The Pharma Data

DECEMBER 31, 2020

Monthly News Roundup – December 2020. Moderna and Pfizer’s COVID-19 Vaccines Roll Out in Early Phase. Food and Drug Administration (FDA) issued Emergency Use Authorization for two COVID-19 vaccines: Pfizer-BioNTech’s BNT162b2 and Moderna’s mRNA-1273. The duration of protection from the vaccines are not known yet.

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The Pharma Data

JANUARY 11, 2021

Moderna is following up on the success of its messenger RNA-based COVID-19 vaccine with plans to develop inoculations for numerous other infectious diseases, the company said Monday. 18, 2020 ). based company has been in business for 10 years, but the COVID-19 vaccine was its first approved product.

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The Pharma Data

JANUARY 6, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union.

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PLOS: DNA Science

MAY 16, 2024

Had we grown complacent in a world freed from a list of once-deadly infectious diseases, thanks largely to vaccines and other public health measures? A few days after New Years, 2020, I heard BBC News report the first cases, in China. Work on vaccines ensued too. COVID clearly caught us off guard.

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The Pharma Data

DECEMBER 19, 2020

20, 2020 02:44 UTC. Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. 11 ACIP members voted in favor of the vaccine and 0 members voted against. We look forward to vaccinations of this important population starting this week.”.

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The Pharma Data

MAY 3, 2021

The European Medicines Agency (EMA) is evaluating an application submitted by Pfizer and BioNTech for use of their COVID-19 vaccine in children aged 12 to 15 years. . The vaccine has been authorized by the EU for use in people 16 years and up since December 2020. . The companies look forward to working closely with the U.S.

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The Pharma Data

SEPTEMBER 9, 2020

Immunization of non-human primates (rhesus macaques) with BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate that expresses the SARS-CoV-2 spike glycoprotein, resulted in strong anti-viral effects against an infectious SARS-CoV-2 challenge. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021. We look forward to sharing initial results by year-end. ”. “

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The Pharma Data

JUNE 25, 2021

In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. About CVnCoV.

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The Pharma Data

DECEMBER 3, 2020

4, 2020 08:00 UTC. The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

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The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.

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The Pharma Data

AUGUST 16, 2021

The study assessed cynomolgus macaques vaccinated with 12µg of either the first or second-generation vaccine candidate. During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the virus in the lungs and nasal passages.

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The Pharma Data

JANUARY 12, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland. million doses of the COVID-19 Vaccine Moderna. About the COVID-19 Vaccine Moderna.

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The Pharma Data

DECEMBER 3, 2020

The Pfizer – BioNTech and Moderna ’s COVID-19 vaccines are currently being reviewed for possible Emergency Use Authorization (EUA) by the U.S. On Tuesday, the Pfizer-BioNTech vaccine was granted temporary authorization in the UK and dosing will begin next week. Pfizer gets its raw materials for the vaccine from the U.S.

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The Pharma Data

MARCH 11, 2021

Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.

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Codon

DECEMBER 12, 2024

DNA and RNA molecules are also built from exclusively right-handed nucleic acids. Across the tree of life, organisms strictly require exactly one of the two chiral forms of their molecular building blocks — amino acids, nucleotides of RNA and DNA. 4 As far as we know, right-handed proteins never occur naturally.

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The Pharma Data

DECEMBER 10, 2020

Unsupervised use of this technique by people without medical training can lead to transmission of pathogens, according to Paul Carlson, principal investigator in the Laboratory of Mucosal Pathogens and Cellular Immunology at FDA’s Office of Vaccines Research and Review. 1, 2019, until effective screening methods are implemented.”.

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The Pharma Data

NOVEMBER 16, 2020

16, 2020– Moderna, Inc. The ability to store our vaccine for up to 6 months at -20° C including up to 30 days at normal refrigerator conditions after thawing is an important development and would enable simpler distribution and more flexibility to facilitate wider-scale vaccination in the United States and other parts of the world.”.

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The Pharma Data

JUNE 25, 2021

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the U.S. government has purchased an additional 200 million doses of Moderna’s COVID-19 vaccine, including the option to purchase other COVID-19 vaccine candidates from Moderna’s pipeline.

