Articles by Erik Greb - BioPharm International

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Articles by Erik Greb

Obama Initiates Partnership to Reinvigorate Manufacturing

Jul 5, 2011

In a speech at Carnegie Mellon University?s National Robotics Engineering Center last Friday, President Obama unveiled an Advanced Manufacturing Partnership (AMP) designed to reinvigorate the country?s manufacturing sector. The partnership between academics, business leaders, and science and technology agencies is intended to create jobs by helping US manufacturers reduce costs, improve quality, and accelerate product development.

FDA Reviews First Year of Bad Ad Program

Jun 21, 2011

After looking back at the first year of its Bad Ad outreach program, FDA judged that the initiative has successfully raised awareness about misleading promotion, according to an FDA press release. The program, which was intended to educate healthcare providers about misleading drug promotions, debuted on May 11, 2010. Since that time, the agency has received 328 reports of potentially untruthful promotion. In contrast, FDA received an average of 104 reports per year before the initiative was launched.

AstraZeneca Settles Sex-Discrimination Lawsuit

Jun 14, 2011

This week, AstraZeneca agreed to settle a sex-discrimination lawsuit by paying $250,000 to 124 women who worked at the company?s Philadelphia Business Center in Wayne, Pennsylvania. The US Department of Labor (DOL) brought the lawsuit in May 2010, alleging that AstraZeneca had discriminated against female sales specialists by paying them salaries that were an average of $1700 less than those of their male counterparts.

FDA Unveils Inspections Database

Jun 7, 2011

Last week, FDA added a searchable database of inspection data to its website. The database lists the names and addresses of facilities that the agency inspected during fiscal years 2009 and 2010. Users can find inspection dates, the type of FDA-regulated products that the facilities produced, and the agency?s final inspectional classification, which reflects each firm?s compliance status.

Teva Acquires Majority Stake in Taiyo

May 24, 2011

On Monday, Teva Pharmaceutical Industries agreed to pay shareholders $460 million in cash to acquire a 57% stake in Taiyo Pharmaceutical Industry. Teva also will offer to buy all outstanding shares of Taiyo. The deal values Taiyo at approximately $1.3 billion.

FTC Finds 60% Increase in Pay-to-Delay Deals

May 17, 2011

In fiscal year (FY) 2010, the number of patent settlements in which the manufacturers of branded products paid makers of generic drugs to postpone the introduction of their products reached its highest level ever, according to a Federal Trade Commission (FTC) staff report. The number of these ?pay-to-delay? deals rose from 19 in FY 2009 to 31 in FY 2010, an increase of more than 60%. FY 2010 agreements involved 22 branded pharmaceutical products with combined annual US sales of about $9.3 billion, according to the report.

Excipient-Certification Standards Presented for Comment

May 10, 2011

The International Pharmaceutical Excipients Council (IPEC) is soliciting public comment about a draft plan for the independent certification of manufacturers and suppliers of pharmaceutical excipients. The document is the second draft of the ?Excipact? set of standards, and the authors sent it to industry stakeholders for review.

FDA Publishes Guidance for Preventing Cross-Contamination

Apr 19, 2011

FDA Publishes Guidance for Preventing Cross-Contamination

J&J Reorganizes Consumer Group

Apr 12, 2011

J&J Reorganizes Consumer Group

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