The Pharma Data

JANUARY 17, 2021

“People living with LN are in need of an advanced therapy that quickly drives the disease into remission and mediates kidney damage,” said Peter Greenleaf, president and chief executive officer of Aurinia, in July 2020 when the FDA accepted the NDA to review. “We As a result, it stabilizes the podocyte in the kidney.

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The Pharma Data

JANUARY 31, 2021

Delivery of viral antigens in potent vaccine vectors to elicit a strong immune response is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone. This press release features multimedia. Gilead Forward-Looking Statements.

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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

DECEMBER 23, 2020

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800. . PLYMOUTH MEETING, Pa. , Only 6 related Grade 1 adverse events in 5 subjects were observed, primarily mild injection site reactions (e.g.,

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The Pharma Data

AUGUST 22, 2021

More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales. 2020; 584: 443-449. Zost SJ, et al.

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The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? billion doses by the end of 2021. Pfizer Disclosure Notice.

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Codon

JULY 14, 2024

This is particularly beneficial for those who need chronic transfusions and are therefore at risk of developing an immune response to transfusion products from other people, or for those with religious beliefs, like Jehovah’s Witnesses, whose faith prohibits blood transfusions from another person.

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The Pharma Data

MARCH 29, 2022

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein16 and were optimised by AstraZeneca with half-life extension and reduction of Fc effector function.

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The Pharma Data

MARCH 25, 2022

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein(10) and were optimised by AstraZeneca with half-life extension and reduction of Fc effector function.

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The Pharma Data

AUGUST 20, 2020

These results informed the selection of the BNT162b2 candidate for the pivotal Phase 2/3 global study in up to 30,000 participants that started in July 2020, which has to date enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission. The information contained in this release is as of August 20, 2020.

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The Pharma Data

SEPTEMBER 9, 2020

The proposed agreement is intended to provide a supply of 200 million doses and an option to purchase additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval. Deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization.

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The Pharma Data

SEPTEMBER 15, 2020

On a non-risk adjusted basis, these opportunities collectively represent more than $15 billion (excluding 20vPnC) in potential incremental revenue for Pfizer from 2020 to 2025, as well as aggregate peak annual sales potential of $35 billion to $40 billion (including 20vPnC). Penta was well tolerated. Safety was consistent with published data.

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The Pharma Data

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. ” $ in millions, exceptper share data Second Quarter % 2021 2020 Change Revenue $ 6,740.1 $ 5,499.4 on a reported basis and increased to $1.87 on a non-GAAP basis.

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Agency IQ

MARCH 7, 2024

For years, advisors have grappled with what to do about a vaccine component that protects against a strain that has not been observed in circulation since March 2020. Both post-infection ferret antisera and post-vaccination human sera studies indicated that the antigens in the vaccine elicit an immune response.

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The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes.

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The Pharma Data

SEPTEMBER 7, 2021

Bristol Myers Squibb has a global exclusive license to develop, manufacture and commercialize the Rockefeller University’s novel monoclonal antibody (“mAb”) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. Contributions to Research, Life-Sciences Industry. Global Relief Efforts.

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The Pharma Data

DECEMBER 15, 2020

In late 2020, the effort received $200,000 in seed funding from the Baker Department of Cardiometabolic Health at the University of Melbourne’s medical school. CUE-300 Series Immuno-STATs may offer autoimmune patients therapeutic benefits without compromising their immune systems.

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The Pharma Data

NOVEMBER 20, 2020

November 21, 2020 – Regeneron Pharmaceuticals, Inc. The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

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The Pharma Data

JUNE 18, 2021

PREVNAR 20 is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older. Presented at ISPPD-12, Toronto, June 21-25, 2020.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. CHATHAM, N.J., 1 Noyce RS, et al. 2018) PLoS One.

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The Pharma Data

APRIL 27, 2021

due to COVID related stocking in Q1 2020 and low demand for cough and cold brands in Europe. Following the communication of our ESG strategy at the end of 2020 and embedding it into our business priorities, we have recently created the Sanofi Global Health Unit, dedicated to increasing access to 30 medicines considered essential by the WHO.

