The one-of-a-kind lawsuit filed last Wednesday against the FDA by Toronto-based Apotex Inc. (joined by the company's U.S. arm, Apotex Corp.) probably will be resolved quickly, said Kurt Karst, director at Hyman, Phelps & McNamara in Washington.

Fibrocell Science Inc. wants to use $45 million from a private placement to reach more customers with LaViv (azficel-T), the personalized wrinkle therapy that harvests a sample of the patient's own cells by way of a skin-punch behind the ear, expands their collagen-making fibroblasts in the laboratory, and returns them by injection to nasolabial folds.

It was an unlikely project, all the way around. First, getting together a syndicate of venture capital investors to bet on vaccines – medicines typically given to healthy subjects, which makes possible toxicity an especially dicey proposition.

Neither the smallish trial size nor two extra-sick patients in the lower-dose arm could dampen Wall Street's enthusiasm for eye-opening Phase IIb results disclosed by Sarepta Therapeutics Inc. in Duchenne muscular dystrophy.

Investors will have to wait for November for details, but Celgene Corp. said Abraxane met its primary endpoint of progression-free survival (PFS) in a Phase III metastatic melanoma trial by the company's Swiss subsidiary.

With added, positive Phase III breast cancer data from a trial called EMILIA for the antibody-drug conjugate T-DM1, Roche AG subsidiary Genentech Inc. and partner ImmunoGen Inc. uplifted – but didn't overly surprise – investors, who are waiting to see whether the first label permits front-line use in metastatic disease.

With fast-track status in hand for prostate cancer and two late-stage trials under way, OncoGenex Pharmaceuticals Inc.'s custirsen entered another Phase III study, this one in patients with non-small-cell lung cancer (NSCLC) whose disease has progressed despite chemotherapy.

CEO Sapan Shah calls ARMGO Pharma Inc. "one of biotech's better-kept secrets," but news about the company has begun to leak – not unlike the faulty calcium channels in diseased tissue that ARMGO's Phase II drug candidates are designed to fix.

Would-be competitors coming up quickly behind Biogen Idec Inc.'s Factor IX (rFIXFc) Fc fusion protein, along with an expectation of good news, may have combined to put a Wall Street damper on favorable Phase III results in hemophilia B, as investors looked ahead to Phase III data later this year in the larger market of hemophilia A with a separate molecule, rFVIIIFc.

A federal court has turned down the Patent and Trademark Office's (PTO) request that judges look again at January's ruling on the statutory deadline for legal challenges to patent term adjustments.