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Sanofi and AstraZeneca Report Results of Nirsevimab in P-III MELODY Study for the Protection of Healthy Infants Against Respiratory Syncytial Virus Disease

Shots: The P-III MELODY study involves evaluating Nirsevimab (50mg/100mg, IM) vs PBO to determine the incidence of medically attended LRTI due to RSV confirmed by RT-PCR testing through 150days after dosing in healthy infants in a ratio (2:1) entering their first RSV season The study met its 1EPs i.e. reduction of LRTI due to RSV …

Sanofi and AstraZeneca Report Results of Nirsevimab in P-III MELODY Study for the Protection of Healthy Infants Against Respiratory Syncytial Virus Disease Read More »

Roche Launches Cobas SARS-CoV-2 Variant Test to Detect Emerging Coronavirus Mutations

Shots: The company has launched the cobas SARS-CoV-2 variant set 1 test to detect spike mutations in virus variants including UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1) The accurate detection and differentiation of SARS-CoV-2 mutations can aid in assessing the spread of circulating variants and monitor their potential impact on diagnostics, vaccines and therapeutics …

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CureVac Collaborate with UK Government to Develop Vaccines Against SARS-CoV-2 variants

Shots: The collaboration combines expertise, resources and technology from both parties to develop and manufacture variant vaccines against SARS-CoV-2 variants. CureVac is expected to supply 50M doses of variant vaccines to the UK, following the regulatory approval The VTF and the CureVac will deploy mRNA platform to assess multiple SARS-CoV-2 variants and are expected to …

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Russia’s Sputnik V Demonstrates 92% Efficacy Against COVID-19

Shots: The P-lll study involves assessing of Sputnik V vaccine vs PBO from 19,866 volunteers with COVID-19. The efficacy of the vaccine is 92% effective in fighting COVID-19 based on peer-reviewed late-stage trial results published in the lancet international medical journal Previous data from two-dose regimen of the vaccine based on two different viral vectors …

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Regeneron’s REGEN-COV Antibody Cocktail Confirms its Effectiveness Against UK and South Africa SARS-CoV-2 Variants

Shots: REGEN-COV neutralizes the SARS-CoV-2 B.1.1.7 variants, identified in the UK & SA. The data was included in a bioRxiv paper and submitted for peer-reviewed publication on the changing resistance of SARS-CoV-2 variants to Ab neutralization REGEN-COV retained its neutralizing capability against the B.1.1.7 variant. The Ab cocktails also retained its potency against the B.1.351 …

Regeneron’s REGEN-COV Antibody Cocktail Confirms its Effectiveness Against UK and South Africa SARS-CoV-2 Variants Read More »

Grifols to Evaluate New Immunoglobulin Therapy Against COVID-19 in Spain

Shots: The company to initiate the clinical trial assessing the safety and efficacy of its COVID-19 drug based on the Grifols’ immunoglobulin Gamunex-C and containing anti-SARS-CoV-2 polyclonal Abs from plasma donors who have recovered from the disease The study is expected to be initiated in Feb’2021. The treatment will be administered in primary care centers …

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Bayer Collaborates with CureVac for CVnCoV Against COVID-19

Shots: Bayer to support the development, supply and key territory operations of CureVac´s COVID-19 vaccine candidate, CVnCoV and will contribute its expertise and established infrastructure in numerous area Curevac will be the MAH for the product while Bayer will support CureVac with country operations within the EU and additional markets. Additionally, Bayer has an option …

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Moderna’s mRNA-1273 Receives the US FDA’s EUA Against COVID-19

Shots: The US FDA has authorized EUA of mRNA-1273 vaccine against COVID-19 in individuals ≥18yrs. The delivery to the US govt. will begin imminently while Moderna will continue to gather additional data and plans to file BLA for full licensure in 2021 Allocation and distribution will be prioritized according to populations identified by the CDC’s …

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Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Shots: The VRBPAC voted 20-0, with one abstention that the benefits of the Moderna’s vaccine outweighed its risks for use in people aged ≥18yrs The recommendation is based on data analysis from the pivotal P-III clinical study that demonstrated 94.1% efficacy The US FDA’s committees provide non-binding recommendations. The FDA will take the VRBPAC’s recommendation …

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19 Read More »

