Drug Target Review

MARCH 17, 2025

Advancing drug candidates across key therapeutic areas Dr John Donello brings over 25 years of experience in pharmaceutical drug discovery, development and collaborations. This has sparked the development of a new approach to treating neuropsychiatric disorders.

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Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. For small- and medium-sized pharmaceutical companies, outsourcing represents a strategic leap forward, offering a gateway to unparalleled expertise and cutting-edge analytical technologies.

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Drug Target Review

MARCH 4, 2025

The MyPhenome test has already gained traction among obesity specialists, particularly in Chicago and Florida, and Phenomix has formed strategic partnerships with multiple pharmaceutical companies to support clinical trials and further analyse obesity-related data.

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BioPharma Drive: Drug Pricing

JUNE 23, 2025

The black and gray market risks Ben warned about the proliferation of counterfeit GLP-1 drugs in unregulated markets, posing significant dangers to patients who might unknowingly use ineffective or harmful products. Additionally, preserving lean muscle mass during weight loss is a key area of focus to improve patient outcomes.

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The Pharma Data

JANUARY 27, 2021

28, 2021 /PRNewswire/ — CASI Pharmaceuticals (Formerly Known As EntreMed, Inc.). technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link].

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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. As soon as drug developers can begin to develop conviction, momentum increases. It’s a great example of how our model works.

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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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Crown Bioscience

MAY 4, 2021

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. used in a way that is not described in the license), and only three drugs have been approved exclusively for use in children.

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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. We interviewed Dr Neil Wilkie, CEO of Mironid Ltd., For more: [link] ; [link] ; [link] ; Neil Wilkie, CEO, Mironid.

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New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Suzetrigine is taken by mouth. [1]

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Drug Target Review

AUGUST 9, 2024

What is drug formulation? Drug formulation is the process of designing and producing a final medicinal product from an active pharmaceutical ingredient (API). 1 The goal is to create a dosage form that delivers the drug effectively to the intended site of action with optimal patient benefit and a good commercial value.

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The Pharma Data

JUNE 30, 2021

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. TEL AVIV, Israel & ZURICH–(BUSINESS WIRE)– Teva Pharmaceutical Industries Ltd.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

Under FDA’s interpretation, it is impossible to determine whether there is a non-public IND prior to starting work on developing an ingredient as a dietary supplement. However, FDA’s interpretation creates that exact risk for a dietary supplement manufacturer who invests in development of a dietary supplement.

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The Pharma Data

JUNE 28, 2021

“Bayer is focused on addressing the various medical needs of cancer patients, providing treatments that improve patient outcomes throughout the different stages of the disease,” said Robert LaCaze, Member of the Executive Committee of the Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer.

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Molecule Blog

JANUARY 9, 2023

IP-NFTs upgrade our legacy intellectual system by unifying IP (patents, legal), underlying data (through decentralized storage and access control), and economics (royalties, license fees, sales) into one programmable, transactable, digital unit. ‍ How will IP-NFTs enable drug development in the future?

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The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.

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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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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.

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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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NIH Director's Blog: Drug Development

FEBRUARY 27, 2018

More than 90 percent of that contributory research was basic—that is, related to the discovery of fundamental biological mechanisms, rather than actual development of the drugs themselves. Previous attempts to quantify the contribution of federal funding to new drug development had looked primarily at patents.

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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

OCTOBER 18, 2020

DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Greg possesses a wealth of experience in developing new cancer therapeutics across multiple U.S. Berk, MD, to its Board of Directors.

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The Premier Consulting Blog

NOVEMBER 20, 2024

Process validation is a critical regulatory requirement in pharmaceutical manufacturing. This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval.

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Molecule Blog

JANUARY 28, 2022

While new laboratory technologies alone have failed to improve efficiency in drug development, we believe that new advances in network, coordination, and incentive technologies at a structural level could reverse this trend by enabling new methods of optimizing collaboration, talent, and capital allocation.

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Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? According to IRLAB’s calculations, the probability that an ISP-generated drug will reach pivotal Phase III studies is almost three times higher than for a drug developed with traditional methods – 20 percent compared to seven percent.

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The Pharma Data

NOVEMBER 1, 2020

The program is based on pioneering science from INSERM, CNRS, Aix Marseille University and the University of Bordeaux , and is being developed in collaboration with REGENXBIO Inc. In addition, Corlieve has licensed REGENXBIO’s NAV AAV9 technology for the TLE program. Maryland , US), a leading gene therapy company.

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The Pharma Data

DECEMBER 8, 2020

AbCellera’s AI-powered antibody discovery platform speeds the otherwise lengthy and grueling process by analyzing the database of natural immune systems to find antibodies that can be developed into drugs. Tackle the toughest problems in drug development.” SciNeuro Pharmaceuticals . Reduce cost. Nuance Pharma .

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Conversations in Drug Development Trends

NOVEMBER 27, 2023

Food and Drug Administration (FDA) announced its acceptance of the Biologics License Application (BLA) for exa-cel. In June 2023, the U.S. In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023.

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Conversations in Drug Development Trends

AUGUST 9, 2024

The International Council for Harmonisation of Technical Pharmaceuticals for Human Use provides guidelines, but local adaptations and interpretations still vary. An import license is necessary for any intellectual property or equipment used during the trial.

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The Pharma Data

DECEMBER 29, 2020

Its drug development pipeline includes thymus, pancreas, and kidney regeneration. is a life sciences company developing therapies to modify aging — increasing human health span and longevity. LyGenesis’s lead allogeneic cell therapy program is focused on liver regeneration for patients with end stage liver disease.

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The Pharma Data

OCTOBER 30, 2020

Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. TARRYTOWN, N.Y. , 30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. Contacts: Media Relations Alexandra Bowie Tel: +1 (914) 847-3407 alexandra.bowie@regeneron.com. View original content: [link].

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The Pharma Data

JANUARY 24, 2021

The company has established a diversified R & D pipeline comprising 27 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases.

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Molecule Blog

MARCH 17, 2023

The Primitives of Biomedical Discovery and Development It’s noteworthy that the majority of approved medicines, around 60%, have their roots in academia, with the remaining 40% stemming from pharmaceutical research and discovery. These studies involve more in vivo testing in increasingly larger animals to evaluate safety and efficacy.

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PPD

JULY 9, 2024

Drug developers need to staff RA teams that can handle regular lifecycle maintenance ebbs and flows across lifecycle maintenance tasks, and plan for a workload that sometimes requires senior-level expertise, while at other times is much more suited to support staff. However, completing this work is only half the challenge.

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Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources. and the E.C.

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Agency IQ

JUNE 29, 2023

The following PDUFA dates were obtained from publicly available sources.

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