Crispr Therapeutics and Vertex Pharmaceuticals CTX001 Granted PRIME Designation by the EMA CRISPR Therapeutics (CRSP) and Vertex Pharmaceuticals (

Sanofi and GlaxoSmithKline Have COVID-19 Vaccines Advancing in Clinical Trial Sanofi (SNY) and GlaxoSmithKline (GSK) started Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. The vaccine candidate developed by both firms uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines, with GSK’s established pandemic adjuvant technology. The Phase 1/2 clinical trial is a randomized, double-blind and placebo-controlled trial. It is …

Moderna Presented Interim Clinical Data about mRNA-1273 for COVID-19 Moderna (MRNA) presented new Interim Clinical Data about . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Impacting News from Novavax, CymaBay Therapeutics and Sanofi SA Novavax  The Grant That Rallied the Stock Novavax (NVAX) stock jumped sky-high following the announcement that the firm has been granted up to $384 million by the coalition for Epidemic Preparedness innovation. The grant is to help the advancement in the clinical development of the firm’s SARS-CoV-2 (COVID . . . This content is for paid …

Sanofi and Regeneron: Results from Libtayo® Trial Sanofi (SNY) and Regeneron (REGN)

The Week in Review #43 This Past Week After hearing hints about the trade war between China and the United States being avoided the market reversed course from faltering to flying at the speed of light. This trade war replaced all important factors that would usually affect the market performances. Unemployment is the lowest since 1969 and is expected to cause a bullish market, but …

The EC Granted Conditional Approval for Regeneron and Sanofi Product Libtayo for CSCC The European Commission (EC) conditional approval for Regeneron Pharmaceuticals’ (REGN) and Sanofi’s (SNY) product Libtayo® (cemiplimab) is a historical event and a game changer in the prognosis of metastatic and locally advanced cutaneous squamous cell carcinoma (CSCC).   Before the approval of Libtayo patients with advanced CSCC , who are not candidates for curative surgery or curative radiation, had …

Prohost Letter #432 The ASCO 2019 Special Edition SPRAYING FEAR The Victims Are The most disturbed victim of the instigated and irrelevant fear against investing in the stock market is the market itself. Indeed, baseless fear campaigns frighten positive investors while encouraging short-selling investors to maximize their selling which intensifies the markets volatility. We have been experiencing this phenomenon since the beginning of 2019. Market …

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 …

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 …

News We Loved to Hear  The First and Only Approval of a Specific Product for Postpartum Depression ZULRESSOTM The FDA granted approval of Sage Therapeutics’ (SAGE) ZULRESSOTM (brexanolone) injection. A product for the treatment of the condition known as postpartum depression (PPD). This makes Zulresso the first and only medicine specifically approved by the FDA to treat PPD; the most common medical complication of childbirth. The product …

The Week in Review #32 POSITIVE NEWS PROTEOSTASIS THERAPEUTICS Cystic Fibrosis Two days ago, a clinical-­stage small firm called Proteostasis Therapeutics (PTI) announced positive preliminary results from ongoing Phase 1 cystic fibrosis studies. The trial involved the firm’s proprietary combination therapy doublet, PTI-­808 + PTI-­801...

In two pivotal Phase 3 placebo-controlled trials Regeneron Pharmaceuticals’ (REGN) and Sanofi’s (SNY) drug, Dupixent® (dupilumab), demonstrated a significant reduction in nasal polyp size, nasal congestion’s severity and the need for systemic corticosteroids and/or surgery. Both trials were evaluating Dupixent® (dupilumab) in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps (CRSwNP). They both met met all their primary and secondary endpoints. Dupixent is a monoclonal antibody designed to …

What Do We Make of the Following Good News? HERON THERAPEUTICS Will HTX-011 Help in the War Against Opioids?  Heron Therapeutics (HRTX), a commercial-stage biotechnology company announced positive results from its completed Phase 3 studies of the investigational agent HTX-011 in people undergoing bunionectomy and hernia repair. HTX-011 is described as the first and only long-acting local anesthetic to demonstrate in Phase 3 studies significantly reduced pain …

Regeneron’s (REGN) pipeline products have still a lot of good news to announce. The latest is about its product Dupixant (dupilumab) which has already been FDA approved for atopic dermatitis. Now, there are reasons to believe that this drug could be also approved as an add-on maintenance for people with moderate to severe Asthma. The news has come from both Regeneron and its partner Sanofi (SNY), stating that …

Prohost Letter #405 Synthetic Biology (3) We have already decided upon becoming shareholders the day synthetic biology firm called Synthetic Genomics turns public. We reiterate that firms specialized in synthetic biology are numerous private and publicly traded. Some are promising, others are walking in place and a few have plummeted. With the general underperformance of synthetic biology stocks, many shareholders abandoned ship. Investors felt that …

Today we have good news and bad news. The good news is coming from Regeneron (REGN)through two sources: The first is the European Medicines Agency accepting Regeneron’s and Sanofi’s (SNY) Filing for the approval of Dupixent (dupilumab) for moderate to severe atopic dermatitis. A probable second source could be the bad news about the failure of Ophthotech’s (OPHT) drug Fovista® combo with Lucentis in demonstrating superiority …

Regeneron (REGN) and Sanofi informed that the FDA has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sarilumab. The drug  is an investigational interleukin-6 receptor (IL-6R) antibody for adult patients with moderately to severely active rheumatoid arthritis (RA). Nothing in the CRL contents insinuates that sarilumab is not safe, or not effective, or that the clinical trial data were not …

News about investigational drugs, which are expected to make big differences in the lives of people with chronic diseases and deadly diseases does not always materialize. Predicting drugs becoming breakthroughs has proven extremely difficult in the early phases of drugs’ development. Some products keep doing well, going from the preclinical testing into several phases of trials then all of a sudden they unexpectedly fail. They …

Good news is not always great news that makes a difference. In the drug industry, clinical trial results that demonstrate a drug has fulfilled the requirements of the trials, including the primary and secondary endpoints does not always guarantee that the drug will be successful if and when it hits the market. Experience and follow up on certain firms enables us to see the real …