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The Pharma Data

DECEMBER 20, 2020

This oncolytic virus has induced long-lasting antitumor immune responses and abscopal effects in several tumor models, and its activity is further enhanced through combination with an anti-PD-1 antibody treatment. LUND, Sweden and STRASBOURG, France , Dec. The Company’s validated, proprietary F.I.R.S.T

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The Pharma Data

DECEMBER 20, 2020

Pfizer and BioNTech announced additional data on neutralizing antibody and T-cell responses from their Phase I/II trial of their COVID-19 vaccine conducted in Germany. Graphite Bio licensed the product from Stanford University. The trial is evaluating the safety and efficacy of VIR-7831 in hospitalized COVID-19 adults.

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The Pharma Data

JANUARY 4, 2021

We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. Chimeric PD-1 T-cells also release cytokines to further initiate immune responses to eradicate the tumor cells. Amorette Barber of Longwood University will be heading up our chPD1 program.

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The Pharma Data

NOVEMBER 29, 2020

. Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results. 30, 2020 (GLOBE NEWSWIRE) — HOOKIPA Pharma Inc. HOOKIPA’s viral vectors target antigen presenting cells in vivo to activate the immune system. NEW YORK and VIENNA, Austria, Nov.

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The Pharma Data

OCTOBER 28, 2020

28, 2020 /PRNewswire/ — . “We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. TARRYTOWN, N.Y. , Regeneron has shared these results with the U.S. Yancopoulos , M.D.,

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The Pharma Data

OCTOBER 28, 2020

29, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the potential pathway to marketing approval for its lead product candidate remestemcel-L. million in the quarter ended September 30, 2020. NEW YORK, Oct.

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The Pharma Data

NOVEMBER 21, 2020

21, 2020 /PRNewswire/ — First treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2. This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors.

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The Pharma Data

DECEMBER 17, 2020

17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020. TARRYTOWN, N.Y. , “The investigational cocktail is now available to indicated high-risk U.S.

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The Pharma Data

FEBRUARY 8, 2021

Q4 2020 sales growth (2) of 4.2% Full-year 2020 performance. In 2020, cost savings of €1,680 million were realized of which approximately 60% were reinvested. In the fourth quarter of 2020, Sanofi sales were €9,382 million, down 2.4% Full-year 2020, Sanofi sales reached €36,041 million, down 0.2% to €982 million).

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The Pharma Data

FEBRUARY 4, 2021

Q4 2020 sales growth (2) of 4.2% Full-year 2020 performance. In 2020, cost savings of €1,680 million were realized of which approximately 60% were reinvested. In the fourth quarter of 2020, Sanofi sales were €9,382 million, down 2.4% Full-year 2020, Sanofi sales reached €36,041 million, down 0.2% to €982 million).

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The Pharma Data

MAY 7, 2021

under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine.

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The Pharma Data

MAY 6, 2021

This donation of the vaccine is another tool in our toolbox of measures to help make the Olympic and Paralympic Games Tokyo 2020 safe and secure for all participants and to show solidarity with our gracious Japanese hosts,” said IOC President Thomas Bach. “We The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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The Pharma Data

DECEMBER 11, 2020

Friday, December 11, 2020. Government to supply doses in 2020 & 2021. Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. In July 2020, Pfizer and BioNTech announced an agreement with the HHS and the DoD to meet the U.S.

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The Pharma Data

MARCH 11, 2021

Following the authorization for emergency use of the Pfizer-BioNTech COVID-19 Vaccine in Israel on December 6, 2020, the Israel MoH launched a national vaccination program targeting individuals age 16 years or older – a total of 6.4 The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

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The Pharma Data

MAY 15, 2023

5 GSK’s MenABCWY vaccine candidate combines the antigenic components of licensed meningococcal vaccines, Bexsero and Menveo. The trial started in August 2020 , and approximately 3,650 participants aged 10-25 were enrolled in the US, Canada, Czech Republic, Estonia, Finland, Turkey, and Australia.

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The Pharma Data

JUNE 24, 2021

Secondary objectives are to describe immune responses produced by each of the vaccines. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech

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