Positive Results from Korsuva for Pruritis Cara Therapeutics Postive Results from Korsuva Trial On May 29, 2019 Cara Therapeutics (CARA) announced positive topline data from the KALM-1 pivotal Phase 3 trial of its Korsuva in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (itching) (CKD-aP). Chronic kidney disease-associated pruritus is an intractable frequent systemic intense itch that occurs in patients undergoing hemodialysis and peritoneal dialysis. …
Incyte's FDA Approval Based on encouraging data from the REACH1 trial the FDA approved a label expansion of the Incyte (INCY) product Jakafi (ruxolitinib) for graft-versus-host disease (GVHD) in people 12 years and older. The FDA previously granted Jakafi Breakthrough therapy designation and orphan drug status for acute GVHD. GVHD is a condition that might occur after an . . . This content is for paid subscribers. Please …
Prohost Letter #431 Genomes, Genes and Gene Therapies In this issue of the Prohost Letter we focus on genomes, genes and gene therapies. National DNA day is April 25th . On this day we commemorate: James Watson, Francis Crick, Maurice Wilkins, Rosalind Franklin and other of their collegues who published papers on the structure of DNA in 1953. It is an opportunity to celebrate the …
Amgen, the Biotech King Amgen (AMGN), the biotech king, wanted to buy all of the Denmark biotech firm Nuevolution's drug discovery platform. This platform attracted Amgen in 2016 as well as many other large pharma firms including: Merck, Johnson and Johnson, GlaxoSmithKline and Novartis.
Vertex’s Good News Vertex and Kymera Therapeutics Collaboration Last week Vertex Pharmaceuticals (VRTX) and Kymera Therapeutics entered into a four-year strategic research and development collaboration to advance small molecule protein degraders against multiple targets. Kymera is an expert in targeted protein degradation and has its own drug discovery program known as Pegasus™. The collaboration will benefit from this program and from Vertex’s scientific, clinical and regulatory capabilities …
Great News for Array BioPharma Array BioPharma (ARRY) announced positive results from the interim analysis of the Phase 3 BEACON CRC trial. The trial evaluates the combination of: Braftovi® (encorafenib), a BRAF inhibitor, Mektovi® (binimetinib), an MEK inhibitor, and Erbitux® (cetuximab), an anti-EGFR antibody (BRAFTOVI Triplet), in patients with
The Medicines Company Are Inclisiran's Clinical Trial Results Impressive? Our answer is YES. The trial results came out with several, not just one, good news. Inclisiran's Good News The first good news came from the ORION-3 study, conducted by The Medicines Company (MDCO)
About Iovance Biotherapeutics Iovance Biotherapeutics (IOVA) is a late-stage biotechnology company developing novel cancer immunotherapies based on its tumor-infiltrating lymphocyte (TIL) technology. Iovance announced promising updates from ongoing clinical trials in advanced cervical cancer and advanced melanoma. The data will be presented at the 55th Annual . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Advaxis Outperformed on a Negative Market Day ADXS Outperformed Advaxis’ (ADXS) stock rallied today as the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on its product AIM2CERV (axalimogene filolisbac). The product is in a Phase 3 clinical trial on patients with high-risk locally advanced cervical cancer. In its letter the FDA acknowledged that the Company has satisfactorily addressed all hold questions. The Story …
The FDA Approval of Regeneron's EYLEA Is Important The PANORAMA Trial of EYLEA for Diabetic Retinopathy The United States Food and Drug Administration (FDA) has approved Regeneron’s (REGN) product EYLEA® (aflibercept) Injection for all stages of diabetic retinopathy. This approval is important. The data demonstrated from the PANORAMA trial showed EYLEA’s . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
The Stock Market The Confused and Confusing Stock Market The stock market is confused and confusing. No analysts’ speculations are materializing and no satisfactory explanations for the market’s agitation and selloff. Although not an unprecedented situation, what makes it strange and more puzzling than previous market’s selloffs is that it is happening at a time when all the prerequisites of a healthy economy exist. Historically …
Why GW Pharmaceuticals Survived the Bear Market Day The DOW Today Sinking for disputed and unfathomed reasons; watching and listening to analysts with antagonistic opinions on the TV screen; the stock market has taken down with it all the DOW companies; and probably all the other companies, in all the other industries; especially those in the drug industry. GW Pharmaceuticals plc Today Attracting our attention …
A Great Day for Bluebird bio and Celgene Read the Clinical Trial Results for Myeloma What a Great Day! Jobs reaching the moon. Inflation not yet showing any concerning signs. A fiercely rebounding stock market. Those who are still listening to pessimistic opinions are missing the fact that technologies and biotechnology are standing at the starting line. They are not at the finish line. For …
Vertex Pharmaceuticals' Product Kalydeco for CF in Young Children Good news for Vertex (VRTX) product Kalydeco® (ivacaftor) is the first cystic fibrosis (CF) product to be prescribed for children ages six months to less than 12 months. Beneficiary children are those who have at least one mutation in their . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
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