The Pharma Data

DECEMBER 20, 2020

UK drug developer Scancell said it has chosen a COVID-19 vaccine candidate, SN14, from more than a dozen potential products to advance to a clinical trial. . SN14 works by targeting the coronavirus’ nucleocapsid and spike proteins to prevent viral replication using the company’s ImmunoBody DNA vaccine technology.

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MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Expected to enroll 415 participants; interim results expected in Q3 2021. The Companies expect interim results from this trial in the third quarter of 2021.

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MARCH 18, 2021

Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) are pleased to announce the start of Phase 3 clinical testing of Medicago’s plant-derived COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, as part of the ongoing Phase 2/3 study. g of CoVLP are administered 21 days apart.

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JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif.

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JANUARY 20, 2021

-based Gritstone Oncology is developing a novel COVID-19 vaccine based on adenovirus and messenger-RNA technology designed to combat future variants of the coronavirus.

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The Pharma Data

JANUARY 25, 2021

In a surprise move, Merck announced that it is giving up on its two coronavirus vaccine candidates after seeing a subpar immune response and shifting its focus to a pair of investigational coronavirus treatments. Initial efficacy data are anticipated in the first quarter and the phase 2/3 trials are expected to wrap up in May.

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DECEMBER 18, 2020

COVAX now has agreements in place to access nearly two billion doses of several promising vaccine candidates, and laid the groundwork for further doses to be secured through contributions from donors. billion donor-funded doses of approved vaccines in 2021 to the 92 low- and middle-income economies eligible for the COVAX AMC.

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JANUARY 13, 2021

Brazil’s Butantan Institute has reported that Sinovac’s COVID-19 vaccine, CoronaVac, demonstrated an overall efficacy of only 50.38 percent in a phase 3 trial, putting it barely over the World Health Organization’s 50 percent efficacy threshold for approval.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

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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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FEBRUARY 25, 2021

Takeda Provides Updates on Phase 1/2 Clinical Trials of Novavax’ and Moderna’s COVID-19 Vaccine Candidates in Japan. – Takeda is making two COVID-19 vaccines available in Japan, by manufacturing Novavax’ recombinant vaccine candidate and distributing Moderna’s mRNA vaccine candidate, with the support of the Japanese Government.

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MARCH 8, 2021

Based on these findings, Merck plans to initiate a Phase 2 trial to further explore the potential of a subdermal implant containing islatravir as a long-acting option for PrEP for up to 12 months. “We For more than 100 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases.

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OCTOBER 26, 2021

Pfizer and BioNTech SE blazoned topline results from a Phase 3 randomized, controlled trial assessing the efficacity and safety of a 30-µg supporter cure of the Pfizer-BioNTech COVID-19 Vaccine in further than individualities 16 times of age and aged. The observed relative vaccine efficacity of95.6 (95 95 CI89.3,98.6)

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JANUARY 11, 2021

In clinical trials, it could detect COVID-19 with 90%+ accuracy in about two minutes. . Testing Therapies, Antivirals and Vaccines. By the end of January, Johnson & Johnson is expected to deliver preliminary trial results for its one-dose COVID-19 vaccine candidate. . Other Industry News.

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MAY 3, 2021

Posted 03 May 2021 | By Kari Oakes . 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. . EMA. . . .

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JANUARY 29, 2021

EU Regulator Approves Oxford-AstraZeneca COVID-19 Vaccine. 29, 2021 — European Union regulators have authorized the AstraZeneca COVID-19 vaccine for use in adults, CBS News reported Friday. The move comes after the European Medicines Agency has been criticized for not moving fast enough to vaccinate its population.

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NOVEMBER 22, 2021

Pfizer-BioNTech vaccine demonstrated 100 efficacity against COVID-19 in longer- term analysis, with no serious safety enterprises linked. Data will support planned cessions for full nonsupervisory blessing of the vaccine in this age group in theU.S. and worldwide NEW YORK & MAINZ, Germany– (BUSINESS WIRE)– PfizerInc.

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MAY 4, 2021

Posted 04 May 2021 | By Kari Oakes . The European Medicines Agency (EMA) has added Sinovac’s COVID-19 vaccine to its portfolio of vaccines under rolling review. . CureVac’s CVnCoV COVID-19 vaccine and NVX-CoV2372, the Novavax candidate, have been under review since February 2021. EMA. . . . . .

