Pharmaceutical Technology

JUNE 19, 2023

Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. Biomm will gain exclusive rights for the distribution and marketing in Brazil of the proposed biosimilar to Janssen’s Stelara.

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Pharmaceutical Technology

DECEMBER 19, 2022

On choosing the candidate, the company will oversee the complete development, production and marketing. Initially, the companies signed a research collaboration and licensing agreement in 2016 to develop and assess up to two bispecific NK cell engagers.

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XTalks

JANUARY 29, 2021

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. Biosimilars are increasingly becoming the standard of care and both have several licensed biosimilar drugs (e.g.

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Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4

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Cloudbyz

MAY 11, 2023

Clinical trials play a vital role in bringing new therapies and treatments to patients, but they can be expensive and resource-intensive endeavors. Understanding the factors driving clinical trial costs is essential for researchers, sponsors, and other stakeholders involved in the drug development process.

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Pharmaceutical Technology

JULY 21, 2022

In June 2020, these antibodies, discovered at Vanderbilt University Medical Center, were licensed to AstraZeneca. According to data from the PROVENT clinical trial, AZD7442 demonstrated a statistically significant decline in symptomatic Covid-19 development risk.

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Antibody Compliance Clinical Trials Clinical Trials 264

Clinical Trial Podcast

JULY 18, 2020

Have you been tasked to develop a clinical trial budget? Well, you’re in luck because I’m going to share everything you need to know about clinical trial costs. Clinical trial budgets are often put together in haste. The focus is on getting the product to market as quickly as possible.

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Pharmaceutical Technology

AUGUST 25, 2022

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency).

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Gene Therapy Gene Clinical Trials Clinical Trials 264

Cloudbyz

MARCH 31, 2024

The landscape of clinical trial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinical trials.

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Clinical Trials Clinical Trials Trials Compliance 103

pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022.

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Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

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Pharmaceutical Technology

OCTOBER 25, 2022

There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).

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Pharmaceutical Technology

MAY 12, 2023

On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. Seagen has three marketed ADCs as well as two novel ones, one of which, disitamab vedotin, is HER2-directed.

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Clinical Trials Clinical Trials Licensing Licensing 162

Cloudbyz

NOVEMBER 22, 2024

This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Our mission is to enable faster, more efficient trials, ultimately supporting the delivery of life-saving therapies.”

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Pharmaceutical Technology

SEPTEMBER 19, 2022

The regulatory agency carried out the review of the Biologics License Application (BLA) for the therapy under the Priority Review approach. The latest development is based on findings from the single-arm, open-label Phase II/III ALD-102 (Starbeam) and Phase III ALD-104 clinical trials. thalassemia.

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Pharmaceutical Technology

MAY 1, 2023

The NDA is supported by the data package licensed to Ocumension by Nicox as well as the Phase III clinical trial in China. Zerviate, 0.24% was compared to emedastine difumarate ophthalmic solution, 0.05%, an antihistamine, which is marketed under undeb Emadine brand name.

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Licensing Licensing Sales Packaging 162

Cloudbyz

AUGUST 2, 2022

Premarketing drug studies vs Post- Marketing research. Premarketing drug studies consist of phase I-III trials, and are represented by pharmacokinetic and pharmacodynamic studies, dose ranging studies, and Randomized Controlled Trials (RCTs). Approximately only 20 % of the drugs that enter phase I are approved for marketing.

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Pharmaceutical Technology

JANUARY 19, 2023

Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. Antigens such as CD123 and CD33, despite being markers of myeloid cells, are shared with their healthy counterparts, and myeloablation following their depletion often leads to detrimental clinical outcomes.

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XTalks

JANUARY 16, 2025

Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinical trial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). Sling Therapeutics in-licensed linsitinib from Astellas Pharma at the time of its launch as a company in 2022.

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Trials Clinical Trials Clinical Trials Insulin 59

Delveinsight

SEPTEMBER 28, 2021

Innovent, UNION Therapeutics Set to Advance Dermatology Market in China. Innovent Biologics and UNION therapeutics have announced a strategic and licensing collaboration to develop and commercialize Orismilast , a next-generation PDE4 inhibitor for inflammatory dermatology conditions in China.

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Clinical Trials Clinical Trials Trials Dermatology 80

pharmaphorum

APRIL 22, 2021

Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinical trials. physIQ has a portfolio of FDA-cleared digital biomarkers and a medical-grade platform that can transform raw sensor data into clinical insight.

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XTalks

DECEMBER 1, 2020

With this has come an increase in the size of the global clinical trials market, with an estimated worth of around $46.8 In the United States, Menarini Silicon Biosystems’ Pennsylvania-based lab is CLIA Certified and ISO 15189-accredited, with licenses from New York, California, Maryland, Pennsylvania, and Rhode Island.

