Optimer receives production patent for CDI treatment
SAN DIEGO The U.S. Patent and Trademark Office has issued a production patent to Optimer Pharmaceuticals covering steps used in the manufacture of fidaxomicin, Optimer announced Monday.
The drug is in phase 3 testing as a treatment for Clostridium difficile infection, also known as CDI.
“The issuance of this production patent is another important milestone in strengthening the patent estate of our lead product candidate, fidaxomicin,” Optimer president and CEO Michael Chang stated. “We believe this patent and the issued polymorphic Form A patent, along with additional pending patent applications, will enhance our intellectual property protection for fidaxomicin.”
CDI causes inflammation of the colon, which often results in diarrhea but can also cause death in extreme cases.
Merck, Cardiome Pharma to collaborate, develop atrial fibrillation treatment
VANCOUVER, B.C. Merck & Co. and Cardiome Pharma Corp. announced this week that they would collaborate to develop and commercialize a drug being investigated as a treatment for atrial fibrillation.
The agreement provides Merck with exclusive global rights to the oral formulation of vernakalant, designed for the maintenance of normal heart rhythm in patients with atrial fibrillation. It also provides Merck with exclusive rights outside North America for an intravenous formulation of the drug used for rapid treatment of the disease.
“This agreement underscores Merck’s ongoing commitment to the research and development of new cardiovascular drugs,” Merck Research Laboratories SVP and franchise head of atherosclerosis and cardiovascular Luciano Rossetti said. “Vernakalant is an important addition to our broad portfolio of products and candidates that target multiple aspects of heart disease.”
FDA approves new topical treatment of head lice
ROCKVILLE, Md. The Food and Drug Administration has approved a new prescription topical medication for treating head lice, the agency announced Thursday.
Sciele Pharma’s Benzyl Alcohol Lotion, 5% is the first head lice treatment approved by the FDA that uses benzyl alcohol as its active pharmaceutical ingredient. It is meant for patients ages 6 months and older.
“Head lice are a problem that impacts more than 1 million children each year and is easily transmitted to others,” FDA Center for Drug Evaluation and Research director Janet Woodcock said. “This drug is an effective first-line treatment to eliminate lice infestation and minimize disruption in the daily routines of families.”