The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

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Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? The pipeline currently includes five drug candidates, all of which have the potential to revolutionise the treatment of PD.

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Predictive Oncology

MARCH 21, 2023

Pamela Bush of Predictive Oncology discuss the potential impact of their collaboration and how it can advance cancer drug development. The post Proactive interviews Predictive Oncology about partnering with Cancer Research Horizons to leverage AI for new cancer drugs appeared first on Predictive Oncology.

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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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Drug Target Review

OCTOBER 14, 2024

who shared his thoughts on the challenges faced by biotech companies in drug discovery, highlighting the critical role of data and technology in overcoming inefficiencies in the pharmaceutical industry. Reflecting on the past 30 years, Wilkie noted the significant shift in how data has been used within drug discovery.

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The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees.

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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

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Drug Patent Watch

MARCH 25, 2020

This article was originally published by Hermann Mucke & Peter Mucke in Future Drug Discovery under a Attribution-NonCommercial-NoDerivatives 4.0 Unported License. link] Drug developers require access to scientific information in….

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J.

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The Pharma Data

JANUARY 17, 2021

plans to create a global R&D achievement based on innovations of inflammation–fibrosis treatment, Triple-acting new drug for NASH (non-alcoholic steatohepatitis) treatment as well as various other innovations in metabolic disease, oncology and rare disease fields. and “Oraxol,” which was licensed out to Athenex, Inc.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients.

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DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The high costs associated with bringing a new drug to market, estimated to be over $2.6

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Conversations in Drug Development Trends

OCTOBER 26, 2022

That’s because psychedelic trials are logistically heavy, requiring special licensing for drug handling, training for staff in Schedule I drug requirements, and standardized facilities. Certain licensing must be obtained. More guidance on safety considerations can be found, here.

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Drug Target Review

FEBRUARY 1, 2024

But commitment to neuroscience drug development is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. Not failed drugs, but failed studies. As soon as drug developers can begin to develop conviction, momentum increases.

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Alta Sciences

DECEMBER 14, 2023

Regulatory Excellence - Licenses for Schedule I through IV drug substances. Clinical Supply Manufacturing Integration with our manufacturing team, ensuring flexibility and adaptability to meet the evolving needs of your studies throughout your drug development program or study. 24/7 monitoring of temperature and humidity.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

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Molecule Blog

JANUARY 9, 2023

In this context, we are building a new intellectual property (IP) system and structure that enables broad collaboration and incentivizes the right participants (including AI drug hunters or contract research organizations) to contribute to research. How will IP-NFTs enable drug development in the future?

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The Pharma Data

NOVEMBER 8, 2020

The Series B financing will be mainly used to conduct global clinical trials, research and development, and product in-licensing activities. Inmagene is a leading drug development company focused on immunology-related therapeutic areas. It has initiated four innovative programs for validated drug targets.

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Drug Target Review

MAY 17, 2024

What is Pepper Bio’s platform ‘COMPASS’, and what sets it apart from other drug discovery platforms? COMPASS is Pepper’s ML-driven transomics platform that unlocks a functional understanding of disease and drugs transcending traditional expression-based approaches.

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Crown Bioscience

MAY 4, 2021

Unfortunately, children have limited access to novel therapies, and new drugs for adults are often only tested in children many years following approval. Among the 180+ cancer drugs approved by the FDA since 1995, only 14 have been approved for pediatric use, with another 26 used off-label (i.e.

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Drug Target Review

NOVEMBER 22, 2023

Whilst TGF-β is an attractive target for cancer therapy because of its critical role in promoting tumor aggressiveness, immune escape and resistance to therapy, activation of alternative resistance pathways has hindered drug development attempts in the past.

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Molecule Blog

AUGUST 6, 2021

An Open Bazaar for Drug Development: Molecule Protocol The complexity of biopharma IP deals When examining the transactional market for biopharma IP, one aspect becomes immediately obvious: IP is not sold in a simple purchase agreement like houses, cars or other physical objects.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1]. In fact, the evidence suggests that such drugs might even offer some protection against heart disease.

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Drug Target Review

APRIL 9, 2024

Initial works from the lab concentrated on exploring the role of replicative stress in cancer and ageing, for which the group combined cell biology, mouse models and drug development projects. Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy.

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Conversations in Drug Development Trends

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.

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The Pharma Data

DECEMBER 9, 2020

Under its ongoing collaboration and license agreement, Crescendo’s proprietary transgenic platform and engineering expertise is being used to build Humabody ® -based therapeutics against certain targets selected by Takeda. This is the sixth technical milestone achieved by Crescendo in its collaboration with Takeda. – Ends-.

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Molecule Blog

AUGUST 19, 2021

In drug development however, when a therapeutic is discovered, or research becomes more akin to product development, the source of funding must change. These grants are utilised by researchers to get to the point of developing a potentially life-saving therapeutic. And this is the best-case scenario. for patents)?

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The Pharma Data

APRIL 12, 2023

Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ). We are pleased with Biogen’s decision to license ATV: Aβ and we are hopeful this will foster the development of next-generation anti- Aβ therapeutics.”

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LifeSciVC

JULY 17, 2024

By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets.

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The Pharma Data

JANUARY 25, 2021

Ambulero holds an exclusive license from the University of Miami to develop and commercialize research from the laboratories of Drs. As part of the investment, Ambulero and Orphinic formed a Polish subsidiary (Ambulero Sp. that will lead clinical testing of a novel gene therapy for a serious vascular disease in Europe.

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Agency IQ

MAY 3, 2024

A new era for DTC advertising: On May 20, the FDA’s final rule requiring that direct-to-consumer television and radio advertising contain “clear, conspicuous and neutral” statements regarding the drug’s major side effects and contraindications will go into effect.

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Metabolite Tales Blog

NOVEMBER 17, 2022

Roquinimex (Linomide), a drug developed by Pfizer for the treatment of multiple sclerosis, is structurally related to laquinimod. Figure 3: Roquinimex (linomide) Clinical development of both laquinimod and roquinimex was halted due to serious cardiovascular events. Teva Pharmaceuticals licensed laquinimod from Active Biotech.

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The Pharma Data

JUNE 28, 2021

The companies acquired by Bayer, Noria and PSMA Therapeutics, have exclusive world-wide rights to technology licensed from Weill Cornell Medicine (New York, NY, USA) and Johns Hopkins University (Baltimore, MD, USA). Xofigo is currently under further evaluation in a broad clinical development program in prostate cancer and beyond.

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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. Of course, neither “cure” nor permanency are the bar for FDA to find that a new drug is effective; simply because there is the potential for something to be a “cure” or offer permanent/near-permanent effects does not mean it should be required to be such.

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The Pharma Data

AUGUST 21, 2020

Eli Lilly, on the heels of detailing a clinical win in China for PD-1 inhibitor Tyvyt, has decided to take a bigger stake in the drug developed by partner Innovent Biologics in an expanded deal that could vault it into the lucrative—yet ultra-competitive—U.S. Lilly first licensed Tyvyt from Innovent in 2015. lung cancer market.

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The Pharma Data

JANUARY 12, 2021

Marianne De Backer, Head of Business Development & Licensing in Bayer’s Pharmaceuticals Division, pictured above. Food and Drug Administration cleared an Investigational New Drug application for a Phase I study of pluripotent stem cell-derived dopaminergic neurons in advanced Parkinson’s disease.

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The Pharma Data

JANUARY 13, 2021

14, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced the addition of Robert Barrow , an accomplished pharmaceutical executive, as Chief Development Officer. We are excited to attract such top tier talent from the psychedelic drug development community.

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