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28-Feb-2013 - Good ideas in drug delivery will continue to attract investment though the increasing cost of clinical trials does pose a difficulty according to MIT Professor Robert Langer.
28-Feb-2013 - The US FDA has warned API manufacturer Abbey Color about its inadequate stability program and unreliable water purification system, both of which were cited as earlier violations.
28-Feb-2013 - Industry groups BIO and PhRMA are airing their discontents about US FDA draft guidance that could force sponsors to submit redundant clinical datasets for each trial site and waste time...
27-Feb-2013 - A South African and Lonza joint project says issues in funding, competitiveness and green technologies have delayed construction of its API plant.
27-Feb-2013 - Glide Pharma says it is working to bring its Solid Dose Injector (SDI) to market in the next 2-3 years.
27-Feb-2013 - As an FDA commissioned report on counterfeit drugs is released the potential to detect them may lie in a handheld API analyzing device.
27-Feb-2013 - Albemarle is adding new capacity at its manufacturing facility in Pennsylvania with a $30 million expansion.
26-Feb-2013 - US API manufacturers are getting increasingly worried about the looming July 2 deadline to come into compliance with the EU’s new requirements for written GMP certification.
26-Feb-2013 - Following a bout of investments, the oral dose solution market has been described as “competitive” and “dynamic” by two of the major players.
25-Feb-2013 - SHL says the prevalence of injectable drugs will drive auto injectors as it ramps up its Taiwanese production plant.
25-Feb-2013 - Pantarhei Bioscience has sold in Estetra, its oral contraceptive development JV, to partner Uteron Pharma and will use the proceeds to fund further development.
25-Feb-2013 - Pharmaceutical omega-3 products are important but will grow more slowly than some expect because of the long timeframe for drug approval, says the chief of the Global Organisation for EPA...
25-Feb-2013 - West Pharmaceuticals says it is still intent on shifting to proprietary products following results from its packaging and contract manufacturing businesses.
25-Feb-2013 - The US FDA says draft guidelines on risk-based immunogenicity testing of protein drugs will encourage the pharma industry to continue development efforts.
25-Feb-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.
25-Feb-2013 - Bend Research has partnered with its second chemistry major in six months, teaming up with BASF to develop bioavailability-boosting excipients.
21-Feb-2013 - European API distributors may see costs increase if guidelines requiring quality systems and ‘management representatives’ at distribution points are adopted.
21-Feb-2013 - Capsugel says it will focus on lipid-based formulations as it launches a new Dosage Form Solutions Business Unit.
21-Feb-2013 - UK CMO Aesica claims its partnership with process innovation group Britest has already increased capacity without capital investment.
21-Feb-2013 - Excipient firms that skip lot testing or use alternative analysis methods should justify their decisions according to a new COA guide issued by IPEC Americas.
20-Feb-2013 - CMOs (contract manufacturing organizations) developing pharmaceutical intermediates have shifted their focus to complex nucleosides, peptides and carbohydrates over the last five years, an expert says.
20-Feb-2013 - Royal DSM expects its pharma unit to perform better in 2013 driven by a generics and end-of-lifecycle drug-focused partnership strategy.
20-Feb-2013 - New innovations in single-use bioprocessing systems are being picked up quicker in Europe than in the US, according to ATMI.
20-Feb-2013 - Chemical distributor IMCD Group says acquisition of Mumbai-based Indchem will build its presence in the Indian pharmaceutical sxcipient sector.
19-Feb-2013 - Mylan Laboratories has purchased a new finished formulations facility in an Indian Special Economic Zone from Unichem Laboratories.
19-Feb-2013 - Biocatalysis is emerging as a hot topic for CMOs in 2013 with AMRI, Almac and DSM all citing drug industry demand as the driver for recent collaborations.
19-Feb-2013 - Dow has contracted Cambrex to make its solubility enhancing polymer HPMCAS, adding manufacturing clout to its bioavailability-focused collaboration with Bend Research.
19-Feb-2013 - ‘Long awaited’ draft guidelines on excipient risk assessments proposed by the European Commission (EC) have been welcomed by industry group IPEC Europe.
18-Feb-2013 - Aesica and EmulTech claim a new sterile formulation technology could help drugmakers resurrect abandoned projects and extend the lifespan of marketed medicines.
18-Feb-2013 - AMRI has predicted continuing revenue growth in its contract manufacturing with its API pipeline and once-troubled Burlington site leading the way.
18-Feb-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.
14-Feb-2013 - Hospira says bringing medical device manufacturing operations up to code will take 'a lot of work' after Lake Forest, Illinois plant is hit with US FDA Form 483.
