The Pharma Data

JUNE 26, 2025

Details of the VEGA-3 Phase 3 Trial The VEGA-3 study is part of Viatris’ broader clinical development program to evaluate MR-141 for presbyopia. The trial was conducted as a randomized, placebo-controlled, double-blind study and enrolled a total of 545 adult participants.

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

Originally developed in the 1970s to treat diabetes, these drugs—such as Ozempic, Wegovy, and Mounjaro—have become headline-makers for their ability to induce significant weight loss. Understanding GLP-1 drugs GLP-1, or glucagon-like peptide-1 receptor modulators, mimic natural hormones that regulate insulin and appetite.

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The Pharma Data

JUNE 6, 2025

has announced encouraging interim findings from the pivotal Phase 3 VISIONARY trial evaluating sibeprenlimab in adults with Immunoglobulin A nephropathy (IgAN), a rare and progressive autoimmune kidney disorder. We are grateful to the patients who have contributed to advancing the science through their participation in this landmark trial.”

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New Drug Approvals

JULY 7, 2025

1] Pimicotinib is under investigation in clinical trial NCT05804045 (Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)). History In December 2023, Abbisko Therapeutics entered into a licensing agreement for pimicotinib in all indications for China rights with Merck KGaA. [2] 6] The U.S. 6] The U.S. 6] The U.S.

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The Pharma Data

JUNE 24, 2025

The partnership represents a major financial and strategic milestone for Revolution Medicines, which has built a robust pipeline of targeted therapies aimed at cancers driven by mutations in the RAS family of genes—some of the most prevalent and historically difficult-to-drug oncogenes in human cancer.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Drug Target Review

NOVEMBER 25, 2024

Her journey in drug R&D and business development has been marked by significant achievements, including leading groundbreaking efforts to treat neglected cancers and breaking barriers for women in the biotech industry. I went on to complete my MBA and PhD at The Institute of Cancer Research (ICR) in drug development.

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Drug Hunter

JUNE 25, 2023

This edition includes Maze’s glycogen synthase 1 (GYS1) inhibitors that were recently licensed to Sanofi, allosteric androgen receptor (AR) modulators that may be of interest to targeted protein degradation researchers, and brain-penetrant HER2 and ROCK2 inhibitors. Get ahead now by requesting a trial. already a member?

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Drug Target Review

MARCH 17, 2025

Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations. An NMDA receptor modulator is a drug that targets the NMDA receptor in the brain, which is crucial for processes like synaptic plasticity, learning and memory.

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Drug Patent Watch

JANUARY 8, 2025

This comprehensive guide will walk you through the intricacies of optimizing your drug patent strategy, ensuring that your innovations are safeguarded and your market position is strengthened. Understanding the Basics of Drug Patents Before diving into the nuances of patent strategy, it’s crucial to grasp the fundamentals.

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The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.

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New Drug Approvals

MAY 17, 2025

4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7] gmol 1 References ^ “Register of Innovative Drugs” Health Canada. 4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7] Food and Drug Administration (FDA). 25 April 2023.

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New Drug Approvals

JULY 2, 2025

Orforglipron ( LY-3502970 ) is an oral, non-peptide, small-molecule GLP-1 receptor agonist developed as a weight loss drug by Eli Lilly and Company. [1] then was licensed to Lilly in 2018. [1] then was licensed to Lilly in 2018. [1] then was licensed to Lilly in 2018. [1] then was licensed to Lilly in 2018. [1]

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Drug Target Review

MARCH 4, 2025

In this interview, Bagnall explains how this approach is improving patient outcomes and driving the development of better obesity drugs. Knowing a patients subtype or phenotype can be used to guide obesity treatments of all kinds, including drug therapy, devices, bariatric surgery and even diet and lifestyle interventions, Bagnall explains.

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The Pharma Data

OCTOBER 27, 2021

NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders.

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Drug Hunter

APRIL 20, 2023

We asked the global drug discovery community to nominate and vote on their favorite molecule from 2022, and the results are in. Here, we highlight what makes deucravacitinib so impressive to the drug discovery community. Here, we highlight what makes deucravacitinib so impressive to the drug discovery community.