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JANUARY 29, 2021

29, 2021 — Interim phase 3 data show that the COVID-19 vaccine developed by Janssen Pharmaceuticals of Johnson & Johnson is 66 percent effective in preventing moderate-to-severe COVID-19 in adults, the National Institutes of Health announced today. The vaccine, known as Ad.26.COV2.S, The vaccine, known as Ad.26.COV2.S,

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MAY 16, 2021

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old).

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The Pharma Data

JANUARY 3, 2021

It’s not particularly surprising that there wasn’t a lot of clinical trial news between Christmas and New Year’s, although there was some. CytoDyn received guidance from the FDA on its open-label extension of its Phase III trial and for the continuation of eINDs for patients receiving Vyrologix (leronlimab-PRO 140) for COVID-19.

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JANUARY 4, 2021

4, 2021 — The mRNA-1273 vaccine has 94.1 from Brigham and Women’s Hospital in Boston, and colleagues conducted a phase 3 randomized trial at 99 centers across the United States. per 1,000 person-years), resulting in vaccine efficacy of 94.1 © 2021 HealthDay. Posted: January 2021. MONDAY, Jan.

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JANUARY 11, 2021

Two Billion COVID-19 Vaccine Doses From BioNTech Expected This Year. 11, 2021 — A boost in manufacturing should enable Germany’s BioNTech to produce 2 billion doses of its COVID-19 vaccine this year, the company says. BioNTech and partner Pfizer developed the first COVID-19 vaccination to be brought to market.

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JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.

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FEBRUARY 22, 2021

Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate. If results are positive, Phase 3 study to start in Q2 2021, with vaccine expected to be available in Q4 2021. The trial will include equal numbers of adults 18 to 59 years and those 60 years and above.

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JULY 29, 2021

Second-Quarter 2021 Revenues of $19.0 Billion The 10% Operational Growth Excluding BNT162b2(1) in Second-Quarter 2021 Builds on the 6% Operational Growth Delivered by the Comparable Business in Second-Quarter 2020 Second-Quarter 2021 Reported Diluted EPS(2) of $0.98, Adjusted Diluted EPS(3) of $1.07

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NOVEMBER 17, 2021

AstraZeneca and its partners have released for supply two billion doses of their COVID-19 vaccine to more than 170 countries across every continent on the planet in the last 11 months. 2) From the body of evidence in clinical trials and real-world data, the vaccine has been shown to have an acceptable safety profile.(3,4,5,6,7).

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The Pharma Data

JANUARY 13, 2021

COV2-S Vaccine Seems Safe, Immunogenic for SARS-CoV-2. 13, 2021 — A candidate vaccine, Ad26.COV2.S, 13, 2021 — A candidate vaccine, Ad26.COV2.S, “Our interim analysis indicates that vaccine candidate Ad26.COV2.S “Our interim analysis indicates that vaccine candidate Ad26.COV2.S

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JUNE 24, 2021

The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. Secondary objectives are to describe immune responses produced by each of the vaccines.

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MARCH 2, 2021

Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. The terms of the EUA allow use of the vaccine while more data are gathered.

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JANUARY 5, 2021

Top FDA Officials Say Two Full Doses of COVID-19 Vaccines a Must. 5, 2021 — Two top officials at the U.S. Food and Drug Administration said Monday that any American who gets the Moderna or Pfizer COVID-19 vaccines must get two full doses, despite international debate on possible ways to stretch vaccine supply.

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SEPTEMBER 5, 2021

AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the Advance Purchase Agreement for the delivery of the COVID-19 vaccine Vaxzevria (ChAdOx1-S [Recombinant]). Legal proceedings by the European Commission against AstraZeneca were initiated in Brussels on 21 April 2021.

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AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

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JANUARY 14, 2021

14, 2021 — Folks who’ve gotten through a COVID-19 infection might naturally question whether they need to get a coronavirus vaccination when their turn comes. ” Until we know more, however, health experts are urging folks who have had COVID to take the cautious approach and get the vaccine. © 2021 HealthDay.

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JANUARY 7, 2021

India’s Bharat Biotech has finalized enrollment for a phase 3 trial of its COVID-19 vaccine, Covaxin, which Indian regulators approved Jan. The study, involving almost 26,000 participants, is the largest phase 3 vaccine trial ever conducted in India, Bharat says. based Ocugen to commercialize the vaccine in the U.S. (

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JANUARY 10, 2021

When our backs were against the wall, the biotech/biopharma community came together to create not one, but two vaccines currently approved for emergency use in the U.S. I think most of what will happen in 2021 is an absolute direct result of the things the world has gone through in 2020. This has earned the industry a lot of respect.

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