The Pharma Data

OCTOBER 19, 2020

. “We are extremely pleased to achieve yet another milestone in our preparation efforts and demonstrate our continued ability to execute upon both our operational and clinical strategies in a timely and proficient manner. We remain committed to further progressing our trial preparations, as we look forward to initiating a U.S.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Treatment 52

Drug Target Review

NOVEMBER 25, 2024

I saw an opportunity which others didn’t, to develop a small molecule targeting a well-known cancer pathway, a master switch of cancer Afterwards, I moved to Germany to work for Merck KGaA, where I headed up the licensing and business development team. Additionally, we are preparing to launch several other trials over the coming months.

Treatment 52

Treatment Small Molecule Clinical Trials Trials 52

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

Clinical Trials 40

Clinical Trials Trials Compliance FDA 40

The Pharma Data

AUGUST 5, 2020

AstraZeneca has signed a licensing deal with UK-based biotech company Redx Pharma for its fibrotic disease candidate RXC006. Following the out licensing agreement, AZ will take RXC006 into clinical development, and will focus on evaluating the asset in a number of fibrotic disease including IPF.

Licensing 52

Licensing Licensing Clinical Trials Disease 52

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

Drug Target Review

MARCH 4, 2025

The MyPhenome test has already gained traction among obesity specialists, particularly in Chicago and Florida, and Phenomix has formed strategic partnerships with multiple pharmaceutical companies to support clinical trials and further analyse obesity-related data. Obesity is rising worldwide, driven by lifestyle, diet, and genetics.

Therapies 52

Therapies Treatment Clinical Trials Science 52

The Pharma Data

JANUARY 13, 2021

Barrow previously served as Director of Drug Development & Discovery at Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona’s development programs.

Clinical Trials 52

Clinical Trials FDA Trials Production 52

Drug Target Review

FEBRUARY 9, 2024

What are the current challenges and limitations surrounding stem cell therapy in preclinical studies, and how are these issues addressed to ensure the safety and efficacy of potential treatments before advancing to clinical trials? Despite their potential, ADSC therapy faces several challenges in preclinical studies.

Therapies 105

Therapies Immune Response Clinical Trials Treatment 105

Drug Hunter

APRIL 20, 2023

The molecule was the first allosteric TYK2 inhibitor to enter clinical trials, is the first JAK-family kinase inhibitor approved for psoriasis, and is also the first approved drug targeting a pseudokinase domain. MRTX1133 is currently in Ph I/II trials as an oral agent. #3: LP0200 has completed a Ph.

Small Molecule 130

Small Molecule Clinical Trials Trials Licensing 130

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.

Licensing 52

Licensing Licensing Clinical Trials Pharmaceutical Companies 52

The Pharma Data

NOVEMBER 5, 2020

There was a handful of positive clinical trial news reported today. The Janssen Pharmaceutical Companies of Johnson & Johnson announced two Phase III trials, DISCOVER-1 and 2 demonstrated Tremfya (guselkumab) improved fatigue in adults with active psoriatic arthritis (PsA). Here’s a look. Janssen’s Tremfya.

Clinical Trials 40

Clinical Trials Trials Hospitals Pharmaceutical Companies 40

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.

Licensing 52

Licensing Licensing Therapies Clinical Trials 52

Conversations in Drug Development Trends

FEBRUARY 21, 2024

The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. ” In May 2020 , Protalix and Chiesi Global Rare Diseases announced the submission of a Biologics License Application (BLA) to the U.S. Protalix has licensed to Pfizer Inc.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites.

Licensing 52

Licensing Licensing Clinical Trials FDA 52

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.”. Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. “We are pleased to work with U.S.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

New Drug Approvals

APRIL 2, 2025

The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo. ESI-MS m/z calc.475.0922,

FDA 62

FDA Therapies Trials Treatment 62

The Pharma Data

OCTOBER 22, 2020

Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate. “W Additional details on the INTERLINK-1 clinical trial can be found here. . MARSEILLE, France, Oct. The financial terms of the agreement include potential cash payments up to $1.275 billion to Innate Pharma.

Clinical Trials 40

Clinical Trials Trials Cell Biology Production 40

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.

Vaccine 52

Vaccine Trials Clinical Trials Small Molecule 52

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.

Licensing 52

Licensing Licensing Disease Small Molecule 52

The Premier Consulting Blog

OCTOBER 21, 2024

However, accelerated approval comes with a condition: sponsors must conduct confirmatory trials to verify the drug’s anticipated clinical benefits using robust outcome measures. Concerns have arisen over delays—sometimes spanning over 7–8 years—that may expose patients to risks before confirmatory trials are completed.

