Merck Loses 4th Bid to Expand Gardasil® to Older Women PR Log April 8, 2011 by Leslie Carol Botha FOR IMMEDIATE RELEASE In a long awaited decision1 the US FDA has ruled against Merck’s supplemental biologics application license (sBLA) for an indication to use Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine Recombinant] […]
Wrongly injected toddler fights leukaemia
Stuff.co.nz New Zealand NATALIE AKOORIE April 9, 2011 A Hamilton toddler who was mistakenly injected with a vaccine to prevent cervical cancer when he was just six weeks old has developed a rare form of leukaemia. Chace Topperwien began chemotherapy for the M7 strand of acute myeloid leukaemia on his second birthday last month, but […]
U.S. Prescribing Information for GARDASIL® Updated; Indication Not Granted for Use in Adult Women
Merck News Room April 6, 2011 WHITEHOUSE STATION, NJ – April 6, 2011 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has completed its review of Merck’s supplemental biologics license application (sBLA) for an indication to use GARDASIL [Human Papillomavirus […]
Lack of information, apathy raise risks of cervical cancer
International Business Times Australia By Alyangka Francheska | March 28, 2011 5:18 PM EST Gotta love it when women’s health issues shows up in the business section of the media. SV A study by scientists at the University of Sydney and the Children’s Hospital at Westmead has found has found that some girls are missing […]
Fast-Tracking Oncology Drugs Questioned
MedPage Today By Kristina Fiore, Staff Writer, MedPage Today Published: March 27, 2011 Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner Cancer drugs rushed to the market via the FDA’s accelerated approval process often languish in confirmatory trials, agency researchers say. Out […]
