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Veteran Marijuana Study Wins Federal Backing

March 17, 2014 4:03 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

The federal government has signed off on a long-delayed study looking at marijuana as a treatment for veterans with post-traumatic stress disorder, a development that drug researchers are hailing as a major shift in U.S. policy.                             

Accelrys Acquires QUMAS

December 10, 2013 8:42 am | News | Comments

Accelrys, a provider of scientific innovation lifecycle management solutions, has acquired...

Biogen Idec Receives Notification from FDA of PDUFA Date Extension for ALPROLIX™

December 2, 2013 8:01 am | News | Comments

Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has extended the...

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Zalviso New Drug Application Accepted for Filing by FDA

December 2, 2013 7:58 am | News | Comments

AcelRx Pharmaceuticals, Inc. has announced that the Zalviso New Drug Application (NDA) was accepted for filing by the FDA on November 26, 2013. The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review.

Class Action Suit Filed Against ARIAD Pharmaceuticals

November 22, 2013 10:29 am | by Associated Press | News | Comments

This class action seeks to recover damages against the Company and certain of its officers and directors as a result of alleged violations of the federal securities laws.                                       

FDA Grants Orphan Drug Designation To Cannabis-Derived Pediatric Epilepsy Drug

November 15, 2013 9:52 am | by Associated Press | News | Comments

GW Pharmaceuticals announced today that the U.S. Food and Drug Administration has granted orphan drug designation for Epidiolex, which contains plant-derived Cannabidiol (CBD) as its active ingredient, for use in treating children with Dravet syndrome, a rare and severe form of infantile-onset, genetic, drug-resistant epilepsy syndrome. 

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Doctors Urge Wider Use Of Cholesterol Drugs

November 15, 2013 9:33 am | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

For decades, if you asked your doctor what your odds were of suffering a heart attack, the answer would turn on a number: your cholesterol level. Now the nation's first new heart disease prevention guidelines in a decade take a very different approach...

FDA Approves Gazyva For Lymphocytic Leukemia

November 1, 2013 11:38 am | by Genentech | News | Comments

Genentech announced today that the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia.

FDA Enlists Companies To Head Off Drug Shortages

November 1, 2013 11:13 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Food and Drug Administration announced a new proposal Thursday to try and head off more shortages of crucial medications that have disrupted care at hospitals and clinics nationwide. Under the proposed rule, companies that make medically important prescription medicines would have to notify the FDA six months ahead of any changes that could disrupt the U.S. supply.

Ariad Suspends Sales Of Cancer Pill Due To Blood Clots

October 31, 2013 10:19 am | News | Comments

The FDA asked Ariad to stop marketing the drug, but the company is negotiating with the FDA about changes to prescribing information and new ways to manage the risks associated with Iclusig. Ariad said it wants to resume marketing the drug. The daily pill is Ariad's only approved product.

Seeing Both Sides

January 25, 2013 3:13 pm | by Mike Auerbach, Editor In Chief | Blogs | Comments

The late, great Yankees player and coach Billy Martin was not known for holding his tongue. Through many seasons as the Yankees skipper, Martin had more than his fair share of arguments, ejections and fights with umpires and, of course, Yankees owner George Steinbrenner.

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Green Validation: Practical Strategies For Paperless Software Validation

February 24, 2010 7:27 am | by Valarie King-Bailey, CEO, OnShore Technology Group | Articles | Comments

For years, life sciences companies have struggled with the documentation burden associated with software validation. Over the past two decades, there has been much discussion about “paperless” validation.

Measuring and Monitoring Quality in Global Clinical Trials (11362)

October 14, 2009 5:31 am | Articles | Comments

With so many moving parts, the ability to repeatedly execute clinical trials with a high level of quality requires a comprehensive and adaptable Clinical Quality Management (CQM) program. The starting point of any CQM program consists of well-defined and documented Standard Operating Procedures (SOPs) for every aspect of running a clinical trial, including the peripheral departments and outsourced services/providers that play a vital role in your ability to execute clinical studies.

Compliance Documents: Solving the Puzzle

July 14, 2009 8:09 am | Articles | Comments

Pharmaceutical manufacturers operate in one of the most highly regulated industries ? facing an array of restrictions and requirements from the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), various state and foreign governments, and their individual customers.

