Moderna COVID-19 vaccine

OCUGEN ALERT: Bragar Eagel & Squire, P.C. is Investigating Ocugen, Inc. on Behalf of Ocugen Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Saturday, June 12, 2021
Legal, Professional services, COVID-19 vaccines, Clinical trials, RNA vaccines, Medicine, Health, Medical research, BioNTech, Covaxin, Emergency Use Authorization, Pfizer–BioNTech COVID-19 vaccine, Moderna COVID-19 vaccine, COVID-19 vaccine

Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Ocugen, Inc. (NASDAQ: OCGN) on behalf of Ocugen stockholders.

Key Points: 
  • Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Ocugen, Inc. (NASDAQ: OCGN) on behalf of Ocugen stockholders.
  • Our investigation concerns whether Ocugen has violated the federal securities laws and/or engaged in other unlawful business practices.
  • On May 26, 2021, Ocugen announced that it planned to submit to the FDA an Emergency Use Authorization (EUA) application for COVAXIN, a COVID-19 vaccine, in June 2021.
  • Shares of Ocugen fell by more than 24% in intraday trading on the same day, based on this news.

Moderna and Tabuk Pharmaceuticals Partner to Commercialize Moderna’s COVID-19 Vaccine in Saudi Arabia

Retrieved on: 
Friday, June 11, 2021
Medical Supplies, Health, Infectious diseases, General Health, Pharmaceutical, Biotechnology, COVID-19 vaccines, Clinical trials, RNA vaccines, Medical research, Health sciences, Medicine, Health, Moderna COVID-19 vaccine, Tabuk, Moderna, COVID-19 vaccine, Moderna, Tabuk, MODERNA, TABUK

Under the terms of this agreement, Tabuk Pharmaceuticals will hold the marketing authorization for the Moderna COVID-19 vaccine in Saudi Arabia.

Key Points: 
  • Under the terms of this agreement, Tabuk Pharmaceuticals will hold the marketing authorization for the Moderna COVID-19 vaccine in Saudi Arabia.
  • We appreciate the collaboration of Tabuk Pharmaceuticals in this new partnership in Saudi Arabia, said Stphane Bancel, Chief Executive Officer of Moderna.
  • We welcome the opportunity to work with Tabuk Pharmaceuticals to bring the Moderna COVID-19 and potentially other Moderna mRNA products to Saudi Arabia in the future, said Corinne Le Goff, Pharm.D., M.B.A., Chief Commercial Officer of Moderna.
  • Established in Saudi Arabia in 1994, Tabuk Pharmaceuticals is a leading regional pharmaceutical in the Middle East and North Africa (MENA).

Moderna Files for Emergency Use Authorization for its COVID-19 Vaccine in Adolescents in the United States

Retrieved on: 
Thursday, June 10, 2021
Health, Infectious diseases, Other Health, General Health, Pharmaceutical, Biotechnology, COVID-19, COVID-19 vaccines, Clinical trials, Medicine, Medical research, Health sciences, RNA vaccines, Moderna COVID-19 vaccine, COVID-19 vaccine, Moderna, Vaccine, Emergency Use Authorization, the Moderna COVID-19 Vaccine, Moderna, THE MODERNA COVID-19 VACCINE, MODERNA

We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States, said Stphane Bancel, Chief Executive Officer of Moderna.

Key Points: 
  • We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States, said Stphane Bancel, Chief Executive Officer of Moderna.
  • We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents.
  • Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
  • Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.

Moderna and Medison Pharma partner to commercialize Moderna's COVID-19 vaccine across Central Eastern Europe and Israel

Retrieved on: 
Monday, June 7, 2021
Medical research, COVID-19 vaccines, Clinical trials, RNA vaccines, Health sciences, Medicine, Health, BioNTech, Moderna COVID-19 vaccine, Moderna, Draft:Medison Pharma, RNA vaccine

and ZUG, Switzerland, June 7, 2021 /PRNewswire/ -- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines and Medison Pharma, a leading commercial partner for highly innovative therapies in international markets, today announced a new agreement to commercialize the Moderna COVID-19 Vaccineacross Central Eastern Europe and Israel.

