Pharma News

Otonomy, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that it has successfully completed an End-of-Phase 2 review with the U.S. Food and Drug Administration (FDA) for OTIPRIO™ (ciprofloxacin otic suspension) in the treatment of acute otitis externa, also known as swimmer’s ear. Based on this review, the company intends to initiate a single Phase 3 clinical trial for OTIPRIO in patients with acute otitis externa during the second quarter of 2016 and expects to complete this trial and report topline results in the fourth quarter of 2016. If the results are positive then Otonomy expects to submit a supplemental New Drug Application (sNDA) to the FDA in the first half of 2017.

The U.S. Food and Drug Administration approved folic acid fortification of corn masa flour. The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with the levels of certain other enriched cereal grains.

Gilead Sciences, Inc, a biopharmaceutical company, announced detailed 48-week results from two large phase 3 clinical trials (Studies 108 and 110) evaluating once-daily tenofovir alafenamide (TAF) 25 mg in treatment-naïve and treatment-experienced adults with HBeAg-negative and HBeAg-positive chronic hepatitis B virus (HBV) infection. Data were presented this week during two oral sessions (GS06 and GS12) at The International Liver Congress 2016 in Barcelona, Spain.

Soligenix Inc announced  that the Chinese Patent Office intends to grant the patent entitled “Novel Peptides for Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity.” The newly issued patent claims composition of matter of dusquetide (research name: SGX94) and related analogs.

AbbVie announced that with eight weeks of treatment, 97-98 percent of genotype 1-3 (GT1-3) chronic hepatitis C virus (HCV) infected patients without cirrhosis treated with AbbVie's investigational, once-daily, ribavirin (RBV)-free, pan-genotypic regimen of ABT-493 and ABT-530 achieved sustained virologic response at 12 weeks post-treatment (SVR12).

Neovacs, a leader in active immunotherapies for the treatment of autoimmune diseases, announced that South Korea health authority approved Neovacs’s Investigational New Drug application for IFN Kinoid in phase IIb development in Lupus.

Shire plc submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a new, alternate formulation of Vyvanse® (lisdexamfetamine dimesylate) as a chewable tablet for patients who may have difficulty swallowing or opening a capsule. Vyvanse capsules can be swallowed whole or consumed by opening and mixing the entire contents into water, orange juice or yogurt. Vyvanse chewable tablets will offer an additional administration option for patients.

Bristol-Myers Squibb’s announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of Opdivo to patients with classical Hodgkin lymphoma (cHL) after prior therapies.

AbbVie announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Venclexta™ (venetoclax) tablets for patients diagnosed with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. The FDA approved this indication under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. The FDA approved Venclexta as a first-in-class, oral, once-daily medicine that selectively inhibits the BCL-2 protein. The BCL-2 protein blocks apoptosis (programmed cell death) of cells, including some cancer cells, and can be overexpressed in CLL cells.Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is marketed collaboratively by the companies in the U.S. and by AbbVie outside of the U.S.

ALK’s partner for North America, MSD (known as Merck in the United States and Canada), announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet for review. MSD submitted the BLA, for a tablet against HDM allergy, to the FDA in February 2016.