What Everyone Wants to Hear from ASCO The American Society of Clinical Oncology (ASCO) meeting is ongoing. What the oncologists, the analysts, the researchers and investors and other interested observers are anxious to hear this year is mostly about the improvements in the immune-oncology approaches. The Oncologists Want to Hear About: Up-to-date information from clinical trials on immunotherapies in order to practice the safest and …

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 …

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.

Exelixis and Daiichi Sankyo launched their novel anitihypertension product Minnebro® in Japan Exelixis (EXEL) and Daiichi Sankyo (

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.

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 …

Exelixis & Aerie Have Good News Exelixis’ Good News about Cabometyx Takeda Pharmaceuticals applied to the Japanese Ministry of Health, Labor and Welfare (MHLW) for approval to manufacture and to sell Exelixis’ (EXEL)product Cabometyx® (cabozantinib) for unresectable and metastatic renal cell carcinoma (RCC) in Japan. The submission brings $10 million in milestone payments to Exelixis from Takeda in the second quarter of 2019. Takeda’s application …

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 …