14-Feb-2013 - Protalix Biotherapeutics is attempting to use its US FDA-approved Gaucher's disease treatment as a proof of concept and springboard for its plant-based cell manufacturing technology.
14-Feb-2013 - Merck says it will keep in-house API production capacity as it continues to evaluate its manufacturing strategy.
14-Feb-2013 - AMRI has teamed up with biocatalysis firm Codexis to develop cheaper, faster and greener ways of manufacturing APIs.
13-Feb-2013 - EpiVax says combining its immune 'off switch’ drugs with Novozymes’ half-life boosting Albufuse platform could deliver a $3bn (€2.2bn) section of the autoimmune disease market.
13-Feb-2013 - Genzyme says it will produce the insulin drug Lantus for Sanofi following a second investment in its Irish facility.
13-Feb-2013 - Drug Master File (DMF) completeness reviews required under GDUFA could take three months and should be sought before ANDA submission according to the US Food and Drug Administration (FDA).
13-Feb-2013 - Bristol-Myers Squibb (B-MS) will continue to make the OTCs it licensed to Reckitt Benckiser for the time being but will hand over manufacturing if the UK drugmaker buys them outright.
12-Feb-2013 - Formulations of two ophthalmic drugs have become the first exports to Europe from Bangladeshi company Beximco as they seek to expand into the EU market.
12-Feb-2013 - Pergamum says its partnership with Cadila will lead to a new type of antibiotic which will overcome the problem of resistance.
12-Feb-2013 - Powder Systems Limited (PSL) says the low OEL achieved by its redesigned containment technologies meet demands of HPAPI focused drug industry.
11-Feb-2013 - in-Pharmatechnologist.com presents a roundup of news in the fine chemicals sector, beginning with Johnson Matthey which has started a review of its active pharmaceutical ingredient (API) business after competition in...
11-Feb-2013 - Teva says the offloading of its Californian manufacturing facility is part of cost-cutting plans designed to save $2bn (€1.5bn). in the next few years.
11-Feb-2013 - Sun Pharmaceutical Industries has abandoned its long running efforts to buy Israel’s Taro, explaining the move is in the best interest of shareholders.
11-Feb-2013 - The FDA and Health Canada recently opened for industry comment new guidance from the International Conference on Harmonisation on the photosafety testing of drug compounds.
08-Feb-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.
07-Feb-2013 - In its third warning letter released this year for a foreign manufacturer, the FDA has warned Novo Nordisk for failing to follow procedures designed to prevent contamination. But the company...
07-Feb-2013 - An Indian export group has published what it claims are draft CDSCO guidelines setting out what API makers must do to comply with EU import rules that come into effect...
07-Feb-2013 - Rexam says that expansion of its French plant is led by Lilly and the growing demand for insulin delivery products.
07-Feb-2013 - Sun Pharma says it is confident that all quality issues are covered as its Doxil generic gets hurried approval from the FDA.
06-Feb-2013 - Merck has revealed plans to sell its Dutch API facility though will retain the sites other manufacturing facilities.
06-Feb-2013 - The SFDA wants to forge closer ties with regulators in Switzerland, to date the only country granted exemption from new EU API import laws.
06-Feb-2013 - The US Food and Drug Administration’s (FDA) release of a final rule on cGMP for combo products raises a number of questions as to how drug and device companies will...
05-Feb-2013 - Aduro says “combinations are the future” after bolstering its immunotherapy portfolio.
05-Feb-2013 - Lonza has reorganised its operations into two new divisions – Pharma and Specialty ingredients – and says more changes are on the way.
05-Feb-2013 - CMOs and CROs must notify sponsors of payments made to physicians on their behalf under long-awaited US 'Sunshine' rules published last week.
05-Feb-2013 - With Angiomax potentially going generic in 2015, The Medicines Company has collaborated with Alnylam over a 'pragmatic' high cholesterol drug to aid future growth.
05-Feb-2013 - The US pharma industry in 2012 saw the lowest number of reported cargo thefts and the lowest average value per incident since the data collection began in 1996.
04-Feb-2013 - Patheon says expanding its UK facility is necessary in offering its Solupath services to a European and Asian market.
04-Feb-2013 - Highly sought-after guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers is expected in 2013, according to a list of future guidance documents released by the US...
04-Feb-2013 - In-PharmaTechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.
04-Feb-2013 - Solvias has bought quality control services firm Confarma, expanding its analytical offering and adding capacity in several EU markets.
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