COVID-19 pandemic in India

Augmenta Bioworks and TFF Pharmaceuticals Announce Positive In Vitro Data Demonstrating Binding and Neutralization of the SARS-CoV-2 Delta Variant by Lead Anti-COVID-19 Antibody, AUG-3387

Retrieved on: 
Thursday, July 29, 2021
Coronaviridae, Sarbecovirus, Zoonoses, Variants of SARS-CoV-2, COVID-19 pandemic in India, SARS-CoV-2 Delta variant, COVID-19, Variant, Delta, Severe acute respiratory syndrome coronavirus 2, Severe acute respiratory syndrome coronavirus, Severe acute respiratory syndrome

MENLO PARK, Calif. and AUSTIN, Texas, July 29, 2021 (GLOBE NEWSWIRE) -- Augmenta Bioworks, a biotechnology company enabling breakthroughs in medicine through immune profiling, and TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced positive in vitro data indicating that their lead anti-COVID-19 monoclonal antibody (“mAb”) therapy, AUG-3387, binds to and neutralizes the SARS-CoV-2 Delta variant (B.1.617.2). The Delta variant is the current dominant strain of SARS-CoV-2 in the U.S., Europe and other geographic regions around the world.

Key Points: 
  • The Delta variant is the current dominant strain of SARS-CoV-2 in the U.S., Europe and other geographic regions around the world.
  • The Delta variant now accounts for 83% of new cases in the U.S., according to recent CDC data.
  • Demonstration that AUG-3387 effectively neutralizes the Delta variant in vitro is an encouraging step towards developing the therapy to slow and prevent ongoing spread of COVID-19.
  • Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially.

New Publications Confirm Paragon Genomics CleanPlex® SARS-CoV-2 Panel Enables Accurate Identification of Variants of Concern

Retrieved on: 
Wednesday, July 28, 2021
Coronaviridae, Variants of SARS-CoV-2, Sarbecovirus, COVID-19 pandemic in India, COVID-19, SARS-CoV-2 lineage B.1.617, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2 Alpha variant, SARS-CoV-2 Delta variant, Severe acute respiratory syndrome coronavirus, COVID-20

The analyses enabled the researchers to assign the viral genomes to SARS-CoV-2 lineages and confirm the presence of the B.1.1.7 variant.

Key Points: 
  • The analyses enabled the researchers to assign the viral genomes to SARS-CoV-2 lineages and confirm the presence of the B.1.1.7 variant.
  • A third study, from a Paragon Genomics public health laboratory customer, describes how the CleanPlex SARS-CoV-2 Panel enabled the early identification of one of the first confirmed cases of the B.1.617.2 Delta variant in Brazil.
  • Paragon Genomics' CleanPlex SARS-CoV-2 technology has powered variant detection and tracking since the virus first appeared.
  • In March 2020, the company launched the CleanPlex SARS-CoV-2 Panel whole genome SARS-CoV-2 sequencing on Illumina and MGI Tech sequencing platforms.

Ocugen, Inc. Announces Initiation of Rolling Submission to Health Canada for COVAXIN™

Retrieved on: 
Thursday, July 15, 2021
COVID-19 vaccines, Clinical trials, Health sciences, Health, Medicine, Covaxin, COVID-19 pandemic in India, Clinical research, Design of experiments, Bharat Biotech, COVID-19 vaccine, CoronaVac

This follows the release by Bharat Biotech of Phase 3 clinical trial results , which demonstrated efficacy and safety in nearly 25,800 adults.

Key Points: 
  • This follows the release by Bharat Biotech of Phase 3 clinical trial results , which demonstrated efficacy and safety in nearly 25,800 adults.
  • Often referred to as a rolling review, this allows Health Canada to start its review right away, as information continues to come in, to accelerate the overall review process.
  • Ocugen initiated the rolling submission through its affiliate, Vaccigen, Ltd. Health Canada will make a decision upon review of the evidence submitted that supports its safety, efficacy and quality.
  • Based on the more than 30 million doses supplied in India and other countries, COVAXIN has an excellent safety record.

The Law Offices of Frank R. Cruz Announces the Filing of a Securities Class Action on Behalf of Ocugen, Inc. (OCGN) Investors

Retrieved on: 
Monday, June 21, 2021
Legal, Professional services, COVID-19 vaccines, Clinical trials, COVID-19 pandemic in India, Covaxin, COVID-19, Bharat Biotech, Drugs, Health

Ocugen investors have until August 16, 2021, to file a lead plaintiff motion.

Key Points: 
  • Ocugen investors have until August 16, 2021, to file a lead plaintiff motion.
  • If you are a shareholder who suffered a loss, click here to participate.
  • Pursuant to an agreement with Bharat Biotech, Ocugen has the exclusive right to develop, manufacture, and commercialize COVAXIN, a vaccine candidate for COVID-19.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

The Law Offices of Frank R. Cruz Announces Investigation of Ocugen, Inc. (OCGN) on Behalf of Investors

Retrieved on: 
Wednesday, June 16, 2021
Legal, Professional services, COVID-19 vaccines, COVID-19 pandemic in India, Covaxin, Bharat Biotech, COVID-19, Drugs, Health

The Law Offices of Frank R. Cruz announces an investigation of Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN ) on behalf of investors concerning the Companys possible violations of federal securities laws.

