Roche Tamiflu Not Proven to Cut Flu Complications, Study Says

RocheRoche Holding AG’s antiviral drug Tamiflu may not prevent complications from influenza in healthy adults, according to a review by an independent research group that reversed its previous findings that the medicine warded off pneumonia and other deadly conditions linked to the disease. The pill has been the mainstay of treatment for pandemic swine flu, which has killed nearly 9,000 people since it emerged in April, according to the World Health Organization.

Daiichi influenza drug successful in Phase 3

DaiichiDaiichi Sankyo Co’s new influenza drug CS-8958 has been successful in the late stage clinical studies. The company is planning to filing for government approval in Japan by March. The new drug has demonstrated better efficacy and safety in its phase-3 studies as compared with Roche’s Tamiflu, one of the most widely prescribed influenza drugs. CS-8958 also produced better results than Tamiflu in pediatric studies without any serious safety problems, Daiichi Sankyo said. Daiichi Sankyo expects CS-8958 to be also effective for treating swine flu.

Novartis starts earlier Fluvirin shipment

NovartisNovartis Vaccines has started shipping the first of 30 million doses of its Fluvirin® seasonal influenza vaccine to the US. The shipping has started weeks ahead of schedule. The vaccine indicated for patients aged four years and over will be used to help meet the anticipated increase in demand for the seasonal vaccine as a result of the current global (A) H1N1 swine flu pandemic.

Novavax’s vaccine candidate works fine in trial’s second phase

Novavax Inc. declared that its candidate for the vaccine against pandemic influenza virus-like particle (VLP)  has shown favorable results for the second stage of the Phase I/IIa of the human clinical trial. The vaccine candidate, which does not include an adjuvant, induced robust neutralizing antibody titers across all three doses tested. Avian influenza, the disease that the vaccine will prevent, emerged in humans in 2005 in Indonesia. 81% of  the 135 documented human cases have been fatal. The safety report for the trial is pending, but no adverse case has been reported.

EMEA accepts review of first ID flu vaccine

sanofi pasteur logoThe vaccines division of sanofi-aventis Group, Sanofi Pasteur, has filed the first centralized marketing authorization application with the European Medicines Agency (EMEA) for the influenza vaccine delivered by an intradermal (ID) microinjection system. ID delivery is an improvement over intramuscular (IM) injection in terms of enhancing the immune response in the elderly. The vaccine uses BD Soluviaä, which is a microinjection system developed by Becton, Dickinson and Company.