December 31, 2009, 1:54 pm
An independent safety monitoring board announced positive findings on December 28, 2009, for the continuation of Phase III trials of the experimental cancer drug Allovectin-7 Immunotherapeutic. Allovectin-7 is currently involved in late-stage trials to treat patients with advanced cases of...
December 30, 2009, 1:03 pm
All product lots of Tylenol Arthritis Pain Caplets 100-count bottles with red EZ-Open caps were recalled by Johnson & Johnson on December 29, 2009, following consumer reports of a nauseating moldy smell that caused some people taking the medication to become ill.
In November...
December 29, 2009, 4:48 pm
After drug manufacturer MedImmune determined the company’s H1N1 nasal spray vaccine appears to lose strength over time, nearly 5 million doses of the vaccine were recalled on December 22, 2009.
MedImmune recalled 13 specific lots of Influenza A (H1N1) 2009 Monovalent Vaccine Live,...
December 28, 2009, 10:24 am
A recent Food and Drug Administration (FDA) review of clinical trial data has shown that Merck & Co.’s Vytorin, a popular cholesterol medication that combines Zocor (simvastatin) with...
December 22, 2009, 3:40 pm
Derek Lagos, a 13-year-old New Jersey middle school student and avid soccer player, committed suicide on October 12, 2009, minutes after arriving home from a normal day at school. According to his parents, Lagos did not have a history of depression and showed no signs of unhappiness.
“...
December 21, 2009, 3:36 pm
Clinuvel Pharmaceuticals Ltd. reported positive late-stage results on December 21, 2009, from clinical trials with the photoprotective drug afamelanotide, nicknamed the “UV vaccine.” The Australia-based biopharmaceutical company has been developing the drug since 2000, and Phase III trials...
December 18, 2009, 1:23 pm
A Phase II clinical study testing an Alzheimer’s disease drug has reported nine patient deaths and other serious side effects in patients receiving the two highest doses of 1,000 mg and 2,000 mg, twice daily. The experimental drug candidate, known as ELND005, will continue to be tested in a...
December 17, 2009, 4:38 pm
The most effective therapy for smokers who wished to quit involved a combination of bupropion SR and nicotine lozenges, revealed a study conducted by Dr. Steven S. Smith and colleagues of the University of Wisconsin School of Medicine and Public Health...
December 16, 2009, 2:26 pm
The U.S. Centers for Disease Control and Prevention (CDC) issued a voluntary recall on December 15, 2009, of 800,000 pre-filled syringes containing the H1N1 swine flu vaccine for children aged 6 months to 3 years....
December 16, 2009, 2:18 pm
The father of a young man who committed suicide in 2007 filed a lawsuit against Harvard University on December 2, 2009, stating that the university’s health services prescribed his son multiple medications known to increase suicide risk.
December 14, 2009, 3:48 pm
A new injectable form of Eli Lilly & Co.’s top-selling drug Zyprexa received U.S. Food and Drug Administration (FDA) approval on December 14, 2009. The injection, called Zyprex Relprevv, is an intramuscular injection administered by a doctor every 4 weeks that offers...
December 11, 2009, 3:09 pm
Researchers have discovered a possible link between women taking bisphosphonate osteoporosis drugs such as Fosamax and Actonel and a reduced rate of developing invasive breast cancer. Results of two separate studies, one in the U.S. and one in...
December 10, 2009, 3:49 pm
Wilate, a drug manufactured by Octapharma USA, was approved on December 8, 2009, by the U.S. Food and Drug Administration for the treatment of spontaneous and trauma-induced bleeding experienced by patients suffering from all types of von Willebrand disease (VWD).
In four clinical...
December 9, 2009, 2:52 pm
Bayer Consumer Care issued a nationwide recall of one lot of Alka-Seltzer Plus Day & Night Liquid Gels on December 8, 2009, citing that certain packaging for the combination product could be mislabeled.
A company spokeswoman said that human error during the label printing process was...
December 8, 2009, 9:40 am
On December 4, 2009, Eli Lilly & Co. received Food and Drug Administration (FDA) approval for the marketing of Zyprexa for schizophrenia and manic depression in people aged 13 to 17. The approval follows an FDA advisory committee recommendation made in June that...
December 7, 2009, 3:29 pm
A voluntary market withdrawal of one lot and a voluntary recall of five lots of the Daytrana patch were issued by Shire Pharmaceuticals, though the safety of the patch was not the concern. The recall was implemented due to an issue with the lining of the Daytrana patch.
“Some Daytrana...
December 4, 2009, 3:21 pm
A Food and Drug Administration (FDA) Enforcement Report dated December 2, 2009, notified consumers and healthcare professionals of an ongoing recall for one lot of Prempro, a hormone replacement therapy used to treat menopause-related conditions including...
December 3, 2009, 4:28 pm
On December 1, 2009, Dyax Corp. received Food and Drug Administration (FDA) approval for Kalbitor (ecallantide), the first injectable medication approved to treat all symptoms of hereditary angioedema (HAE) attacks in patients 16 years of age and older.
December 3, 2009, 9:40 am
The Agriflu vaccine was approved by the U.S. Food and Drug Administration (FDA) on November 27, 2009, for patients 18 years and older. Agriflu, manufactured by Novartis Vaccines and Diagnostics, prevents disease caused by the influenza virus subtypes A and B.
The vaccine received approval...
December 1, 2009, 3:42 pm
On November 30, 2009, Eli Lilly and Co. received Food and Drug Administration (FDA) approval for the antidepressant Cymbalta (duloxetine) to be used in the maintenance treatment of generalized anxiety disorder (GAD). In long-term clinical studies, adults taking Cymbalta...
