Pharma News

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.

Serotonin, a brain chemical which is believed to influence various physiological and psychological factors including our mood and appetite has now been directly implicated in rheumatoid arthritis that can cause chronic inflammation of the joints and other areas of the body.

High levels of insulin are bad for lungs and for Indians who have the lowest lung function, the focus should be on improving diet and lifestyle to tackle pre-diabetes and diabetes, according to a study.

Controlling diabetes by diet or pills such as metformin may decrease the mammographic density or high breast density which poses a higher risk of developing cancer.

Australian researchers have debunked fish oil and vitamin D as treatments for knee osteoarthritis in a clinical trial.The Australian team, from the University of Tasmania's Menzies, found that vitamin D and fish oil, both widely to slow knee cartilage loss and and reduce inflammation, had no distinguishable impact on knee osteoarthritis, Xinhua news agency reported.

A heart pump using flywheel technology, developed by engineers at NASA's Glenn Research Centre, has raised hope of a better life for children born with only one heart ventricle, or essentially half a heart.