The Week in Review #31 IN THE DEPARTED WEEK NOVEL MIGRAINE DRUGS ARE APPROVED ELI LILLY AFTER AMGEN AND TEVA In less than five months, the FDA approved three products belonging to four drug developers – all targeting calcitonin gene-related peptide (CGRP) for the prevention of migraine headache. The latest for Eli Lilly (LLY) last week . . . This content is for paid subscribers. …

Seattle Genetics (SGEN) and Takeda Pharmaceutical Limited (TKPYY) announced results from Phase 3 ECHELON-2 clinical trial evaluating Adcetris as part of a frontline combination chemotherapy regimen in patients with previously untreated CD30-expressing peripheral T-cell lymphoma (PTCL), known also as mature T-cell lymphoma (MTCL). The data from the trial with Seattle Genetics' conjugated monoclonal antibody Adcetris (brentuximab vedotin) in combination with CHP (cyclophosphamide, doxorubicin, prednisone) versus the control …

The high risk of premature death from cardiovascular disease is believed to be caused by an elevated level of lipoprotein (a) {Lp(a)}. Elevated Lp(a) is described as an independent, hereditary risk factor for cardiovascular disease (CVD). Diet and exercise, or even currently prescribed cholesterol-lowering treatments do not help the devastating outcome of this condition. Around 8 to 10 million people are living with established cardiovascular …

Stage III (locally-advanced) NSCLC is commonly divided into three sub-categories: IIIA, IIIB and IIIC, defined by how much the cancer has spread locally and the possibility of surgery. The difference between Stage III and Stage IV disease (cancer (metastasized to distant organs)) is that Stage III is treated now with curative intent. The majority of Stage III NSCLC patients are diagnosed with unresectable tumors. It …

The Week in Review #30 FROM THE DEPARTED WEEK In the past week, we came across a lot of news announcing research, clinical trial results, collaborations, product approvals and acquisitions. Much of the departed week’s news though, does not represent complete stories, especially the ones related to research. They represented early works in progress offering no concrete results that we can evaluate. Important news for …

While preparing The Week in Review issue from Prohost, our attention  shifted towards historical news about a procedure that improved the heart function in severe heart failure patients. For cardiologists and their patients, the positive results were surprising, stunning and beyond anticipation. Current treatments of severe heart failure are only symptomatic and do not stop the heart muscle deterioration that results in imminent death. Data …

Compugen Again On Sept 10, 2018, we posted in The Week in Review #28 news we found very interesting about Compugen (CGEN). The news announced that Compugen has dosed its first patient in Phase 1 clinical trial with its first-in class immunotherapy antibody product COM701 targeting the firm's in house discovered immune checkpoint protein PVRIG. In The Week in Review article we wrote in the beginning, investors …

Portola Pharmaceuticals Appoints Scott Garland as President and Chief Executive Officer, Effective October 8, 2018. Portola (PTLA) appointed a new president, Mr. Scott Garland, who was Relypsa’s president and previously chief commercial officer and responsible for the integration and growth of the U.S. operations after Relypsa was acquired by Vifor Pharma Group in 2016. Prior to Relypsa, Mr. Garland was executive vice president and chief commercial officer of Exelixis, Inc., …

Exelixis’ (EXEL) partner Ipsen Biopharmaceuticals Canada Inc. received approval of Cabometyx®(cabozantinib) tablets from Health Canada for adults with advanced renal cell carcinoma (RCC) who have received prior vascular endothelial growth factor (VEGF) targeted therapy. Health Canada had granted Cabometyx priority review status, which resulted in the accelerated review of Ipsen’s new drug submission. Explaining the importance of Cabometyx’s additional approval, Michael M. Morrissey, Ph.D., President and Chief Executive Officer …

CRISPR Gene Editing Beyond Bringing Cures to disease-causing genes, CRISPR gene editing technology can change the way diseases are being treated and treat diseases that have yet to find a treatment. CRISPR gene editing can play a key role in solving a lot of problems that prevent breakthrough treatments and approaches from reaching their ultimate goals. A best example is chimeric antigen receptor (CAR T) Cell immunotherapy approach to …

