The Pharma Data

MARCH 14, 2021

This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19.

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Vaccination Vaccine Licensing Licensing 52

XTalks

JANUARY 28, 2022

Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators. Kimmtrak is a bispecific protein that contains a soluble T cell receptor fused to an anti-CD3 immune-effector function.

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The Pharma Data

OCTOBER 20, 2020

Patent and Trademark Office covering the use of Fatty Acid Binding Protein 5 (FABP5) inhibitors for the treatment of psychological disorders such as anxiety and post-traumatic stress disorder (PTSD). Chronic stress and anxiety disorders, including PTSD, represent significant healthcare and economic burdens worldwide.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

Antibody 52

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Pfizer

FEBRUARY 16, 2023

The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium’s ability to leave the tick and infect humans.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

The Pharma Data

NOVEMBER 17, 2021

It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. About AstraZeneca.

Vaccination 52

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Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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Pfizer

JANUARY 27, 2023

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

Marketing 75

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The Pharma Data

DECEMBER 19, 2020

Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. On July 28, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in The New England Journal of Medicine. W911QY-20-C-0100.

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Vaccination Vaccine Licensing Licensing 52

The Pharma Data

JANUARY 4, 2021

The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. ” About the License Agreement. Effective 4 January 2021 , the License Agreement is terminated. TOKYO and CAMBRIDGE, England , Jan. About Muscarinic Receptors.

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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.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. The European Medicines Agency has also granted orphan drug designation to INZ-701 for the treatment of ENPP1 deficiency. Food and Drug Administration cleared Investigational New Drug Application. About INZ-701.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Containment 52

The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 .–(BUSINESS WIRE)–Dec. 8, 2020– Moderna, Inc., million to 7.5

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The Pharma Data

JUNE 24, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for 20vPnC with a Prescription Drug User Fee Act (PDUFA) goal date in June 2021. In December 2020, Pfizer announced that the U.S.

Vaccination 52

Vaccination Vaccine Immune Response Licensing 52

The Pharma Data

OCTOBER 19, 2020

Pneumococcal serotypes not in the currently licensed conjugate vaccine, such as 22F and 33F, are among the most common serotypes causing invasive pneumococcal disease in parts of the world, including the U.S., PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

Pfizer

SEPTEMBER 28, 2022

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. Tue, 09/27/2022 - 16:15. Wednesday, September 28, 2022 - 11:45am.

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The Pharma Data

SEPTEMBER 8, 2020

About AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

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The Pharma Data

JANUARY 18, 2021

In-licensed from Merck KGaA, Darmstadt, Germany , atacicept has been studied previously in autoimmune diseases and shown to reduce autoantibodies in a dose-dependent fashion with once-weekly subcutaneous dosing and has a well-established and acceptable clinical safety profile. .” For more information please visit: www.veratx.com.

Development 52

Development Life Science Protein Clinical Development 52

The Pharma Data

SEPTEMBER 8, 2020

(LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Cambridge, UK.

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Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

JANUARY 14, 2021

Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Wainberg, M.D.,

Trials 52

Trials HR Containment Development 52

The Pharma Data

JULY 27, 2021

Amgen’s R&D resources and its extensive clinical experience in immuno-oncology are ideally suited to applying and advancing Teneobio’s differentiated technologies and multispecific antibodies to deliver transformative medicines,” said Roland Buelow, Ph.D., chief executive officer of Teneobio.

Production 52

Production Antibody Sales Manufacturing 52

Pfizer

AUGUST 15, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. 07.19.2022.

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pharmaphorum

SEPTEMBER 18, 2020

The same year, AZ also entered into its third collaboration agreement with Astex Therapeutics, this time to develop small-molecule protein kinase B (PKB) to further contribute in the fight against cancer. While Gaithersburg was already home to MedImmune’s headquarters, it also became home to AZ’s US Global Medicines Development department.

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The Pharma Data

MAY 4, 2021

This donation furthers both Lilly and Direct Relief’s charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries. Click here for resources related to Lilly ‘s COVID-19 efforts and here for baricitinib’s EUA.

