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FDA Releases Guidance Electronic Submission of Lot Distribution Reports

September 5, 2014

FDA releases draft guidance on electronic submission of lot distribution reports.

Infinity and AbbVie Collaborate to Develop Oncology Drug

September 5, 2014

The companies plan to develop and commercialize duvelisib (IPI-145).

Pfizer's Vaccine for C. Difficile Receives FDA Fast Track Designation

September 2, 2014

Pfizer announced that its investigational vaccine candidate for the treatment of Clostridium difficile has been granted the Fast Track designation from FDA.

NIH Launches Human Safety Study of Ebola Vaccine Candidate

August 29, 2014

The National Institute of Allergy and Infectious Diseases will begin the first in a series of trials for an Ebola vaccine during the week of Sept. 1.

Suppliers Seek to Boost Single-Use Technology

August 21, 2014

Attendees at the Bio-Process Systems Alliance annual summit discuss the benefits of single-use technology in biopharmaceutical manufacturing.

Bristol-Myers Squibb and Celgene Collaborate on Immunotherapy and Chemotherapy Combination Regimen

August 20, 2014

The companies will conduct clinical trials to evaluate a combination immune checkpoint inhibitor and a chemotherapy.

USP Center in Ghana Receives International Lab Accreditation

August 15, 2014

The Center for Pharmaceutical Advancement and Training receives a top international laboratory accreditation for quality control testing.

Report Predicts Generics Production Return to US

August 15, 2014

Concerns about quality in overseas production may bring generic drug production back to the United States, concludes CPhI study.

Amgen Recalls Aranesp Prefilled Syringes

August 15, 2014

Amgen has issued a voluntary recall of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes in several countries because of the presence of visible particulates.

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