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June 08, 2015
In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”
June 04, 2015
FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.
June 03, 2015
Baxter announces that it will partner with Mayo Clinic and Velocity Pharmaceutical to form Vitesse Biologics, a Baxalta-managed company focused on immunology, hematology, and oncology.
June 02, 2015
The directorate highlights achievements accomplished during the year of its 50th anniversary.
May 27, 2015
Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.
May 21, 2015
The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.
May 20, 2015
The new guideline replaces the previous version-CHMP/EWP/240/95 Revision 1.
The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.
May 18, 2015
The Irish company Endo International announced that it would acquire Par Pharmaceutical for $8.05 billion.
May 07, 2015
BASF announces that it will sell its custom synthesis business and parts of its API business to focus its expertise on pharmaceutical excipients.