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 …
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.
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.
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.
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 …
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.
Praluent's Approval Is a Big Deal The approval of the Regeneron / Sanofi supplemental biological license application (sBLA) aimed at updating Praluent’s (alirocumab) prescribing information is, indeed, a big deal. Proven life-saving benefits are confirmed. Comprising reducing the overall risk of major adverse cardiovascular events (MACE), i.e., heart attack, ischemic stroke, death from coronary heart disease and unstable angina requiring hospitalization, would change the lives of …
The Misleading Market? The biotech stocks continue to begin their daily trading relying on opinionated articles implanted by bloggers on the Internet rather than on the firms’ voiced news. It is unfortunate that we continue to observe many investors incapable of pinpointing the differences between the fake and the real in interpreting the news. We do not blame them; however, as those who are misleading …
About Trovagene Trovagene (TROV) is still a clinical-stage company. The precision cancer medicine approach is practicing what it preaches right now in order to develop drugs that target cell division (mitosis) for: leukemias, lymphomas and solid tumor cancers. In March 2017, Trovagene licensed global development and commercialization rights for Onvansertib (PCM-075);
Zolgensma Findings The FDA submission of the gene therapy product Zolgensma was based on positive findings from a trial of 15 babies treated with it. Recently; however, at the Orlando meeting of the Muscular Dystrophy Association Novartis (NVS) presented interim results for 22 babies with Type 1 SMA which is considered the . . . This content is for paid subscribers. Please click here to subscribe …
Novartis Has More Promising Data from Their Phase 3 Gene Therapy Trial with AveXis AveXis Inc., a Novartis (NVS) company, announced positive interim data from its Phase 3 STR1VE trial of Zolgensma® (onasemnogene abeparvovec-xio (AVXS-101) gene therapy in spinal muscular atrophy (SMA) Type 1. About Spinal Muscular Atrophy (SMA . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
The Market is Outperforming Today. There is important news today about Novartis; part of which we are posting now. There is still more news related to Novartis as well as other biotech and biopharmaceutical companies. All will be in the upcoming Prohost Letter #430. We believe that the news we are posting will have a positive impact on the firms that announced them. Today’s news …
Following Seattle Genetics' (SGEN) and Astellas Pharma's announcement of positive results, from pivotal trial of the conjugated monoclonal antibody drug Enfortumab Vedotin in locally advanced or metastatic urothelial cancer, the stock experienced a selloff. Prohost Observations We do not believe that there is anything wrong with the positive results coming out of EV-201 trial investigating Enfortumab Vedotinfor locally advanced or metastatic urothelial cancer who have received previous …
The uncontrolled blowing toxic wind contaminates this country’s environment, it brings down the oversold scientifically solid and promising biotech stocks together with the undersold disappointing firms’ stocks. All we want is peace of mind, fairness and well being for America and the rest of the world. We are confident that this wish will materialize when the country’s leaders work together in harmony to make it …
Governor Cooper to cut ribbon on bluebird bio facility Bluebird bio (BLUE) announced today, in its press release, the official opening of its first wholly owned manufacturing facility in Durham, N.C. The new facility will produce the lentiviral vector for the company’s investigational gene and cell therapies, including bb2121 and bb21217 for the treatment of multiple myeloma, and potentially LentiGlobin™ for transfusion-dependent β-thalassemia (TDT) and …
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