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. About MODAG.

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

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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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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.

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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. Omidubicel is the first bone marrow transplant cell therapy product to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the U.S.

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Codon

JULY 14, 2024

receives a blood transfusion or a blood product every two seconds. But currently, traditional blood transfusions face significant challenges, including a dwindling pool of donors and a limited shelf life for stored blood products. However, the subsequent death of another patient thrust Denys into a contentious trial.

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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. We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

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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.

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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The Pharma Data

DECEMBER 22, 2020

Approximately 74 patients are planned for this trial in Head and Neck Squamous Cell Carcinoma (HNSCC) and Cutaneous Squamous Cell Carcinoma (CuSCC). The trial will enroll three cohorts of patients within distinct populations – all with locally advanced, recurrent and/or metastatic HNSCC or locally advanced or metastatic CuSCC.

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The Pharma Data

MAY 6, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. The sBLA includes updated longer-term follow-up data from the companies pivotal Phase 3 clinical trial of 2,228 participants 12 through 15 years of age.

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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.

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DrugBank

AUGUST 15, 2024

This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks. Additionally, industry partners bring a wealth of experience in drug development and commercialization strategies, essential for translating scientific discoveries into marketable products that can reach patients worldwide.

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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.

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The Premier Consulting Blog

NOVEMBER 8, 2022

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. prefilled syringe) A drug used with a specified device in clinical trials — but that may be used with other devices once marketed (e.g.,

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Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER.

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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

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. Efforts are also underway to enable the product to be stable at routine refrigerator temperature (2-8°C).

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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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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.

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

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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? The past year has seen an explosion in “fast follower” approaches to improve on existing target product profiles for select mechanisms, and was exceptionally apparent for antibodies and other biologics.

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The Pharma Data

JANUARY 13, 2021

This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients.”. Tislelizumab is being investigated in a broad clinical program, including five Phase 3 trials in lung cancer indications.

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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,

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

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The Pharma Data

JANUARY 13, 2021

Prior to joining Usona, Mr. Barrow served as Chief Operating Officer of Olatec Therapeutics where he oversaw the execution of numerous early- and late-stage clinical trials in the fields of analgesics, rheumatology, immunology and cardiovascular disease.

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The Pharma Data

NOVEMBER 2, 2020

(NASDAQ:ADIL; ADILW) , a clinical-stage biopharmaceutical company focused on the development of treatments for addictions, today provided an update on its landmark ONWARD Phase 3 pivotal trial. 40% of expected Trial patient screenings have been completed and the Trial is more than 25% enrolled relative to planned enrollment.

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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.

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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.

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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies. “We

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Conversations in Drug Development Trends

NOVEMBER 27, 2023

Casgevy, the commercial product formerly known as exa-cel, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a laboratory, with the modified cells then infused back into the patient after conditioning treatment to prepare the bone marrow. What Does the Future of Gene Editing Hold?

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FDA Law Blog: Biosimilars

AUGUST 29, 2024

That bill, addressing drug (and later biological product) patent settlement agreements (pejoratively referred to as “reverse payment agreements” by their opponents), was first introduced by Senator Herb Kohl (D-WI) in June 2006 as S. As well as some exclusions: (b) Exclusions.

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Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

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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.

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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). AXS-05 was well tolerated in the COMET trial.

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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.

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Drug Target Review

DECEMBER 11, 2024

Purity and radioactive enrichment are key factors in ensuring the IS aligns with product specifications. Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials.

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