In this special edition of the Pharmaceutical Technology eNewsletter, the editors share the top feature articles and news stories of 2015, as selected by readers.
MOST VIEWED NEWS STORY OF 2015
Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.
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MOST VIEWED NEWS STORIES OF 2015
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.
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GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions.
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In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.
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Merck relaunches brand identity to reflect transformation into a science and technology company.
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In a smoldering letter, Mylan’s executive chairman announced the unanimous rejection of a $40-billion unsolicited acquisition offer from Teva.
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The combined company has been created through the integration of Huntingdon Life Sciences and Harlan Laboratories.
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Mylan received an FDA warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.
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Operations at Catalent’s Beinheim, France, softgel facility were suspended following suspected deliberate action to misplace capsules.
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Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.
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FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.
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Pfizer closes the acquisition of Hospira, adding sterile injectables business to portfolio.
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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.
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New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.
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Pharmaceutical CEO Martin Shkreli was arrested on Dec. 17, 2015 at his New York apartment and charged with securities fraud.
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Understanding Water Activity to Ensure Microbial Safety and Product Stability LIVE WEBCAST: Wednesday, January 27, 2016 at 11:00 am EST
Register for free at
www.pharmtech.com/pt/wateractivity |
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TOP FEATURED TOPICS OF 2015 |
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MANUFACTURING
Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry.
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ANALYTICS
Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
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QUALITY
New guidelines and best practices may lead to improved quality and reduced recalls due to visual defects.
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REGULATIONS
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.
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DEVELOPMENT
Stronger pipelines, the need for complex chemistries, and the rise of small- to mid-size innovators are driving demand for small-molecule APIs.
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DOSAGE FORMS
This article looks at key considerations in excipient selection during formulation development and their impact on the performance of the finished drug product.
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OUTSOURCING
What if the expanding pipeline isn’t enough to fuel CMO growth?
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PEER-REVIEWED RESEARCH
A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.
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WebcastS
On Demand
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
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Tablet Coating
Blow-Fill-Seal for Aseptic Processing
Cell Therapies
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Events
January 19-20, 2016
January 24-27, 2016
February 2–4, 2016
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REFERENCE BOOKS |
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A compilation of articles Pharmaceutical Technology in a three-handbook set covering general analytical testing and stability in the manufacture, packaging, storing, and testing of formulated products.
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eBOOKS
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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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