This article was originally published in The Gray Sheet
Safety Tip-Lok syringes with SafetyGlide needles, prefilled with pediatric doses of Havrix vaccine for hepatitis A and the hepatitis B vaccine Engerix-B, gain FDA approval, announced June 18. BD supplies the devices to drug maker GSK. The delivery system complies with the Occupational Safety and Health Administration's revised bloodborne pathogens standard to prevent needle-sticks, which went into effect April 18 ("The Gray Sheet" April 23, 2001, p. 13)...
You may also be interested in...
Pfizer has now received a formal European Commission approval for its Nyvepria biosimilar pegfilgrastim. The approval puts the firm in direct competition with several other versions of the Neulasta original.
AstraZeneca's research head admits that the half dose approach was a lucky mistake - but one that could boost the vaccine's effectiveness and supplies. The US regulator may not be persuaded, however.
Alvotech has struck a major deal with Yangtze River Pharmaceutical that will allow eight of the biosimilars developer’s products to be commercialized in China.