FDA iffy on Abott's Humira for bowel disease; Forest makes it official, Icahn won one;

> Just ahead of an FDA advisory panel decision Tuesday, FDA staff suggested that Abbott Laboratories ($ABT) may need to do more testing on whether its cornerstone drug, Humira, provides any benefit in treating inflammatory bowel disease. Story

> The U.K.'s European Medicines Agency (EMA) has issued a warning about Pacira Pharmaceuticals' brain cancer drug DepoCyte after fining manufacturing issues at a San Diego plant. Story

> Watson Pharmaceuticals ($WPI) says it believes it is entitled to 180-day exclusivity on its generic version of Endo Pharmaceutical's Lidoderm topical patch, which it will launch next under an agreement with Endo ($ENDP). Story

> Reports in a medical journal take Canadian officials to task for their poor response to drug shortages. Story

Biotech News

@FierceBiotech: New CEO tapped to run armed-antibody biotech Actinium. News | Follow @FierceBiotech

@JohnCFierce: Talked yesterday with Andrea Pfeifer of AC Immune, working on a new Alzheimer's drug with Roche. Said: We've got to move to earlier stage. | Follow @JohnCFierce

@RyanMFierce: A question now is how far will $LLY fall with sola failure, far enough for CEO John L. to change tune on internal R&D w/o mega-merger? | Follow @RyanMFierce

> GlaxoSmithKline ($GSK) says it has wrapped up studies of its LAMA/LABA therapy for COPD and is prepared to file for approvals as planned. The pharma giant is partnered with Theravance on the program. Story

> Synergy Pharmaceuticals has acquired FV-100, an experimental treatment for shingles, from Bristol-Myers Squibb ($BMY). Release

> The Leukemia & Lymphoma Society has provided $12 million in new grants for key research efforts. Release

Medical Device News

@FierceMedDev: Medtronic gained FDA approval and a CE mark for a new atrial fibrillation treatment. News | Follow @FierceMedDev

@MarkHFierce: LabCorp says no, but analysts believe the company is a buyout target for private equity firms--via Bloomberg. Report | Follow @MarkHFierce

@DamianFierce: Bolstered by Myriad's court decision, Rosetta is expanding its capacity and soaring on the Street. More | Follow @DamianFierce

> Tornier snags OrthoHelix for $135M. More

> Hybrid microscopy tech produces sharper imagery of the brain's finer details. Item

> Rosetta boosts capacity, soars on the Street. Article

And Finally... In case anyone in the world was unaware, Forest Laboratories ($FRX) announced the official results of its board elections, confirming that while 9 of its 10 members were re-elected, one of investor Carl Icahn's four nominees, Pierre Legault, joins the board. Release

Suggested Articles

With generics at the gates, Novartis’ Gilenya secured a breath of fresh air—and protection for its blockbuster sales—with a federal injunction.

Akorn has been slammed with another FDA warning letter even as it is in the process of renegotiating its loans with lenders.

Horizon Therapeutics is preparing for the potential launch of inflammatory eye drug teprotumumab with team building.