Industry News

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.

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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.

Baxalta Incorporated announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval of ADYNOVI, an extended circulating half-life recombinant Factor VIII (rFVIII) treatment, for pediatric, adolescent and adult patients with hemophilia A and for use during surgery. Currently licensed in the U.S. as ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] and under regulatory review in Japan, Canada and Switzerland, ADYNOVI is the only rFVIII treatment for hemophilia A developed based on the demonstrated efficacy of ADVATE [Antihemophilic Factor (Recombinant)].

BioMarin Pharmaceutical Inc. announced positive 48-week results from its Phase 1/2 pivotal study for cerliponase alfa, a recombinant human tripeptidyl peptidase 1 (rhTPP1) to treat children with CLN2 disease, a form of Batten disease.  CLN2 disease is a rapidly progressing, fatal neurodegenerative disease with no approved treatments, where the majority of affected children lose their ability to walk and talk by approximately six years of age.

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Sangamo BioSciences, Inc. announced the presentation of new preclinical data in disease models from its In Vivo Protein Replacement Platform™ (IVPRP) programs for MPS I (Hurler syndrome) and MPS II (Hunter syndrome). The data demonstrate that the Company's IVPRP approach enabled stable production of therapeutic levels of replacement enzyme from the liver into the circulation and secondary tissues, including the brain, resulting in significant reduction in biomarkers of the disease and, importantly, statistically significant improvements in cognitive function in treated animals.