Key Points: 
  • and ZUG, Switzerland, June 7, 2021 /PRNewswire/ -- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines and Medison Pharma, a leading commercial partner for highly innovative therapies in international markets, today announced a new agreement to commercialize the Moderna COVID-19 Vaccineacross Central Eastern Europe and Israel.
  • "We are excited to partner with Moderna in 20 markets, covering over 175 million lives across the entire Central Eastern Europe region and in Israel," said Meir Jakobsohn, Founder and CEO of Medison Pharma.
  • "Moderna's breakthrough mRNA vaccine and Medison's international commercialization platform for highly innovative treatments, makes our partnership a natural fit."
  • This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding an agreement between Moderna and Medison Pharma to commercialize the Moderna COVID-19 Vaccine (known as COVID-19 Vaccine Moderna outside the U.S.) in Central Eastern Europe and Israel.

Moderna Files for Authorization with Health Canada for its COVID-19 Vaccine in Adolescents

Retrieved on: 
Monday, June 7, 2021
Research, General Health, Family, Pharmaceutical, Consumer, Infectious diseases, Teens, Science, Biotechnology, Medical Supplies, FDA, Health, Other Science, Medical research, COVID-19, COVID-19 vaccines, Clinical trials, RNA vaccines, Health sciences, Medicine, BioNTech, Moderna COVID-19 vaccine, Moderna, COVID-19 vaccine, Vaccine, the COVID-19 Vaccine Moderna, Moderna, THE COVID-19 VACCINE MODERNA, MODERNA

Moderna, Inc. , (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted for authorization of its COVID-19 vaccine in adolescents with Health Canada.

Key Points: 
  • Moderna, Inc. , (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted for authorization of its COVID-19 vaccine in adolescents with Health Canada.
  • We are pleased to announce that we have submitted for authorization of our COVID-19 vaccine for use in adolescents with Health Canada, said Stphane Bancel, Chief Executive Officer of Moderna.
  • We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents.
  • The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100% when using the same case definition as in the Phase 3 COVE study in adults.

Moderna Files for Conditional Marketing Approval for its COVID-19 Vaccine in Adolescents in the European Union

Retrieved on: 
Monday, June 7, 2021
Biotechnology, FDA, Health, Other Health, Pharmaceutical, Other Science, Research, Medical devices, Infectious diseases, General Health, Hospitals, Fitness & Nutrition, Science, Clinical trials, COVID-19, COVID-19 vaccines, Clinical trials, Medicine, Vaccines, Medical research, RNA vaccines, Moderna COVID-19 vaccine, Adenoviridae, COVID-19 vaccine, Vaccine, Moderna, the COVID-19 Vaccine Moderna, Moderna, THE COVID-19 VACCINE MODERNA, MODERNA

We are pleased to announce that we have submitted for conditional marketing approval of our COVID-19 vaccine with the European Medicines Agency for use in adolescents in the European Union, said Stphane Bancel, Chief Executive Officer of Moderna.

Key Points: 
  • We are pleased to announce that we have submitted for conditional marketing approval of our COVID-19 vaccine with the European Medicines Agency for use in adolescents in the European Union, said Stphane Bancel, Chief Executive Officer of Moderna.
  • We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents.
  • In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition.
  • The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100% when using the same case definition as in the Phase 3 COVE study in adults.

Moderna Announces Agreement to Supply the Republic of Botswana with its COVID-19 Vaccine

Retrieved on: 
Thursday, June 3, 2021
Medical Supplies, Health, Infectious diseases, General Health, Pharmaceutical, Biotechnology, COVID-19 vaccines, Clinical trials, Medical research, Medicine, Health sciences, Articles, RNA vaccines, BioNTech, Moderna COVID-19 vaccine, Emergency Use Authorization, Moderna, Pfizer–BioNTech COVID-19 vaccine, the COVID-19 Vaccine Moderna, Moderna, THE COVID-19 VACCINE MODERNA, MODERNA

The Company also announced that the Botswana Medicines Regulatory Authority (BMRA) has issued an emergency use authorization for the COVID-19 Vaccine Moderna.

