Lundbeck gets 2nd go at FDA for schizophrenia drug; Aurobindo goes generic on Lexapro;

 @FiercePharma: Sanofi workers to strike as day of reckoning nears. More | Follow @FiercePharma

> An analysis of 133 print and broadcasting ads for four different medicines that were switched to over-the-counter sales found that more of them touted benefits after the switch than when they were sold by prescription. Story 

> Danish drugmaker Lundbeck says it will get a new meeting with the FDA next year for the resubmission for its schizophrenia treatment, aripiprazole depot formulation. Story 

> Aurobindo Pharma has final approval from the FDA to make and market a generic of Forest Laboratories' anti-depressant Lexapro. Item

> The DEA will revoke the license of two CVS drugstores in Florida over "suspicious sales" of oxycodone and other painkillers. Story

> Pfizer ($PFE) is using a new cloud-based software system for its supply chain operations. Story

Biotech News

 @FierceBiotech: D-Day for Sanofi multiples cerlosis drug Aubagio as deep R&D cuts loom. Story | Follow @FierceBiotech

 @JohnCFierce: Lundbeck, Otsuka scramble to get antipsychotic back on FDA track--(competing with Alkermes). Article | Follow @JohnCFierce

 @RyanMFierce: My take on Illumina's alliance with Partners HealthCare to combine sequencing and software. Story | Follow @RyanMFierce

> UNC biotech spinoff grabs J&J deal and $16M A round for diabetic nephropathy drug. Story

> GlaxoSmithKline anti-smoking drug combats addictive cravings. Report

> Sanofi's dengue fever vaccine trial flop rattles the experts. News

Medical Device News

 @FierceMedDev: J&J has settled the first three lawsuits involving failure of its ASR hip implants. Thousands more to come. Release | Follow @FierceMedDev

 @MarkHFierce: bioMerieux got slapped with an FDA warning letter for quality violations regarding a NC Dx manufacturing facility. Warning Letter | Follow @MarkHFierce

 @DamianFierce: Berkeley's Ekso Bionics is looking to expand the use of its robotic walking aid. Report | Follow @DamianFierce

> IntraPace preps anti-obesity device for U.S. regulatory path. More

> PrimeraDx snags CE marks for assays. News

Biomarkers News

> Janssen's Remicade attacks inflammation to beat depression. Article

> Increased antibody levels tag raised rheumatoid arthritis risk. Story

> Researchers develop genetic test to fine-tune warfarin dose. Item

> Breast cancer protein pinpoints survival chances. More

Drug Delivery News

> Hopkins cracks blood-brain barrier with nanobeads. More

> Sublingual opioid addiction therapy moves closer to market. Report

> Silence breaks out with preclinical data on Atu111. Story

> InSite eyes next-generation DuraSite delivery. Article

> Anti-HIV vaginal ring shows hints of efficacy. More

> AZ goes Down Under for cancer conjugate deal. Item

And Finally... Cosmetics behemoth Lancôme has received a warning letter from the FDA over what the agency says are unacceptable medical claims for some its anti-aging creams, such as that they boost "the activity of genes and stimulates the production of youth proteins." Warning letter

Suggested Articles

The FDA has slapped a U.S. drug repackager, saying in a warning letter that its storage processes and equipment cleaning are not up to expectations.

In an effort to stop an Ebola outbreak that has claimed 2,200 lives at the Rwanda border, J&J is shipping 200,000 doses of its vaccine to the country.

By extending the tender offer for just six days, Roche seems confident it will receive positive reviews from U.S. and U.K. watchdogs in time.