Exelixis and Bristol-Myers Squibb sNDA and sBLA Accepted by the FDA Exelixis (EXEL) and Bristol-Myers Squibb (

COVID-19 Vaccines from Pfizer/BioNTech and Moderna The three products whose trials were halted are not vaccines but, rather, antibodies that treat patients who already have COVID-19. With regard to the COVID-19 vaccines we believe we have encouraging news from Pfizer/BioNTech’s and Moderna’s mRNA vaccines. The Pfizer/BioNTech Vaccine  Pfizer (PFE) Chairman and CEO, Albert Bourla, stated that the mRNA vaccine developed together with BioNTech (BNTX) will …

Cytokinetics Omecamtiv Mecarbil for Heat Failure Three biotech firms: Amgen (AMGN), Cytokinetics (

Celldex Therapeutics After an expected resurrection, Celldex Therapeutics (CLDX) stock recovered and went as high as over $19 from less than $2 after an exaggerated selloff caused by  investors following the failure to treat the still untreatable glioblastoma multiforme brain cancer. Today Celldex announced that enrollment has opened, in its randomized, double-blind Phase 1b study of CDX-0159 in patients with . . . This content …

Gilead and Galapagos Granted Marketing Authorization for Filgotinib by the EC Gilead Sciences (GILD) and Galapagos NV (

Compugen New Addition, Dr. Nils Lonberg, PhD. Compugen (CGEN) announced the addition of Nils Lonberg, Ph.D., to its Scientific Advisory Board (SAB). Dr. Lonberg is a pioneer in the field of immuno-oncology and has more than 30 years of experience in the biopharmaceutical industry. Concurrently, Charles (Chuck) Drake, M.D., Ph.D. will be stepping down from Compugen’s . . . This content is for paid subscribers. …

Bristol-Myers Squibb Increased activity being observed at Bristol-Myers Squibb (BMY) is aimed at further empowering the firm's various franchises. It all started with the firm’s attempt to empower its oncology franchise with the creation and approval of its checkpoint protein inhibitor Opdivo (nivolumab) - a programmed Death-1 (PD-1) inhibitor. This antibody has been the most successful attempt . . . This content is for paid …

President Trump, the First Lady and COVID-19 Indeed, the complicated, nasty SARS-CoV-2 virus managed to infect President Trump and the First Lady when we were expecting a vaccine to soon be ready to protect the country and the world from COVID-19. The president’s physicians did not treat the him with any of the investigational vaccines in late-phase trials; vaccines being developed by: Moderna (

Solid Biosciences Clinical Hold on IGNITE DMD is Lifted by the FDA Solid Biosciences (SLDB) - a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, announced that the U.S. FDA has lifted the clinical hold placed on the Company’s IGNITE DMD Phase 1/2 clinical trial. The FDA had requested further manufacturing information, updated safety and efficacy . . . This content …

Enlivex Therapeutics Positive Results for Severe and Critical COVID-19 Patients Enlivex Therapeutics (ENLV) – a clinical-stage immunotherapy company, reported positive results of an investigator-initiated clinical trial of the firm’s product AllocetraTM in severe/critical COVID-19 patients. The clinical trial included as few as five COVID-19 patients, three of whom were in severe condition, and two in critical condition. The good news is that all five patients …

News from Cassava Sciences, Moderna and Sorrento Therapeutics  Cassava Sciences  Cassava Sciences (SAVA) announced that clinical results of its Phase 2b study of sumifilam have been selected as a late-breaking oral presentation by the 13th international conference on Clinical Trials on Alzheimer’s Disease (CTAD). What is CTAD? CTAD is a prestigious annual conference focused on Alzheimer’s . . . This content is for paid subscribers. …

Sorrento Therapeutics Preclinical Data of Neutralizing Antibodies Against SARS-CoV-2 In preclinical studies, both STI-1499 and STI-2020 demonstrated potent neutralizing activity against SARS-CoV-2 virus isolates, including the emerging Spike D614G variant virus. Both STI-1499 and STI-2020 demonstrated protective activities against SARS-CoV-2 infection in Syrian golden hamsters. At day 5, STI-2020 at 500 µg reduced virus load in hamster lungs to undetectable levels in 100% of animals …

Johnson & Johnson ENSEMBLE Trial for Its COVID-19 Vaccine Candidate Johnson & Johnson (JNJ) announced the launch of its large-scale, pivotal, multi-country Phase 3 trial, ENSEMBLE, for its COVID-19 vaccine candidate, JNJ-78436735. The initiation of the ENSEMBLE trial follows positive interim results from Phase 1 . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Revolution Medicines Inc Revolution Medicines (RVMD) is a clinical-stage precision oncology company focused on developing targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company possesses capabilities including deep chemical biology and cancer pharmacology know-how and novel proprietary technologies that help create small molecules tailored to . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Amgen and the KRAS G12C Protein Discovery The RAS gene family has been a subject for four decades of research. The family contains some of the most frequently mutated oncogenes in human cancers. Targeting the KRAS protein, the most commonly altered family member in solid tumors, has been the toughest and most challenging in oncology research. A specific mutation known as KRAS G12C is a major driver …

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

Eli Lilly and AbCellera Collaboration Result LY-C0V555  A lot of discoveries, followed by thorough experimentation beyond the vaccines, are taking place in the biotechnology and large biopharmaceutical companies to defeat COVID-19. The most recently discovered product by AbCellera, which was developed by Eli Lilly (LLY), is LY-CoV555 - a potent, neutralizing IgG1 monoclonal antibody (mAb), directed . . . This content is for paid subscribers. …

Seattle Genetics Two New Strategic Oncology Collaborations with Merck Seattle Genetics (SGEN) and Merck (

Cassava Sciences Study Results of Sumifilam for Alzheimer's Disease Prohost is happy to inform our subscribers that our positive opinion about Cassava Sciences' product created and developed for Alzheimer’s disease happens to be right. Cassava Sciences (SAVA) announced today the final results of a Phase 2b study with its lead drug candidate, sumifilam, in Alzheimer’s disease. The results . . . This content is for paid …

Gilead Sciences News Is Not Just Gossip Real news, not just gossip, is spreading today about Gilead Sciences (GILD) nearing a deal to acquire the biotech firm Immunomedics (IMMU) for $20 billion. Immunomedics current market value is around $10 billion which means that Gilead is buying it at double its value. The deal could be announced on Monday, if not sooner, if the talks go …