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The Lead

How New Drug Development is Harder than Rocket Science

August 31, 2015 | by PhRMA | Comments

Last week Pharmaceutical Research and Manufacturers of America (PhRMA) released an infographic depicting how new drug development is actually harder than rocket science.


Pharmaceutical Marketplace Q&A with Atsushi Inoue

September 25, 2015 3:14 pm | by Atsushi Inoue, R&D Manager, Mitsubishi Gas Chemical Company | Comments

Atsushi Inoue from Mitsubishi Gas Chemical Company answers questions regarding the pharmaceutical marketplace, covering topics such as regulatory requirements, technology, trends, and recommendations.


Pharmaceutical Marketplace Q&A with Chris Oostyen

September 24, 2015 7:00 am | by Chris Oostyen, Iwata Label | Comments

Chris Oostyen from Iwata answers questions regarding the pharmaceutical marketplace, covering topics such as regulatory requirements, technology, trends, and recommendations.


Nexvet Develops Treatment for Pain in Cats and Dogs

September 23, 2015 7:00 am | by Meg Snyder, Editor, @PharmProEditor | Comments

Nexvet is developing species-specific monoclonal antibody therapies to treat pain—particularly degenerative joint disease—in cats and dogs.


Dust Deflagration Hazards in Pharmaceutical OSD Facilities and the Requirements of the New NFPA 652

September 16, 2015 4:37 pm | by Vahid Ebadat, Ph.D., Chilworth Technology, a DEKRA Insight Company | Comments

Many of the powders that are used in the production of pharmaceutical oral solid dosage (OSD) formulations are combustible, and since most operations in pharmaceutical facilities can create explosible atmospheres, dust cloud explosion hazards should be expected. 


Pharma EXPO: Fertile Ground for Cross Pollinating Ideas

September 16, 2015 4:24 pm | by Julie Ackerman Montross — The Association for Packaging and Processing Technologies (PMMI) | Comments

Learn about this year's upcoming Pharma EXPO, which will be taking place in Las Vegas at the Las Vegas Convention Center Sept. 28–30.


Hand Protection in Cleanroom Environments

September 16, 2015 4:12 pm | by Don Cronk, Regulatory Affairs & Technical Services Manager, Ansell | Comments

Maintaining the safety of workers and avoiding contamination in an aseptic pharmaceutical manufacturing context, particularly in a cleanroom setting, starts with the right gloves.


Lessons Not Learned: Tips to Avoiding Repeat Recalls

September 16, 2015 3:55 pm | by Mohan Ponnudurai, Industry Solutions Director at Sparta Systems | Comments

Mohan Ponnudurai, Industry Solutions Director at Sparta Systems, discusses the realities and preventability of recalls in today's world. 


The Industry Reacts to DSCSA

September 16, 2015 3:45 pm | by Jason Lomberg | Comments

Readers offer their insights on counterfeiting, compliance levels, investments, and the overall impact of the Drug Supply Chain Security Act. 


NextGen Pharma Takes Smart Strides with IoT

September 16, 2015 3:35 pm | by Akash Shrivastava, Lead Consultant in Wipro’s Life Sciences Business Unit | Comments

Digitization of processes and data across the value chain, along with the emergence of the Internet of Things (IoT), has transformed the pharma industry.


Special Delivery

September 16, 2015 3:19 pm | by Jeff Reinke, Editorial Director | Comments

Fueled by a 90-year legacy of patient-centric approaches, West Pharmaceutical Services has been able to capitalize on the growth of personalized medicine and the advanced delivery devices it requires.


Whatever It Takes … Unless It’s Difficult or Expensive

September 16, 2015 3:00 pm | by Jeff Reinke, Editorial Director | Comments

Jeff Reinke, Editorial Director, hits on key points such as Drug Supply Chain Security Act—specifically how it impacts one's approach to quality.


MAPI Forecast: Construction To Bolster U.S. Manufacturing

September 8, 2015 1:16 pm | by by Andy Szal, Digital Reporter | Comments

The MAPI Foundation reduced its growth forecasts for both U.S. GDP and manufacturing production in 2015 and 2016. Manufacturing is not expected to return to its pre-recession peak until the third quarter of next year.


Case Study: Aseptic Filling & Sealing

September 4, 2015 12:27 pm | by Marco Benvenuti, Business Manager SGS SERTEC | Comments

Validation, and associated activities around qualification and calibration, must continue on an on-going basis to ensure that production remains within specification, and does not drift out of compliance over time.


Report: Manufacturing Mergers Remain Active In First Quarter

September 2, 2015 11:11 am | by by Andy Szal, Digital Reporter | Comments

The report added that equity firms showed increased flexibility in the structure of acquisitions, which included complete buyouts and minority investments. Private equity exits from the market increased by more than 20 percent last year.


Mylan, Perrigo Continue Acquisition Dance

August 28, 2015 12:52 pm | by Jeff Reinke, editorial director | Comments

A combination of the two companies would create one of the world's largest makers of generic and over-the-counter medications.



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