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The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials. LOS ANGELES , Jan.

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The Premier Consulting Blog

OCTOBER 21, 2024

Accelerated approval is an expedited regulatory pathway designed to hasten the availability of drugs (including biologics) that treat serious conditions, offer advantages over existing therapies, and address unmet medical needs. In essence, these trials are the final step that turns provisional approval into full approval.

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New Drug Approvals

MAY 9, 2025

1] History The efficacy of elacestrant was evaluated in the EMERALD trial, which was a randomized, open-label, active-controlled, multicenter study involving 478 postmenopausal women and men with ER-positive, HER2-negative advanced or metastatic breast cancer. Food and Drug Administration (FDA). 1] [4] It is taken by mouth. [1]

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Drug Target Review

DECEMBER 11, 2024

This shift in focus is especially critical in toxicology, where accurate target analysis plays a vital role in identifying toxic effects and ensuring patient safety, particularly as the field transitions from traditional drugs to the promising realm of biotherapeutics, especially for rare diseases.

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LifeSciVC

APRIL 24, 2024

Is a novel target at the inflection point where enough evidence is available to suggest it may prove to be a compelling drug? In the absence of a clinical trial result or FDA label to point to, how does one create the case and target product profile (TPP) around a new target?

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) on Friday, December 11, 2020. The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.

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The Pharma Data

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. “We are pleased to work with U.S.

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New Drug Approvals

JUNE 15, 2025

Retrieved 15 September 2024. ^ “Notice: Multiple additions to the Prescription Drug List (PDL) [2024-08-13]” Health Canada. Retrieved 15 August 2024. ^ “Regulatory Decision Summary for Zilbrysq” Drug and Health Products Portal. Food and Drug Administration (FDA). Food and Drug Administration (FDA).

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New Drug Approvals

APRIL 2, 2025

2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2]

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The Pharma Data

MARCH 8, 2021

Of 202 treated participants, no safety signals have been identified and of the 4 serious adverse events reported, none were considered to be study drug related. This program included assays such as Big Blue and PIG-a designed to provide a robust measure of a drug or chemical’s ability to induce mutations in vivo.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. Of course, neither “cure” nor permanency are the bar for FDA to find that a new drug is effective; simply because there is the potential for something to be a “cure” or offer permanent/near-permanent effects does not mean it should be required to be such.

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The Pharma Data

OCTOBER 19, 2020

manufacturer, Pharmaceutics International, Inc. (“Pii”), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable. About CNS Pharmaceuticals, Inc.

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The Pharma Data

DECEMBER 20, 2020

Allecra, subject to the satisfaction of terms and conditions as set forth in the Exclusive Licensing Agreement, is to receive an upfront cash payment and is eligible to receive additional development and commercial milestone payments with an overall deal value of $78 million, in addition to royalties.

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New Drug Approvals

MAY 8, 2025

1] [11] In December 2023, the US Food and Drug Administration (FDA) expanded the indication for pirtobrutinib to include the treatment of adults with chronic lymphocytic leukemia or small lymphocytic leukemia. [7] 4] The trial was conducted at 49 sites in 10 countries in the United States, Europe, Australia, and Asia. [6]

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New Drug Approvals

JUNE 29, 2025

1] [3] History The efficacy of taletrectinib to treat ROS1-positive non-small cell lung cancer was evaluated in participants with locally advanced or metastatic, ROS1-positive non-small cell lung cancer enrolled in two multi-center, single-arm, open-label clinical trials, TRUST-I (NCT04395677) and TRUST-II (NCT04919811). [3] April 2025.

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Conversations in Drug Development Trends

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

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The Pharma Data

JUNE 24, 2025

In just three years, nine promising research projects have received funding under the program, setting the stage for innovative breakthroughs in drug discovery. Notably, over 80% of Bayer’s major global multi-center clinical trials now include study sites in China, spanning early-phase development to late-stage pivotal trials.

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The Pharma Data

AUGUST 17, 2020

Food and Drug Administration clearance in May 2020 for its investigational new drug application to develop DF6002. In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. Dragonfly received U.S.

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The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

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The Pharma Data

OCTOBER 15, 2020

Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial.

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