Laboratory Compliance: Making The Grade

June 1, 2009 11:13 am | Articles | Comments

What is "laboratory compliance"? It is a general term used by many people, but which means different things to different people. There is no definitive answer or even one in Wikipedia the "on-line" encyclopedia!

Security and RFID's Place in the Pharmaceutical Supply Chain

May 11, 2009 10:13 am | Articles | Comments

At INTERPHEX, in March 2009, an expert panel convened to discuss the challenges facing the pharmaceutical industry in meeting the FDA's guidance regarding e-pedigree, and to address the larger global issues surrounding the implementation of RFID as part of a secure supply chain solution.

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Needles And Pins

March 12, 2009 6:53 am | Articles | Comments

Through the years, there has been very little change in the appearance of components in packaging and delivery systems for injectable drug products. The material science and manufacturing technologies that go into the creation of these systems, on the other hand, have undergone significant advancement.

Validating Electronic Spreadsheets or Automated Forms

March 9, 2009 11:22 am | Articles | Comments

Since the release of 21 CFR Part 11 in 1997, the validation and verification of electronic records has been at the forefront of the Information Technology (IT), Quality Assurance (QA) and Regulatory departments of the medical device and pharmaceutical industries.

A Closer Examination of X-Ray Technology…Answers to Your Most Asked Questions

March 6, 2009 7:00 am | Articles | Comments

Most are familiar with X-Ray technology and its use in airports to inspect baggage or in medical and dental offices for examinations. However, the general public is less aware of the important role X-Ray technology plays in the pharmaceutical and other industries

Microbiology Innovation: The Evolution of Microbiological Methods Into The 21st Century at Ortho-Clinical Diagnostics (Rochester, NY)

March 6, 2009 7:00 am | Articles | Comments

Ortho-Clinical Diagnostics Microbiology Department in Rochester, NY, has demonstrated innovation by using the Process Excellence Define; Measure; Analyze; Innovative/Improvement; Control Road Map (DMAIIC) to improve the product release process. By selecting a rapid technology, testing cycle time was reduced as well as warehouse storage costs.

Conveying Solution Saves Labor And Improves Operator Environment

March 4, 2009 4:35 am | Articles | Comments

Surepharm Services Ltd, located in Staffordshire, UK, is a contract tablet manufacturer specializing in tablet production

Following The Path To Compliance

February 9, 2009 9:07 am | Articles | Comments

Drug companies lose upwards of $600,000 - $1M of revenue for every day their drug is not available in the market

A New World of Excipients for Oral Solid Dosage Formulation

February 2, 2009 4:38 am | Articles | Comments

To meet emerging challenges, the pharmaceutical industry is currently in the midst of reinventing itself

Quality by Design: Four years and three myths later

January 28, 2009 9:54 am | Articles | Comments

In the four years since the ICH outlined the concept of design space in its Q8 guideline, pharmaceutical companies – despite depending on innovation for their livelihood – have been slow to adopt QbD. One year ago in this publication, two colleagues and I identified what we saw as the most common reasons that life sciences organizations resist QbD:

Using Vision to Your Advantage

December 16, 2008 6:02 am | Articles | Comments

To meet ever-increasing industry regulations, pharmaceutical companies need to employ strict inspection and verification tools during product manufacturing and packaging processes. While simple sensors can be used for presence detection on the automated production line, to achieve accurate results in more sophisticated pharmaceutical applications?such as those requiring analysis of more than one product feature at a time?vision sensors can deliver a more comprehensive and cost-effective solution.

Reduce Your Recall Risks and Boost Supply Chain Efficiencies with Rapid Screenings for Microbial Contamination

December 1, 2008 5:46 am | Articles | Comments

Contamination in pharmaceutical products makes headlines, creates potential nightmares for drug manufacturers, and shakes the confidence of patients, physicians and regulatory authorities. Contamination causes a ripple effect that magnifies costs exponentially the further from the source it is detected. Yet for many pharmaceutical development and manufacturing companies, traditional testing methods are so slow

Single-Supplier Sourcing in Clinical Trials

November 18, 2008 10:01 am | Articles | Comments

The healthcare industry is in a state of evolution. As a result, the efficiency of clinical trials materials (CTM) management services have come under increased scrutiny

5 Steps to Achieving Paperless ePedigree Compliance

October 13, 2008 11:25 am | Articles | Comments

Whether you're developing an in-house solution or outsourcing to a managed service provider, this guide will help manage your company's IT infrastructure to meet changing ePedigree requirements.

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