pharmaphorum

JULY 19, 2022

Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. The rise of patient centricity. “We Personal approach.

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pharmaphorum

AUGUST 17, 2021

Rapid advances in the use of artificial intelligence (AI) in healthcare and medicines development are at risk of outstripping current regulatory frameworks, according to a new report. The post Global regulators seek permanent working group on AI appeared first on.

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Pharmaceutical Technology

MAY 19, 2023

SiteOne Therapeutics has received a $15m grant from the National Institute on Drug Abuse (NIDA) to develop the investigational selective NaV1.8 Titled ‘Development of a potent and selective Nav1.8 The company stated that the grant from NIDA will support the clinical development of its NaV1.8

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BioPharma Reporter

MARCH 3, 2021

The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.

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BioTech 365

FEBRUARY 4, 2022

Evotec SE / Key word(s): Miscellaneous Evotec SE: Bayer discontinues clinical development candidate eliapixant (BAY1817080), Evotec regains the rights to all P2X3 assets 04-Feb-2022 / 13:17 CET/CEST Disclosure of an inside information acc. to Article 17 MAR of the Regulation … Continue reading →

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Scienmag

SEPTEMBER 8, 2021

BORDEAUX & NARBONNE, France – The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) apply an aligned and complimentary mindset when advising the clinical development steps for live biotherapeutic products (LBPs), YSOPIA Bioscience and the Pharmabiotic Research Institute have found.

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Camargo

DECEMBER 20, 2021

One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). The increase is designed to strengthen CBER’s capacity and capabilities for regulating cell and gene therapies. 2024: 48 staffers. 2025: 29 staffers.

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Outsourcing Pharma

JULY 24, 2023

Phesi, a global provider of patient-centric data analytics, has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

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Drug Discovery World

MARCH 30, 2023

According to data and analytics company Globaldata, the approval of LK101 injection sets the stage for exciting developments in the field. According to GlobalData’s Pharma Intelligence Center, there are currently four personalised cancer vaccines in clinical development in China.

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Outsourcing Pharma

SEPTEMBER 13, 2023

In the rapidly evolving world of pharmaceutical development, high-potency active pharmaceutical ingredients (HPAPIs) are becoming powerful tools.

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XTalks

OCTOBER 7, 2020

Not only did this baby survive to do all these things, but he became a poster child for gene therapy with the regulators at the U.S. However, these complex treatments present challenges to developers over and above the well-documented hurdles of rare-disease research. Who wasn’t supposed to sit up. Food and Drug Administration (FDA).

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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. Aflibercept is a key treatment in ophthalmology.

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Outsourcing Pharma

MAY 4, 2023

Sam Whittaker is founder, and CEO of multiple clinical trial technology companies, including Greenphire and Mural Health.

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Clinical Development Clinical Trials Clinical Trials Development 52

Outsourcing Pharma

MARCH 18, 2024

In an encouraging development, neuromodulation, a form of bioelectric medicine, has emerged as a promising avenue for enhancing health by regulating the nervous system.

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BioPharma Reporter

MARCH 3, 2021

Convergence towards common global standards for clinical trial application (CTA) rules, along with unilateral and mutual recognition of CTA approvals are some suggestions made by industry insiders in a new paper to enable robust and timely development of vaccines.

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The Pharma Data

JULY 28, 2021

The FDA’s Breakthrough Therapy designation process is designed to expedite the development and review of a drug that is intended to treat a serious condition, for which preliminary clinical evidence exists indicating it may demonstrate a substantial improvement over available therapies on at least one clinically significant endpoint.

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Pharmaceutical Technology

MARCH 10, 2023

It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulations. The regulator granted the approval based on two pivotal placebo-controlled, double-blind, randomised trials.

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VirTrial

FEBRUARY 28, 2024

If you missed Signant’s February 2024 webinar about optimizing patient-reported outcomes measurement strategy throughout oncology drug development, we’ve summarized the key takeaways and provided a link for you to watch the recording. Watch the recording You can watch the recorded webinar here.

