Tag: SARS-CoV-2 (the virus that causes COVID-19)

Regeneron Granted FDA Emergency Use Authorization for its COVID-19 Antibody Cocktail Therapy

Regeneron Pharmaceuticals Receives EUA from the FDA for REGEN-COV2 Regeneron Pharmaceuticals’ (REGN) antibody cocktail therapy casirivimab and imdevimab, known also REGN-COV2 or REGEN-COV2, received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The FDA EUA is for the treatment of mild to moderate COVID-19 in adults as well as pediatric patients at least 12 years of age and weighing at least …

PTC Therapeutics’ Many Attractive Achievements and Approvals

PTC Therapeutics Approvals and Achievements PTC Therapeutics (PTCT) has achieved a lot recently. The latest is the August approval from the U.S. FDA of its product Evrysdi (risdiplam), the first orally administered at-home treatment for spinal muscular atrophy (SMA) in adults and children 2 months and older.   Evrysdi has been granted approvals in Brazil, Chile and Ukraine as . . . This content is …

Inovio to Proceed with Phase 2 Trial of INO-4800 Vaccine Candidate for COVID-19

Inovio Announced FDA Clearance to Proceed with Trial for COVID-19 Vaccine Candidate Inovio (INO) announced the receipt of the U.S. FDA clearance to proceed with the Phase 2 segment of its planned Phase 2/3 clinical trial for INO-4800, its COVID-19 vaccine candidate. Inovio Planned Phase 2/3 INNOVATE Trial The INNOVATE trial - a . . . This content is for paid subscribers. Please click here to …

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 …

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 …

We Continue to Track the COVID-19 Vaccines. See Also: CRISPR Therapeutics Immuno-Oncology Results are Good.

The Latest on the COVID-19 Vaccines AstraZeneca (AZN): After pausing for more than a month, AZN is expected to resume its Phase 3 US study of its COVID-19 vaccine. The trial was paused after a patient, who received the vaccine, developed an illness suspected to be a serious spinal inflammatory condition known as transverse myelitis. The patient was . . . This content is for …

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 …

An Acquisition & a Collaboration You Must Know About

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 …

Cassava Sciences, Moderna and Sorrento Therapeutics All Have News

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 Releases Preclinical Data from STI-1499 and STI-2020 Demonstrating Potent Neutralizing Antibodies Against SARS-CoV-2

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 Launches a Large Scale Phase 3 Trial of Its COVID-19 Vaccine. See Also: Intellia to Prove the Advantages of CRISPR Gene-Editing

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.

Eli Lilly Neutralizing Antibody LY-CoV555 Promises a Reduction in the Rate of COVID-19 Hospitalizations  

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. …

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 …