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BioNTech provides update on vaccine production status at Marburg manufacturing site

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26 March 2021
BioNTechBioNTech SE today announced that the European Medicines Agency (EMA) approved the manufacturing of the COVID-19 vaccine drug product at the facility in Marburg. As part of the process, EMA has approved the production of the drug substance, the mRNA, at the Marburg site over the course of this week.
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NIAID statement on AstraZeneca vaccine and AstraZeneca update

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23 March 2021
Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.
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Bharat Biotech announces Phase 3 results of COVAXIN®: India's first COVID-19 vaccine demonstrates interim clinical efficacy of 81%

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18 March 2021
Bharat BiotechBharat Biotech, a global leader in vaccine innovation, developing vaccines for infectious diseases, announced the first interim analysis of its BBV152 (COVAXIN®). The whole virion inactivated COVID-19 vaccine candidate demonstrated an interim vaccine efficacy of 81% in its Phase 3 clinical trial.
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WHO statement on AstraZeneca COVID-19 vaccine safety signals

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17 March 2021
WHOSome countries in the European Union have temporarily suspended use of the AstraZeneca COVID-19 vaccine as a precautionary measure based on reports of rare blood coagulation disorders in persons who had received the vaccine. Other countries in the EU - having considered the same information - have decided to continue using the vaccine in their immunization programmes.
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First participants dosed in Phase 1 study evaluating mRNA-1283, Moderna's next generation COVID-19 vaccine

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15 March 2021
Moderna, Inc.Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participants have been dosed in the Phase 1 study of mRNA-1283, the Company's next generation COVID-19 vaccine candidate.
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European Commission purchases additional 150 million doses of COVID-19 vaccine Moderna

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17 February 2021
Moderna, Inc.Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission purchased an additional 150 million doses of the COVID-19 Vaccine Moderna, which are scheduled to be delivered in the third and fourth quarter of 2021.
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U.S. government purchases additional 100 million doses of Moderna's COVID-19 vaccine

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15 February 2021
Moderna, Inc.Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the U.S. government has purchased an additional 100 million doses of Moderna's COVID-19 Vaccine, bringing its confirmed order commitment to 300 million doses.
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More Pharma News ...

  1. CureVac initiates rolling submission with European Medicines Agency for COVID-19 vaccine candidate, CVnCoV
  2. Sinovac receives conditional marketing authorization in China for its COVID-19 vaccine
  3. Pfizer and BioNTech publish data from in vitro studies demonstrating COVID-19 vaccine elicits antibodies that neutralize SARS-CoV-2 with key mutations present in U.K. and South African variants
  4. Efficacy of Sputnik V against COVID-19 was reported at 91.6%
  5. In vitro studies demonstrate Pfizer and BioNTech COVID-19 vaccine elicits antibodies that neutralize SARS-CoV-2 with key mutations present in U.K. and South African variants
  6. Valneva commences manufacturing of its inactivated, adjuvanted COVID-19 vaccine, completes Phase 1/2 study recruitment
  7. Pfizer and BioNTech publish results of study showing COVID-19 vaccine elicits antibodies that neutralize pseudovirus bearing the SARS-CoV-2 U.K. strain spike protein
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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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