The Challenge of Change - Managing Excipients Control
Colorcon
31-Oct-2007 - There are lessons to be learned about the importance of rigorous due diligence of pharma contractors, now that Inyx' customers are facing possible supply issues and a scramble to find alternative manufacturers after the firm's collapse.
30-Oct-2007 - Sanofi-Aventis has had to take Inyx USA to court after it failed to deliver on a contract manufacturing and supply agreement, a situation that Aventis feared could "seriously harm its interests". There may be important lessons to be learned for all of big pharma.
23-Oct-2007 - Inyx Pharma has been given a new lease on life after it was bought by another UK firm, bringing relief after it was dragged into administration when its US parent company Inyx Inc. ran aground financially.
27-Sep-2007 - Pall Life Sciences gave Outsourcing-Pharma.com an update on its budding operations in India, one of the most promising markets for the firm, where the pharmaceutical industry is growing at a rate of nearly 9 per cent annually.
25-Sep-2007 - Following the recent news that pharma heavyweight Pfizer has also been struck by contamination of its HIV drug Viracept (nelfinavir), in-PharmaTechnologist.com spoke to the US Food and Drug Administration (FDA) to find out how far reaching the consequences of this latest contamination case could be.
25-Sep-2007 - Indian drug manufacturers need to rid themselves of their generic mindset in order to evolve and remain competitive for the future.
24-Sep-2007 - The key to the future of India's pharmaceutical industry will depend on its ability to scale back its over-reliance on low-cost manufacturing and to foster innovation, with drug discovery and biosimilars presenting particular opportunities.
07-Aug-2007 - A US bankruptcy court judge ruled on Friday that Puerto Rican-based pharma services firm Inyx USA be put under the control of an independently-appointed trustee.
02-Aug-2007 - The latest twists and turns in the Inyx Inc. bankruptcy saga include an attempted power seize by its creditor, fraud allegations thrown around courtrooms and in the media, the resignation of Inyx' accountants, and increasing signs of links between Inyx and a company called Karver.
12-Jul-2007 - As Outsourcing-Pharma.com continues to investigate the circumstances of the Inyx group's insolvency problems, it can be revealed that some of the senior management have been involved at a senior level in other firms that have also experienced financial breakdowns over the last few years, along with a small current venture that is also in financial trouble.
10-Jul-2007 - Almost the entire international operations of specialty pharma contract manufacturer Inyx is facing insolvency and the company is locked in a legal battle with its principal financier.
10-Jul-2007 - With a knife-edge financial history of spiralling debts, exacerbated by continued borrowing, Inyx' recent insolvency problems are hardly surprising.
07-Mar-2007 - In-PharmaTechnologist takes an indepth look at the new radio frequency identification (RFID) technology that will soon revolutionise pharmaceutical supply chain management.
20-Jul-2006 - Specialty chemicals firm Cognis has received good manufacturing practice (GMP) certification for its production of pharmaceutical excipients in Germany, the first chemical company in the world to do so but certainly not the last.
15-May-2006 - The Tech Group has experienced a quarter of explosive growth as it ramps up production for the launch of Exubera - Pfizer's newly-approved and much-anticipated needle-free insulin.
09-May-2006 - Animal rights activists have continued their campaign of intimidation after it was revealed the GlaxoSmithkline (GSK) shareholders were sent letters demanding they sell any shares held within the company.
29-Mar-2006 - New legislation on the good manufacturing practice (GMP) of pharmaceutical excipients in Europe, which could complicate the quality control of imports of excipients to the EU and make it unattractive for some vendors to remain in the market, is in the works at the European Commission (EC). In-PharmaTechnologist.com spoke to Sabine Atzor, who is charged with coordinating the drafting of the directive at the EC, about what it is likely to look like.
22-Mar-2006 - Unlike with active pharmaceutical ingredients (APIs), there are no clear governmental good manufacturing practice (GMP) guidelines for excipients in the US, Europe or China. Now the International Pharmaceutical Excipients Council (IPEC) is launching a new guide for the GMP manufacturing of excipients and is warning the industry: agree on what the exact standards should be or the regulators will do it for you.
03-Mar-2006 - India is suddenly a safer place to research and manufacture pharmaceuticals, thanks to legal reform, raised manufacturing standards and reduced bureaucracy. But risk still lurks in the loopholes and protectionism.
01-Mar-2006 - The rejection by the European Medicines Agency (EMEA) of ATryn has given the biotech industry some unappetising food for thought.
27-Feb-2006 - India is emerging as a powerhouse of pharmaceutical R&D. Backed by a scientist president and with an army of talented scientists, the country now has R&D capacity second only to the US, at one-fifth of the cost.
24-Feb-2006 - India has overtaken Germany and China as the pharmaceutical industry western executives most want to know about.
17-Feb-2006 - The insulin delivery devices thriving in today's market will slowly be replaced as new and better technologies continue to rise from the R&D pipeline. For current market leader, Novo Nordisk, this threat is particularly dangerous.
13-Feb-2006 - Recently approved, Exubera is the first in a line up of needle-free insulins promising to win the hearts of diabetics. Amidst all the hype, some market analysts predict it will be a blockbuster, while others believe it has been overvalued. Many industry experts are also being cautious.
01-Feb-2006 - On your marks, get set go! The FDA has fired the starting gun and Pfizer is finally off and running after the long-awaited approval of Exubera - the world's first non-injectable insulin - expected to hit the US market by mid-year and Europe shortly after.