In this special edition of the Pharmaceutical Technology Europe e-Alert, the editors share the top feature articles and news stories of 2015, as selected by readers.
The deal may offset billions of dollars in waning sales from Pfizer drugs slated to lose patent protection and provides Pfizer with a whole portfolio of biosimilar products. / read more /
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EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA's recommended suspension of 700 drugs is disproportional to reported infractions. / read more /
In a smoldering letter, Mylan's executive chairman announced the unanimous rejection of a $40-billion unsolicited acquisition offer from Teva. / read more /
Mylan received an FDA warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India. / read more /
FDA's quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate. / read more /
The proposed merger of Pfizer and Allergan will create a new top drug maker and cut Pfizer's tax bill with a headquarters move to Ireland. / read more /
Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry. / read more /
The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States. / read more /
Stronger pipelines, the need for complex chemistries, and the rise of small- to mid-size innovators are driving demand for small-molecule APIs. / read more /
This article looks at key considerations in excipient selection during formulation development and their impact on the performance of the finished drug product. / read more /
Merger and acquisition (M&A) trends in the contract services and biopharma space are set to continue in the coming years. Although M&A at contract manufacturing organizations (CMOs) can be a stressful time for clients, customers should know that M&As offer various opportunities for continuous improvement and the service providers that go through M&A integration most frequently are likely to be among the best proponents of the process. Learn best practices in approaching integration planning. Find out why change management is vital during acquisitions and learn what you should be communicating during integrations and when you should be talking to the CMO. Sponsored by AMRI
On Demand
Proper drug release of high-dose hydrophilic drugs is a challenge for formulators since both the initial drug burst release, as well as the consequent sustained release, need to be controlled. Excipients can provide an answer to drug release challenges when their hydrophobic nature is coupled with thermal sintering. This approach intensifies the retardation of drug release by forming plastic matrices of high mechanical strength, which can withstand dose dumping and achieve controlled release. In this webcast, a formulation expert will discuss BASF's Kolliwax grades and their suitability for thermal sintering; describe how high-dose hydrophilic actives were selected to demonstrate the efficacy of thermal sintering (60-65% w/w) using Kolliwax grades; and present processing parameters to enable customers to reproduce controlled drug release of hydrophilic drugs using thermal sintering. Sponsored by BASF
A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects. / Click here /
