The Pharma Data

JANUARY 13, 2021

GMP Production of TNX-1500 is Expected to be Available in the Third Quarter of 2021. 14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. WO 2021/001458 A1. Lederman added, “We believe the development risk of TNX-1500 is mitigated by previous clinical data and extensive preclinical science with ruplizumab.

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The Pharma Data

JANUARY 7, 2021

08, 2021 (GLOBE NEWSWIRE) — Galecto, Inc., NASDAQ: GLTO) a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced the appointment of Dr. Anne Prener to its Board of Directors. “We a gene therapy company focused on eye diseases. BOSTON, Jan.

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The Pharma Data

JANUARY 3, 2021

Based on the strong scientific rationale for telaglenastat in KEAP1/NRF2 mutant non-small cell lung cancer patients, and the safety profile observed in CANTATA, we remain dedicated to advancing our randomized KEAPSAKE trial.”. million, with the majority to be completed by the first quarter of 2021. SOUTH SAN FRANCISCO, Calif.,

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The Pharma Data

JANUARY 11, 2021

11, 2021 (GLOBE NEWSWIRE) — MediciNova, Inc. , commented, “We believe that this investment will meaningfully accelerate MediciNova’s drug development in the pipeline and could lead to unleashing its highest potential in value. LA JOLLA, Calif., About MediciNova. MediciNova, Inc. For more information on MediciNova, Inc.,

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The Pharma Data

APRIL 27, 2021

All doses expected to be delivered in 2021. NEW YORK and MAINZ, GERMANY, April 19, 2021 (GLOBE NEWSWIRE) — Pfizer Inc. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021.

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The Pharma Data

DECEMBER 27, 2020

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021.

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The Pharma Data

JULY 21, 2021

To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately. Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021. CEO and Co-founder of BioNTech. “We

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The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., CTP-543 THRIVE-AA2 Phase 3 Trial Planned for First Half of 2021. Revenues.

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The Pharma Data

DECEMBER 12, 2020

Dedicated rare disease unit to be headquartered in Boston. Subject to receipt of regulatory clearances and approval by shareholders of both companies, the acquisition is expected to close in Q3 2021, and upon completion, Alexion shareholders will own c.15% 15% of the combined company. ” Ludwig Hantson , Ph.D.,

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The Pharma Data

SEPTEMBER 9, 2020

billion doses by the end of 2021. Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 About BioNTech.

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The Pharma Data

MAY 7, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The information contained in this release is as of May 7, 2021. AUTHORIZED USE IN THE U.S.: About BioNTech.

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The Pharma Data

MAY 6, 2021

Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The information contained in this release is as of May 6, 2021. This press release features multimedia.

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The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021. immediately, with delivery fulfillment expected to be completed in 2021.

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The Pharma Data

NOVEMBER 22, 2020

Omecamtiv mecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial.

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The Pharma Data

NOVEMBER 20, 2020

billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. billion doses by the end of 2021 (subject to clinical success, manufacturing capacity, and regulatory approval or authorization). About BioNTech.

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The Pharma Data

DECEMBER 1, 2020

The delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts. in the coming days, with complete delivery fulfilment expected in 2021. In July 2020, Pfizer and BioNTech announced an agreement with the U.K. About BioNTech.

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The Pharma Data

AUGUST 20, 2020

Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021. About BioNTech.

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Drug Discovery World

APRIL 29, 2024

He holds a PhD in Chemistry for early work on antibody drug conjugates in 1987 and was awarded the Bioprocessing Lifetime Achievement Award in 2021. Dr Uwe Gottschalk, Chairman of the Board of Directors, Cellevate: Dr Gottschalk currently serves as an Operating Partner at Keensight Capital.

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The Pharma Data

NOVEMBER 9, 2020

The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease. billion doses in 2021. About Pfizer: Breakthroughs That Change Patients’ Lives. About BioNTech.

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The Pharma Data

DECEMBER 10, 2020

These pivotal data demonstrate that our COVID-19 vaccine candidate is highly effective in preventing COVID-19 disease and is generally well-tolerated. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

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The Pharma Data

JANUARY 7, 2021

Pivotal Data Anticipated in 2021 to Support Potential Registration, Addressing an Estimated Market Opportunity of Greater than $500 Million. a privately-held, clinical-stage biotechnology company developing imipridones, a novel class of compounds. . The final confirmatory data analysis is expected in 2021.

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The Pharma Data

DECEMBER 15, 2020

A healthy immune system defends the body against disease and other conditions. Autoimmune disease impacts different parts of the body, weakening functionality. Researchers are aware of more than 80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. It may be life-threatening.

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The Pharma Data

FEBRUARY 22, 2021

(Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. About Rigel. Rigel Pharmaceuticals, Inc.,

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LifeSciVC

APRIL 27, 2023

Fourteen years on, this corporate experiment has gone far beyond the initial idea, and has established an R&D engine more effective than most big pharma R&D groups at producing best-in-class small molecules against targets that matter in human disease biology.

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The Pharma Data

JANUARY 10, 2021

10, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, will provide an update on Vision 3×3 and the company’s 2021 key milestones at the 39 th Annual J.P. Pipeline Updates.

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Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. However, this guideline is primarily intended to provide recommendations on evaluating the immune system’s response to small molecule drugs.

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New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

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The Pharma Data

NOVEMBER 8, 2020

Likewise, we continue to build an R&D pipeline to make a significant difference in patients’ lives by treating a wide range of skin diseases. 10% of its Net Sales in R&D and also invests significantly in business development and in-licensing. Almirall expects to make an option exercise decision in Q1 2021.

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The Pharma Data

OCTOBER 14, 2020

Potential Development of Human Monoclonal Antibody Therapeutics to SARS-CoV-2. Results from the PRECISION Study Expected in First Half of 2021. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases.

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The Pharma Data

OCTOBER 26, 2020

Companies enter into exclusive license and co-development agreement to accelerate global reach of Tukysa (tucatinib), a small molecule tyrosine kinase inhibitor for the treatment of HER-2 positive cancers. Research and development expenses were $3.4 (formerly known as Seattle Genetics, Inc.) Canada and Europe.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

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The Pharma Data

DECEMBER 2, 2020

Food and Drug Administration (FDA) for Onivyde (irinotecan liposome injection) for study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen. Top-line results of the Phase IIb UC induction study are expected to be available in Q2 2021. Elsewhere around the globe: RevoluGen – U.K.-based

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The Pharma Data

SEPTEMBER 9, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease. billion doses by the end of 2021. Argentina and Brazil. About BioNTech.

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The Pharma Data

JUNE 26, 2021

“Our vision is to harness the power of the immune system against cancer and infectious diseases. “BNT111 has already shown a favorable safety profile and encouraging preliminary results in early clinical evaluation. The first patient has been dosed in the EU. BioNTech retains global commercial rights to BNT111.

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The Pharma Data

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. Rare Disease. BNT162 mRNA-based Vaccine Program.

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The Pharma Data

APRIL 7, 2021

The Prescription Drug User Fee Act (PDUFA) goal date has been extended three months to early Q3 2021. Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. If a serious infection develops, interrupt XELJANZ until the infection is controlled. About Abrocitinib. INDICATIONS.

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The Pharma Data

APRIL 6, 2021

Bayer will present new research across its oncology portfolio at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 , taking place over two weeks on April 10-15 and May 17-21, 2021. and China for marginal zone lymphoma (MZL) based on clinical data of MZL patients enrolled in the CHRONOS-1 study.

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