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Shots: Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized according to the populations identified in guidance from the JCVI The MHRA’s decision is based on a rolling submission, including data from the P-III study, …

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Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

Shots: Moderna amended its current supply agreement with the UK govt. for an additional 2M doses of mRNA-1273 against COVID-19. The UK govt. has now secured 7M doses of mRNA-1273 The agreement reflects Moderna’s commitment to making its vaccine available in multiple countries. Moderna ramp up its global manufacturing to be able to deliver ~500M …

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Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19

Shots: Following the successful completion of the interim analysis from the P-I & P-II clinical trials of Covaxin, the company has received the DCGI approval to conduct a P-III study of its COVID-19 vaccine The study will assess Covaxin (6mcg, IM at an interval of 28days) vs PBO in ~26,000 volunteers in a ratio (1:1) …

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AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US

Shots: The US FDA authorizes the restart of the P-III clinical study in the US following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from studies globally and concluded it was safe to resume the trial A voluntary pause across all global studies was triggered on Sept …

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Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19

Shots: The companies reported the preclinical results of MRT5500 demonstrating the potential of the vaccine in neutralizing the Abs against SARS-CoV-2. The two doses of MRT5500 induced neutralizing antibody levels significantly higher than those observed in COVID-19 patients The preclinical data support the advancement of MRT5500 for clinical development. The companies anticipate the initiation of …

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AbbVie and Harvard University Collaborate to Develop Novel Therapies Against Emergent Viral Diseases

Shots: AbbVie and Harvard University enter a $30M research alliance to study & develop novel therapies against emergent viral infections with an initial focus on coronavirus and the viruses leading to hemorrhagic fever The focus of the collaboration is to integrate fundamental biology into the pre/clinical development of new therapies for viral diseases AbbVie will …

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AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19

Shots: The first participants have been dosed in a P-I trial of AZD7442 to assess safety, tolerability, and PK of the combination mAbs in up to 48 healthy participants aged 18-55 yrs. in the UK. The study is funded by DARPA If AZD7442 proves to be tolerated and has a favorable safety profile in the …

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Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19

Shots: The two global companies collaborated to develop, manufacture, and distribute REGN-COV2 across the globe. The agreement is expected to increase the supply of REGN-COV2 to at least 3.5 times the current capacity with the potential for expanding it further Regeneron will lead the distribution in the US while Roche will be responsible for the …

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BioNTech and Fosun Pharma Initiate Clinical Trial of BNT162b1 Against COVID-19 in China

Shots: The P-I study will evaluate the safety and immunogenicity of the vaccine as well as confirm dose selection in ~144 healthy subjects aged 18-55 and >55 yrs. As part of the two-dose cohort design, subjects will receive two injections (prime-boost), 21 days apart  BNT162b1 vs PBO The dose range was determined based on early …

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Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Shots: The companies commence global (Ex- China) P-II/III study to evaluate a modRNA candidate (BNT162b2, 30µg dose level in a 2 dose regimen) from their BNT162 mRNA-based vaccine program against SARS-CoV-2 The P-II/III study follows the US FDA’s guidance on clinical trial design, will evaluate up to 30,000 participants in a ratio (1:1)  aged 18 …

Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19 Read More »

Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Shots: The companies reported that most advanced of four COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program demonstrated the ability to elicit high SARS-CoV-2 neutralizing titers following the second dose in an ongoing P-I/II study in Germany The results divulge that BNT162b1 candidate induced strong CD4+ and CD8+ T-cell responses. BNT162b1 elicits RBD-specific, interferon-g+, …

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AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Shots: The P-II/III COV001 designed to determine the safety, immunogenicity, and efficacy of the AZD1222 (single dose or two doses of AZD1222 at 5×1010 viral particles) vs single dose of meningococcal conjugate vaccine (MenACWY) as control vaccine in up to 1,077 healthy adults aged 18-55yrs. in 5 trial centers in the UK The study demonstrated …

AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19 Read More »

Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India

Shots: Zydus has commenced the adaptive P-I/II human clinical trials of its plasmid DNA vaccine, ZyCoV-D and reported its first human dosing The Adaptive P-I/II dose escalation study will assess the safety, tolerability, and immunogenicity of the vaccine in ~1000 candidates across multiple clinical sites in India. The company has already manufacture clinical GMP batches …

Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India Read More »