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The Pharma Data

OCTOBER 23, 2020

23, 2020 — In a Society for Healthcare Epidemiology of America white paper, published online Oct. The authors recommended viral load thresholds of 1,000 IU for hepatitis B virus (HBV), hepatitis C virus (HCV) RNA undetectable for HCV, and suppressed viral RNA for HIV for determining any restrictions on HCP practice.

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The Pharma Data

OCTOBER 25, 2020

26, 2020 11:00 UTC. We appreciate the confidence of the Ministry of Health of Qatar in our mRNA vaccine platform and the collaboration we have had to date,” said Stéphane Bancel, Moderna’s Chief Executive Officer. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients.

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The Pharma Data

AUGUST 3, 2021

Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology.

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The Pharma Data

DECEMBER 18, 2020

18, 2020 /PRNewswire/ — Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SILVER SPRING, Md. , Hahn , M.D.

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The Pharma Data

DECEMBER 10, 2020

11, 2020 02:48 UTC. –( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. CULVER CITY, Calif.–(

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The Pharma Data

JANUARY 6, 2021

Under the terms of the agreement, Bayer will support the further development, supply and key territory operations of CureVac’s COVID-19 vaccine candidate CVnCoV. “The need for vaccines against COVID-19 is enormous. CureVac had its initial public offering on the New York Nasdaq in August 2020. billion euros.

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The Pharma Data

MAY 17, 2021

Sanofi and GlaxoSmithKline (GSK) have reemerged as COVID-19 vaccine contenders after their reformulated candidate delivered a strong immune response across all age groups in a phase 2 study. 14, 2020 ). Although wealthy territories like the U.S., The mRNA candidate is currently being assessed in a phase 1/2 study. Jason Scott.

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Broad Institute

JANUARY 30, 2024

He has also emerged in recent years as a skilled and relatable science communicator, renowned for his efforts at Broad and beyond during the COVID-19 pandemic to unpack the fast-moving research on the new virus in an accessible way and give practical advice about masking, vaccines, and other public health measures.

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The Pharma Data

NOVEMBER 16, 2020

16, 2020– Moderna, Inc. The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. .–(BUSINESS WIRE)–Nov.

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The Pharma Data

JANUARY 4, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Israel’s Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna in Israel. The MOH has secured 6 million doses of the COVID-19 Vaccine Moderna.

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The Pharma Data

NOVEMBER 30, 2020

30, 2020– Moderna, Inc. The data analysis indicates a vaccine efficacy of 94.1%. The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Nov.

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The Pharma Data

DECEMBER 8, 2020

8, 2020– Moderna, Inc., Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 8, 2020– Moderna, Inc.,

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The Pharma Data

JUNE 26, 2021

BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), announced that the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). We were able to demonstrate the potential of mRNA vaccines in addressing COVID-19.

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The Pharma Data

NOVEMBER 17, 2020

17, 2020 — As the U.S. Moderna’s COVID Vaccine Shows 94.5% announced on Monday that early results show that its coronavirus vaccine is 94.5 The researchers behind the vaccine said the results were better than they had dared to imagine, though it will probably not be available until spring, the Times reported.

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The Pharma Data

MAY 17, 2021

The investigational COVID-19 vaccine uses the same recombinant protein-based technology as one of Sanofi’s seasonal flu vaccines, along with GSK’s established pandemic adjuvant technology. The interim results from the phase 2 trial on the vaccine, published today, on the contrary, showed a “ strong neutralizing antibody response” ?

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The Pharma Data

OCTOBER 28, 2020

29, 2020 06:00 UTC. Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., CAMBRIDGE, Mass.–(

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The Pharma Data

NOVEMBER 18, 2020

18, 2020 – The first rapid coronavirus test that can be taken at home with results delivered in 30 minutes was cleared for emergency use by the U.S. ” COVID Vaccines Move Closer to Emergency Use Approval. The vaccine’s efficacy was consistent across age, race and ethnicity, the companies said. WEDNESDAY, Nov.

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