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Pfizer and BioNTech sign new global collaboration agreement to develop first mRNA-based shingles vaccine

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06 January 2022
BioNTechPfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a new research, development and commercialization collaboration to develop a potential first mRNA-based vaccine for the prevention of shingles (herpes zoster virus, or HZV), a debilitating, disfiguring and painful disease that impacts about one in three people in the United States during their lifetime.
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Leiden University Medical Center and Intravacc to start clinical trial with new intranasal corona vaccine

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05 January 2022
IntravaccIntravacc, a global leader in translational research and development of therapeutic vaccines and vaccines against infectious diseases, today announced a partnership with Dutch Leiden University Medical Center (LUMC) to develop and evaluate a new nasal spray corona vaccine in a clinical phase I/II study.
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European Commission grants conditional marketing authorization for Novavax COVID-19 vaccine

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20 December 2021
Novavax, Inc.Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the European Commission (EC) has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
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Pfizer and BioNTech receive expanded U.S. FDA emergency use suthorization of COVID-19 vaccine booster to include individuals 18 and older

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22 November 2021
BioNTechPfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 18 years of age and older. The booster dose is to be administered at least six months after completion of the primary series, and is the same dosage strength as the doses in the primary series.
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Petrovax Pharm is taking part in the international pharmaceutical exhibition CPhI Worldwide-2021

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19 October 2021
Petrovax PharmPetrovax Pharm, the Russian biopharmaceutical company, will participate in CPhI Worldwide-2021 - the international specialized pharmaceutical industry exhibition. This year, it will be held from 9 to 11 November in Italy (Milan) on the territory of the largest exhibition complex Fiera Milano.
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Pfizer and BioNTech receive CHMP positive opinion for COVID-19 vaccine booster in the European Union

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04 October 2021
BioNTechPfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies' COVID-19 vaccine as a booster dose at least six months after the second dose in individuals 18 years of age and older.
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University of Oxford and Oracle Cloud System helping researchers identify COVID-19 variants faster

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20 September 2021
The fast spread of the highly infectious Delta variant underscores the need for faster identification of COVID-19 mutations. Uniting governments and medical communities in this challenge, the University of Oxford and Oracle's Global Pathogen Analysis System (GPAS) is now being used by organizations on nearly every continent.
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More Pharma News ...

  1. Pfizer and BioNTech submit a variation to EMA with the data in support of a booster dose of COMIRNATY®
  2. U.S. FDA grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 vaccine
  3. Moderna announces emergency use authorization for its COVID-19 vaccine granted by government of India
  4. BioNTech announces first patient dosed in Phase 2 clinical trial of mRNA-based BNT111 in patients with advanced melanoma
  5. CureVac provides update on Phase 2b/3 trial of first-generation COVID-19 vaccine candidate, CVnCoV
  6. U.S. government purchases additional 200 million doses of Moderna's COVID-19 vaccine
  7. Novavax COVID-19 vaccine demonstrates 90% overall efficacy and 100% protection against moderate and severe disease in PREVENT-19 Phase 3 trial
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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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