Dealing With Bacterial Resistance To Antibiotics    In the NEWS THERAVANCE BIOPHARMA At the 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Theravance Biopharma (TBPH) demonstrated that its drug Vibativ® (televancin) possesses a potent in vitro activity against broad range of Staphylococcus aureus (S. aureus) clinical isolates. These isolates included Methicillin-resistant S. aureus (MRSA). The antibiotic activity for VIBATIV was seen in 100% of the evaluated S. aureus clinical isolates regardless of their type or resistance …

Years ago, a friend who is a highly regarded Immunologist lectured us during one of our visits to his home city Milano in Italy about the important role well written press releases play in highlighting the prominence of unknown, yet, capable biotech firms. “If not for its announced news, millions of interested people around the world, including myself, wouldn’t have heard on time about Genentech …

Many in Wall Street have been anxious, sitting on fire while waiting to learn, which biotech company Gilead Sciences (GILD) would decide upon acquiring that would deepen and enhance its pipeline. In Today’s news, a firm called Nimbus Therapeutics, LLC today announced that it has signed a definitive agreement under which terms Gilead will acquire Nimbus Apollo, Inc., a Nimbus Therapeutics wholly-owned subsidiary. Important is that the acquisition …

Alder Reports Phase 2b Trial of ALD403 Meets Primary and Secondary Endpoints Demonstrating Migraine Prevention in Patients with Chronic Migraine Alder Also Reports Positive Phase 1 Data Supporting Quarterly Single Injection Dosing Strategy for ALD403 Alder BioPharmaceuticals (ALDR) announced positive rrsults from two clinical trials evaluating its preventive chronic migraine monoclonal antibody drug ALD403. The drugtargets calcitonin gene-related peptide (CGRP). ALD403 acted rapidly and prevented migraine over …

Published articles in peer review journals cited that pharmacologic inhibition of RORγt regulates Th17 signature gene expression and suppresses cutaneous inflammation in vivo. Here we are, a clinical stage small company called Vitae Pharmaceuticals (VTAE) has just announced positive results from its Phase 2a proof-of-concept clinical trial of its RORyt inhibitor drug VTP-43742 in psoriatic patients. VTP-43742 is wholly owned by Vitae. It is an orally active RORyt inhibitor said to …

London, UK, 14 March 2016:  GW Pharmaceuticals (GWPH), is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform. The firm announced the positive results of the first pivotal Phase 3 study of its investigational medicine Epidiolex®(cannabidiol or CBD) for the treatment of Dravet syndrome. In this study, the firm’s product, Epidiolex, achieved the primary endpoint of a significant reduction in convulsive …

Agenus (AGEN) is a project in the making since the firm has decided to play an integral part in immuno-oncology, doing everything possible towards building checkpoint modulator antibodies, in addition to its protective and therapeutic vaccines. Missing analysts’ expectation by one cent, which leads to stocks’ punishment has become an accepted routine, satisfying daily traders and other investors. The substance, however, which  interests us, is in …

Exelixis’ (EXEL) quarterly results beat analysts’ expectations, which was the least of our concerns. The details of the firm’s actions during the past year, however, confirmed our conviction that the recently approved products will be taken care of responsibly by the firm that created them and believed in them against all pessimistic opinions. Indeed, more important than the firm’s current revenues and spending was the firm’s ability …

On February 4, 2015, we wrote an article titled, “Aerie Pharmaceuticals is speeding towards improving the treatment of glaucoma”, posted under News & Comments at the Prohost website, we wrote the following: YOUNG BUT STRONG COMPETITOR IN THE GLAUCOMA HUGE MARKET Aerie Pharmaceuticals has eye drops that could become a game changer in the management of glaucoma. The firm’s lead drug, Rhopressa™, is a one drop once-daily …

Regulus Pharmaceuticals (RGLS) a biopharmaceutical company that discovers, designs and develop treatments targeting microRNAs announced interim results from one of the company’s ongoing Phase 2 studies of its hepatitis C virus (HCV) product RG-101.  The study was designed to evaluate a shortened, four-week treatment regimen containing a subcutaneous administration of 2 mg/kg of RG-101 at Day 1 and Day 29, in combination with 4 weeks of once/daily approved anti-viral …