Key Points: 
  • The Company also announced that the Botswana Medicines Regulatory Authority (BMRA) has issued an emergency use authorization for the COVID-19 Vaccine Moderna.
  • We appreciate the collaboration with the Government of the Republic of Botswana for this supply agreement and with the Botswana Medicines Regulatory Authority for this EUA, said Stphane Bancel, Modernas Chief Executive Officer.
  • This agreement with Botswana is separate from the supply agreement with Gavi, the Vaccine Alliance, which Moderna announced in May.
  • The COVID-19 Vaccine Moderna has been granted emergency use authorization by the Botswana Medicines Regulatory Authority for use in adults aged 18 years and older.

UNICEF and Moderna Announce Long Term Agreement to Supply Vaccine on Behalf of the COVAX Facility

Retrieved on: 
Wednesday, June 2, 2021
Infectious diseases, Biotechnology, Pharmaceutical, Health, COVID-19, COVID-19 vaccines, Clinical trials, Medicine, Responses to the COVID-19 pandemic, Medical research, RNA vaccines, Moderna COVID-19 vaccine, COVID-19 vaccine, COVAX, Moderna, RNA vaccine, the COVID-19 Vaccine Moderna, Moderna, THE COVID-19 VACCINE MODERNA, MODERNA

We are proud and humbled to be able to supply our vaccine through this long-term agreement with UNICEF in support of efforts to end this pandemic, said Stphane Bancel, Chief Executive Officer of Moderna.

Key Points: 
  • We are proud and humbled to be able to supply our vaccine through this long-term agreement with UNICEF in support of efforts to end this pandemic, said Stphane Bancel, Chief Executive Officer of Moderna.
  • We share in the mission of the COVAX Facility to ensure global access to vaccines including in low- and middle-income countries around the world.
  • The COVID-19 Vaccine Moderna (referred to in the U.S. as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.
  • On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation.

Moderna Announces New Drug Substance Production Agreement with Lonza in the Netherlands

Retrieved on: 
Wednesday, June 2, 2021
Health, Infectious diseases, Genetics, Other Health, Pharmaceutical, Biotechnology, Companies, COVID-19 vaccines, Clinical trials, RNA vaccines, Life sciences, Health sciences, Moderna COVID-19 vaccine, Medical research, Catalent, Sanofi, COVID-19 vaccine, Thermo Fisher Scientific, the COVID-19 Vaccine Moderna, Moderna, THE COVID-19 VACCINE MODERNA, MODERNA

Both new drug substance lines in the European Union are expected to be operational before the end of 2021.

Key Points: 
  • Both new drug substance lines in the European Union are expected to be operational before the end of 2021.
  • This additional production will help us continue to scale up our production as we continue to develop best-in-class variant boosters so we can help end this pandemic as fast as possible.
  • In the U.S., the Company also works with Lonza Portsmouth for drug substance production, and partners with Catalent, Baxter BioPharma Solutions, Sanofi and Thermo Fisher Scientific for fill/finish services.
  • On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation.

Moderna Announces Agreement with Thermo Fisher Scientific for Fill/Finish Manufacturing of Moderna’s COVID-19 Vaccine

Retrieved on: 
Tuesday, June 1, 2021
Packaging, Health, Infectious diseases, Manufacturing, Genetics, Pharmaceutical, Biotechnology, Medical research, COVID-19 vaccines, Clinical trials, RNA vaccines, Health sciences, Medicine, Health, Moderna COVID-19 vaccine, Pfizer–BioNTech COVID-19 vaccine, Fill and finish, Moderna, Thermo Fisher Scientific

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has entered into an agreement with Thermo Fisher Scientific (NYSE: TMO) for fill/finish sterile manufacturing services and supply packaging for Modernas COVID-19 vaccine.

Key Points: 
  • Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has entered into an agreement with Thermo Fisher Scientific (NYSE: TMO) for fill/finish sterile manufacturing services and supply packaging for Modernas COVID-19 vaccine.
  • Under the terms of the agreement, Thermo Fishers commercial manufacturing site in Greenville, North Carolina will be used for aseptic fill/finish, labeling and packaging to support the production of hundreds of millions of doses of the Moderna COVID-19 vaccine.
  • Thermo Fisher has been a critical partner in supplying raw materials for our COVID-19 vaccine and we are now pleased to further expand our relationship as an important manufacturing partner as well, said Juan Andres, Modernas Chief Technical Operations and Quality Officer.
  • The addition of Thermo Fisher to our network will support our efforts to scale up our manufacturing ability.