The Pharma Data

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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The Pharma Data

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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The Pharma Data

JANUARY 25, 2021

25, 2021 — Giving melanoma patients a “personalized” vaccine can prompt an anti-tumor immune response that lasts for years, an early study finds. So researchers gave them an experimental vaccine called NeoVax. Unlike traditional vaccines, it is not a one-size-fits-all jab. MONDAY, Jan.

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The Pharma Data

OCTOBER 14, 2021

Biogen today announced results of a new analysis of immune response to the COVID-19 vaccine among people with multiple sclerosis (MS). Germany and Spain, researchers evaluated blood samples from 322 participants 28-90 days after their last COVID-19 vaccine dose. Using data from the MS PATHS network in the U.S.,

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The Pharma Data

JANUARY 8, 2021

8, 2021 — As Americans await their COVID-19 shot, a new study of a different vaccine shows the power of Facebook posts in fueling “anti-vax” resistance to immunization. The study included more than 10 years of public Facebook posts on the human papillomavirus (HPV) vaccine. 8 in the journal Vaccine.

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The Pharma Data

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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The Pharma Data

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. If data from the new Phase 2 trial are positive, a global Phase 3 study is planned for Q2 2021.

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The Pharma Data

JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Nasdaq: GILD) announced today its results of operations for the second quarter 2021. “We The series of promising pipeline updates included the data from the landmark ZUMA-7 study for the treatment of second-line large B-cell lymphoma.

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The Pharma Data

JANUARY 11, 2021

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. . One of the open questions about the various vaccines against COVID-19 has been how long the protection offered will last. Other Industry News.

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The Pharma Data

MAY 5, 2022

The Fact Sheet for Healthcare Providers Administering Vaccine now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS.

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The Pharma Data

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Sanofi continued its growth trajectory.

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The Pharma Data

JANUARY 3, 2021

which demonstrated statistically significant data and completed enrollment of 390 patients in its Phase IIb/III trial in severe-to-critically ill COVID-19 patients with data to be released mid-January 2021. Novavax initiated the PREVENT-19 Phase III trial of its COVID-19 vaccine candidate, NVX-CoV2373. Vyrologix is a CCR5 antagonist.

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The Pharma Data

MARCH 11, 2021

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. the vaccines global business unit of Sanofi, to develop mRNA vaccines for up to five infectious disease pathogens.

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The Pharma Data

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. Two doses of 3.75?g

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The Pharma Data

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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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. JUNE 22 , 2021. 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.

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The Pharma Data

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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The Pharma Data

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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The Pharma Data

FEBRUARY 8, 2021

PARIS – February 5, 2021 – Today, Sanofi holds a virtual investor event with key members of the Sanofi leadership team to share and discuss the overall progress in implementing the strategy in core parts of the business as well as the transformation of R&D. Key highlights to be presented at Capital Markets Day 2021.

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National Drug & Alcohol Research Centre Blog

FEBRUARY 24, 2022

Olivia Price It has been one year since the COVID-19 vaccine rollout commenced in Australia, and while vaccination rates initially lagged behind other countries, over 95% of Australians aged 12 years and older are now fully vaccinated. We tend to consider the remaining unvaccinated people a homogenous ‘anti-vax’ group.

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Eye on FDA

AUGUST 4, 2021

Each committee is comprised of a number of experts, diverse for their expertise, geography and specialty – with some focused on statistics while others may be focused on areas of concentration within the category, such as the treatment of pediatric patients. Fewer meetings – more approvals. That gets us to the issue of vacancies.

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The Pharma Data

MARCH 11, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.

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The Pharma Data

NOVEMBER 22, 2021

Company Welcomes Leadership Shown by the European Commission and EU Member States, plus Norway and Iceland to Help Advance Equitable Access to Our Vaccine. As a practical rapid response to the urgent need to scale up equitable access to vaccines, these doses will be utilized to help protect individuals in lower-income countries.

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The Pharma Data

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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The Pharma Data

JULY 23, 2021

government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses are expected to be delivered from October 2021 through April 2022. In a separate announcement on June 10, 2021, Pfizer and BioNTech shared plans to provide the U.S. This press release features multimedia. Eligible U.S.

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The Pharma Data

MAY 7, 2021

Posted 07 May 2021 | By Michael Mezher . Pfizer-BioNTech files for US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) ( Politico ) ( Press ). Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ). The US opened pandora’s box on IP waivers for Covid-19 vaccines. .

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The Pharma Data

APRIL 18, 2022

Takeda today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid ® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. TAK-019 Clinical Trial.

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The Pharma Data

MARCH 5, 2021

Novartis announced today that it has signed an initial agreement to manufacture the mRNA and bulk drug product for the COVID-19 vaccine candidate CVnCoV from CureVac to aid in the fight against the COVID-19 pandemic. Following final agreement, Novartis plans to start production in the second quarter of 2021.

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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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Codon

AUGUST 26, 2024

He also explains how they could be used to combat pandemics on “day zero,” well before vaccines are developed. After the outbreak ended, it took another three years for the first Ebola vaccine by Merck to be approved. Timelines for vaccine development are shrinking, but can it move even faster?

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The Pharma Data

JANUARY 17, 2021

The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. 18, 2021 /PRNewswire/ — Grifols (MCE: GRF, MCE: GRF.P,

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Pfizer and BioNTech completed the rolling submission of the BLA in May 2021. About Pfizer: Breakthroughs That Change Patients’ Lives.

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The Pharma Data

MARCH 2, 2021

Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. “For

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The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.

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The Pharma Data

JANUARY 6, 2021

6 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted emergency use authorisation in India as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco for the active immunisation of adults. Additional safety and efficacy data will continue to accumulate from ongoing clinical trials.

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The Pharma Data

OCTOBER 6, 2021

GlaxoSmithKline (GSK) plc welcomes and applauds the WHO recommendation for the broader deployment of GSK’s RTS,S malaria vaccine to reduce childhood illness and deaths from malaria in children living in sub-Saharan Africa and other regions with moderate to high transmission as defined by WHO. More than 2.3

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The Pharma Data

DECEMBER 30, 2020

30 December 2020 — AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. This is the first authorisation for this vaccine.

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