• Cel-Sci Corp., of Vienna, Va., said a second interim review of the safety data from its open-label, randomized, Phase III study of immunotherapy candidate Multikine (leukocyte interleukin, injection) was conducted, with the independent data monitoring board recommending that the study continue unmodified.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., posted U.S. net sales of ophthalmic drug Eylea (aflibercept) of $363 million for the third quarter, a 49 percent jump over the same period last year and topping consensus estimates of $350 million.

• Shire plc, of Dublin, reported positive top-line results from two identically designed randomized placebo-controlled Phase III studies evaluating the efficacy and safety of Vyvanse (lisdexamfetamine dimesylate) capsules (CII) vs. placebo in adults with binge eating disorder (BED).

• Pfizer Inc., of New York, said the FDA approved a prior approval supplement for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release capsules CII.

Keryx Biopharmaceuticals Inc.’s Zerenex (ferric citrate) may be poised to become the first oral iron booster that also provides phosphorous control in chronic kidney disease (CKD) patients, if new top-line data from a Phase II trial hold up.

VIENNA – Astrazeneca plc’s Marc Dunoyer made his scheduled appearance at a plenary session on transformational dealmaking during day two of the BIO-Europe 2013 meeting here at the Messe Wien Exhibition & Congress Center.

Shares of Paladin Labs Inc. soared 49.4 percent Tuesday on news of an acquisition by Endo Health Solutions for $1 .6 billion in stock and cash. The merger will marry Paladin’s pipeline of products in attention deficit hyperactivity disorder, pain, urology and allergy with Endo’s health care assets under a newly formed entity based in Ireland, led by Endo’s management team.

All the hurdles in developing drugs to fight cancer in children came to the fore this week as the Pediatric Oncology Subcommittee of the FDA’s Oncology Drugs Advisory Committee (ODAC) grappled with the unknowns of science and a pressing unmet need as they discussed global pediatric development plans for Bristol-Myers Squibb Co.’s (BMS) nivolumab, Merck Sharp and Dohme’s MK-3475 and Novartis Pharmaceuticals Corp.’s LEE011.

• Biolinerx Ltd., of Jerusalem, received approval from the Finnish National Supervisory Authority for Welfare and Health to begin a Phase I/II trial of BL-7010 for celiac disease.