Wyeth Wins Thimerosal-Autism Case
Wyeth announced today that Circuit Court in Baltimore, Maryland, has granted Wyeth's motion for summary judgment in the case of Blackwell, et al. v. Sigma Aldrich, Inc., et al an alleged vaccine injury case claiming that Jamarr Blackwell's exposure to thimerosal-containing vaccines caused him to become autistic
Previously, the Court had granted Wyeth's motion to preclude all five of plaintiffs' expert witnesses from offering testimony at trial following extensive briefing and a 10-day evidentiary hearing held by the Court last August.
In his December 21, 2007 Memorandum and Order pertaining to Wyeth's evidentiary motion, Judge Berger found that "it is generally accepted in the relevant scientific community that thimerosal in vaccines does not cause or contribute to neurodevelopmental disorders such as autism," also noting that "it is generally accepted in the relevant scientific community that autism is genetic in origin except in rare instances of prenatal exposures to certain substances at defined periods during pregnancy."
"This is a significant victory for good science generally," says Daniel J. Thomasch, a partner at Orrick, Herrington & Sutcliffe LLP, who served as lead counsel for Wyeth in this matter. "The Court appropriately found that plaintiffs' attempt to link autism to childhood vaccines is contrary to generally accepted science." (Pharmalive)
FDA Approves Xyzal (Levocetirizine dihydrochloride) Oral Solution
Previously, the Court had granted Wyeth's motion to preclude all five of plaintiffs' expert witnesses from offering testimony at trial following extensive briefing and a 10-day evidentiary hearing held by the Court last August.
In his December 21, 2007 Memorandum and Order pertaining to Wyeth's evidentiary motion, Judge Berger found that "it is generally accepted in the relevant scientific community that thimerosal in vaccines does not cause or contribute to neurodevelopmental disorders such as autism," also noting that "it is generally accepted in the relevant scientific community that autism is genetic in origin except in rare instances of prenatal exposures to certain substances at defined periods during pregnancy."
"This is a significant victory for good science generally," says Daniel J. Thomasch, a partner at Orrick, Herrington & Sutcliffe LLP, who served as lead counsel for Wyeth in this matter. "The Court appropriately found that plaintiffs' attempt to link autism to childhood vaccines is contrary to generally accepted science." (Pharmalive)
FDA Approves Xyzal (Levocetirizine dihydrochloride) Oral Solution
UCB and sanofi-aventis announced today that the USFDA approved a New Drug Application (NDA) for XYZAL® (levocetirizine dihydrochloride) 0.5 mg/mL oral solution, a prescription antihistamine indicated for the relief of symptoms associated with indoor and outdoor allergies, as well as the treatment of chronic idiopathic urticaria. XYZAL® tablets received FDA approval on May 25, 2007 and both formulations are now approved for use in adults and children 6 years and older.
"The oral solution of XYZAL® provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication," said Michael S. Blaiss, MD, Clinical Professor of Pediatrics and Medicine at the University of Tennessee Health Science Center in Memphis, Tennessee. "Both the oral solution and tablets offer patients powerful and long-lasting allergy relief."
Studies in allergic rhinitis patients demonstrated levocetirizine significantly reduced the symptoms of sneezing, itchy nose, runny nose, and itchy eyes. Studies in chronic idiopathic urticaria patients showed levocetirizine significantly reduced the severity of itching and the number and size of wheals.
In September 2006, UCB and sanofi-aventis entered into an agreement to launch and co-market XYZAL® in the U.S. UCB and sanofi-aventis have a long history in the allergy treatment arena and are committed to advancing treatment for allergy sufferers and helping meet unmet medical needs for patients with chronic allergy symptoms.
About Allergic Conditions Many people suffer from the symptoms associated with common allergic conditions. The immune system of allergy sufferers over-reacts to something in the environment, leading to symptoms that affect their respiratory system, eyes, or skin. Estimates from the American Academy of Allergy, Asthma & Immunology (AAAAI) suggest that indoor and outdoor allergies affect as many as 40 million people in the United States. (Pharmalive)
"The oral solution of XYZAL® provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication," said Michael S. Blaiss, MD, Clinical Professor of Pediatrics and Medicine at the University of Tennessee Health Science Center in Memphis, Tennessee. "Both the oral solution and tablets offer patients powerful and long-lasting allergy relief."
Studies in allergic rhinitis patients demonstrated levocetirizine significantly reduced the symptoms of sneezing, itchy nose, runny nose, and itchy eyes. Studies in chronic idiopathic urticaria patients showed levocetirizine significantly reduced the severity of itching and the number and size of wheals.
In September 2006, UCB and sanofi-aventis entered into an agreement to launch and co-market XYZAL® in the U.S. UCB and sanofi-aventis have a long history in the allergy treatment arena and are committed to advancing treatment for allergy sufferers and helping meet unmet medical needs for patients with chronic allergy symptoms.
About Allergic Conditions Many people suffer from the symptoms associated with common allergic conditions. The immune system of allergy sufferers over-reacts to something in the environment, leading to symptoms that affect their respiratory system, eyes, or skin. Estimates from the American Academy of Allergy, Asthma & Immunology (AAAAI) suggest that indoor and outdoor allergies affect as many as 40 million people in the United States. (Pharmalive)
