NIH Director's Blog: Drug Development

MAY 21, 2020

Science, 2020 We now know that the immune system of nearly everyone who recovers from COVID-19 produces antibodies against SARS-CoV-2, the novel coronavirus that causes this easily transmitted respiratory disease [1]. Preprint Posted May 5, 2020. [2] Preprint Posted May 5, 2020. [2] 2020 May 18.

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The Pharma Data

JANUARY 19, 2021

Its lead candidate is CLN-081, an oral small molecule designed to be a next-generation, irreversible EGFR inhibitor. Other products include CLNB-049, a bispecific antibody against FLT3 and CD3 and CLN-619, a monoclonal antibody that simulates NK and T-cell responses. It hopes to raise $125 million in the IPO.

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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

DECEMBER 11, 2020

Friday, December 11, 2020. Government to supply doses in 2020 & 2021. In July 2020, Pfizer and BioNTech announced an agreement with the HHS and the DoD to meet the U.S. The information contained in this release is as of December 11, 2020. immediately. Pfizer is leveraging three of its U.S.

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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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The Pharma Data

DECEMBER 10, 2020

Thursday, December 10, 2020 – . Based on a data cut-off date of October 9, 2020, 37,706 participants had a median of at least two months of safety data available after dose 2 and contributed to the main safety dataset. The information contained in this release is as of December 10, 2020. Pfizer Disclosure Notice.

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The Pharma Data

DECEMBER 27, 2020

28, 2020 13:00 UTC. To Our Shareholders, As we reach the end of an eventful 2020, we are inspired by the many healthcare providers and biopharmaceutical companies that worked to combat the COVID-19 pandemic. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

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The Pharma Data

MAY 7, 2021

under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S.

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Agency IQ

JUNE 9, 2023

The guidance looks very different from the draft that was published in February 2020, including changes in the scope of the guidance, its sponsorship, and the removal of all mentions of nonhuman primates for animal testing. BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development?

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Drug Target Review

OCTOBER 4, 2023

Groundbreaking strategies like proteolysis-targeting chimeric molecules (PROTACs) are also being explored. 6 Combining the effect of payloads with different mechanisms of action – an approach that revolutionised small molecule chemotherapy – also holds the promise of enhanced therapeutic activity for ADCs. 52 , 79–91 (2020).

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The Pharma Data

JULY 21, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. Procedures should be in place to avoid injury from fainting. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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The Pharma Data

SEPTEMBER 8, 2020

NEW YORK, September 8, 2020 — The CEOs of AstraZeneca (LSE/STO/NYSE: AZN), BioNTech (NASDAQ: BNTX), GlaxoSmithKline plc (LSE/NYSE: GSK), Johnson & Johnson (NYSE: JNJ), Merck (NYSE: MRK), known as MSD outside the United States and Canada, Moderna, Inc.

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The Pharma Data

SEPTEMBER 8, 2020

Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. March 31, 2020. June 30, 2020. , www.sec.gov. December 31, 2019. ,

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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

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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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). These results were published in Nature in July 2020. About BioNTech.

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Codon

AUGUST 27, 2024

Extra pieces of data, including proteins, lipids, or small molecules, are helpful when a particular DNA sequence is difficult to amplify or isolate from a sample, or when sequencing results don’t point squarely at a single disease-causing organism. We lost valuable time.

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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

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. Small Molecule Inhibitors. NMD670 is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel.

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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

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. Auxora is a potent and selective small molecule CRAC channel inhibitor that prevents CRAC channel overactivation.

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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 Detailed findings from this collaboration also will be submitted to a peer-reviewed journal.

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The Pharma Data

JUNE 24, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech Procedures should be in place to avoid injury from fainting. BioNTech COVID-19 Vaccine. The Pfizer?BioNTech BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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