American Academy of Pediatrics updates flu vaccination recommendations
WASHINGTON The American Academy of Pediatrics released a policy statement regarding its recommendations for routine use of trivalent seasonal influenza vaccines and antiviral medications for the prevention and treatment of influenza in children.
For the 2010-2011 flu season, the organization recommended that all children 6 months of age and older should receive a seasonal influenza vaccine each year, especially those at high risk of influenza complications (e.g., children with such chronic medical conditions as asthma, diabetes, morbid obesity, immunosuppression or neurologic disorders). AAP also added that household contacts and out-of-home care providers of children with high-risk conditions and healthy children younger than 5 years, as well as healthcare personnel and pregnant women, also should receive a season flu shot.
Click here for the full statement.
MedImmune confirms second CRL from FDA for motavizumab
GAITHERSBURG, Md. AstraZeneca’s biologics unit has received a second complete response letter from the Food and Drug Administration regarding an investigational drug designed to treat respiratory syncytial virus disease.
In the second CRL, the FDA requested that MedImmune complete an additional clinical trial that supports a satisfactory risk/benefit profile to advance the registration of motavizumab, its investigational monoclonal antibody.
MedImmune filed the original biologics license application in January 2008 and received its first complete response letter in November 2008. Motavizumab was reviewed by the FDA’s Antiviral Drugs Advisory committee on June 2 of this year.
Somaxon, P&G to co-promote Silenor
SAN DIEGO A drug maker and a consumer packaged goods company will co-promote a newly approved insomnia treatment.
Somaxon Pharmaceuticals and Procter & Gamble announced their co-promotion agreement for Silenor, in which Somaxon’s promotion of the drug will target physicans, while P&G will promote Silenor to targeted pharmacies.
Somaxon will record all sales of Silenor and will pay P&G a combination of fixed fees and a royalty based on U.S. net sales. Each party will be responsible for the costs of maintaining and operating its own sales force, and Somaxon is responsible for all other costs pertaining to the commercialization of Silenor.
The term of the agreement runs through Dec. 31, 2012, renewable thereafter, and Somaxon will pay P&G a reduced royalty based on U.S. net sales of Silenor for one year after the expiration of the agreement or its earlier termination under certain circumstances. Governance of the collaboration will occur through a joint commercialization committee.
“We are extremely excited to add Procter & Gamble’s highly regarded and tenured professional sales force to our commercialization effort for Silenor,” said Richard Pascoe, Somaxon’s president and CEO. “With the combined effort of both sales forces, we will target 35,000 of the highest prescribers of insomnia products, as well as 25,000 pharmacies, which we believe will allow us to be highly competitive in the insomnia market. In addition, we are excited about the potential to partner with Procter & Gamble for the OTC rights to Silenor as a future life cycle management opportunity.”