Pfizer Inc. announced today that the EMA has accepted for review the Marketing Authorization Application (MAA) for XELJANZ® (tofacitinib citrate) 5 mg tablets twice daily for the treatment of patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX). The EMA will now initiate its review of the…
Bristol-Myers Squibb to Acquire Padlock Therapeutics, Inc.
Bristol-Myers Squibb Company and Padlock Therapeutics, Inc. announced that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of Padlock, a private, Cambridge, Massachusetts-based biotechnology company dedicated to creating new medicines to treat destructive autoimmune diseases. The acquisition will give Bristol-Myers Squibb full rights to Padlock’s Protein/Peptidyl…
GNS & Pfizer Study Reveals Risk Factors Driving Diabetes Progression
GNS Healthcare (GNS), a leading precision medicine company that applies causal machine learning technology to match health interventions to individual patients and discover new intervention pathways, today announced publication of a study conducted jointly with leading pharmaceutical company Pfizer Inc. by the Journal of Diabetes Science and Technology (JDST). The study is unique in its application of causal machine learning…
Astellas Files NDA for IBS-C Treatment
Phase 3 Results: Merck’s HIV Therapy
Merck, known as MSD outside the United States and Canada, today announced top-line results from the company’s Phase 3 pivotal trial, ONCEMRK. ONCEMRK is evaluating an investigational once-daily formulation of ISENTRESS® (raltegravir), known as raltegravir 600 mg (to be given as 2 x 600 mg once-daily), for previously untreated HIV-1 infected adults. The study met its primary…
Global Nebulizers Market: Driven by Respiratory Disorders
Technavio analysts forecast the global nebulizers market to post a CAGR of over 6 percent by 2020, according to their latest report. The research study covers the present scenario and growth prospects of the global nebulizers market for 2016-2020. The report classifies the market based on product segmentation, which include nebulizer devices and nebulizer accessories. Nebulizer devices comprise of jet…
Japan Biosimilar Report: Active Players in Specialty & Niche BS Space
Research and Markets has announced the addition of the “Japan Biosimilar – Active Players In Quest of a Specialty & Niche BS Space” report to their offering. The encouraging uptake of Filgrastim BS and Lantus BS in 2015 in Japan is indicative of Japan being one of the key markets, after the EU, for the growth of…
Major Regulatory Changes in China Will Impact Western Drug Development & Manufacturing Strategies
China’s Food and Drug Administration (cFDA) has recently published long-anticipated reforms designed to accelerate the regulatory review of new drugs and expand options for manufacturing those approved. According to PaizaBio, the new policies, which went into effect December 1 and are posted on cFDA’s website, will impact both Chinese and Western pharmaceutical companies. The reforms represent…