Category Archives: News

FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin

FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin Print this page INCHEON, South Korea & JERUSALEM–(BUSINESS WIRE) December 14, 2018 –Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Herceptin®1 (trastuzumab) for the following indications: Adjuvant Breast… Read More »

FDA Approves Motegrity (prucalopride) for Adults with Chronic Idiopathic Constipation (CIC)

FDA Approves Motegrity (prucalopride) for Adults with Chronic Idiopathic Constipation (CIC) Print this page Cambridge, Mass. – December 17, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG) has announced that the U.S. Food and Drug Administration (FDA) has approved Motegrity™ (prucalopride), a once-daily, oral treatment option for adults with Chronic Idiopathic Constipation (CIC).1 Motegrity, a… Read More »

Health Law Could Be Hard to Knock Down Despite Judge’s Ruling

Could a federal judge in Texas be the catalyst that finally brings down the Affordable Care Act, a law that has withstood countless assaults from Republicans in Congress and two Supreme Court challenges? On the morning after Judge Reed O’Connor’s startling ruling that struck down the landmark health law, legal scholars were doubtful. Lawyers on… Read More »

Viewpoints: Lessons On Stopping E. Coli Outbreaks; Government Steps Up To Monitor Emerging Technologies

Editorial pages focus on these health care issues and others. The Hill: Preventing The Next Romaine Lettuce E. Coli Outbreak  Seven years after Congress passed the 2011 Food Safety Modernization Act (FSMA), the FDA still hasn’t implemented a number of key reforms required by that law. Among other things, the law required the FDA to… Read More »

Chronic fatigue: Overactive immune system 'may trigger ME-like symptoms'

An overactive immune system may help explain the cause of chronic fatigue syndrome, scientists from King’s College London have suggested. Many sufferers of CFS, or ME, say their condition began with a challenge to their immune system like an infection. The scientists studied 55 patients with Hepatitis C who were given a drug that causes… Read More »