Category: News & Comments

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 …

The U.S. CDC Tells the 50 States to Prepare for COVID-19 Vaccines by the End of October

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 …

Kazia Therapeutics Product Paxalisib Beats Temozolomide in Overall Survival in Mid-Phase Trial

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: Good News About the Firm’s COVID-19 Vaccine’s Capability and Durability

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 Encouraging Oncology Results

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 …

Jazz Pharmaceuticals: A New FDA Approval

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 …

INmune Bio: A Novel Approach Towards Treating Alzheimer’s Disease

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’ Product Efruxifermin Demonstrates Strong Positive Results in NASH Patients

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: The Beginning of the Firm’s Resurrection

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, …

A Potential Merger Between AstraZeneca Plc and Gilead Sciences?

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 …