AT A GLANCE IMPORTANT NEWS A New FDA Commissioner The U.S. Senate Voted in Favor of Scott Gottlieb as the FDA Chief – Dr. Gottlieb, a medical doctor graduated from Mount Sinai – He held a high ranking position in the FDA during George W. Bush’s Presidency – Senators who voted for based their choice on Mr. Gottlieb’s knowledge of the FDA and of the …

Indeed, Saving One Life is Important. Yet, Important Too is Saving Many Lives The Risk Vs. The Reward We keep repeating that the CAR-T treatment is created to stay, not because somebody loves the firms developing the CAR-T immunotherapy, but because this novel approach to cancer is saving the lives of the condemned. In addition, many reasons exist that make oncologists and regulators believe that …

EPIZYME Many oncologists, we believe, must be impatient to learn about the outcome of a first-in-class cancer drug based on epigenetics in upcoming oncology conventions. The drug tazemetostat was created and is being developed by Epizyme. Epizyme (EPZM) is a clinical-stage biotech company having proprietary platform, which  enabled it to identify and develop small molecule inhibitors of chromatin modifying proteins (CMPs), such as tazemetostat. CMPs, …

MERCK Merck (MRK) has beaten analysts’ expectations generating $9.4 billion for revenues in the first quarter of 2017. Its GAAP EPS was $0.56 for the first quarter of 2017 and the Non-GAAP EPS $0.88 for the first quarter of 2017. The outperformance occurred in spite of the declining sales of some aging drugs, which is a normal recurrent phenomenon especially with the increase in break-through …

ImmunoGen is one of two firms Prohost selected for investment on February 2011 based on the promises of its novel antibody-drug conjugate (ADC). An ADC drug is an antibody that carries highly potent cancer-killing agent attached to the antibody by a linker. The linker is designed to release an exceptionally toxic agent only as the ADC reaches the cancer cells in order not to harm …

Eli Lilly (LLY) and Incyte (INCY) announced that the FDA has issued a complete response letter for the New Drug Application (NDA) of baricitinib for moderate-to-severe rheumatoid arthritis (RA). The FDA letter indicated that additional clinical data are required to determine the most appropriate doses. The FDA also stated that additional data are necessary for further characterization of safety concerns across treatment arms. The timing …

On March 27, we wrote about how positive results of Neurocrine Biosciences (NBIX) drug Ingrezza on Tardive Dyskinesia (TD) will highlight Neurocrine Biosciences and its Scientists. We wrote: The results published online by The American Journal of Psychiatry demonstrate that Phase 3 trial with Ingrezza conducted on patients with tardive dyskinesia showed significant and meaningful reduction in symptoms. We elaborated on the trial that provided …

The FDA Approves Harvoni® and Sovaldi® in Pediatric Patients 12 Years and Older with Chronic Hepatitis C Infection First HCV Direct-Acting Antivirals Approved for Adolescents Gilead Sciences (GILD) announced that the FDA has approved its supplemental application for its HCV drugs HARVONI® (ledipasvir 90 mg/sofosbuvir 400 mg) for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection and its HCV drug SOVALDI® …

Positive Results of INGREZZA on Tardive Dyskinesia Highlights Neurocrine Biosciences Sciences and Scientists     The results published online by The American Journal of Psychiatry demonstrate that Phase 3 trial with Neurocrine Biosciences (NBIX) drug Ingrezza conducted on patients with tardive dyskinesia showed significant and meaningful reduction in symptoms. The positive results came out of the Kinect 3 — a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, …

OncoCyte (OCX) has news. This firm, which develops non-invasive blood and urine liquid biopsy diagnostic tests has good news about its lung cancer liquid biopsy. Liquid biopsy is a term recently coined for a simple blood test that can replace current invasive and expensive biopsy procedures for the detection of cancers at their early stages. This simple blood test is expected to lessen the need …

