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FDA approves Novartis’ CAR-T therapy, marking the first time a cell therapy based on gene transfer has been approved in the United States for any indication.

FDA Approves Novartis’ CAR-T Drug, First Gene Therapy Approval in US

Pilot tests will evaluate a system developed by Ambrosus Technologies, using smart contracts and advanced sensors to ensure pharmaceutical quality, safety, and traceability.

Trek Therapeutics to Test Blockchain-Based Smart Contracts for Clinical Supply Chain Safety

On August 10, 2017, FDA announced a voluntary recall of all liquid products manufactured by PharmaTech and distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories because of possible Burkholderia cepacia (B. cepacia) contamination. 


FDA Recalls PharmaTech Liquid Products for B. cepacia Contamination Risk

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The Senate voted 94–1 to approve legislation reauthorizing user fees and a series of program changes.

Congress Meets Deadline for Reauthorizing FDA User Fees

A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs. 


Merck and Pfizer Collaborate with Corning to Modernize Pharmaceutical Glass Packaging

The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.


Opioid Report Recommends Coordinated Effort to Fight Epidemic

FDA advisory committee has recommended for approval Novartis CAR-T cell therapy CTL019 for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia in pediatric and young adult patients.

Novartis CAR-T Cell Therapy CTL019 Recommended for FDA Approval

The 2017 CPhI Pharma Awards program features 20 categories covering achievements in the pharma industry.

2017 CPhI Pharma Awards Open for Entries

After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.

Endo Withdraws Opioid Drug from Market

The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.


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