FDA pushes back deadline on Santarus drug; Aegerion pencils in adcomm meeting;

 

Conversations on  Twitter :

 @FierceBiotech: On eve of Forest proxy showdown, Icahn takes aim at management for undisclosed FDA warning letters. Article | Follow @FierceBiotech

 @JohnCFierce: Booming Shire closes in on new campus site for U.S. HQ. More | Follow @JohnCFierce

 @RyanMFierce: Quintiles, the big CRO, gets bigger via buyout of DNA sequencing and analysis shop Expression Analysis. News | Follow @RyanMFierce

> Regulators at the FDA have pushed back their PDUFA deadline on Santarus' application for its bowel disease drug to January 16. The agency wants more time to review information in the NDA. Story

> Aegerion Pharmaceuticals ($AEGR) says it has scheduled an October 17 advisory committee session to review its application for lomitapide, an experimental therapy for adult patients with homozygous familial hypercholesterolemia. Story

> The penny stock company Cortex Pharmaceuticals ($CORX) has acquired Pier Pharmaceuticals in Louisville in an all-stock transaction. Story

Medical Device News

 @FierceMedDev: Roche Holdings' heart attack test helped reduce emergency room diagnoses in a new stud--via BloombergReport | Follow @FierceMedDev

 @MarkHFierce: Think an epipen, but shaped like a credit card that offers voice and written instructions. Sanofi made; FDA approved. More | Follow @MarkHFierce

 @DamianFierce: More M&A for Teleflex, this time spending $276M on Singapore's LMA. News | Follow @DamianFierce

> Jarvik moves toward FDA nod for cardiac assist device. Article

> Sanofi's new epinephrine device guides users with voice and written instructions. Item

> Teleflex ponying up $276M for laryngeal mask firm. More

Pharma News

 @FiercePharma: Merck KGaA's Rebif (for MS) and Erbitux (cancer) helped push Q2 sales past expectations. Weak euro helped, too. More | Follow @FiercePharma

> Icahn slams Forest for undisclosed FDA warning. News

> What are Avastin's chances in its next NICE review? More

> Pfizer, AstraZeneca strike $250M-plus deal for OTC Nexium. Article

Biotech Research News

> Gene offers tantalizing leukemia target. Story

> University of Cambridge debuts latest stem cell research institute. More

> Nanomaterial propels self-repair for damaged hearts. Article

Pharma Manufacturing News

> Internet drug dealer gets 10 years but feds want his Chinese boss. Story

> FTC says GPhA drug shortage plan avoids antitrust issues. More

> FDA asks Merck to make up for Sanofi cancer drug shortage. News

> Thieves target pharmacies, not trucks, in Mexico. Item

> More drugs for U.S. to come from Ranbaxy's Mohali, India, plant. Article

And Finally… Investigators at Virginia Commonwealth University Massey Cancer Center say that lab and animal experiments underscore the promise of a new combo treatment for multiple myeloma. Release

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