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BioPharma Reporter

JANUARY 23, 2023

Phesi led analysis reveals an overall decrease in the number of recruiting trials and higher proportion of Phase 2 terminations in 2022.

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The Pharma Data

SEPTEMBER 29, 2021

The new FIND-CKD study extends our clinical research for finerenone to a non-diabetic population where the unmet need is high for brand spanking new treatments to delay disease progression.”. They also control how much water and electrolytes are in the body, regulating blood pressure.

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Clinical Development Development Clinical Trials Clinical Trials 52

The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. About Sandoz. billion.

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pharmaphorum

NOVEMBER 12, 2020

Swiss startup Synendos Therapeutics has raised CHF 20 million (almost $22 million) in first-round financing that will be used to develop its endocannabinoid drugs for central nervous system disorders. Synendos says the cash will allow it to take its lead product SYT-510 through preclinical and proof-of-concept clinical development.

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BioPharma Reporter

AUGUST 13, 2020

CureVac files to raise upward of $200 million in Nasdaq IPO to fund clinical development of COVID-19 vaccine.

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XTalks

MARCH 1, 2021

The study is part of a broad development plan to assess the durability of the immunogenic responses elicited by its vaccine and the emergence of new SARS-CoV-2 variants. Our proactive clinical development strategy aims to create the foundation today, that will enable us to address the challenges of tomorrow.

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VirTrial

OCTOBER 25, 2023

While vaccine development has come a long way, there is much to accomplish in the future. Let’s take a brief look at the history of vaccines, how the COVID-19 pandemic changed the landscape, and where the future of vaccine development is headed. Today, smallpox is the only human disease to have been eradicated.

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pharmaphorum

NOVEMBER 27, 2020

New models of drug development are fuelling life-changing advantages in the rare disease space, previously an economic no-go area for pharma and biotech companies. The interplay between technological advances, new models of drug development, and an increase in patient centricity, has created fertile ground for progress, the panel said.

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Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. Cameron Ross, SVP, Generative AI, Elsevier “AI has the potential to dramatically shorten one of the most costly areas of early drug development – small molecule discovery.

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BioPharma Reporter

OCTOBER 18, 2023

Emma Harvey is global head of medical affairs at F2G Ltd, a UK and Austria based biotech where she is responsible for the global medical and commercial strategies for a novel antifungal drug for serious systemic infections, in clinical development.

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Pharmaceutical Technology

NOVEMBER 2, 2022

There are currently 378 drugs indicated for rare diseases under pre-clinical and clinical development, 66% of which are in late-stage development (Phase II to Pre-registration stage). This included the implementation of priority review, breakthrough therapy and accelerated approval designations.

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Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). 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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Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). 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.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Outsourcing Pharma

JULY 13, 2023

company Arthrosi Therapeutics has bagged $75 million in a Series D round to fund the clinical development of a small molecule drug for chronic gout.

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Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. Danicamtiv overview Danicamtiv (MYK-491, DCM-1) is under development for the treatment of dilated cardiomyopathy (DCM), atrial fibrillation and systolic heart failure.

Drugs 100

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Pharmaceutical Technology

JANUARY 2, 2023

Lifirafenib maleate is under clinical development by BeiGene and currently in the Phase II in clinical pathway. It is specialized in the development and commercialization of immuno-oncology medicines to treat cancers. The drug candidate is administered orally. BeiGene overview BeiGene is a biotechnology company.

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Pharmaceutical Technology

FEBRUARY 26, 2023

CUE-102 is under clinical development by Cue Biopharma and currently in Phase I for Metastatic Colorectal Cancer. 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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Pharmaceutical Technology

FEBRUARY 26, 2023

CUE-102 is under clinical development by Cue Biopharma and currently in Phase I for Gastroesophageal (GE) Junction Carcinomas. 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.

Drugs 100

Drugs Clinical Trials Clinical Trials Development 100

Pharmaceutical Technology

JANUARY 2, 2023

BI-1361849 is under clinical development by Boehringer Ingelheim International and currently in the Phase II in clinical pathway. BI-1361849 overview BI-1361849 (CV-9202) is under development for the treatment of non-small cell lung cancer in combination with radiation therapy and afatinib.

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