Articles by Alexis Pellek - Pharmaceutical Technology

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Articles by Alexis Pellek

FDA Mulls More Obesity Drugs

Three therapies under review could help Americans attain a healthy weight.
Aug 2, 2010

Three therapies under review could help Americans attain a healthy weight.

A Timeline of J&J/McNeil's Recent Recall Troubles

Jul 15, 2010

The timeline below summarizes the recent events surrounding J&J/McNeil's recalls and news.

H1N1 Vaccine Trial Data Still Needed for High-Risk Groups

Sep 18, 2009

The US Food and Drug Administration approved on Tuesday four H1N1 flu vaccines that demonstrated in clinical studies that a single dose produced a strong immune response in healthy adults after 8?10 days. But clinical trials of the vaccine are still underway on pregnant women and children, two groups that the Centers for Disease Control and Prevention (CDC) says are especially vulnerable to the H1N1 flu.

Drug Serialization and Supply-Chain Security

As regulators work to curb counterfeiting, industry finds benefits to gaining granular data about the supply chain. This article contains bonus online-exclusive material.
Jun 2, 2009

As regulators work to curb counterfeiting, industry finds benefits to gaining granular data about the supply chain. This article contains bonus online-exclusive material.

Pharma Forecast

A recent reader poll focused on predictions for the industry's future.
Feb 2, 2009

A recent reader poll focused on predictions for the industry's future.

Billion-Dollar Deals of 2008

The past year saw major acquisitions attempted, completed, rejected, and stalled.
Dec 2, 2008

The past year saw major acquisitions attempted, completed, rejected, and stalled.

FDA Draft Guidance Reviews Priority-Review Voucher Plan

Oct 23, 2008

The US Food and Drug Administration released a draft guidance that reviews the agency's plan to offer priority-review vouchers to companies developing new treatments for neglected tropical diseases.

Continuous Processing: Moving with or against the Manufacturing Flow

Fueled by a need to reduce costs and improve efficiencies, continuous processing may be the next paradigm shift in pharmaceutical manufacturing.
Sep 2, 2008

Fueled by a need to reduce costs and improve efficiencies, continuous processing may be the next paradigm shift in pharmaceutical manufacturing.

Senate Committee Passes Kennedy's FDA Budget Increase Amendment

Mar 20, 2008

The US Senate passed an amendment to the fiscal year 2009 budget bill that will increase the amount allotted to FDA by $71 million, bringing the agency's total FY 2009 budget increase to $375 million.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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