Key Points: 
  • The Law Offices of Frank R. Cruz announces an investigation of Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN ) on behalf of investors concerning the Companys possible violations of federal securities laws.
  • If you are a shareholder who suffered a loss, click here to participate.
  • Pursuant to an agreement with Bharat Biotech, Ocugen has the exclusive right to develop, manufacture, and commercialize COVAXIN, a vaccine candidate for COVID-19.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Ocugen Secures Manufacturing Partnership for US Production of COVID-19 Vaccine Candidate, COVAXIN™

Retrieved on: 
Tuesday, June 15, 2021
COVID-19 vaccines, Clinical trials, COVID-19, COVID-19 pandemic in India, Vaccination, Covaxin, Medicine, Bharat Biotech, COVID-19 vaccine, Inactivated vaccine, COVID-19 vaccination in India

Securing US-based manufacturing capability is a critical step as we prepare to submit our regulatory submissions to the FDA and Health Canada.

Key Points: 
  • Securing US-based manufacturing capability is a critical step as we prepare to submit our regulatory submissions to the FDA and Health Canada.
  • Based on Bharat Biotechs strong track record of developing and commercializing vaccines globally and Jubilants proven track record in manufacturing, we are well-prepared to transition US manufacturing of COVAXIN to our new partner.
  • COVAXIN, India's COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
  • COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

S.P. Hinduja Banque Privée & The Desai Foundation Partner to Create Heroes for Humanity, a COVID Response Recovery Initiative With Both Short and Long Term Impact in India

Retrieved on: 
Wednesday, June 9, 2021
Hinduja Group, COVID-19 pandemic in India, Desai, Companies, Economy of India

Hinduja Banque Prive & The Desai Foundation partner to create Heroes for Humanity, a COVID Response Recovery Initiative with both short and long term impact in India

Key Points: 
  • Hinduja Banque Prive & The Desai Foundation partner to create Heroes for Humanity, a COVID Response Recovery Initiative with both short and long term impact in India
    S.P.
  • Hinduja Banque Prive is proud to announce a new partnership with the Desai Foundation to expand the organization'swork to address the COVID-19 crisis in India and specificallyits rural areas.
  • Hinduja Banque Prive's COVID Relief Fund to the Desai Foundation Trust will cover the costs of 500 new membersfor the Foundation, bolstering the Foundation'swork with rural communities across six states in India.
  • Over the last two months, The Desai Foundation has focused on work in response to the COVID-19 pandemic in India.

Ocugen Expands COVAXIN™ Commercialization Rights to Include Canada

Retrieved on: 
Thursday, June 3, 2021
COVID-19 vaccines, Clinical trials, COVID-19 pandemic in India, COVID-19, Covaxin, Bharat Biotech, Drugs, Health

This amendment to expand our rights to commercialize COVAXIN into Canada speaks to our strong relationship with Bharat Biotech and our joint dedication to bring this unique yet traditional vaccine to additional countries.

Key Points: 
  • This amendment to expand our rights to commercialize COVAXIN into Canada speaks to our strong relationship with Bharat Biotech and our joint dedication to bring this unique yet traditional vaccine to additional countries.
  • COVAXIN has demonstrated an excellent safety record in human clinical trials and in vaccine administration under emergency use in India.
  • As consideration for Bharat Biotechs grant of the rights to commercialize COVAXIN in Canada, Ocugen will make an upfront payment and milestone payment upon first commercial sale in Canada to Bharat Biotech, in addition to sharing the profit from sales of COVAXINTM in Canada.
  • Similar to the US profit share arrangement, Ocugen will retain 45% of the profits from sales of COVAXINTM in Canada.

Ocugen On Track to Submit Emergency Use Authorization Application to U.S. FDA for its COVID-19 Vaccine Candidate, COVAXIN™

Retrieved on: 
Thursday, May 27, 2021
COVID-19 vaccines, Clinical trials, COVID-19, Vaccination, Covaxin, Medicine, COVID-19 pandemic in India, Bharat Biotech, COVID-19 vaccine

We believe that the FDAs new guidance confirms that Ocugen continues to meet all criteria for submission of an EUA.

Key Points: 
  • We believe that the FDAs new guidance confirms that Ocugen continues to meet all criteria for submission of an EUA.
  • Once the EUA application has been submitted, Ocugen intends to commence pre-biologics license application (BLA) discussions with the FDA, said Dr. Shankar Musunuri , Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.
  • COVAXIN, India's COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
  • We are co-developing Bharat Biotechs COVAXIN vaccine candidate for COVID-19 in the U.S. market.For more information, please visit www.ocugen.com .

EMA Issues Positive Scientific Opinion on GSK and Vir Biotechnology’s Sotrovimab For the Early Treatment of COVID-19

Retrieved on: 
Friday, May 21, 2021
Variants of SARS-CoV-2, Medical specialties, Clinical medicine, Medicine, Immunology, COVID-19 pandemic in India, Lineage B.1.617, bioRxiv, Monoclonal antibody, Epitope

Based on our most recent in vitro data, sotrovimab continues to combat COVID-19 as it evolves and has retained activity against all circulating variants of concern.

Key Points: 
  • Based on our most recent in vitro data, sotrovimab continues to combat COVID-19 as it evolves and has retained activity against all circulating variants of concern.
  • As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy.
  • Additional in vitro data demonstrating activity against variants from New York (B.1.526) and India (B.1.617) were also recently published by bioRxiv.
  • Sotrovimab targets a conserved epitope of the spike protein which is less likely to mutate over time.