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Schering-Plough cuts deal with FDA on production

05-Jun-2003 - Troubled US pharmaceutical major Schering-Plough has reached an agreement with the US Food and Drug Administration to correct the firm's manufacturing compliance problems, which led...

DTI sets up 'good bioanalytical practice' programme

04-Jun-2003 - The UK Department of Trade and Industry has commissioned a new national programme designed to develop and share good practice in bioanalytical methodology. The programme,...

EU hangs back from mandatory EMEA filings

03-Jun-2003 - At a 2 June meeting, the European Union's Employment, Social Policy, Health and Consumer Affairs Council reached an agreement on the proposals by the European...

Industry group calls for pharma regulation shake-up

30-May-2003 - The European Federation of Pharmaceutical Industries and Associations has called for the European Commission to set up a more favourable legal framework to help the...

GMP for Atrix

23-May-2003 - Drug delivery company Atrix Laboratories confirmed this week that the German regulatory authority, Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM), had recently completed a successful inspection...

DSM/Roche deal under further review

23-May-2003 - The European Commission is currently investigating theplanned acquisition of the Roche Vitamins and Fine Chemicals division by Dutch company DSM due to competition concerns in...

Research base linked to Intellectual property issues

23-May-2003 - EU Commissioner for Research Philippe Busquin underlined the importance of improving training and information exchange among scientists on intellectual property (IP) issues at the PATLIB ...

EC reports progress on PECA negotiations

30-Apr-2003 - The European Commission has published a table on its web site detailing the progress it has made in negotiating Protocols to the Europe Agreements on...

FDA planning GMP revamp

07-Apr-2003 - The US Food and Drug Administration is gearing up for the first major overhaul of its current Good Manufacturing Practice guidelines in 25 years, according...

Bar codes to reduce errors

17-Mar-2003 - Patient safety, care quality, and efficiency in the supply chain are likely to improve with new proposals from the US Food and Drug Administration (FDA)...

EU: Investment in R&D slipping

17-Mar-2003 - European scientists continue to be strong in areas such as medical research and chemistry and Europe may produce the highest number of science graduates but...

Commission calls on states to intensify efforts in life sciences and biotechnology

06-Mar-2003 - In its first progress report since adopting the EU strategy on life sciences and biotechnology in 2002, the European Commission yesterday indicated that the risk...

Green light for Pfizer

03-Mar-2003 - The European Commission has given Pfizer the all clear to acquire Pharmacia corporation - paving the way for the creation of the largest pharmaceutical company...

Steps forward for US cGMP

26-Feb-2003 - The US Food and Drug Administration (FDA) announced this week that it has accomplished the initial objectives outlined in its ongoing initiative to modernise the...

Shire goes to court

26-Feb-2003 - UK Shire Pharmaceuticals group said this week that its US subsidiary Shire Laboratories has filed a lawsuit in the US District Court against Barr Laboratories...

Mylan agreement over buspirone

20-Feb-2003 - US company Mylan Laboratories has reached a final agreement with Bristol-Myers Squibb, which resolves all disputes between the companies related to buspirone. Under the terms...

Canadian approval for Astra's Crestor

20-Feb-2003 - AstraZeneca Canada has received approval from the Therapeutic Products Directorate of Health Canada to market CRESTOR (rosuvastatin) 10 to 40 mg, a new medicine for...

Cognis denies patent infringement

20-Feb-2003 - Cognis Nutrition & Health, a nutritional ingredients supplier, has responded to claims made earlier this week by Dutch rival Loders Croklaan regarding the infringement of...

Roche vitamin E fits Dutch regulations

12-Feb-2003 - Swiss pharmaceuticals company Roche yesterday released a statement that its vitamins and fine chemicals unit, recently sold to DSM, fully complies with new requirements for...

Biolog patent

11-Feb-2003 - US company Biolog this week received a patent for its Phenotype MicroArray technology. The patent, number US 6,472,201, is granted for comparative phenotypic analysis of...

Ribapharm responds to court action

11-Feb-2003 - In response to recent news regarding patent litigation surrounding its drug ribavirin, biopharmaceutical company Ribapharm announced this week that it believes its patent position to...

Patent for HCS

03-Feb-2003 - High Content Screening company Cellomics announced today that the Canadian Intellectual Property Office has issued Cellomics' Canadian Patent No. 2,328,194 entitled 'A System for Cell-Based...

Valentis wins ruling

30-Jan-2003 - US Valentis announced that its wholly-owned subsidiary, PolyMASC Pharmaceuticals, has received a favourable ruling from the Japanese Patent Office in regard to patent invalidation proceedings...

AAC drives submissions to the FDA

28-Jan-2003 - AAC Consulting Group, the regulatory consulting subsidiary of contract research organisation Kendle International, has signed an agreement with two toxicologists - Gary Flamm and James...

Accreditation for food packaging inspection body

28-Jan-2003 - London zoo was the setting last week for UK inspection body Select QA to formally receive certification from the United Kingdom Accreditation Service, involving the...