Gilead Sciences Gilead (GILD) Shareholders wouldn’t expect to watch short investors make billions of dollars going against Gilead during this firm’s most glorious times. We never imagined negative analysts could have the capability of persuading millions of shareholders to sell and cause a selloff of the most productive, most growing, most achieving and extremely well run biotech company. Gilead reported quarterly earnings and revenue on …

Yes. Dana-Farber Cancer Institute and Array Pharmaceuticals (ARRY) announced an immuno-oncology collaboration with potential applicability in a wide range of cancer indications. Who are these people, meaning Danna-Faber Cancer institute? Founded in 1947, Dana-Farber Cancer Institute in Boston, Massachusetts has been providing cancer patients, including adults and children, with the best treatment available today, while developing tomorrow’s cures through cutting-edge research. The Institute is one of the world’s leading …

EXELIXIS Good News about CABO The FDA has determined that Exelixis’ (EXEL) cabozantinib New Drug Application (NDA) for advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The NDA will be considered officially filed 60 days from the date of the completion of the submission, or February 20, 2016. The FDA granted Priority Review to the filing and assigned a Prescription Drug User …

The Evolution of Liquid Biopsy TWO PIANISTS, GUARDANT HEALTH and C4 THERAPEUTICS Biotech firms are bringing future technologies and treatments into the present days, while Stock Market’s evaluators are assessing their values with out-of-date inappropriate methods. The unfair evaluations add to the firms’ burdens and devastate investors who pick the best biotech firms and lose their money nonetheless. The two players we are presenting today …

The market looks like angry, probably very angry, as stocks are in a severe selloff mood. There will be many explanations like usual, but it is difficult for us to speculate this time over the correctness of the offered explanations, including the Iran Saudi Arabia crisis, which led to an increase in the oil price whose decrease has caused the previous market’s bad mood. Like …

When you do your due diligence, you do not lose your faith in what you believed in giving up to the hype that’s sprayed around you. We were happy today to hear Array BioPharma (ARRY) report that results from the Phase 3 NEMO clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma. The trial met its primary endpoints. We are happy, but not surprised, …

Halozyme Therapeutics (HALO) and Eisai Inc. presented a scientific poster entitled, “Pegylated Recombinant Human Hyaluronidase PH20 (PEGPH20) Enhances Efficacy of Eribulin Mesylate (HALAVEN®) in Triple Negative Breast Cancer Xenografts” at the 38th Annual San Antonio Breast Cancer Symposium (SABCS). The Combination used in the preclinical testing HALAVEN® (eribulin mesylate) injection, which belongs to Eisai inc., is indicated for patients with metastatic breast cancer who have received at least two prior …

XOMA Announces License Agreement with Novo Nordisk for XMetA Program in Diabetes – Novo Nordisk acquires exclusive global rights to XMetA program, but for diabetes only, while XOMA  retains commercialization rights for rare disease indications – $5.0 million upfront payment. But the agreement includes up to $290.0 million in additional potential milestone payments – XOMA is entitled to tiered royalties XOMA (XOMA) announced it has …

In our yesterday’s article asking about how the FDA advisory committee has to vote regarding Biomarin product Kyndrisa (drisapersen) for Duchenne muscular dystrophy. We got the answer yesterday during the meeting that took a much longer time than committees’ meetings usually take. At the end of the long session that included several patients’ and patients’ relatives’ testimonies, the FDA Advisory Committee was incapable of voting for …

Today, the FDA advisory panel will discuss BioMarin (BMRN) product drisapersen for Duchenne muscular dystrophy based on documents released to the committee by the FDA. The FDA said, “The benefit of drisapersen in exon 51 skip amenable patients is inconclusive at this time. Therefore, the benefit-risk assessments were not made.” Analysts interpreted the FDA statement as a condemnation of the drug, which does not really tell what the FDA meant …