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Challenges in Global Biosimilar Development: A Regulatory Perspective
By Patricia Hurley, Joan Boren and Costantino Congiatu, PPD
Published June 2, 2015
More than $60 billion worth of patents on biological products are expiring before 2020, representing a major opportunity for the pharmaceutical industry. Read More »
Published May 21, 2015
Former director, global regulatory strategy for Bristol-Myers Squibb Read More »
Published May 18, 2015
NIS Regulatory Intelligence Database aims to clarify new EU regulation Read More »
Published May 18, 2015
Will continue to supply Sodium Chloride Injection to alleviate drug shortage Read More »
Published May 15, 2015
Marks the first approved combination and sumatriptan migraine product for patients 12-17 Read More »
Published May 7, 2015
Peltier brings more than 30 years of regulatory experience Read More »
By S. Harachand, Contributing Editor
Published May 6, 2015
States hire services to train officers to be audit-ready Read More »
Published April 17, 2015
Samcyprone used for the treatment of malignant melanoma stage IIb to IV Read More »
Published April 1, 2015
Completes operational transformation to meet newly established federal guides Read More »
Published March 27, 2015
Eye injection receives FDA approval for the treatment of diabetic retinopathy in patients with diabetic macular edema Read More »
Published March 12, 2015
Moore brings 20 years of global drug development experience Read More »
Published March 9, 2015
Sandoz Zarxio approved for all indications on Filgrastim label Read More »
Published March 3, 2015
Mayers brings 25 years of pharma manufacturing experience Read More »
Published March 2, 2015
Many of the pharmaceutical companies we work withcontact us with questions about scaling up the manufacturing process. Read More »
Published February 27, 2015
Shifts production in-house after US FDA concerns about CMO Emcure Read More »
Published February 27, 2015
New drug company launched by former CEO of Retrophin Read More »
Published January 29, 2015
Dr. Cheng and Dr. Yang join the senior leadership committee Read More »
By S. Harachand, Contributing Editor
Published January 29, 2015
Can it snip contested clauses? Read More »
Supplier Selection: A Roadmap to a Good Start
By George Tyson, CMC and supply chain consultant
Published January 29, 2015
Good supplier selection is a key element of success in the pharmaceutical industry today. Read More »
Published January 21, 2015
Nelson Patterson elected to board Read More »
Published January 6, 2015
New office in Manchester, UK to support European R&D hub Read More »
Published November 25, 2014
Number of executives reduced from seven to six Read More »
Newsmakers: CMOs and CDMOs Have a Trade Association to Call Their Own
Published November 13, 2014
The new Pharma & Biopharma Outsourcing Association aims to help advance the industry’s regulatory, legislative and business interests. Read More »
The New EU GMPs for Cross Contamination
By Stephanie Wilkins , PharmaConsult US, Inc.
Published November 13, 2014
Industry needs to prepare in order to comply with the updates. Read More »
The Nuances of Branded Rx Drug Fee Regulations
By Alice Valder Curran, John S. Stanton and Andrew S. Furlow , Hogan Lovells
Published October 14, 2014
Final ACA revisions and clarifications: a drug manufacturers guide Read More »
Published October 13, 2014
Baker and Aleman bring extensive healthcare technology and compliance expertise Read More »
Published September 24, 2014
PBOA to represent CMO/CDMO interests Read More »
Published September 12, 2014
Aims to help pharma meet strict quality requirements Read More »
The Audit Trail Advantage
By Carol Brandt , GMP Compliance Consulting, NNE Pharmaplan
Published September 8, 2014
Why one of FDA’s most misunderstood rules can help ensure data integrity and compliance, and help in root cause analysis Read More »
Clinical Trial Supplies 101: An Outsourcing Primer for Virtual Pharma and Biopharma Companies, Part1
By Joseph Iacobucci and Damian Gant , Clinical Supplies and Xcelience
Published September 8, 2014
Getting packaged investigational materials dispensed to the patients taking part in clinical trials, on time and correctly, requires orchestrating myriad activities. Outsourcing makes the process even more complex. This series of articles presents tips on how to do it right. Read More »
Published August 15, 2014
Vassilopoulo and Chaturvedi to head QA and QC Read More »
Published August 12, 2014
Ambrose and Garstka bring extensive quality experience Read More »
Published August 6, 2014
Whitaker brings more than 20 years of pharma experience Read More »
Published July 23, 2014
Agarwal to head clinical operations Read More »
Published July 22, 2014
Williams and Schultz take on VP roles Read More »
20	Astellas
Published July 21, 2014
Headquarters: Tokyo, Japan twitter: @AstellasUS www.astellas.com Headcount:  17,454   Year Established:  2005   Pharma Reveneus:  $11,086… Read More »
2014 - Fifteenth Annual Salary and Job Satisfaction Survey
By Agnes Shanley , Editor
Published July 21, 2014
Hiring is up, recruiters say, and soft skills are in short supply. Survey respondents say they’re happy now, but will likely change employers within five years. Read More »
Published July 10, 2014
Orloff to head pipeline innovation Read More »
Published June 9, 2014
Anicetti brings 30+ years of quality and regulatory experience Read More »
2014 - Fifteenth Annual Salary and Job Satisfaction Survey
By Agnes Shanley, Editor
Published June 5, 2014
Hiring is up, recruiters say, and soft skills are in short supply. Survey respondents say they’re happy now, but will likely change employers within five years. Read More »
What You Need to Know About QbR
By Emil W. Ciurczak , DoraMaxx Consulting
Published June 3, 2014
FDA’s Question-Based Review requires more information in key areas Read More »
Improving the Functional Characterization of Biosimilars
By Delana Butz, Ph.D., Manuela Grassi, Ph.D, Onesmo Mpanju, Ph.D., Duu-Gong Wu, Ph.D., Peter Wunderli, Ph.D. , PPD
Published June 3, 2014
New bioassay methods may help reduce the variability of analytical methods required to demonstrate comparability Read More »
Published May 20, 2014
McSorley and Zunggeemoge take on management roles Read More »
Published May 16, 2014
Severino to drive pipeline advancement Read More »
Published May 13, 2014
Galson responsible for all regulatory and patient safety functions Read More »
Published May 5, 2014
Zeiher and Barrett to head Global Development and Medical Affairs Read More »
By Girish Malhotra, EPCOT International
Published May 1, 2014
Will Sun’s latest acquisition, and India’s first peer-to-peer pharma mega-buy, change the global pharma landscape, or result in yet another problem-filled “me too” pharma company? Read More »
Ensuring Drug Quality in a Global Economy
By Helena Champion , Principal Consultant, Drug Quality Assurance LLC
Published May 1, 2014
Offshore CMO’s have proven a weak link in pharma’s supply chain. Will recent quality problems in India and China increase oversight? Read More »
Published April 17, 2014
Brown brings 20 years of industry experience Read More »

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