Johnson & Johnson Receives an EUA from the U.S. FDA We appreciate the U.S. Food and Drug Administration's emergency use authorization (EUA) for the third vaccine for the prevention of SARS-CoV-2 (the virus that causes COVID-19). Three vaccines are definitely better than two and now, the third vaccine, which belongs to Johnson & Johnson (

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 …

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 …

Immunome, Inc. Immunome, Inc (IMNM) announced today that its discovery engine has isolated potent antibodies capable of neutralizing several SARS-CoV-2 (the virus that causes COVID-19) variants, including the South African Variant (B.1.351), in pseudovirus testing.  This effort is part of the company’s . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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 …

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 …

Merck Discontinues Development of COVID-19 Vaccine Candidates Merck (MRK) known as MSD outside the United States and Canada announced yesterday that the company is discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines. In these studies, both V590 . . . This content is for paid subscribers. Please click here …

Inovio Phase 1 Data of INO-4800 for COVID-19 Peer-reviewed Phase 1 data shows Inovio COVID-19 DNA Vaccine Candidate, INO-4800, to be immunogenic in 100% of subjects, inducing neutralizing antibody and/or T cell responses. INO-4800 demonstrates favorable safety and tolerability. No serious adverse events reported. Offers best-in-class thermostability, including a five-year projected shelf life at normal refrigeration temperature and no frozen transport or storage requirements. INOVIO …

Intellia Therapeutics Intellia Therapeutics (NTLA) stock price headed south probably because some robots learned that the firm commenced an underwritten public offering of $150 million of shares of its common stock. In addition to the commenced public offering Intellia announced its intention to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares . . . This content is …

COVID-19 Vaccine Updates Pfizer's (PFE)/BioNTech's (BNTX) and Moderna . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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 …

Pfizer, BioNTech & Moderna When asked whether we heard the news about the submission of the Emergency Use Authorization (EUA) and whether we will inform our readers about it. Our answer was that we have posted many articles about Pfizer's (PFE) and BioNTech’s (

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 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 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 …

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 …

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 …