Trials 52

Trials FDA Clinical Trials Disease 52

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 Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Pfizer Inc.

Licensing 52

Licensing Licensing Vaccine FDA 52

The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

DECEMBER 30, 2020

Long-term safety profile consistent with previously completed controlled trials. Treatment with AXS-07, rapidly, substantially, and durably relieved migraine pain and associated symptoms in this trial. The study enrolled patients who had completed the previous pivotal studies of AXS-07: the MOMENTUM and INTERCEPT trials.

Trials 52

Trials Treatment Clinical Trials Therapies 52

LifeSciVC

JULY 17, 2024

Identifying the right targets, de-risking those targets, and then executing trials requires significant capital, strategic focus, and time. Fortunately, AbbVie felt the same way, which is why we initiated discussions to in-license AbbVie’s most promising CF pipeline programs.

Clinical Research 74

Clinical Research Disease Research Clinical Trials 74

The Pharma Data

DECEMBER 1, 2020

(NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced positive results from the open-label Phase 2 COMET-TRD trial of AXS-05 in patients with treatment resistant depression (TRD). Clinical response on the SDS (defined as a total score of ?12)

Treatment 52

Treatment Trials Clinical Trials Therapies 52

Conversations in Drug Development Trends

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In trials, Casgevy was shown to help prevent episodes of debilitating pain, known as vaso-occlusive crises, that often plague patients affected by sickle cell disease.

Treatment 75

Treatment FDA Clinical Trials Therapies 75

Predictive Oncology

MARCH 17, 2023

Cancer Research Horizons to incorporate PEDAL into future drug discovery processes to enable drug development on a global scale 11 marketed drugs 2nd largest oncology out-licensor globally 150+ active licenses 160+ new drugs into early-phase clinical trials $647 million revenue from royalties & IP $2.8

Research 52

Research Clinical Trials Licensing Licensing 52

Drug Target Review

DECEMBER 11, 2024

Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials. An approach grounded in GLP, coupled with advanced analytical techniques, is essential for effectively mitigating matrix effects.

International 52

International Laboratories Drugs Pharmacokinetics 52

Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based

Licensing 52

Licensing Licensing Pharmacy FDA 52

Advarra

AUGUST 2, 2022

The pandemic proved decentralized clinical trials (DCTs) can reduce patient burden while delivering quality data in a streamlined environment. Could our Trial Lend Itself Well to a DCT Model? Clinical trials are slow and costly, built around the research centers studying local participants.

Clinical Trials 52

Clinical Trials Trials Licensing Licensing 52

The Pharma Data

DECEMBER 13, 2020

RLY-1971 is currently being evaluated in a first-in-human trial designed to treat patients with advanced or metastatic solid tumors. To learn more about the first-in-human clinical trial of RLY-1971, please visit here. About Relay Therapeutics.

Licensing 40

Licensing Licensing Clinical Trials Small Molecule 40

The Pharma Data

NOVEMBER 25, 2020

Under the agreement, which may generate revenue for BioInvent of up to SEK 30 million , BioInvent will provide process development, scale-up, supply of material for toxicological studies and clinical grade material in 1000L scale for use in phase I and II clinical trials. The Company’s validated, proprietary F.I.R.S.T

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

The Pharma Data

AUGUST 11, 2020

Researchers at University College London conducted the two year clinical trial which showed that the progression of the disease could be halted for over two years. Researchers want to investigate this drug further and are hoping to collaborate with AstraZeneca on a larger clinical trial.

Clinical Trials 52

Clinical Trials Licensing Licensing Drugs 52

The Pharma Data

JANUARY 3, 2021

The company expects to dose the first patient for the global PBGM01 clinical trial program in the first quarter of 2021. FDA clearance of our IND represents a significant milestone that supports the transition of Passage Bio to a clinical-stage company,” said Bruce Goldsmith, Ph.D., Imagine-1 study to commence in 1Q 2021.

Therapies 52

Therapies FDA Treatment Clinical Trials 52

LifeSciVC

JANUARY 16, 2024

Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Finally, I would be remiss if I didn’t caveat that we still see many clinical failures even for “de-risked” biology, as nothing is ever truly low-risk in our industry. Additional trials (e.g.,

Small Molecule 142

Small Molecule Trials Therapies Disease 142