PharmTech News

Articles

The agency announced a plan to eliminate its existing orphan designation request backlog.


FDA to Eliminate Backlog of Orphan Drug Designation Requests

Charlie Baker announced a plan to invest up to $500 million in the MA life-science industry. 


MA Governor Announces $500-Million Investment in Life-Science Industry

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval. 


Supreme Court Rules in Amgen v. Sandoz

FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.  

FDA Asks Endo to Remove Opioid From Market

Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.


FDA Warns Utah Company for Repeated Quality Failures

The state is alleging that misleading marketing practices contributed to the opioid epidemic in Ohio.  

Ohio Sues Five Opioid Manufacturers

The company voluntarily recalled one lot of Brilinta 90 mg professional samples because it contained another medicine.


AstraZeneca Recalls Samples of Brilinta

A recent survey suggests that 36% of pharmaceutical companies and contract development and manufacturing companies have not started working on serialization, and that those who are working on it are focusing on basic compliance rather than potential long-term business benefits.

Survey Suggests that One-Third of Pharma Companies Aren't Ready for Serialization

Thermo Fisher will acquire Patheon for approximately $7.2 billion, including the assumption of approximately $2 billion of net debt. 

Thermo Fisher Scientific to Acquire Patheon

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

User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb. 

Top News