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FDA Approves Crestor to Reduce Stroke, Heart Attack Risk

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New Drug Approval

FDA Approves Crestor to Reduce Stroke, Heart Attack Risk

February 9, 2010

Approval based on JUPITER study which evaluated Crestor in a previously unstudied population

WILMINGTON, Del., Feb. 8 /PRNewswire-FirstCall/ -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Crestor (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction (heart attack) and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD)...

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EU ponders GMP for excipients - again / Actavis, expands / ISCO, stem cell plant / Pharmadule, China

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	EU revives GMP for excipients
	Actavis to boost tablet capacity; and looking at Ratiopharm
	ISCO stem cell production site passes building inspection
	Pharmadule targets China with Morimatsu accord
	US FDA asks for $4bn for 2011

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	BioClinica and Cephalon ink data management deal
	Gorbec opening analytical laboratory in China
	MENA emerging as trial destination says ClinTec CEO

Breaking News on Pharmaceutical Technology

Daily 08-Feb-2010



		WHITE PAPER Future in ophthalmic delivery will go through preservative free multidose packaging Preservatives have been linked to side effects and allergic reactions. Their use in chronic treatments should be avoided wherever possible. However in order to maintain sterility of the content and convenience for patients, it has been a challenge to create multidose preservative free devices... Click Here

ACCESS FULL STORIES

EU revives GMP for excipients

The EFCG has welcomed the addition of excipient GMP requirements to the draft amendments of the EU falsified medicines directive but warned that deeper analysis is needed to establish which products warrant further regulation... Read

Actavis to boost tablet capacity; and looking at Ratiopharm

Icelandic generics firm Actavis says expansion of its tablet plant will boost production capacity 50 per cent and create 50 new jobs... Read

ISCO stem cell production site passes building inspection

ISCO's stem cell manufacturing facility has passed final building inspection, enabling it to implement the processes and cGMP standards needed to produce clinical-grade products... Read

Pharmadule targets China with Morimatsu accord

Pharmadule has teamed up with Morimatsu to capture a share of Chinese pharma and biotech manufacturing markets' "huge potential.".. Read

News in brief

US FDA asks for $4bn for 2011

The US FDA says regulating the safety of drugs will cost $100m more in fiscal 2011 than it will this year, and has asked for a 23 per cent increase in its budget to $4.03bn... Read

All News Headlines for: February | January | December

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Phase Forward says ICRS a must for data management market

Integrated solutions are the future of trial data management according to Phase Forward as growth of the electronic data capture (EDC) market begins to slow... Read

BioClinica and Cephalon ink data management deal

BioClinica is providing Cephalon with end-to-end clinical data management services and hiring some of the biotech's staff under a three-year, multi-million dollar deal... Read

News in brief

Gorbec opening analytical laboratory in China

Gorbec Pharmaceutical Services is opening a GMP compliant analytical laboratory in Yantai, China to improve the service it offers to US-based clients and expand its presence in Asia... Read

MENA emerging as trial destination says ClinTec CEO

Improving healthcare infrastructure across the region and a large treatment-naïve patient population makes the Middle East and North Africa (MENA) an increasingly attractive destination for drug trials says ClinTec CEO Rabinder Buttar... Listen

PREVIOUS HEADLINES

People on the move: pharma jobs

in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including Genzyme strengthening its manufacturing team and Carl Icahn's representative joining Adventrex's board... Read

Schott launches InJentle syringe to improve drug stability

Schott AG has launched its InJentle syringe to improve the stability of highly sensitive drugs, which is a "major topic" for the company's clients, according to a company director... Watch

Pfizer, Roche and GSK report 2009 results

In a busy week of Big Phama results Pfizer reports sales boost from Wyeth, Roche says Genentech hit profits and GSK unveils surge in Relenza sales and plans to expand R&D restructuring... Read

NAFDAC launches mobile anti-counterfeiting service

Biofem Pharmaceuticals and NAFDAC have launched an anti-counterfeiting pilot project in Nigeria, using a mobile authentication service (MAS) to validate if a medicine is genuine... Read

