2019, Licensing, Pharmacokinetics and Therapies

Preparing the next generation of drug discovery scientists

Drug Discovery World

NOVEMBER 29, 2022

The new Clinical Pharmacology degree was launched in 2019 by Professors Emma Baker and Iain Greenwood and aims to take a holistic view of the development of drugs and create graduates that will stand out in the job market. Pharmacokinetics: How the body handles drugs. Providing a broad view.

Clinical Pharmacology

Clinical Pharmacology Clinical Trials Drugs Drug Development

FDA Action Alert: MacroGenics and Amgen

The Pharma Data

DECEMBER 13, 2020

MacroGenics , based in Rockville, Maryland, has a target action date of December 18 for its Biologics License Application (BLA) for margetuximab in combination with chemotherapy for patients with metastatic HER2+ breast cancer. That collaboration was to develop and commercialize four oncology antibody biosimilar therapies.

FDA

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic.

Therapies

Therapies Hospitals FDA Approval Long-Term Care Facilities

FDA Action Alert: Supernus, Adamis, Alkermes, Amgen, BMS and Eiger

The Pharma Data

NOVEMBER 8, 2020

The resubmission came after a meeting with the FDA in February 2020 and addresses issues raised by the agency’s Complete Response Letter (CRL) in November 2019. “We Celgene acquired it in 2018 from bluebird bio, who originally developed the therapy. The NDA was resubmitted on May 2020.

FDA

FDA Trials Pharmacokinetics Pharmaceuticals

NorthSea Therapeutics doses first patient in Phase 1 trial of SEFA-1024 in dyslipidemia and further expands its clinical pipeline

The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. 19, 2020 09:00 UTC. SEFA-1024 is one of NST’s three SEFA programs. NST’s lead program, icosabutate, is currently in a phase 2b ‘ICONA’ study for the treatment of NASH.

Trials

Trials Engineering Pharmacokinetics Therapies

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). Pfizer Inc. NYSE: PFE) today announced that the U.S.

Etrasimod

New Drug Approvals

OCTOBER 24, 2023

“Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies” Lancet. June 2019). . | twitter +919321316780 call whatsaapp EMAIL. “Velsipity (etrasimod) tablets, for oral use” (PDF). . 401 (10383): 1132–1133. PMID 36871570.

FDA

FDA FDA Approval International Pharmacokinetics

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

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., million as of December 31, 2019. million for the same period in 2019. Revenues.

Pharmaceuticals

Pharmaceuticals Clinical Trials Trials Small Molecule

United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

The Pharma Data

OCTOBER 27, 2020

2019. 2019. million for the three months ended September 30, 2020 , compared to the same period in 2019. In addition, as previously disclosed, our 2019 revenues were impacted by a mistake by one of our U.S. million in total, during the third quarter of 2019. 2019.

FDA

FDA Production Licensing Licensing

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

DECEMBER 5, 2020

” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. With a median follow up of 2.6 Multiple myeloma is not curable despite treatment advances.

Production

Production Trials Treatment Pharmaceuticals

Ascentage Pharma’s Licensee UNITY Biotechnology Announces Milestone Reached in Clinical Development of Treatments for Age-Related Disease, Leading to Milestone Payment

The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

Clinical Development

Clinical Development Disease Treatment Licensing

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

JANUARY 21, 2021

Prior to initiating treatment with CABENUVA, oral cabotegravir (VOCABRIA) and oral rilpivirine (EDURANT ® ) should be administered for approximately one month to assess the tolerability of each therapy. Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI).

FDA Approval

FDA Approval Treatment RNA FDA

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

Of note, The Phase 1b study is a double-blind, placebo-controlled clinical trial evaluating the safety, tolerability and pharmacokinetics of PF-07304814, a phosphate prodrug that when administered intravenously is metabolized to the active compound PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.

Vaccine

Vaccine Therapies Trials Clinical Trials

Ascendis Pharma A/S Provides Vision 3×3 Update at 39th Annual J.P. Morgan Healthcare Conference

The Pharma Data

JANUARY 10, 2021

In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021.

Clinical Trials

Clinical Trials Small Molecule Clinical Development Trials

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area. Priority B List.

FDA

FDA Science Biosimilars Production

Drug Discovery Digest

Preparing the next generation of drug discovery scientists

FDA Action Alert: MacroGenics and Amgen

Trending Sources

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

FDA Action Alert: Supernus, Adamis, Alkermes, Amgen, BMS and Eiger

NorthSea Therapeutics doses first patient in Phase 1 trial of SEFA-1024 in dyslipidemia and further expands its clinical pipeline

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

Etrasimod

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

Ascentage Pharma’s Licensee UNITY Biotechnology Announces Milestone Reached in Clinical Development of Treatments for Age-Related Disease, Leading to Milestone Payment

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Ascendis Pharma A/S Provides Vision 3×3 Update at 39th Annual J.P. Morgan Healthcare Conference

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Stay Connected