PDUFA V: What you need to know about the upcoming Prescription Drug User Fee Act
Rho
07-Dec-2005 - After a two-year tug-of-war, the World Trade Organization (WTO) has solidified a landmark agreement to allow poor nations to import generic versions of patented drugs to treat serious diseases or epidemics.
01-Dec-2005 - A new report suggests that up to 30 biopharmaceutical products developed by UK companies using cell-based manufacturing techniques could be approved by 2012, reinforcing the idea that biopharmaceuticals are increasingly being seen as a viable alternative.
30-Nov-2005 - Merck is to cut 7,000 jobs, close five factories and three research facilities, as the US pharmaceutical company continues to suffer from the devastating repercussions caused by its painkiller Vioxx and the pending lawsuits.
21-Nov-2005 - Avecia spin-off, Reaxa, has announced that Umicore has taken a 21 per cent stake in a move that underlines Reaxa's business strategy in looking at joint R&D, new product development and toll manufacturing agreements.
18-Nov-2005 - Chemical company Lanxess, release its third quarter results that show restructuring strategy is bearing fruit, with sales up and the reduction of net financial debt that is supported by strong growth in the chemical industry.
16-Nov-2005 - Specialty chemical company Avecia featured prominently at the recent CPhI Expo in Madrid, announcing investments and activity, which hint at the business of custom synthesis of APIs and advanced intermediates coming back into favour.
16-Nov-2005 - Catch-up legislation from the EU has swept away the handicap on European generics companies, allowing them to research copycat drugs before patent expiry.
17-Oct-2005 - Sterling Biotech, India's largest gelatin producer, has struck a deal with Gujarat Biotech (TGBL) to purchase its manufacturing unit for Rs 55 cr ($12.3 million) in an all cash deal. Sterling's acquisition brings it one step closer to becoming the world's second largest gelatin maker.
18-Aug-2005 - Portuguese contract manufacturer Hovione has expanded the range of services it can offer its pharmaceutical customers with the addition of a new suite of spray drying (lyophilisation) systems in Europe and the US.
17-Aug-2005 - Who's making what for whom? In-PharmaTechnologist provides its periodic round-up of new deals and developments in the pharmaceutical contract manufacturing sector.
16-Aug-2005 - French chemicals company Rhodia has effectively written off the value of its troubled Rhodia Pharma Solutions division in its second quarter accounts, giving it a book value of zero.
11-Aug-2005 - Diosynth Biotechnology, the contract manufacturing subsidiary of Dutch chemicals and pharmaceuticals group Akzo Nobel, has won a new contract to manufacture a cardiovascular imaging agent due to start Phase III testing in 2006.
04-Aug-2005 - Dowpharma has announced the addition of an oligonucleotide synthesizer for its manufacturing of nucleic acid medicines. The new oligo synthesizer is said to increase speed and flexibility in producing clinical quantities for customers.
03-Aug-2005 - The Hovione Group revealed its yearly figures for 2005, which revealed that sales grew by 8 per cent. The company's performance is in contrast to the pharma fine chemicals sector, which between 2002 and 2004 had an average 14 per cent negative sales growth.
02-Aug-2005 - Cambrex has recorded a gain in the second quarter of this year, with growth in its Bioproducts and Human Health segments. The performances overshadow the company's troublesome BioPharma division, indicative of a market for outsourced manufacturing of biological drugs.
27-Jul-2005 - Swiss chemicals firm and contract manufacturer Lonza fulfilled its promise of stronger financial results in the first half of 2005, with profits coming in at the lower end of the forecast range, but still on target, reports Phil Taylor.
11-Jul-2005 - Cardinal Health has completed the manufacturing of an antibody destined for human clinical trials, using a cell line that was made with its patented GPEx (Gene Product Expression) technology.
04-Jul-2005 - Balchem has acquired the encapsulation and agglomeration business of IOI Group - part of Loders Croklaan USA - in a move that extends its activities in the food and pharmaceutical ingredient sectors.
27-Jun-2005 - Belgian chemicals and pharmaceuticals company Solvay has launched a bid to acquire at least a 51 per cent stake in German pharmaceutical and cosmetic ingredients company Girindus, reports Phil Taylor.
22-Jun-2005 - US drug major Bristol-Myers Squibb has turned to Celltrion, a company based in South Korea, for the manufacture of biologic drugs, in another example of companies 'offshoring' production to Asia, reports Phil Taylor.
21-Jun-2005 - Lonza has started a SF 14 million (€9m) expansion of its biologics manufacturing facility in Slough, UK, in response to what it said was increasing demand for mammalian cell production for clinical trials, reports Phil Taylor.
20-Jun-2005 - In-PharmaTechnologist provides its periodic round-up of new deals and developments in the pharmaceutical contract manufacturing sector.
31-May-2005 - Singapore contract biologics manufacturer A-Bio has added another top pharmaceutical company to its list of customers, just over 18 months after starting operations, reports Phil Taylor.
24-May-2005 - Norbrook Laboratories of Northern Ireland has acquired two anaesthetic product lines and a production facility from Czech company Synthesia, part of the Aliachem group, reports Phil Taylor.
19-May-2005 - Switzerland's Siegfried Group, a specialist in active pharmaceutical ingredients (APIs), dosage forms and biopharmaceuticals, has boosted its position in the production of controlled substances with the acquisition of US-based Penick Corporation in a deal worth $30 million, reports Phil Taylor.