Heplisav studies put on hold while adverse reaction is investigated
BERKELEY, Calif. & WHITEHOUSE STATION, N.J. Dynavax Technologies and Merck have been informed by the Food and Drug Administration that the agency has put a hold on further studies of their experimental hepatitis B vaccine Heplisav, according to Reuters.
The FDA placed two drug applications for the drug on clinical hold after a patient receiving the vaccine was preliminary diagnosed with Wegener’s granulomatosis, a disease in which the blood vessels become inflamed.
No additional clinical trials with the vaccine will be initiated until the clinical hold has been resolved, the companies said in a joint statement. The companies also said they were investigating whether the patient’s illness stemmed from a pre-existing condition or was related to the vaccine administration.
Study of Copaxone reveals that drug is not effective for patients in treatment of ASL
WASHINGTON Copaxone, a blockbuster drug manufactured by Israel’s Teva Industries, has proven to be ineffective for the treatment of amyotrophic lateral sclerosis, according to the company.
Copaxone, which earned Teva $436 million in revenue, was subjected to a 366-patient Phase II trial to investigate if it was able to reduce deterioration in patients with ALS. According to published reports, the study showed that the drug, although safe, did not increase rate of survival among patients battling the disease.
ALS, commonly known as Lou Gehrig’s disease, plagues about 10,000 people in the U.S. and Europe. ASL leads to paralysis, and those who are diagnosed are expected to live within 3-5 years experiencing weakness in limbs, twitching and respiratory impairment, as well as other painful symptoms. Copaxone was the leading therapy for multiple sclerosis in the U.S., but based on the new findings, Teva will continue to search for other options in treating the disease.
Manitoba pharmaceutical regulator tries to end online pharmacies
MANITOBA, Canada The Manitoba Pharmaceutical Association is attempting to put a stranglehold on the province’s Internet pharmacy business, according to CBC news. Manitoba conducts a good deal of online pharmacy business.
The association has approved a new rule that would prevent pharmacies from filling out-of-province prescriptions starting June 30. If pharmacies don’t comply with this new rule, they can have their licenses revoked.
Troy Harwood-Jones, of the Manitoba International Pharmacy Association, said that kind of rule is unheard of in other provinces, and in a recent vote, more than 70 percent of pharmacists voted against it.
In response, the province has assigned a mediator to try to work something out between the Internet pharmacies and the association. Although, Harwood-Jones said that if a deal wasn’t reached, he thought many of the 20 Internet pharmacies in the province would leave.