Report: FDA’s Hamburg says creating biosimilars pathway likely to be complex
NEW YORK To express it in modern parlance, follow-on biologics will be a hot mess.
While speaking at the Reuters Health Summit, according to Reuters, Food and Drug Administration commissioner Margaret Hamburg didn’t put it quite that colorfully, but she had said the science will evolve, meaning a regulatory approval pathway never will be a truly done deal.
The healthcare-reform law requires the FDA to create a regulatory approval pathway for follow-on biologics, also known as biosimilars. Last week, the agency sponsored a hearing to get input from the public that attracted representatives from the branded and generic pharmaceutical and biotech industries, as well as individual companies, such as Teva Pharmaceutical Industries and Sandoz, both of which already make biosimilars for the European market.
FDA grants fast-track designation for CDI vaccine
SWIFTWATER, Pa. A vaccine for a bacterial infection that affects the gastrointestinal tract has been granted expedited approval by the Food and Drug Administration.
French drug maker Sanofi-Aventis announced Tuesday that it had received fast-track designation from the FDA for its investigational Clostridium difficile vaccine. The FDA grants the designation to ease the development of new drugs and vaccines for serious or life-threatening conditions or unmet medical needs.
C. difficile infection, or CDI, is one of the most common hospital-acquired infections in the developed world. The bacteria are present without causing symptoms in around 60% of infants and 3% of adults. Antibiotic treatments sometimes can disrupt the bacteria in the gut, causing C. difficile to multiply and release toxins that cause the symptoms associated with CDI.
American Greetings’ Yakety Yaks cards talk back
CLEVELAND Everyday objects are taking center stage in a new line from American Greetings.
The new Yakety Yaks line features innovative music and motion technology in which quirky characters belt out hilarious songs that are perfect for celebrating any occasion, the company said.
"[Yakety Yaks] definitely put a smile on our faces while we were working on the line, and they are sure to put a smile on any recipient’s as well," said Carol Miller, executive director of new product concepts at American Greetings.