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 …
Inovio COVID-19 Vaccine Candidate Will be Manufactured by Thermo Fisher Scientific Thermo Fisher Scientific (TMO) joins other contract development and manufacturing organizations in Inovio's global manufacturing consortium enabling Inovio (
Compugen Announced Encouraging News from Its Phase 1/2 Study of COM701 Compugen (CGEN) announced that the first patient has been dosed in the Phase 1/2 study of the triple combination of COM701 - Compugen’s first-in-class anti-PVRIG antibody, with Bristol Myers Squibb’s (
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 …
Agenus Announced Data from Phase 2 Trials of Balstilimab Agenus (AGEN) immuno-oncology company announced that data from two Phase 2 trials of balstilimab alone and in combination with zalifrelimab will be orally presented in at the upcoming European Society of Medical Oncology (ESMO) Conference on September 18, 2020. The data will be presented by Dr. David O'Malley, Professor . . . This content is for paid subscribers. Please click here …
Moderna Inc Late August Announcements On August 28, 2020 Moderna Inc (MRNA) issued a press release confirming that the Company is engaged in discussions with the Ministry of Health, Labor and Welfare of Japan (MHLW) to potentially purchase 40 million or more doses of its COVID-19 vaccine candidate, mRNA-1273. Under the terms of this arrangement the . . . This content is for paid subscribers. …
Rhythm Pharmaceuticals Inc Rhythm Pharmaceuticals (RYTM) is a late-stage biopharmaceutical company with a product pipeline that reflects its focus of developing treatments for rare genetic obesity. The firm’s lead product, setmelanotide, is a melanocortin-4 receptor (MC4R) agonist being developed for severe obesity and hyperphagia associated with rare genetic obesity. The United States FDA has accepted Rhythm’s . . . This content is for paid subscribers. Please …
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.
Exelixis Announces Submission of sNDA to US FDA for CABOMETYX® Exelixis (EXEL) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. FDA for CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) for patients with advanced renal cell carcinoma (RCC). From Exelixis According to Gisela Schwab, M.D., President, Product Development and Medical . . . This content is for paid subscribers. Please click here …
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 …
Recent Gene Therapy News On August 20, 2020 Audentes Therapeutics, which was taken over by Astellas (ALPMY) for over $3 billion, announced that a third patient has passed away in a clinical trial evaluating its gene therapy product AT132 for the treatment of the life-threatening neuromuscular X-linked Myotubular Myopathy (XLMTM). The neuromuscular disease is . . . This content is for paid subscribers. Please click here …
Yesterday, under Today’s Highlights, we posted that the U.S. FDA issued a Complete Response Letter (CRL) to Gilead Sciences (GILD) with regard to the New Drug Application (NDA) for . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Gilead Sciences Was Issued a CLR from the FDA for Filgotinib Gilead Sciences (GILD) is in receipt of a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
CureVac is Publicy Trading on the NASDAQ CureVac is now publicly trading on the NASDAQ stock exchange with the symbol CVAC, as of August 14, 2020. We assume you must have heard the name of this firm by now and of America’s attempts to buy it for its messenger ribonucleic acid (mRNA) approach. This approach creates vaccines and drugs inside the living bodies. CureVac (CVAC) mRNA-derived …
Sorrento Therapeutics Announcement Sorrento Therapeutics (SRNE) announced that it believes it has uncovered fraudulent attempts to manipulate the Company’s stock. In a press release . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
A Predictive COVID-19 Test? COVID-19 infected people are not all affected to the same degree with regards to the severity of the disease complications. There is no doubt that a test that can predict which patients will be severely affected and which will not might save a lot of lives, money and unnecessary time spent in crowded hospitals. Monopar Therapeutics in the NEWS Monopar …
Intellia Therapeutics Reporting operational highlights and financial results for the second quarter ended June 30, 2020, Intellia Therapeutics (NTLA) announced its first Clinical Trial Application to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 1 study of NTLA-2001 for transthyretin . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Seres Therapeutics Oral Microbiome Product SER-109 for Recurrent C. Difficile Infection Meets Trial Endpoint SER-109 demonstrated a highly statistically significant 30.2% absolute reduction in the rate of C. difficile infection recurrence compared to placebo. Efficacy results Support BLA filing as a single pivotal trial. The Company will meet with the FDA to discuss filing for product approval as soon as possible. Positive SER-109 Phase 3 …
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