Top News

Pfizer Receives FTC Clearance for Hospira Acquisition

August 25, 2015

Pfizer agrees to divest four sterile injectable assets to clear the way to complete acquisition of Hospira.

Mylan Receives FDA Warning Letter for Manufacturing Sites in India

August 19, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

Mylan received a warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.

GSK Factory in Tianjin Affected by Explosion

August 18, 2015

GSK reports no employee injuries at the facility and is assessing damage.

Pluristem's PLX Cell Therapy Considered for Accelerated Development

August 14, 2015

The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.

Bacteria in Cooling Tower Causes Shut Down of GSK’s North Carolina Plant

August 12, 2015

GlaxoSmithKline has temporarily shut down its manufacturing plant in Zebulon, North Carolina after Legionnella bacteria was found in a stand-alone cooling tower during routine inspection.

Merck KGaA’s Acquisition of Sigma-Aldrich Approved by Anti-Trust Regulators

August 11, 2015

Following a divestiture of certain assets in Europe, the acquisition of Sigma-Aldrich by Merck KGaA will be complete.

Regulators Call for the Revision of Part B Reimbursement Rules for Biosimilars

August 11, 2015

The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.

Ebola Vaccine Shows 100% Efficacy in Phase III Trial

August 04, 2015

World on the verge of an effective Ebola Vaccine according to WHO.

Shire Proposes Combination with Baxalta

August 04, 2015

Shire takes its offer for an all-stock transaction to combine with Baxalta to shareholders after Baxalta declines to discuss the proposal.

FDA Approves First 3D-Printed Drug Product

August 03, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.