Patients who have anaphylactic reactions to certain vaccines may be allergic to gelatin. The "allergy has been particularly noted in Japanese patients." But, the country "has since removed gelatin from its vaccines, or more thoroughly degrades it before putting it into the immunization, and has since 'seen a huge drop-off in anaphylactic death.'" Notably, "gelatin is used as a stabilizer in vaccines, with some of the highest doses in the MMR and varicella vaccines, at 14.5 mg and 12.5 mg, respectively." John Kelso, MD, of Scripps Clinic in San Diego, "who previously conducted one of the largest US studies on gelatin allergy," noted that a number of "vaccine manufacturers in the US are 'probably considering removing gelatin' from their products."
FDA extends review of neuropathic pain drug.
Reports in Triangle Business Journal state that the FDA "needs three more months to review an application to a neuropathic pain drug being developed by XenoPort Inc. and GlaxoSmithKline PLC," called gabapentin enacarbil, according to the companies. The companies said the FDA "should complete its review of the drug" by Feb. 9, 2010. Further, the FDA seem to want the companies to develop a strategy to evaluate the drug's risks, and after GlaxoSmithKline submitted that strategy, the agency needed additional time to review it.
Merck seeks reversal of Singulair patent rejection.
Publications report that Merck & Co., facing a rejection of its patent for asthma drug Singulair (montelukast sodium), has asked the US Patent and Trademark Office to reconsider its decision. The patent is due to expire in 2012, but in September the PTO found that the Singulair patent was anticipated by previous patents.