Clinical Research Informer

Merck and Eisai's Keytruda-Lenvima combo chalks up 2 more losses, this time in non-small cell lung cancer

Fierce Pharma

SEPTEMBER 22, 2023

Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break.

Clinical Trials

Clinical Trials Clinical Trials Trials

Grand Rounds February 24, 2023: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials (Konstantin Dragnev, MD; Karen Reckamp, MD, MS)

Rethinking Clinical Trials

MARCH 1, 2023

S1800A was a Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for NSCLC patients previously treated with immunotherapy performed within the Lung-MAP platform. They are both approved and used widely in lung cancer, and combining two existing agents is logistically and clinically simpler.

Clinical Trials

Clinical Trials Clinical Trials Trials Packaging

FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag

pharmaphorum

JANUARY 5, 2022

The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. The post FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag appeared first on.

Antibody

Antibody Drugs Protein Gene

First patient dosed with PI3K? inhibitor for solid tumours

Drug Discovery World

APRIL 17, 2023

Totus Medicines has dosed its first patient in a Phase I clinical trial of TOS-358, a first-in-class covalent PI3Kα inhibitor for the treatment of numerous cancers with known PIK3CA mutations. The study will be conducted in two parts.

Clinical Trials

Clinical Trials Clinical Trials Trials Medicine

FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag

pharmaphorum

DECEMBER 23, 2021

Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The post FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag appeared first on. Daiichi Sankyo and AZ are close collaborators in the ADC arena.

Drugs

Drugs Antibody Clinical Trials Clinical Trials

Enhertu gets breakthrough tag in HER2-low breast cancer

pharmaphorum

APRIL 27, 2022

AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after showing the drug extended survival in patients with HER2-low metastatic breast cancer. The post Enhertu gets breakthrough tag in HER2-low breast cancer appeared first on.

Sales

Sales Drugs Antibody Licensing

Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

FDA Approval

FDA Approval Manufacturing In-Vivo Trials

Roche nabs breakthrough tag for TIGIT cancer immunotherapy

pharmaphorum

JANUARY 5, 2021

Like PD-L1, TIGIT is thought to act as a molecular brake that stops T cells from attacking tumours, and tiragolumab is currently leading the pack among drugs targeting the immune checkpoint. The post Roche nabs breakthrough tag for TIGIT cancer immunotherapy appeared first on.

Immune Response

Immune Response FDA Approval Drugs Sales

Clover biopharmaceuticals raises $230 M; BrainStorm after ALS; BARDA grants $5.65 M LightDeck for SARS-CoV-2 antigen test; Libtayo for first-line advanced NSCLC subset

Delveinsight

FEBRUARY 23, 2021

The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform. Libtayo for First-line Advanced Non-small Cell Lung Cancer Subset.

In-Vitro

In-Vitro Vaccination Vaccine Licensing

Unveiling Potential: Exploring Alpha Emitter Radiopharmaceuticals

XTalks

JANUARY 19, 2024

Radiobiological and Clinical Considerations from CRO and Emerging Biotech Radiopharmaceuticals are medicinal formulations containing radioisotopes that are used in the field of nuclear medicine primarily for the diagnosis and treatment of various diseases, particularly cancer.

DNA

DNA Radiology FDA Approval Development

CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision

pharmaphorum

JULY 25, 2022

The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for multiple myeloma , joining a growing group of BCMA-targeted therapies for the blood cancer.

Antibody

Antibody Medicine Drugs Trials

Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

XTalks

AUGUST 17, 2020

To learn more about innovations in the field, Xtalks spoke to Anish Suri, PhD, president and chief scientific officer of Cue Biopharma about the company’s initiatives in the development of immune-based biological compounds for the treatment of cancers and autoimmune diseases. Cell-Based Immunotherapy vs. Immune Biologics.

Protein

Protein Engineer Immune Response In-Vivo

What to expect from PEGS Europe 2023: Day 3

Drug Discovery World

NOVEMBER 13, 2023

Alexander Yermanos, PhD, Lecturer, Systems & Synthetic Immunology, ETH Zurich, on: ‘Integrating single-cell immune repertoire sequencing, machine learning, and biophysical properties of antibodies’. He will discuss selection technologies for membrane targets using advances in whole cell panning and comparative deep sequencing.

Protein

Protein Antibody Engineer Scientist

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

The favorable impact in first-quarter 2021 from selling days was partially offset by the non-recurrence of favorable impacts related to COVID-19 on first-quarter 2020, including increased demand for certain products of approximately $150 million and additional wholesaler inventories of approximately $100 million. in December 2019; and.

Vaccination

Vaccination Vaccine Production Sales

Clinical Research Informer

Merck and Eisai's Keytruda-Lenvima combo chalks up 2 more losses, this time in non-small cell lung cancer

Grand Rounds February 24, 2023: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials (Konstantin Dragnev, MD; Karen Reckamp, MD, MS)

Trending Sources

FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag

First patient dosed with PI3K? inhibitor for solid tumours

FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag

Enhertu gets breakthrough tag in HER2-low breast cancer

Amtagvi (Lifileucel) Scores Landmark Win as First FDA-Approved T-Cell Therapy for a Solid Tumor

Roche nabs breakthrough tag for TIGIT cancer immunotherapy

Clover biopharmaceuticals raises $230 M; BrainStorm after ALS; BARDA grants $5.65 M LightDeck for SARS-CoV-2 antigen test; Libtayo for first-line advanced NSCLC subset

Unveiling Potential: Exploring Alpha Emitter Radiopharmaceuticals

CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision

Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

What to expect from PEGS Europe 2023: Day 3

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

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