A few days ago, the FDA approved Lexicon Pharmaceutical’s (LXRX) drug Xermelo™ (telotristat ethyl) 250 mg for the treatment of metastatic neuro-endocrine syndrome (mNET) patients who suffer from carcinoid syndrome diarrhea. The drug will be launched and sold today, March 6, in select specialty pharmacies. Carcinoid syndrome is a rare condition that occurs in patients with mNETs. It is characterized by frequent debilitating diarrhea that …

Exelixis (EXEL) announced a new collaboration with Roche on a phase 1b dose escalation study of a combination of Exelixis cabozantinib in combination with Roche’s anti-PD-L1 immuno-therapy drug atezolizumab. The study aims at evaluating the safety and tolerability  of the combination in patients with locally advanced or metastatic solid tumors. Enrollment is scheduled to begin mid-year 2017. Exelixis will sponsor the trial, and Roche will …

Some investors are selling AGEN in premarket trading for a reason that might be unimportant anymore with Agenus’ totally changed status now with its new immunotherapy pipeline. The new checkpoint inhibitors products and their checkpoint targets products are the talk of the cancer community and having them has attracted large companies, including Incyte. Nevertheless, the stock will be trading down today because in a regulatory …

Immunomedics (IMMU) and Seattle Genetics (SGEN) announced an exclusive global licensing agreement enabling Seattle Genetics to develop, fund, manufacture, and commercialize Immunomedics’ solid tumor drug candidate IMMU-132. Seattle Genetics accepted to take the responsibility for initiating Phase 3 clinical trial of IMMU-132 for patients with metastatic triple-negative breast cancer (TNBC) and submitting the initial Biologics License Application (BLA) to the FDA for accelerated approval. Also …

The FDA’s Center for Drug Evaluation and Research (CDER) informed Portola (PTLA) that it does not plan to hold an Advisory Committee meeting for its Product betrixaban. What is betrixapan? Betrixapan is a small molecule oral, once-daily, Factor Xa inhibitor anticoagulant. The drug directly inhibits the activity of Factor Xa, which is a validated target in the blood coagulation pathway. Why it is used? Betrixapan …

It seems that the global Takeda (TKPYY) has guessed well what it should pick in order to bring the most effective targeted treatments to cancer patients allover the globe. Cancer management has unreservedly changed. What seems now to have become the best treatment choices are those that would accommodate the new wave of extremely promising immunotherapy approaches. To reach its ultimate success, immunotherapy drugs require …

Today, Jounce Therapeutics has begun trading on the NASDAQ under the ticker symbol (JNCE).  The Company, which focuses on the discovery and development of novel cancer immunotherapies and predictive biomarkers, announced the pricing of its initial public offering of 6,365,000 shares of common stock at a public offering price of $16.00 per share for aggregate gross proceeds of $101,840,000. In addition, Jounce granted the underwriters …

Vertex (VRTX) entered into a licensing agreement with Merck KGaA, Darmstadt, Germany for the worldwide development and commercialization of four research and development programs that the firm believes represent novel approaches to cancer treatment Merck KGaA will license two clinical-stage programs targeting DNA damage and repair, along with two additional novel pre-clinical programs. Upon the agreement Vertex will receive an upfront payment of $230 million, …

ARIAD Pharmaceuticals’ (ARIA) stock jumped 75% today. The oncology firm entered into a definitive agreement to be acquired by Takeda Pharmaceutical Company Limited under which Takeda will acquire all of the outstanding shares in ARIAD for $24.00 per share in cash, or a total enterprise value of approximately $5.2 billion, representing a premium of approximately 75 percent over ARIAD’s closing price on January 6, 2017. Under …

Extremely important, not just exciting, were the results of Halozyme Therapeutics’s (HALO) Phase 2 randomized, multi-center clinical trial of its PEGPH20 in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer. The results demonstrated a statistically significant increase in progression-free survival (PFS) in patients with high levels of hyaluronan (HA-High) treated with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High patients receiving …