Category: News & Comments

Cassava Sciences: Good News During Bad Market Days

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 is Bringing its COVID-19 Vaccine to the World’s Markets

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 Agreement

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 …

Researchers at the Children’s Hospital of Philadelphia are Improving Gene Therapy Vectors

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 Vaccine Produced Neutralizing Titers Against Key Emerging Variants Tested

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: The FDA Approved Cabometyx in Combination with Opdivo as a First Line Treatment of RCC

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: Advancing its Gene Therapy Pipeline and its Rare Neurodegenerative Disease Platform with Non-Dilutive Capital

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 has Good News for Relapsed or Refractory Mantle Cell Lymphoma and More

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 Announced the First Patient has been Dosed in the Phase I/II trial of RGX-111 for MPS I

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’s Successful COVID-19 Vaccine Results

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’s Future Growth

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 Vaccine Candidate Against COVID-19 Achieved a Sweet Success

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 …

Imminent Announcements of Important Quarterly Results

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 …

Tracking the News from AstraZeneca About Experimental Vaccine, AZD1222, for COVID-19

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 …

The U.S. FDA Approves Gilead Sciences Antiviral Veklury® (remdesivir) for COVID-19

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 News About ALS Treatment Attempts

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 …

Tracking COVID-19 Vaccines

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 …

Enlivex Therapeutics Product AllocetraTM Saves Severe/Critical COVID-19 Patients

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 …

Gilead Sciences Could Acquire Immunomedics at $20 Billion. See Also: AstraZeneca Vaccine Trial Resumed

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 …

Sanofi and GlaxoSmithKLine COVID-19 Vaccines are Advancing in Clinical Trial

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 …