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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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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Cloudbyz

MAY 1, 2023

Clinical trial budget management is a complex yet crucial aspect of conducting a successful clinical trial. One of the most challenging tasks for project managers and sponsors is to identify and account for all possible costs, including hidden ones, to ensure that the trial runs smoothly and within budget.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 16, 2023

At least seven more pharma companies and a federation of pharma manufacturers have approached the Delhi High Court against the Central Government’s order in the beginning of June prohibiting manufacturing, distribution and sale of 14 fixed dose combinations (FDCs) licensed prior to the year 1988.

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Drug Discovery World

FEBRUARY 1, 2023

Big pharma is helping to shape the focus The good news is that clinical trials are on the increase and market education is upping pace. This data is proving useful in testing hypotheses before starting any clinical trials. Germany only has three licenses, and the current facilities are a small fraction of total sales.

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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.

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AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 11, 2023

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]

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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. Developing a clinical trial budget can be a confusing exercise for sponsors and CROs.

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AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 22, 2023

The point of contention, they pinpoint, is that if any retailer and manufacturer fails to display the license in a prominent place and is not conspicuous to the public, it amounts to violation of the […]

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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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pharmaphorum

FEBRUARY 24, 2022

It is currently the only oral small molecule RAGE inhibitor in human clinical trials. According to Cantex, azeliragon has previously been tested for Alzheimer’s disease and diabetic nephropathy, where the drug demonstrated high levels of safety in phase 3 clinical trials involving more than 2,000 patients.

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XTalks

AUGUST 25, 2020

Business as usual is anything but in the COVID-19 era, but as the pharmaceutical and clinical trials industries adjust, the US Food and Drug Administration (FDA) has received an influx of questions regarding site inspections and manufacturing-related queries. Impact of COVID-19 on FDA Inspections. Pharmaceutical Safety Concerns.

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Pharmaceutical Technology

JUNE 2, 2023

It also noted that the combination of the company’s development and manufacturing capabilities and the Synaffix ADC technology platform will offer a comprehensive service for customers and licensees to quickly discover, develop, scale up and commercialise new ADCs.

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Pharmaceutical Technology

DECEMBER 19, 2022

Initially, the companies signed a research collaboration and licensing agreement in 2016 to develop and assess up to two bispecific NK cell engagers. These two molecules are presently being analysed by the research and development (R&D) team of Sanofi, with one currently being evaluated in clinical trials.

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Drug Discovery World

DECEMBER 14, 2023

Dr Amrolia is Professor of Transplantation Immunology at the UCL Great Ormond Street Institute of Child Health and an international leader in CAR T-cell therapy for paediatric ALL, and ViroCell Biologics is a specialist viral vector CDMO for cell and gene therapy (CGT) clinical trials. The study is expected to initiate in Q2 2024.

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The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About BioInvent.

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Pharmaceutical Technology

DECEMBER 2, 2022

Under the Mission COVID Suraksha Program, DBT, the Indian Government and BIRAC provided funding for the development and clinical trials of the vaccine. Phase III trials of BBV154 were conducted to evaluate its safety and immunogenicity in approximately 3100 participants in 14 trial sites across the country.

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pharmaphorum

OCTOBER 27, 2021

Merck & Co has signed a licensing deal with the UN-backed Medicines Patent Pool (MPP) that could pave the way for generic companies to manufacture its much-anticipated oral antiviral for COVID-19. ” Under the agreement, MPP will sublicense manufacturing rights to other drugmakers.

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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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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. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.

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Pharmaceutical Technology

MARCH 27, 2023

Faced with such a disappointing approval number last year, manufacturers hope for more NMEs to enter the market in 2023. Veklury’s API is manufactured by Cambrex (East Rutherford, NJ, US), Esteve Pharmaceuticals (Barcelona, Spain), and Flamma (Bergamo, Italy). During 2013–2022, NME approvals were lower only in 2013 and 2016.

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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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Drug Discovery World

JANUARY 30, 2024

Natalia Elizalde, Chief Business Development Officer, VIVEbiotech, says that Dr Naldini’s award represents the significant benefits and demonstrated safety of the therapies developed using lentiviral vectors that are being used for more and more clinical trials and more prevalent diseases.

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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. Specifically, the FDA requested that Gamida Cell demonstrate analytical and clinical comparability from the company’s planned commercial manufacturing sites.

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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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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

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. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

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Pharmaceutical Technology

JUNE 10, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Puma in-licenses its drug candidates and advances its development through clinical testing and for commercial use. The drug candidate is administered through oral route.

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Pharmaceutical Technology

JUNE 10, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. Puma in-licenses its drug candidates and advances its development through clinical testing and for commercial use. The drug candidate is administered through oral route.

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Pharmaceutical Technology

AUGUST 23, 2022

The submission comes after the regulatory agency provided guidance to incorporate clinical findings of the bivalent Omicron BA.1-adapted The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 1-adapted vaccine. On obtaining the FDA EUA, the Omicron BA.4/BA.5-adapted

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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

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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Roots Analysis

FEBRUARY 27, 2024

Currently, product licensing agreements, technology licensing agreements, research and development agreements and clinical trial agreements are the common types of partnerships inked by developers that are currently focused on the development of ADCs pipeline.

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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.

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Pharmaceutical Technology

MARCH 1, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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World of DTC Marketing

APRIL 12, 2021

A blood-thinning agent, heparin, had been adulterated due to the product license holder (Baxter) procuring a toxic substance that had been illegally substituted for the genuine registered material. We can’t continue to develop drugs the same way as we have done before. We need a 21st-century approach that puts patient safety first.

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Drug Discovery World

OCTOBER 3, 2023

It is an easily deployable vaccine that can be manufactured at mass scale and modest cost, enabling hundreds of millions of doses to be supplied to countries which are suffering a significant malaria burden. The post WHO recommends cost-effective and easily deployable malaria vaccine appeared first on Drug Discovery World (DDW).

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