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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 Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade.
ResMed announced primary results from a multicenter, randomized controlled phase II trial known as CAT-HF presented at the European Society of Cardiology's 2016 Annual Heart Failure Congress. CAT-HF assessed whether the treatment of moderate to severe sleep-disordered breathing (obstructive or central sleep apnea) with adaptive servo-ventilation (ASV) therapy could improve cardiovascular outcomes in patients who were hospitalized for a sudden worsening of their heart failure symptoms (acute decompensated heart failure) over six months.
Biocept, Inc. announces the launch of its test to detect RET oncogene fusions from a simple blood draw. Positive identification of patients with the RET gene provides important information in determining therapy options including targeted tyrosine kinase inhibitors.
Concert Pharmaceuticals, Inc. announced that it has initiated its Phase 1 clinical program for CTP-543, which is being developed for the treatment of alopecia areata, an autoimmune disease for which there are currently no approved treatments. CTP-543 was discovered by applying Concert's deuterium chemistry technology to modify ruxolitinib, which is commercially available under the name Jakafi® in the United States for the treatment of myelofibrosis and polycythemia vera. Ruxolitinib has been used to treat alopecia areata in academic settings, including an investigator-sponsored clinical trial, and has been shown to promote hair growth in individuals with moderate to severe disease. Concert's Phase 1 program will assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of single- and multiple-ascending doses of CTP-543 in healthy volunteers.
Genmab A/S announced that the first participants have been dosed in a clinical study of a DuoBody bispecific antibody under Genmab’s DuoBody technology platform collaboration with Janssen Biotech, Inc. (Janssen). The phase I study investigates the human bispecific antibody JNJ-61178104, which is directed to two inflammatory disease targets, for potential use in treating autoimmune disorders. Genmab will receive a $2 million milestone payment for the progress in the study.
Neurotrope, Inc., a clinical-stage company developing a disruptive therapy for the treatment of severe Alzheimer's disease (AD), has entered into a research collaboration with the International Rett Syndrome Foundation, DBA: Rettsyndrome.org, to explore the potential of Bryostatin for the treatment of Rett syndrome.
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Boston Scientific Corporation announced the introduction of the Precision Montage MRI Spinal Cord Stimulator (SCS) System after receiving approval from the US Food and Drug Administration.
Entresto® (sacubitril/valsartan) has been given a Class I recommendation, the strongest endorsement, in updated clinical practice guidelines simultaneously released by the American College of Cardiology (ACC), the American Heart Association (AHA) and the Heart Failure Society of America (HFSA) in the US, and the European Society of Cardiology in the EU.
In the US Entresto is now a standard therapy for heart failure with reduced ejection fraction (HFrEF) as an alternative to an ACE inhibitor or an angiotensin II receptor blocker, given together with a beta blocker and an aldosterone antagonist. In addition, the guidelines call for doctors to switch HFrEF patients with mild to moderate symptoms from ACEs or ARBs to Entresto.
"These strong, swift and broad recommendations by US cardiology organizations, redefine the standard of care for how reduced ejection fraction heart failure is treated," said Vas Narasimhan, Global Head of Development and Chief Medical Officer for Novartis. "We know patients with heart failure suffer reduced quality of life and remain at high risk of hospitalization or death, and these new guidelines are a strong call to action to ensure patients receive the most effective therapies."
In the EU, the ESC HF guidelines recommend doctors switch HFrEF patients meeting the PARADIGM-HF criteria to Entresto from an ACE or ARB. Both guideline committees considered evidence from PARADIGM-HF, the largest heart failure trial ever, which showed Entresto significantly reduced deaths from cardiovascular causes and heart failure hospitalizations in patients with HFrEF.
Waters has now unveiled the new Xevo TQ-XS mass spectrometer, which is far advanced sensitive bench-top tandem quadrupole instrument. It features a unique combination of ion optics, detection and ionization technologies resulting in levels of sensitivity not previously seen. The Xevo TQ-XS is expected to be available for shipment in June 2016 and was on public display for the first time at MSSJ in Osaka, Japan, May 18 – 20. It will be on display at ASMS in San Antonio, TX, June 5 – 9.
Pfizer Inc. (NYSE:PFE) and Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Anacor for $99.25 per Anacor share, in cash, for a total transaction value, net of cash, of approximately $5.2 billion, which assumes the conversion of Anacor’s outstanding convertible notes. The Boards of Directors of both companies have unanimously approved the transaction. Anacor’s flagship asset, crisaborole, a differentiated non-steroidal topical PDE4 inhibitor with anti-inflammatory properties, is currently under review by the U.S. FDA for the treatment of mild-to-moderate atopic dermatitis, commonly referred to as eczema.
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