Pharma News

Visunex Medical Systems, Inc. announced the FDA clearance of the Visunex Medical Systems PanoCam Pro Wide-field Imaging System for the imaging of all newborn infants.PanoCam Pro is a wireless imaging system that fills an unmet need in the imaging of all newborn babies that may help detect external, anterior, and posterior segment vision disorders that may have long-term effects on the vision of millions of children around the world each year.

Soricimed Biopharma Inc. ("Soricimed"), a clinical-stage pharmaceutical company discovering and developing peptide-based cancer therapeutics, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to peptide SOR-C13 for the treatment of ovarian cancer.

Genmab A/S announced that a supplemental Biologics License Application (sBLA) has been submitted to the U.S. Food and Drug Administration (FDA) for the use of ofatumumab (Arzerra®) in combination with  fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL).

Sanofi Pasteur, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs,  and MSD, known as Merck in the United States and Canada, announced their intent to end their joint vaccines operations in Europe.  Upon concluding their joint venture, both companies plan to integrate their respective European vaccine businesses into their operations, independently manage their product portfolios and pursue their own distinct growth strategies in Europe.

Pfizer Inc. announced the publication of the Phase 3 study results of a once-weekly regimen of BeneFIX® Coagulation Factor IX (recombinant) 100 IU/kg prophylaxis versus on-demand treatment in people with moderately severe or severe hemophilia B. The findings were published inHaemophilia, the official journal of the World Federation of Hemophilia.

Pharma Major Lupin Limited (Lupin) announced that it has completed its acquisition of privately held US based GAVIS Pharmaceuticals LLC and Novel Laboratories Inc. (GAVIS). Lupin had announced the acquisition on July 23rd 2015. The acquisition enhances Lupin’s scale in the US generic market and also broadens Lupin’s pipeline in dermatology, controlled substance products and other high-value and niche generics. GAVIS brings to Lupin a highly skilled US based Manufacturing & Research organization which would complement Lupin’s Coral Springs, Florida based R&D center for Inhalation. GAVIS’s New Jersey based manufacturing facility also becomes Lupin’s first manufacturing site in the US.

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational anti-CD19 monoclonal antibody, MEDI-551, for the treatment of patients with neuromyelitis optica (NMO) as well as neuromyelitis optica spectrum disorders (NMOSD). Developed by MedImmune, MEDI-551 is currently in Phase IIb clinical development for NMO.

Cepheid announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Carba-R, a qualitative in vitro diagnostic test for fast, accurate, and reproducible identification of 5 distinct families of carbapenem resistance genes that together represent the most common carbapenemases identified globally, including KPC, NDM, VIM, OXA-48 and IMP.

Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, to include data from KEYNOTE-010.