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Clinical Trials Clinical Trials Trials Clinical Research 96

Pharmaceutical Technology

AUGUST 4, 2022

According to the deal, Poseida will offer either exclusive rights or options to Roche for developing and marketing various allogeneic CAR-T programmes in its portfolio targeting hematologic malignancies. Furthermore, Roche will oversee the late-stage clinical development and worldwide marketing of all products under the alliance.

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XTalks

MARCH 7, 2025

Scientific Breakthroughs and Ongoing Research In recent years, a surge in clinical trials for kidney disease has brought innovative therapeutic options to the forefront. The approval spurred investor interest and market projections, with experts predicting rapid patient adoption. billion in 2023 to $168.92

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Clinical Trials Clinical Trials Marketing Research 59

pharmaphorum

MARCH 19, 2021

Under the clinical trial supervision of the Royal College of Surgeons, Ireland, 40 subjects, 16 of which were independently confirmed as COVID19 positive with PCR tests, provided breath samples that were tested on the Microtox BT nano-optofluidic chip surface. It has licensed in a patented breathalyser, the analysts noted.

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Contamination Clinical Trials Clinical Trials Protein 145

Delveinsight

AUGUST 23, 2021

The present treatment approach in the Von Hippel-Lindau therapy market revolves around controlling and preservation of functional parenchyma to avoid the morbidity associated with renal or adrenal loss. The drug is in one Phase I and two Phase II clinical trials to treat VHL-associated Renal Cell Carcinoma and Pheochromocytoma/ Paraganglioma.

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Marketing Clinical Trials Clinical Trials Trials 98

pharmaphorum

JANUARY 9, 2023

Swiss biotech Stalicla has continued to diversify its pipeline from a focus on autism therapies with a deal to license Novartis’ mavoglurant, in clinical trials for cocaine use disorder (CUD) as well as neurodevelopmental disorders (NDD). STP-2 was licensed from Evgen Pharma in October last year.

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Licensing Licensing Trials Clinical Trials 59

XTalks

FEBRUARY 12, 2025

LIB Therapeutics has announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel investigational treatment aimed at reducing low-density lipoprotein cholesterol (LDL-C) in a broad patient population. This gives lerodalcibep an edge to approved PCSK9 inhibitors.

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Cardiology Trials Clinical Trials Clinical Trials 59

Pharmaceutical Technology

JUNE 2, 2023

This is expected to streamline the path for ADCs to clinical trial and commercialisation. Lonza Licensing vice-president Ulrich Osswald said: “The Synaffix ADC technology is the gold standard, helping clinical-stage developers to design potentially curative therapies in areas of high unmet medical need.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Clinical Trials Clinical Trials Vaccine Vaccination 76

Pharmaceutical Technology

FEBRUARY 17, 2023

Under the multiyear deal, Zephyr AI will license M2Gen’s RWD and will, in return, provide M2Gen will AI and machine learning technologies to enhance its products and services. M2GEN and Zephyr AI will together discover new cancer treatments and expanded use cases for better identifying new targets and enhancing clinical trial design.

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. The second option is to do more random testing of prescription drugs already on the market to ensure they meet FDA guidelines. Patients should be scared.

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pharmaphorum

AUGUST 18, 2021

Akili already has the first and only FDA cleared video game-based digital therapeutic (DTx) for children with attention-deficit hyperactivity disorder (ADHD), but is looking to add to its range via a licensing deal with Australia’s TALi Digital. . Akili is one of a group of companies that were founded by PureTech, which retains a stake.

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Licensing Licensing Sales FDA Approval 64

Pharma Mirror

MAY 7, 2022

a market leading global biotechnology company focused on developing next generation ImmunoPET imaging agents and therapeutic radiopharmaceuticals (RPT), is pleased to announce it has signed a new multi-year, non-exclusive supply agreement with Genmab A/S, an international biotechnology company. Los Angeles, CA, USA, ImaginAb, Inc.,

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Clinical Trials Clinical Trials Licensing Licensing 100

Pharma Mirror

MAY 7, 2022

a market leading global biotechnology company focused on developing next generation ImmunoPET imaging agents and therapeutic radiopharmaceuticals (RPT), is pleased to announce it has signed a new multi-year, non-exclusive supply agreement with Genmab A/S, an international biotechnology company. Los Angeles, CA, USA, ImaginAb, Inc.,

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Clinical Trials Clinical Trials Licensing Licensing 100

Pharmaceutical Technology

JANUARY 31, 2023

Daewoong Pharmaceutical has entered an exclusive licensing agreement with CS Pharmaceuticals (CSP) for Bersiporocin, a first-in-class PRS inhibitor, in the Greater China region for Idiopathic Pulmonary Fibrosis (IPF). The Korea Drug Development Fund is supporting the trial by providing funds.

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