XELJANZ/XELJANZ XR, THE FIRST ORAL JAK INHIBITOR IN THE U.S. FOR ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS, IS NOW APPROVED FOR ADULTS WITH ACTIVE PSORIATIC ARTHRITIS
New European research has found that a good social life could lower the risk of developing type 2 diabetes and pre-diabetes.
Spark Therapeutics $ONCE has scored an historic FDA approval of Luxturna, the world’s first such AAV-delivered gene therapy designed to cure a rare eye disease triggered by a genetic mutation. The drug is OK’d for RPE65 mutation linked retinal dystrophy. The treatment uses a viral vector to insert the correct copy of a gene retinal cells need to create a protein that turns light into electric signals which can restore vision lost to the disease. As with the earlier pioneering approval of the world’s first CAR-T, FDA commissioner Scott Gottlieb did the honors in recognizing the importance of this approval. And he says the agency will make sure that the regulatory path is straight and clear for the rest of the field looking to following Spark’s footsteps. “We’re at a turning point when it comes to this novel form of therapy and at the FDA, we’re focused on establishing ...
“The sale of the PRV provides us with an important source of non-dilutive capital to help advance our pipeline of rare and ultra-rare therapies, and accelerates the availability of these potential therapies to patients,” said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx.
AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of TAGRISSO® (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations). The FDA has granted TAGRISSO Priority Review status, and previously granted Breakthrough Therapy Designation for TAGRISSO in the 1st-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine. Additionally, the FDA has granted fast track designation for fremanezumab for the prevention of cluster headache.
The Montreal-based startup ODS Medical is developing a handheld surgical guidance tool to improve accuracy in cancer surgery. Based on a set of advanced optical techniques, such as Raman spectroscopy, intrinsic fluorescence and diffuse reflectance spectroscopy, together with sophisticated machine learning algorithms, their laser technology measure scattered light to provide more specific information about the molecular makeup of the targeted brain tissue.
Kyn is led by an Atlas entrepreneur-in-residence Mark Manfredi, who was previously chief scientific officer at Raze Therapeutics (also an Atlas-funded startup). Raze raised a $24 million Series A in 2014, but the company appears to have wound down pretty quickly. The website is no longer active, and Manfredi said Raze still has some assets and collaborations, but no longer employs anyone. Atlas’ Bruce Booth says the underlying cancer metabolism biology was too complicated to warrant further investment. Before Raze, Manfredi was VP of oncology biology at Takeda.
Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated the United States Phase I bridging clinical trial of fruquintinib. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) 1, 2 and 3, that has met its primary endpoint in several Phase II and III clinical trials in China for the treatment of colorectal, lung and gastric cancers. The clinical study in the U.S. is a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. The first drug dose was administered earlier this month. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03251378.
Google has become as much of a necessity to modern life as eating.Google’s search is a learning curve and odd one, too. WeYou use it every day, but very few of us actually use it to its full potential. With that being said, the search engine has plenty of tricks up its sleeve. If you want to streamline your search, it’s time to start implementing these 6 simple Google tricks.
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