Pall launches PallSep Biotech for bioprocessing

Pall Life Sciences plans to shake up bioprocessing with a vibration-based filtering tech that can cut costs and simplify process design by combining harvest and clarification in the same system... Read

News in brief

Seidenader system detects pierced needle shields

Seidenader Maschinenbau has developed a system which can check up to 600 syringes per minute for pierced needle shields... Read

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Cocrystal Engineering - A Promising Solution for Poor API Solubility - Technical / white paper

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SOTAX offers Upgrades for outdated Zymark TPW II and Prelude Models - Data Sheet

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ClinTec, MENA / Phase Forward, ICRS / BioClinica, Cephalon / TTP

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Today on Outsourcing-Pharma.com

	MENA emerging as trial destination says ClinTec CEO
	Phase Forward says ICRS a must for data management market
	BioClinica and Cephalon ink data management deal
	TTP launches contract screening service
	Gorbec opening analytical laboratory in China

Related Industry News

	EU revives GMP for excipients
	ISCO stem cell production site passes building inspection

Breaking News on Contract Research, Manufacturing & Clinical Trials

Daily 08-Feb-2010



		PRODUCT BROCHURE 505(b)(2): Who Says You Can’t Teach An Old Dog New Tricks? Camargo Pharmaceutical Services provides end-to-end drug development services through the 505(b)(2) process. With 3-5 pre-IND meetings a month, worldwide reach in 25 countries and a 95% client referral rate; it’s easy to see how our success breeds your success. Visit www.camargoblog.com or for more... Click Here

ACCESS FULL STORIES

MENA emerging as trial destination says ClinTec CEO

Phase Forward says ICRS a must for data management market

Integrated solutions are the future of trial data management according to Phase Forward as growth of the electronic data capture (EDC) market begins to slow... Read

BioClinica and Cephalon ink data management deal

BioClinica is providing Cephalon with end-to-end clinical data management services and hiring some of the biotech's staff under a three-year, multi-million dollar deal... Read

TTP launches contract screening service

TTP LabTech has launched a contract screening service to assist various aspects of clients' drug development programmes, from target identification through to preclinical toxicology... Read

News in brief

Gorbec opening analytical laboratory in China

Gorbec Pharmaceutical Services is opening a GMP compliant analytical laboratory in Yantai, China to improve the service it offers to US-based clients and expand its presence in Asia... Read

All News Headlines for: February | January | December



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RELATED INDUSTRY NEWS

EU revives GMP for excipients

ISCO stem cell production site passes building inspection

ISCO's stem cell manufacturing facility has passed final building inspection, enabling it to implement the processes and cGMP standards needed to produce clinical-grade products... Read

PREVIOUS HEADLINES

Onyx invests in solid-state chemistry offering

UK CRO Onyx Scientific says that new solid state chemistry service will meet growing demand of drug industry "squeezed" by escalating R&D costs... Read

ClearTrial stresses cost benefits of trial management solutions

ClearTrial says information is power in trial talks and claims its CTO software helped biotech firm save 20 per cent of bid cost through more informed negotiations with its CRO... Read

Galapagos buys Argenta to strengthen discovery services

Belgium-based Galapagos NV has acquired Argenta Discovery for €16.5m ($23.1m), creating a drug discovery service company with 390 employees and estimated revenues of €70m... Read

Novella to occupy OSI's Boulder, Colorado campus

CRO Novella Clinical is providing OSI Pharmaceuticals with clinical research and related services over the next two years and will gain use of facilities in Boulder, Colorado, US as part of the deal... Read

BioStorage Technologies "rolls out" mobile biorepository for samples and APIs

BioStorage Technologies has come up with a novel solution to cold-chain transport, launching a mobile biorepository that is capable of transporting samples across the continental US on a single tank of fuel... Read

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Oracle launches integrated pharmacovigilance suite

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