Intrexon and Fibrocell hit an FDA speed bump; Sarepta schedules DMD update;

@FierceBiotech: ICYMI: Aduro adds checkpoint inhibitors to a 'breakthrough' mix in $32M buyout. Article | Follow @FierceBiotech

@JohnCFierce: Think the drug pricing issue is going away? Washington Post: The secret truth. Report | Follow @JohnCFierce

@DamianFierce: As a longtime appreciator of dumb corporate M&A codenames, "Project Potsticker" is a solid addition. Bloomberg story | Follow @DamianFierce

> Intrexon ($XON) and Fibrocell Science ($FCSC) are postponing plans for a clinical trial of their gene therapy after the FDA requested more preclinical toxicology data. The companies expect to get back on track in the second quarter of next year. News

> Sarepta Therapeutics ($SRPT) is planning to provide an update Oct. 1 on its efforts to develop a treatment for Duchenne muscular dystrophy. More

Medical Device News

@FierceMedDev: ICYMI: Study: 3-D tissue marker helps improve breast cancer monitoring, aids recovery. Article | Follow @FierceMedDev

@VarunSaxena2: Four key medical device recalls of 2015. Feature | Follow @VarunSaxena2

@EmilyWFierce: ICYMI: EU regulators crack down on Brazilian devicemaker for implant safety scare. Article | Follow @EmilyWFierce

> Pathway Genomics' direct-to-consumer cancer diagnostic earns FDA warning letter. Report

> Sientra off by more than 50% after it discloses CE mark suspension for its contract manufacturer. More

> FDA panel grills Bayer over Essure safety. Story

Pharma News

@FiercePharma: Investors trounce Aratana on dashed hopes for canine lymphoma drugs. FierceAnimalHealth article | Follow @FiercePharma

@EricPFierce: Sun Pharma unit Mutual Pharma recalls 216,766 bottles that may have chemical leaching labels. FiercePharmaManufacturing story | Follow @EricPFierce

@CarlyHFierce: Proud to say my home state is like, basically, the champion of pumpkin-growing. Where America's pumpkins come from. More | Follow @CarlyHFierce

> Novartis scores EU rec for blockbuster-to-be Entresto. News

> Alexion sues Canada over Soliris price cut attempt as drug cost debate explodes on center stage. Story

> Shire chalks up victory in Vyvanse patent battle. Report

Suggested Articles

As Relay looks to enter the clinic in 2020, the company is adding a trio of biopharma vets to its leadership team.

A phase 3 trial of Myovant Sciences’ relugolix in prostate cancer has met its primary endpoint, teeing the company up to file for FDA approval.

The Medicines Company, fresh from its turn at the AHA this weekend, has seen its shares jump on growing rumors that Novartis wants to acquire it.