By Elizabeth Finkel MELBOURNE, AUSTRALIA—A warning letter from the U.S. Food and Drug Administration (FDA) to Australian vaccine maker CSL Biotherapies has shaken confidence in the country’s biotech superstar. The 15 June letter accuses CSL of failing to adequately investigate why its Fluvax influenza vaccine last year caused a sharply elevated rate of febrile convulsions […]
CSL influenza vaccine investigation 'inadequate'
By Nick Evans, Perth Now US REGULATORS have hammered Australian vaccine maker CSL over its “inadequate” investigation of manufacturing problems that may have led to severe reactions in children given the flu vaccine last year. In April last year Australian health authorities withdrew CSL’s season flu vaccine from use in children under five after 23 […]
Merck Dodges FDA Bullet and Wins Approval for Gardasil Expansion from Health Canada
By Leslie Carol Botha, Vice President Public Relations, SaneVax Inc. PRLog (Press Release) – May 02, 2011 – SANE Vax Inc. is highly disturbed Merck has not taken FDA advice to prove vaccine efficacy in 26 to 45 year old women prior to getting approval from other governments for use in this age group. According […]
SaneVax Inc. Protests FDA Approval of Roche's cobas HPV Genotyping Test
MarketWatch The Wall Street Journal Digital Network Business Wire press release April 29, 2011, 5:07 p.m. EDT TROY, Mont., Apr 29, 2011 (BUSINESS WIRE) — In an April 22, 2011 letter to FDA Commissioner; Dr. Margaret Hamburg, Norma Erickson on behalf of the SaneVax Inc. Board of Directors, criticized the FDA for not following its own […]
SaneVax Letter to Dr. Margaret Hamburg, FDA Commissioner
April 22, 2011 Dear Dr. Hamburg: I have just read a press release issued by Roche announcing the FDA approval of its cobas HPV Test. The press release states “The cobas HPV Test is the only FDA-approved cervical cancer screening test that allows HPV 16 and 18 genotyping concurrently with high-risk HPV testing.” It is […]
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