• Alimera Sciences Inc., of Atlanta, received its third complete response letter from the FDA for the new drug application for Iluvien. Identifying concerns regarding the benefit to risk and safety profiles, the FDA stated that the NDA could not be approved in its present form. To address the clinical and statistical deficiencies identified, the FDA said results from a new clinical trial would need to be submitted, together with at least 12 months of follow-up for all enrolled patients. The FDA also referenced deficiencies at the facility where Iluvien (fluocinolone acetonide intravitreal insert) for chronic diabetic macular edema is manufactured. Alimera’s stock (NASDAQ:ALIM) closed Friday at $2.48, down 23 cents, or 8.5 percent.

• Avexis Inc., of Dallas, and Biolife Science Ltd., of Brisbane, Australia, said the Research Institute at Nationwide Children’s Hospital received fast-track designation from the FDA for its scAAV9.CB.SMN gene therapy product for the treatment of spinal muscular atrophy (SMA). The new gene therapy product created by scientists at the Research Institute was granted fast-track status after demonstrating preliminary effectiveness in mouse models of SMA.

• Bionomics Ltd., of Adelaide, South Australia, said it would present posters on BNC101 and BNC105 at the American Association for Cancer Research International Conference on Molecular Targets and Cancer Therapeutics in Boston. The first poster, “Therapeutic targeting of colorectal cancer stem cells [CSCs] with BNC101, a functional anti-LGR5 monoclonal antibody,” will show preclinical data supporting Bionomics’ therapeutic strategy for treating cancer by the targeting of CSCs with BNC101 , prolonging patient survival by preventing CSCs from re-seeding cancer following frontline surgery and standard-of-care chemotherapy. BNC101 is an LGR5 targeting monoclonal antibody. The BNC105 presentation will highlight data that further expands and consolidates the therapeutic utility of BNC105 in renal cancer. BNC105 is based upon the identification of a compound that potently and selectively restricts blood flow within tumors, the company said.

• Cleveland Biolabs Inc., of Buffalo, N.Y., said that because of maturation of its development pipeline and a reduced need for certain services, it has transferred laboratory and preclinical services personnel to Buffalo Biolabs LLC, an entity affiliated with one of the company’s co-founders, Andrei Gudkov. The company has executed a service agreement providing for continued access to this team on an as-needed basis.

Britain’s National Institute for Health and Clinical Excellence recommended Xtandi (enzalutamide) by Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, for treatment of advanced prostate cancer in the state health service. The guidance is conditional on Xtandi being offered at an undisclosed discount to the list price of about $4,400.

• UCB SA, of Brussels, Belgium, said the FDA approved Cimzia (certolizumab pegol) for the treatment of adults with active ankylosing spondylitis, the drug’s fourth approval. The FDA also issued a complete response letter relating to the supplemental biologics license application of Cimzia for the treatment of adults with active axial spondyloarthritis. UCB is working with the FDA to determine a path forward in that indication.

Vaccinogen Inc., of Frederick, Md., was notified by the SEC that the agency completed its review of the company’s form 10 statement, clearing comments. Upon SEC clearance, Vaccinogen upgraded its marketplace tier on the OTC Link of OTC.QB status. The company views the upgrade as a step toward its goal of trading on a major exchange.