Viking Therapeutics Announces Positive Top-Line Results from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol – The Study Achieves Primary Endpoint, Demonstrating Statistically Significant Reductions in LDL-C in Patients Receiving VK2809  – 57% to 60% Median Liver Fat Reduction Observed in VK2809-Treated Patients  – 77% to 91% of VK2809-Treated Patients Experienced ≥ 30% Reduction in Liver Fat …

Phase 2 clinical trial data of argenx’s (ARGX) product Efgartigimod (ARGX-113) in adult patients with primary immune thrombocytopenia (ITP)  showed a favorable safety and tolerability profile. The results also demonstrated that efgartigimod caused meaningful platelet count improvements across doses and ITP patient classifications, including newly diagnosed, persistent and chronic, and correlated with a consistent reduction in IgG levels. Commenting on the news, Nicolas Leupin, Chief Medical …

Today, we see are observing an increased interest in AcelRx Pharmaceuticals (ACRX). The increased investors’ activity happened following the announcement that an Advisory Committee meeting will soon review the firm’s New Drug Application (NDA) for Dsuvia (Sufentanil) developed for the management of moderate-to-severe acute pain in medically supervised settings in adult patients. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia …

Gilead Sciences (GILD) has news that we felt good about it for a company that saved millions of lives from the minute, but monster viruses HIV and HCV. Curing millions of patients with HCV, has led Gilead to decide that the time has come for bringing cures to many horrible diseases. Yesterday, September 12, the news announced that Gilead and Precision BioSciences have entered into …

Playing buy and sell games with the CRISPR gene editing stocks is sometimes based on scientific articles that meant to caution about possible problems or by patents that were given to some Universities and denied it to others and vice versa. Different Universities back different CRISPR gene-editing firms, which constituted a reason for the volatility of the gene-editing stocks. Finally, CRISPR Therapeutics (CRSP), Intellia Therapeutics …

In the Week in Review posted yesterday on our website that is experiencing several attempts on its life, we wrote about some firms, including Amgen. In the Amgen’s article we tried to let the reader recognize the importance of Amgen’s (AMGN) asthma product tezepelumab and how it differs from all other asthma drugs on the market, including the conventional tablets, inhalers and infusions. The Novel …

The Week in Review #29 PROHOST AGGRESSIVE PORTFOLIO  - The aggressive portfolio hosts biotech firms with solid scientific fundamentals and prominent scientists whose stocks have plummeted following some setbacks. A setback could be a failure of an investigational product to meet the endpoints of its clinical trial or that the small biotech firm has taken long to achieve its goals . . . This content …

Gilead Sciences’ (GILD) and Galapagos’ (GLPG) product filgotinib – a highly selective JAK1 inhibitor has met the primary efficacy endpoint in Phase 2 TORTUGA trial in adults with moderately to severely active ankylosing spondylitis (AS). Patients treated with filgotinib achieved significantly greater improvements compared to those who took a placebo. The results came from the Phase 2 of the TORTUGA – a multi-center, randomized, double-blind, …

The disease, mucopolysaccharidosis (MPS) type II, also known as the horrible Hunter syndrome is a killer with no specific treatment anywhere, except enzyme replacement therapy (ERT) that is not stopping the complications of the disease or preventing death. Sangamo (SGMO) made a presentation at the Society for the Study of Inborn Errors of Metabolism in Athens, Greece to demonstrate preliminary results, which included the safety …

The Week in Review #28 The approval of revolutionary products created by biotech firms with solid scientific fundamentals, superior scientists and advanced technologies is what motivates us to pick for investment biotech and biopharmaceutical firms. So, let’s see what has been approved in the parting week  from firms that we picked for investment.       IMPORTANT APPROVALS       Prohost Picked Firm     …