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Podcasts

Webcast: When Softgels Are a Good First Option: Overcoming Bioavailability Challenges
June 12, 2012—Sponsored by Patheon

Webcast: Meeting New USP Method Transfer Requirements
May 15, 2012—Sponsored by SGS Life Science Services

Webcast: Scale up and Manufacturing Challenges of Controlled-Release Parenteral Drugs
May 15, 2012—Sponsored by Evonik Industries

Webcast: 21 CFR Part 11 Compliance and Business Benefits of Digital Signatures in cGMP Pharmaceutical Manufacturing
May 9, 2012—Sponsored by ARX

MORE WEBCASTS

Podcast: Single-Use Pumps in Biologicals Production

Podcast: Drug Delivery Insights

Podcast: What You Should Know About Lean Six Sigma Initiatives

Podcast: DCAT President Discusses Industry Trends and Association Activities

MORE POCASTS

Events

CPhI South East Asia
May 10, 2012—May 12, 2012
Jakarta, Indonesia

PDA Chemistry Manufacturing & Controls (CMC) Workshop
May 14, 2012
Bethesda, Maryland

Global Clinical Trials Outsourcing Summit
May 14, 2012–May 15, 2012
Seoul, South Korea

Sixth International Pharmaceutical Compliance Congress
May 14, 2012—May 16, 2012
Budapest, Hungary

PDA FDA Virus and TSE Safety Conference
May 15, 2012—May 17, 2012
Bethesda, Maryland

More events


FindPharma Search
May 3, 2012 PharmTech.com

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News

FDA Issues Warning Letters to Ten Companies for Lack of Safety Evidence
FDA has issued Warning Letters to 10 companies that manufacture and distribute dietary supplements that contain dimethylamylamine. FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.
Click Here to Read More

Watson Pharmaceuticals to Acquire Actavis for $5.6 Billion
In a move designed to increase its international presence, Watson Pharmaceuticals has agreed to acquire Actavis for EUR 4.25 billion ($5.6 billion).
Click Here to Read More

Anticounterfeiting Strategy Launched in UK
The UK’s Medicines and Healthcare products Regulatory Agency has launched a new anticounterfeiting strategy with the aim of curbing the occurrence of falsified medicines in the county’s supply chain.
Click Here to Read More

Institute of Medicine Releases Report on Studying the Safety of Approved Drugs
At the request of FDA, the Institute of Medicine prepared a report containing recommendations for how FDA might better monitor the safety of drugs after they have been approved.
Click Here to Read More


Product Spotlight

Programmable automation controllers provide integrated motion control

A new programmable automation controller (PAC) from Rockwell Automation gives machine builders a high-performance, compact option for integrated motion control. The Allen-Bradley CompactLogix 5370 controllers have increased processing speeds to boost system performance and enhance access to real-time information for improved productivity. User memory ranges from 384KB to 3MB, which makes these controllers ideal for applications such as sorting, labeling and packaging, blending, batching, and filling. The series includes three controllers that support integrated motion: L1 for two axes, L2 for up to four axes, and L3 for up to 16 axes. The series has battery-free energy storage, which, along with other design enhancements and technology developments, allows a more compact size than earlier PAC generations. The PACs are used on a standard EtherNet/IP network that offers more communication bandwidth than available to previous CompactLogix controllers. The controllers use the common design and networking environment of the Rockwell Automation Integrated Architecture system.


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Brabender® Pharma USA, Inc. is an innovative company specializing in the manufacturing of twin-screw extruders for HME applications. The effort has been to concentrate on the finest quality equipment to produce small batch sizes up to production scale processes. The 12mm Mini-Compounder is ideally suited to this undertaking while other models offer options to achieve production capacity. For further details on the Mini-Compounder Click Here.

Company Notes

Amgen will acquire 95.6% of shares in Mustafa Nevzat Pharmaceuticals (MN), a privately held Turkish pharmaceutical company, for an amount that values MN at $700 million. The all-cash transaction will expand Amgen's presence in Turkey and the surrounding region, which are priority markets for Amgen. Read More

Advertisement:
How-to Video Series: Tablet Press Setup
Get the most from your processing equipment by learning how to properly setup your tablet press. Natoli's newest "how-to" video series demonstrates the correct way to setup your tablet press with step-by-step tooling installation instructions. If you want to get the most from your tablet press and tooling, you can't afford to miss this must-see video series!
http://www.natoli.com/Press-Setup/Press-Setup-Videos-PT2.html

AstraZeneca has announced that CEO and Board Member David Brennan has decided to retire, effective June 1, 2012. The board has asked executive director and chief financial officer Simon Lowth to act as interim CEO from June 1 until a permanent successor is in place. Julie Brown, vice-president of the company's group finance division, will become interim chief financial officer on the same date. AstraZeneca also announced today that Leif Johansson will succeed Louis Schweitzer as nonexecutive chairman on June 1—three months earlier than previously announced. Read More

Advertisement:
21 CFR Part 11 Compliance and Business Benefits of Digital Signatures in cGMP Pharmaceutical Manufacturing
Live Webcast: Wednesday, May 9, 2012 at 11:00 AM EDT
Register Free at http://www.pharmtech.com/signature

The United States District Court for the District of New Jersey has ruled in Merck & Co.'s favor in two jointly related patent-infringement lawsuits against Mylan Pharmaceuticals. In its decision, the court upheld Merck’s patent on Zetia (ezetimibe) and Vytorin (ezetimibe; simvastatin) and ruled that the patent was valid and enforceable. The court also issued an injunction blocking the approval of Mylan's generic versions until the expiration of the patent. Mylan had been seeking FDA approval to sell generic versions of Zetia and Vytorin. In December 2009, Merck filed the lawsuit against Mylan regarding Mylan's application to the FDA seeking prepatent expiration approval to sell a generic version of Vytorin. In June 2010, Merck filed a separate lawsuit against Mylan regarding Mylan's application seeking prepatent approval to sell a generic version of Zetia. Read More

Advertisement:
Meeting New Method Transfer Requirements
Live Webcast: May 15, 2012 at 11:00 AM EDT for North America and May 22, 2012 at 11:00 AM CET for Europe
Register Free at http://www.pharmtech.com/method.

PRA, a CRO, has reached a new agreement with Amgen for a series of Phase III studies to develop several biosimilar drugs on a worldwide basis. It is intended that PRA will serve as the sole provider of CRO services for these studies. Amgen and PRA signed the agreement in April 2012. Under the new agreement, Amgen and PRA will work together to execute Phase III studies related to Amgen's current biosimilar portfolio. The agreement is intended to govern the entire anticipated scope of Amgen's global biosimilar portfolio. Read More

Advertisement:
Screening Methods for Elemental Impurities: New Regulatory Expectations
Event Date: June 14, 2012 at 11:00 AM EDT for North America and on June 21, 2012 at 11:00 AM CET for Europe.
Register Free at http://www.pharmtech.com/metals.

Industry Briefs:

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More

Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com

PharmTech, the magazine
Current Issue cover
Compendial Globalization: Achieving Harmonization through Standardized Practices and Collaboration
by: J. Mark Wiggins and Howard D. Schneider, Jr.
The authors discuss a new approach to address globally harmonized compendial standards.
Click Here to Read More

Coming soon: Coming soon: Don't miss our biopharmaceutical manufacturing coverage in Pharm Tech's June issue.


Know Before You Go—2012 Conference Previews

Visit our Show & Exhibition Gateway 2012 to see which companies are exhibiting at upcoming industry conferences.

Find company backgrounders, new product releases, booth materials, and more. Let PharmTech's online Gateway be your guide to the season's leading shows.

 
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