chain, Technology | Tagged , , , , , , , , , , , , , | Leave a comment

FDA, CDER Weigh Organizational Changes

FDA commissioner Margaret Hamburg has formed a top-level working group to propose strategies for enhancing agency functions and processes, starting with the relationship between FDA Centers and its field force. The Program Alignment Group (PAG), announced Sept. 6, 2013, will seek to clarify the roles and responsibilities of product centers and the Office of Regulatory […]
Also posted in FDA, Legal, People, Regulatory, Strategy | Tagged , , , , , , | Leave a comment
  • Categories

  • Meta