J&J gets FDA approval for Pancreaze
SILVER SPRING, Md. The Food and Drug Administration has approved a drug for diseases that affect the pancreas, the agency announced Monday.
The FDA approved Johnson & Johnson’s Pancreaze (pancrelipase) delayed-release capsules, a pancreatic enzyme product. Pancreatic enzyme products improve digestion in patients who can’t produce enough of it to digest food properly because of such pancreatic diseases as cystic fibrosis, chronic pancreatitis, pancreatic tumors and removal of the pancreas. Pancreaze is the third such product, after Abbott Products’ Creon (pancrelipase [amylase, lipase, protease]) and Eurand Pharmaceuticals’ Zenpep (pancrelipase [amylase, lipase, protease]).
“The approval of Pancreaze, along with Creon and Zenpep, allows patients and healthcare professionals to choose the approved pancreatic enzyme product that is appropriate for them,” FDA Division of Gastroenterology Products director Donna Griebel said.
Upsher-Smith inks deal with Proximagen for tonabersat
MAPLE GROVE, Minn. Upsher-Smith Labs has acquired exclusive North American rights for an investigational drug designed to treat such conditions as migraine and epilepsy, the drug maker announced Monday.
Under the deal, with Proximagen Neuroscience, Upsher-Smith will be responsible for development, regulatory filing and commercialization activities for the drug tonabersat in the North American market.
“This agreement supports our strategic vision of building a leadership position in the central nervous system field,” Upsher-Smith president Mark Evenstad said. “We are excited about our growing [central nervous system] development portfolio that we hope will provide benefit to patients suffering from neurologic conditions.”
The company is also developing USL255, a once-daily formulation of the generic drug topiramate. The drug is in phase 3 trials as a treatment for epilepsy. Johnson & Johnson originally marketed topiramate under the brand name Topamax.
Vaccines with two strains of influenza may be more effective in children, research team says
ST. LOUIS Vaccines likely would work better in protecting children from flu if they included both strains of influenza B instead of just one, a St. Louis University press report stated last week, citing research conducted through its Center for Vaccine Development.
"Adding a second influenza B virus strain to the seasonal influenza vaccine would take some of the guesswork out of strain selection and help improve the vaccine’s ability to prevent influenza," stated Robert Belshe, lead investigator and director of the center. "Since in five of the last 10 years, the influenza B component in the vaccine has been the incorrect one, this seems like an obvious advance to me."
Every spring, scientists predict which strain of influenza will be circulating in the community the following fall. Historically, they choose two different subtypes of influenza A and one of influenza B.
Research findings in the March issue of Vaccine highlight the importance of adding both lines of influenza B into the vaccine to better protect against the flu, Belshe noted.
The research team examined how well current vaccines protect against influenza B by looking at the immune response of ferrets that were given FluMist, a live attenuated influenza vaccine manufactured by MedImmune.
When ferrets were vaccinated against influenza, the ferrets that were exposed to a strain of influenza B virus that did not match what was in the vaccine didn’t have a strong antibody response. However they had a vigorous antibody response when given a vaccine that contained both strains of influenza B.
This showed that immunizing against one strain of influenza B does not appear to protect against the other strain and that a vaccine containing both influenza B strains is likely to offer greater protection from flu.
"These data highlight the need for vaccination strategies that provide enhanced protection against both lineages of influenza B," Belshe said.
The study was sponsored by MedImmune. Belshe has served as a consultant and as part of the speakers bureau for MedImmune and other study authors are MedImmune employees.