Antibody 52

Antibody Medicine FDA Approval Licensing 52

The Pharma Data

JUNE 26, 2021

Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S.

Drug Delivery 52

Drug Delivery Clinical Trials Clinical Trials Medicine 52

The Pharma Data

DECEMBER 23, 2020

Cellular (T cell) response were observed to multiple regions of the spike protein including the RBD region. The lead Principal Investigator for the INNOVATE trial is Dr. Pablo Tebas , Professor of Medicine at the Hospital of the University of Pennsylvania. About INOVIO’s DNA Medicines Platform.

DNA 40

DNA Vaccination Vaccine Immune Response 40

Pharmaceutical Technology

JUNE 21, 2023

In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This followed positive results from CSL’s Phase III HOPE-B trial (NCT03569891).

Gene Therapy 246

Gene Therapy Gene Protein Sales 246

The Pharma Data

NOVEMBER 20, 2020

Zokinvy blocks the accumulation of defective, farnesylated proteins which form tight associations with the nuclear envelope, leading to cellular instability and the process of premature aging in children and young adults with Progeria and processing-deficient Progeroid Laminopathies. LIMITATIONS OF USE. Outside the U.S.,

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

XTalks

DECEMBER 13, 2023

These efforts encompass programs related to the shingles vaccine, Tdap vaccine and plague vaccine, reinforcing Dynavax’s commitment to advancing the field of vaccines and medicine. Alpine Immune Sciences has recently announced an augmentation in its R&D investment. million and $38.8 million, respectively, as compared to $17.6

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The Pharma Data

DECEMBER 5, 2020

BCMA (B-cell maturation antigen) is a protein that is typically over-expressed on multiple myeloma cells. Assistant Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York and a trial investigator. All patients were triple-refractory, with 57% being penta-refractory,” said Deepu Madduri , M.D.,

Antibody 40

Antibody Production Trials Medicine 40

The Pharma Data

OCTOBER 30, 2020

The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.

Production 52

Production Antibody Manufacturing Trials 52

The Pharma Data

SEPTEMBER 20, 2020

20, 2020 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that updated data from the full Phase 1 cohort of the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 129 patients across multiple advanced solid tumors, were published in the New England Journal of Medicine (NEJM). THOUSAND OAKS, Calif.

Medicine 52

Medicine Production Sales Clinical Trials 52

The Pharma Data

JANUARY 15, 2021

1] Darzalex Faspro® is the first and only FDA-approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which leads to the deterioration of vital organs, most notably the heart, kidneys and liver.[2],[3] About Darzalex Faspro® In August 2012, Janssen Biotech, Inc.

FDA Approval 52

FDA Approval Production Research Doctors 52

The Pharma Data

APRIL 23, 2021

The European Medicine Agency’s approval of dostarlimab is based on results from the multi-cohort GARNET study, which included women with recurrent or advanced dMMR/MSI-H endometrial cancer who progressed on or after a platinum-based chemotherapy regimen in cohort A1 (n=108 evaluable for efficacy). [iii] containing regimen.

Antibody 52

Antibody Hormones Licensing Licensing 52

Druggist

FEBRUARY 17, 2021

Insect venoms (wasps) contain several allergens, which cause unpleasant symptoms, and in some cases, may cause an anaphylactic reaction (Moffitt, 2003). Hydrocortisone cream is classified as pharmacy-only medicine (P), which means it can only be sold in pharmacies, including online chemists and sellers on Amazon.co.uk. 822 Reviews.

Pharmacy 98

Pharmacy Containment Production Sales 98

Pfizer

DECEMBER 13, 2022

Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

Drugs 110

Drugs Licensing Licensing Production 110

The Pharma Data

DECEMBER 20, 2020

GPS has previously been shown to invoke multi-epitope, broad cross-reactivity along the full-length of the WT1 protein, suggestive of epitope spreading, and immunologically mediated cancer cell destruction, which are hallmarks of an effective cancer vaccine. This press release contains forward-looking statements.

Life Science 52

Life Science Immune Response Trials Clinical Trials 52