Pharmaceutical Technology ePT Weekly
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PharmTech
January 7, 2016
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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

FDA Approves First 3D Printed Drug Product

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.
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MOST VIEWED NEWS STORIES OF 2015

Pfizer to Acquire Hospira for Nearly $17 Billion

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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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 /


FDA Approves First Biosimilar

In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.
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Merck Serono and Merck Millipore Become
Merck

Merck relaunches brand identity to reflect transformation into a science and technology company.
/ read more /


Mylan Rejects Teva’s $40 Billion Offer

In a smoldering letter, Mylan’s executive chairman announced the unanimous rejection of a $40-billion unsolicited acquisition offer from Teva.
/ read more /


Huntingdon and Harlan Laboratories to Become Envigo

The combined company has been created through the integration of Huntingdon Life Sciences and Harlan Laboratories.
/ read more /


Mylan Receives FDA Warning Letter for Manufacturing Sites in India

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 /

 

Catalent Reports Action to Restart Softgel Facility

Operations at Catalent’s Beinheim, France, softgel facility were suspended following suspected deliberate action to misplace capsules.
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First Hospira Biosimilar mAb Approved in West Europe

Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.
/ read more /


FDA Issues Quality Metrics Draft Guidance Document for Comment

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 /


Pfizer Completes Acquisition of Hospira

Pfizer closes the acquisition of Hospira, adding sterile injectables business to portfolio.
/ read more /


Pfizer-Allergan Merger Valued at $160 Billion

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 /


EMA Sets Elemental Impurities Implementation Dates

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.
/ read more /


Pharmaceutical CEO Martin Shkreli Arrested for Securities Fraud

Pharmaceutical CEO Martin Shkreli was arrested on Dec. 17, 2015 at his New York apartment and charged with securities fraud.
/ read more /


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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


TOP FEATURED TOPICS OF 2015

MANUFACTURING

Top Trends in Biopharmaceutical Manufacturing in 2015

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

Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
/ read more /


QUALITY

Improving Visual Inspection Practices

New guidelines and best practices may lead to improved quality and reduced recalls due to visual defects.
/ read more /


REGULATIONS

Litigation and Manufacturing Hurdles Block US Biosimilars Market Success

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 /

 

DEVELOPMENT

Pharma APIs: It’s Still a Small World

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 /


DOSAGE FORMS

Innovative Excipients in Solid-Dosage Manufacturing

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 /


OUTSOURCING

What’s Next for the CMO Industry?

What if the expanding pipeline isn’t enough to fuel CMO growth?
/ read more /


PEER-REVIEWED RESEARCH

Black Specks in Tablet Stability Samples

A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.
/ read more /



WebcastS

Optimizing M&A Integration for Customer Success: The CMO Perspective

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


Thermal Sintering for Controlled Drug Release of Hydrophilic Drugs

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


more webcasts


on pharmtech tv

PharmTech TV

Tablet Coating

Blow-Fill-Seal for Aseptic Processing

Cell Therapies

Events

Access to Safe Medicines Europe 2016

January 19-20, 2016

IFPAC Annual Meeting

January 24-27, 2016

InformEX USA 2016

February 2–4, 2016


more events

REFERENCE BOOKS

Analytical Testing Resource Guide Combo

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.
/ Learn more /

More Reference Library

eBOOKS

Bioprocessing and Sterile Manufacturing 2015 eBook

This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.

more ebooks

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