Recalls and Warning Letter; Multiple Suppliers Announce Expansions

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API Characterization for a Speedy and Successful Formulation Strategy
Thursday, September 18, 2014, 8:00 am PDT/ 10:00 am CDT/ 11:00 am EDT
Sponsored by: Patheon

Navigating the Analytical Development Challenges for Bioprocess Residuals and Impurities
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Sponsored by: Eurofins Lancaster Laboratories

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Learn about the CPhI Pharma Awards

Deadline for Submission: 22 August

2014 PDA/FDA Joint Regulatory Conference
September 8-10, 2014
Washington, D.C, USA

2014 PDA Drug Shortage Workshop
September 10-11, 2014
Washington, D.C., USA

APV/IPEC Europe Excipient Conference 2014
September 23-24, 2014
Düsseldorf, Germany

August 21, 2014

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Pharma Investments Reflect Key Industry Trends
Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments.

Changes and Challenges for Generic Drugs
FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

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Ebola Outbreak Raises Ethical Issues
The recent outbreak of the Ebola virus has escalated testing of high-risk compounds and raised questions about the ethics of testing unproven medicines and which patients should have access to the therapies.

Guilty Plea to Importing Illegal Cancer Drugs
The owner of an Istanbul-Turkey drug company has pleaded guilty to charges of smuggling a misbranded and adulterated version of Avastin.

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FDA Issues Warning Letter to India's Marck Biosciences
FDA found violations of cGMP at finished-drug manufacturer in India.

Report Predicts Generics Production Return to US
Concerns about quality in overseas production may bring generic drug production back to the United States.

Baxter Recalls Peritoneal Dialysis Solution
Baxter voluntarily recalls two lots of peritoneal dialysis solution because of the presence of particulate matter.

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Analytical Challenges and Case Studies in Method Development for Fixed-Dose Combinations
On Demand Webcast
To Register Free:

www.pharmtech.com/method_development

Amgen Recalls Aranesp Prefilled Syringes
Amgen has issued a voluntary recall of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes in several countries because of the presence of visible particulates.

AstraZeneca and Mitsubishi Tanabe Pharma Collaborate in Diabetic Nephropathy
The companies will research small-molecule candidate drugs for diabetic nephropathy.

Bristol-Myers Squibb and Celgene Collaborate on Immunotherapy and Chemotherapy Combination Regimen
The companies will conduct clinical trials to evaluate a combination immune checkpoint inhibitor and a chemotherapy drug.

WuXi Facility Passes FDA Inspection for Manufacture of API
Shanghai SynTheAll Pharmaceutical facility passed inspections for API and advanced intermediate manufacture.

Fujifilm Diosynth Biotechnologies Expands Cell-Culture Capacity
Additional single-use bioreactors will meet demand and offer a low-risk route to market.

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API Characterization for a Speedy and Successful Formulation Strategy
September 18, 2014 at 11:00 AM EDT
To Register Free:

www.pharmtech.com/strategy

GE Healthcare Life Sciences Announces New US Headquarters in Massachusetts
The new US headquarters for GE Healthcare Life Sciences in Marlborough, Mass. will house more than 500 employees.

Ashland To Expand Hydroxypropylcellulose Capacity
Ashland will expand production for its tablet binding and coating ingredient at its Virginia, US plant.

Almac to Create 348 New Jobs and Invest GBP 54 Million in Pharma and Clinical Services
Enterprise, Trade and Investment Minister Arlene Foster has announced that the Almac Group is investing more than GBP 54 million and creating 348 high quality jobs over the next five years.

Catalent Appoints Two Executives to Board of Directors
Catalent names Jack Stahl and Rolf Classon to board of directors.

BPTC Promotes Jones and Ransohoff to Principal Consultants
Bioprocess Technology Consultants has promoted Susan Dana Jones and Thomas C. Ransohoff to principal consultants.

3M Drug Delivery Systems Forms Collaboration with Presspart Group for Dose Counter Technologies
Opportunity to accelerate growth of dose counter technology in existing and future MDI developments.

G-CON Manufacturing Launches Transmissible Disease Containment POD
G-CON's newest autonomous cleanroom production POD supports transmissible disease containment needs.

USP Awards Analytical Research
USP awards research in analytical tools, anticounterfeiting, and dry powder inhaler products.

PharmTech Europe
25th Anniversary
Pharmaceutical Technology Europe celebrates 25 years of publishing with a retrospective of drug development trends and expert insight into emerging trends.

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