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Pfizer and BioNTech to provide 500 million doses of COVID-19 vaccine to U.S. government for donation to poorest nations

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Business
10 June 2021
BioNTechPfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced plans to provide the U.S. government at a not-for-profit price 500 million doses of the companies' COVID-19 vaccine, 200 million doses in 2021 and 300 million doses in the first half of 2022, to further support the multilateral efforts to address the surge of infection in many parts of the world and to help end the pandemic.
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Valneva completes Phase 3 trial recruitment for its inactivated COVID-19 vaccine candidate

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09 June 2021
ValnevaValneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced that it has completed recruitment for the pivotal Phase 3 trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
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Pfizer and BioNTech receive first authorization in European Union for COVID-19 vaccine in adolescents

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02 June 2021
BioNTechPfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the Conditional Marketing Authorization (CMA) for COMIRNATY® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. This follows the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group.
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Vaccination with Sputnik V launched in India

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14 May 2021
Russian Direct Investment Fund (RDIF)The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the launch of vaccination with the Russian Sputnik V vaccine against coronavirus in India today.

Sputnik V has become the first foreign-made vaccine that is used in India contributing to the world’s largest COVID-19 vaccination campaign.

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Second-generation COVID-19 vaccine candidate, CV2CoV, demonstrates high immunogenicity against virus variants in preclinical study

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13 May 2021
CureVacCureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today announced together with its collaboration partner GSK, first preclinical data in a rat model, showing that its second-generation COVID-19 vaccine candidate, CV2CoV, induces high levels of antigen production as well as strong and dose-dependent immune responses in vaccinated animals.
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Novavax Announces positive preclinical data for combination influenza and COVID-19 vaccine candidate

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10 May 2021
Novavax, Inc.Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced data from a preclinical study of the company's combination quadrivalent seasonal flu vaccine (NanoFlu™) and COVID-19 vaccine candidate (NVX-CoV2373).
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Moderna announces emergency use listing granted by the World Health Organization for its COVID-19 vaccine

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03 May 2021
Moderna, Inc.Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
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More Pharma News ...

  1. Moderna announces additional investments to increase global supply for COVID-19 vaccine to up to 3 billion doses in 2022
  2. CureVac Swiss AG initiates rolling submission process for mRNA-based COVID-19 vaccine candidate, CVnCoV, with Swissmedic
  3. Valneva switches focus to bilateral discussions to supply its inactivated, adjuvanted COVID-19 vaccine candidate VLA2001
  4. Pfizer and BioNTech to supply the European Union with 100 million additional doses of COMIRNATY®
  5. Pfizer and BioNTech request regulatory agencies expand emergency use of their COVID-19 vaccine to adolescents
  6. Valneva reports positive Phase 1/2 data for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001
  7. Pfizer and BioNTech confirm high efficacy and no serious safety concerns through up to six months following second dose in updated topline analysis of landmark COVID-19 vaccine study
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Business & Industry

  • Bayer opens new Research & Innovation Center in Boston-Cambridge demonstrating its commitment to precision oncology
  • New Novartis extension phase data show nearly 80% of RMS patients treated with Kesimpta® (ofatumumab) had no evidence of disease activity (NEDA-3)
  • Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against Omicron
  • GSK announces £1 billion R&D investment over ten years to get ahead of infectious diseases in lower-income countries
  • Novartis announces Nature Medicine publication of Zolgensma data demonstrating age-appropriate milestones when treating children with SMA presymptomatically

Research & Development

  • Oral antiviral drug effective against respiratory syncytial virus (RSV) identified by researchers
  • Biomarkers found that could be drug targets against a deadly form of brain cancer
  • COVID-19 rebound after taking Paxlovid likely due to insufficient drug exposure
  • Novel drug combo activates natural killer cell immunity to destroy cancer cells
  • Broadly neutralizing antibodies could provide immunity against SARS-CoV-2 variants
  • A new technology offers treatment for HIV infection through a single injection
  • Proteomic study of 2,002 tumors identifies 11 pan-cancer molecular subtypes across 14 types of cancer

Conferences & Events

  • New approach to treatment of deadly kidney cancer
  • SAE Media Group proudly presents the 2nd Annual Aseptic Processing Conference
  • Pharma join together to achieve new standards in digital and patient innovation for clinical transformation
  • SMi's 22nd Annual Pain Therapeutics Conference
  • SMi Group Introduces the 4th Annual Injectable Drug Delivery Conference 2022
  • SMi's 5th Annual Pharmaceutical Microbiology East Coast Conference
  • SMi's 3rd Annual AI in Drug Discovery Conference

Regulatory Affairs

  • FDA approves first systemic treatment for alopecia areata
  • FDA urges drug manufacturers to develop risk management plans to promote a dtronger, resilient drug supply chain
  • FDA limits use of Janssen COVID-19 vaccine to certain individuals
  • EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
  • FDA approves first generic of Symbicort to treat asthma and COPD
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  4. Positive Phase 1 data from mRNA-based individualized neoantigen specific immunotherapy in patients with resected pancreatic cancer

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