Industry News

The assay assesses the ability of antibodies to neutralize the Ebola virus.

The National Institutes of Health says a new study showed that hydroxychloroquine reduced the transmission of Zika in pregnant mice.

The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.

FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

A new study predicts a potential disconnect between regulatory science and biotechnology product development, unless regulators scan the horizon for new developments and consider new potential risk pathways.

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

The conference will return to the EU and is featuring its Start-Up Hub and Pharmapack Awards.

The directorate highlights its 2016 achievements.

BIO report measures decade-long investment and acquisition trends for emerging biotech companies.

Drug sales forecasts fall for first time in 10 years, thanks to pressures to reduce drug prices and the advent of biosimilars.

The agency announced it is taking steps to increase competition within the prescription drug market.

Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.

The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.

The company successfully produced cell-based influenza vaccines at a commercial scale in its facility in NC.

FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.

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

The organization released principles related to workforce development, diversity, and inclusion that it believes are key to the biotechnology industry.

The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.

The company recalled a variety of products due to the potential of microbial contamination.

The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.

The company is voluntarily recalling all unexpired lots of nitroglycerin products produced at its Houston location for potency issues.

Congressional measures lack the support to move forward.

The agency sent a warning letter to A-S Medication Solutions LLC after it found the company didn’t comply with drug listing file requirements.

FDA Commissioner Scott Gottlieb announced the July meeting as part of his commitment to address opioid abuse.

FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.

The three regulatory agencies have agreed to data requirements for development of new antibiotics.

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