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 …

CDC Is Asking States to Prepare for COVID-19 Vaccines The U.S. Center of Disease Control and Prevention (CDC) has asked the 50 states’ public health officials to be ready to distribute potential COVID-19 vaccines to high-risk people, healthcare workers and others as soon as late October, as showed in a document yesterday. The New York Times (NYT) has also reported today that the CDC has …

The US FDA Awards Fast Track Designation to Paxalisib for Glioblastoma  Kazia Therapeutics Ltd (KZIA) – an Australian oncology biotechnology company, announced that the United States FDA has granted Fast Track Designation (FTD) to Kazia’s paxalisib for glioblastoma, the most aggressive primary brain cancer. The FTD has been granted for the treatment of newly diagnosed glioblastoma with unmethylated O6-Methylguaninemethyl transferase (MGMT) promotor status who have completed initial …

Inovio Inovio’s COVID-19 Vaccine INO-4800 Accomplished the Following: Durable antibody and T cell responses in rhesus macaques for 4 months. Long-term protection in non-human primates challenged with SARS-CoV-2 virus 13     weeks from vaccination. No other vaccine has demonstrated it. Reduced viral loads and faster viral clearance in macaques’ lungs and nasal passages as a result of a good Memory T and B cell …

TCR2 Therapeutics Announcement TCR2 Therapeutics (TCRR) – a clinical-stage immunotherapy company with a pipeline of novel T cell therapies for cancer, announced positive interim data from the first five patients treated in the Phase 1 portion of the TC-210 Phase 1/2 clinical trial for mesothelin-expressing solid tumors. All five patients have demonstrated tumor regression including two RECIST unconfirmed partial responses (one of which remains subject to independent central …

People living with narcolepsy who develop cataplexy and excessive daytime sleepiness have a new treatment called Xywav, from Jazz Pharmaceuticals. Jazz Pharmaceuticals NEWS On July 21, 2020 the U.S. FDA approved Jazz Pharmaceuticals’ (JAZZ) product Xywav™ (calcium, magnesium, potassium and sodium oxybates) oral solution for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.  About Narcolepsy …

Alzheimer’s Disease Alzheimer’s Disease has proven very difficult to treat through many of the trials’ attempts by both small and large biotechnology and biopharmaceutical companies. Analysts and investors are skeptical about all promised successes in defeating this disease. However,  knowing that we are in the middle of a biological scientific revolution we are keeping our eyes and ears open each and every time a firm, …

Akero Therapeutics Efruxifermin Positive Results in NASH Akero Therapeutics (AKRO) results of a 16-week analysis of secondary and exploratory endpoints in Phase 2a BALANCED study of its product efruxifermin (EFX), formerly known as AKR-001, in patients with nonalcoholic steatohepatitis (NASH) are beating everybody’s expectations, including Akero Therapeutics.    Of the 40 responders, the firm observed that 48% achieved at least a one-stage improvement in fibrosis without …

Celldex Therapeutics A few years ago Celldex Therapeutics (CLDX) was known for its superior pipeline products. The most promising product in the firm’s pipeline was Celldex’s lead drug designed to treat the untreatable terrible brain cancer known as glioblastoma multiforme. What excited oncologists and investors at the time were the successful results coming out from early- and mid-phase clinical trials. Then, all of a sudden, …

AstraZeneca Plc and Gilead Sciences Potential Merger News spread through the media announcing that AstraZeneca Plc (AZN) has approached Gilead Sciences (GILD) regarding a possible, potential merger. People familiar with the subject (we don’t know who they are) believe that such a merger, if it materializes, would be the highest healthcare business deal on record. As told, the story recounts that AstraZeneca got in touch …

Navidea Biopharmaceuticals Stock Soared Navidea Biopharmaceuticals (NAVB) stock price jumped from $1.27 to $3.04 this morning. The reason for the stock’s soaring, according to the firm’s press release, was that interim data from a trial have further corroborated Navidea’s hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls as well as in patients with active rheumatoid arthritis (RA). Furthermore, this imaging …

Moderna Postive News for mRNA-1273 Vaccine Against Novel Coronavirus (COVID-19) Moderna (MRNA) announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2 or COVID-19), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID) which is part of the National Institutes of Health (NIH). According to the firm’s press release, Immunogenicity data are currently available …

Sorrento Therapeutics Anti-SARS-CoV-2 Antibody STI-1499 Sorrento Therapeutics (SRNE) announced that its anti-SARS-CoV-2 antibody, STI-1499, demonstrated 100% inhibition of SARS-CoV-2 (COVID-19) virus infection in an in vitro virus infection experiment at a very low antibody concentration. Sorrento has screened billions of antibodies in its proprietary G-MAB™ fully human antibody library and has so far identified hundreds of antibody candidates that bind the S1 subunit of the SARS-CoV-2 Spike protein. …

Alexion to Acquire Portola Alexion (ALXN) and Portola (PTLA) entered into a definitive merger agreement and Alexion acquired Portola. The Terms of the Merger A subsidiary of Alexion will commence a tender offer to acquire all of the outstanding shares of Portola’s common stock at a price of $18 per share in cash. The tender offer is subject to customary conditions including the tender of …

Moderna Submitted an IND for Its mRNA Vaccine Candidate for Novel Coronavirus  Moderna (MRNA) announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its mRNA vaccine candidate, mRNA-1273, against the novel coronavirus, SARS-CoV-2. The filing is for the evaluation in Phase 2 and for late-stage studies if supported by safety data from the Phase …

Compugen: In the NEWS Compugen (CGEN) was granted a new patent for the composition of COM701 or backup antibodies for the treatment of cancer by the European Patent Office (EPO). The EPO Patent No. 3295951 titled, “Anti-PVRIG Antibodies and Methods of Use”, covers the composition of matter for COM701 and backup antibodies including any anti-PVRIG antibody having the binding fragments of COM701 or backup antibodies …

Gilead Sciences Gilead (GILD) stock soared after market hours adding $11 to the $1.90 the stock had gained during trading hours. Investors’ enthusiasm was raised when very promising results came out of a clinical trial for Gilead’s drug remdesivir given to COVID-19 infected people.   According to the news the University of Chicago’s Phase 3 trial results demonstrated that most COVID-19 infected patients treated with …

Compugen to Present Data Update on COM701 Phase 1 Clinical Trial at the 2020 AACR Virtual Annual Meeting Compugen (CGEN) announced that it will present updates on its ongoing Phase 1 clinical trial evaluating COM701, a first-in-class therapeutic antibody targeting PVRIG for the treatment of advanced solid tumors, in an oral presentation at the 2020 American Association for Cancer Research (AACR) Virtual Annual Meeting I …

Coronavirus: The Possible Treatments While Moderna’s (MRNA) vaccine is being tested and its stock price continued to rise in the worst market performance day; other companies demonstrated readiness to bring their vaccines against the life-threatening virus into human clinical trials in the next few months. Regeneron (REGN) is one of the most trusted companies. In collaboration with Sanofi (SNY) the companies are on the top of …

Gilead Sciences to Acquire Forty Seven Gilead Sciences (GILD) and Forty Seven (FTSV) announced today that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Forty Seven for $95.50 per share in cash. The transaction, which values Forty-Seven at approximately $4.9 billion, was unanimously approved by both the Gilead and Forty Seven Boards of Directors and is anticipated to close during the second quarter …