Novartis Positive Results for Radioligand Therapy, 177Lu-PSMA-617, for mCRPC Novartis (NVS) reported the first interpretable results of evaluating the efficacy and safety of 177Lu-PSMA-617, a targeted radioligand therapy, in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) compared to the best standard of care alone. The good news is that the trial has met both primary endpoints of overall survival (OS) and radiographic progression-free …

Immutep Ltd and Merck Announce Second Clinical Trial Collaboration Immutep (IMMP) develops novel immunotherapy treatments for cancer, infectious disease and autoimmune diseases. Today, Immutep announced a second clinical trial collaboration and supply agreement with Merck & Co (MRK) subsidiaries, Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada). Immutep will conduct a new Phase IIb clinical trial in 1st line head and …

Aveo Oncology Received FDA Approval for FOTIVDA for Advanced RCC Aveo Oncology (AVEO) drug FOTIVDA is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO plans to make FOTIVDA available to patients in the U.S. by March 31, 2021. …

Johnson & Johnson COVID-19 Vaccine According to a new analysis posted online by the FDA, the Johnson & Johnson (JNJ) vaccine is providing strong protection against severe disease and death related to COVID-19 infection. The vaccine may reduce the spread of the virus from vaccinated people. The vaccine is said to have a 72% efficacy rate in the U.S. and 64% in South Africa. The …

The market is sinking in a furious mood caused by the failure to figure out the pathway of criteria, which is currently controlling the stocks’ volatile performances. Today we are posting good news coming from a few biotech companies with solid fundamentals. Unfortunately, all of these firms are tumbling instead of soaring, or at least performing positively. Look for them under Impacting News. Cassava Sciences …

Novavax Inc The Novavax (NVAX) COVID-19 Vaccine NVX-CoV2373 is on its way to reaching worldwide markets.  The Serum Institute of India (SII) and the Vaccine Alliance (Gavi) are to ensure equitable access to Novavax’s, NVX-CoV2373, vaccine worldwide across the low-, middle- and high-income countries. Memorandum of Understanding (MOU) between Gavi and Novavax to make available a cumulative volume of 1.1 billion doses of the Novavax vaccine to the COVAX Facility. The …

Vir Biotechnology and GlaxoSmithKline Expanded Collaboration  Vir Biotechnology (VIR) and GlaxoSmithKline plc (GSK) announced the signing of a binding agreement to expand their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses. The Expanded Collaboration This new collaboration builds on a 2020 agreement to research and develop therapies for coronaviruses and provides GlaxoSmithKline exclusive rights to collaborate …

The Children’s Hospital of Philadelphia: Improving Gene Therapy Vectors Improving gene therapy vectors seems to have come at the hands of researchers at Children’s Hospital of Philadelphia (CHOP). A gene therapy vector was developed for blood disorders like sickle cell disease (SCD) and beta-thalassemia, stating that this vector is potentially safer and more effective than those currently used in gene therapy trials for those conditions. …

Moderna COVID-19 Vaccination News A vaccination with the Moderna (MRNA) COVID-19 produced neutralizing titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and the Republic of South Africa, respectively. The study showed no significant impact on neutralizing titers against the B.1.1.7 variant relative to prior variants. A six-fold reduction in neutralizing titers was observed with the B.1.351 variant …

Exelixis: FDA Approval for Cabometyx in Combination with Opdivo  Exelixis (EXEL) announced that the United States FDA has approved CABOMETYX (cabozantinib) in combination with OPDIVO® (nivolumab) as a first-line treatment for patients with advanced renal cell carcinoma (RCC). RCC is among the 10 most frequently diagnosed cancers in the U.S. annually. Dr. Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and The …

Regenxbio Regenxbio (RGNX) announced that it is selling a portion of its royalty rights from the net sales of Zolgensma® by Novartis to entities managed by Healthcare Royalty Management, LLC (HCR) for $200 million. This transaction provides immediate, non-dilutive capital to Regenxbio in order continue the development of its gene therapy pipeline products and complete its internal manufacturing capabilities. Morgan Stanley & Co. LLC served …

Gilead Sciences Company, Kite Pharma, News Kite Pharma, a Gilead Company (GILD), announced that the European Commission has granted conditional marketing authorization for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Conditional …

Regenxbio Dosed First Patient with RGX-111 for MPS I Regenxbio (RGNX) has dosed the first patient with RGX-111 in the Phase I/II trial for the treatment of Mucopolysaccharidosis Type I (MPS I). About Regenxbio Product RGX-111 RGX-111 is an investigational one-time gene therapy designed to deliver the α-l-iduronidase (IDUA) gene directly to the central nervous system (CNS) using the NAV AAV9 vector. RGX-111 is a …

Moderna Has Successful COVID-19 Vaccine Results and News Moderna’s Phase 3 study met statistical criteria with a vaccine efficacy of 94.5%. Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months. Moderna (MRNA) announced that …

Moderna Inc COVID-19 Vaccine Candidate Moderna Inc (MRNA) announced the completion of the case accrual for the first interim analysis of Phase 3 COVE study of mRNA-1273, its COVID-19 vaccine candidate. The firm announced a significant increase in the rate of case identification across sites in the last week. As a result, the Company expects the first interim analysis will include substantially more than 53 …

Pfizer and BioNTech Good News Regarding COVID-19 Vaccine Candidate Pfizer (PFE) and BioNTech (BNTX) announced that their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 (the virus that causes COVID-19) has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of the SARS-CoV-2 infection; this is based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee …

Important Quarterly Results Announcements Monday, November 2, 2020 at 8:PM ET IVERIC bio IVERIC bio’s (ISEE) management team will host a live conference call and webcast following the announcement to discuss the Company’s financial results and provide a general business update. To participate in this conference call please dial 866-575-6539 (USA) or 323-794-2575 (International) using passcode 6339331. A live, listen-only, audio webcast of the conference …

News from AstraZeneca About COVID-19 Vaccine, AZD1222 From AstraZeneca (AZN) we learned that its COVID-19 vaccine, AZD1222, which is being developed in collaboration with Oxford University, has produced a similar immune response in older and younger adults. A spokesman from the firm stated that the results have further built the body of evidence for the safety and immunogenicity of AZD1222. On October 23, 2020 AstraZeneca’s …

Gilead Sciences Veklury® (Remdesivir) was Approved by the US FDA The U.S. FDA approved Gilead Sciences (GILD) antiviral drug Veklury® (remdesivir) for COVID-19 infected patients who require hospitalization. Veklury halts the SARS-CoV-2 replication that causes COVID-19. Veklury is the first and only approved COVID-19 treatment (not vaccine) in the U.S.. The news announced that the drug is widely available in hospitals across the country. The …

Ionis Pharmaceuticals Dosed First Patients with ION541 for ALS Ionis Pharmaceuticals (IONS) announced that the first patients have been dosed with ION541 (also known as BIIB105) – an investigational antisense medicine being developed as a potential therapy to treat most forms of amyotrophic lateral sclerosis (ALS), regardless of family history. This is another milestone in the continuing progress of Ionis’ ambitious program to develop novel …