Amy Ritter, PhD

Scientific Editor, BioPharm International

Articles

Job Security in a Changing Biopharma Environment

Results from the 2012 employment survey.

First Seasonal Influenza Vaccine Produced in Cell Culture Approved in US

Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.

FDA Adopts Final Version of Q11 Guidance

FDA announced the availability of the guidance, “Q11 Development and Manufacture of Drug Substances,†in the Nov. 20, 2011 edition of the Federal Register.

Legislators Request Info on Link Between Drug Shortages and Increased Reliance on Compounding

House Democrats have requested the Government Accountability Office (GAO) to conduct an inquiry into factors leading to an increased reliance on compounded products.

Raid Captures 82 Million Doses of Counterfeit Drugs in Africa

An operation spanning 16 African countries and conducted by the World Customs Organization (WCO) in partnership with the Institute of Research against Counterfeit Medicines (IRACM) led to the seizure of more than 82 million doses of counterfeit medicines.

Boehringer Ingelheim Settles False Claims Act Allegations for $95 Million

Boehringer Ingelheim agreed to pay $95 million to settle allegations that it improperly promoted four of its drugs.

Technical Forum: Disposable Chromatography

Industry experts from GE Healthcare, Tarpon Biosystems, Polybatics, Merck Millipore, and Repligen discuss the challenges of adapting disposable technology to the chromatography process.

Discovery Pipeline: Improved Delivery of RNA Vaccines

Creating an effective nucleic acid-based vaccine requires protecting the fragile nucleic acid from degradation, effective transfection of the targeted cells, and producing high enough levels of antigen to evoke a robust immune response.

Watson Receives Clearance for Actavis Acquisition

Watson Pharmaceuticals has received clearance from the Federal Trade Commission (FTC) for its acquisition of generic drug manufacturer, Actavis.

FDA Investigates Compounded Medication Tied to Meningitis Outbreak

FDA announced that it is working closely with the Centers for Disease Control to identify the source of an outbreak of meningitis among patients who had received an epidural steroid injection.