In an eagerly awaited milestone for the company – and for Belgian biotech – the FDA approved ThromboGenics NV's biologic drug Jetrea (ocriplasmin) for treating symptomatic vitreomacular adhesion (VMA). Read More

Kynamro (mipomersen) for homozygous familial hypercholesterolemia (HoFH) overcame testimony about liver problems, cancer in mice, possible cardiac risk, troubling immune responses and significant trial dropout rates to win a vote recommending approval from an FDA advisory panel. Read More

BioCryst Pharmaceuticals Inc., of Research Triangle Park, N.C., will acquire Presidio Pharmaceuticals Inc., of San Francisco, in an all-stock transaction valued at about $101 million, creating a new company centered on hepatitis C virus (HCV) and rare disease hereditary angioedema (HAE). Read More

Reata Pharmaceuticals Inc. ended a Phase III trial testing bardoxolone methyl in patients with Stage IV chronic kidney disease (CKD) and Type II diabetes after the independent data monitoring committee (IDMC) pointed to safety signals in the treatment arm, halting development of a drug that had once been hailed a potential blockbuster. Read More

• Cleveland BioLabs Inc., of Buffalo, N.Y., said it submitted a proposal to the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services for funding to complete the development steps needed for FDA licensure of Entolimod as a medical radiation countermeasure. Read More

• Sanofi Pasteur, of Swiftwater, Pa., the vaccines division of Sanofi SA, said it filed a supplemental biologics license application for a quadrivalent formulation of its Fluzone (influenza virus vaccine). The filing was accepted by the FDA for full review, and an action date is anticipated in the second quarter of 2013. Read More

• Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index, compared to patients receiving placebo (40 percent vs. 24 percent). Read More

• Novavax Inc., of Rockville, Md., said top-line results from two Phase I trials of its A/H5N1 avian influenza vaccine candidate showed that the vaccine is safe and produces immunogenicity with and without adjuvant. It also showed statistically significant adjuvant effects on immune responses. Read More

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., said it terminated its proposed convertible preferred stock offering due to current market conditions. The company, which is developing cancer drug PV-10, had filed a preliminary prospectus supplement in September. Shares of Provectus (NASDAQ:PVCT) gained 12 cents, or 23 percent, to close Thursday at 65 cents. Read More