Drug Discovery World

JULY 20, 2023

Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023. However, even then, companies need a strong business case and a clear development plan to secure investment from the limited funds available.

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Alta Sciences

OCTOBER 31, 2023

“Our integrated CRO/CDMO services combine bioanalytical services with preclinical and clinical study solutions, manufacturing services, and all complementary research support services, for maximum efficiency.” This is Altasciences’ third purpose-built laboratory.

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Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Drug Discovery World

JULY 15, 2024

Key takeaways The mission of the AACR is to prevent and cure cancer through research, education, communication, collaboration, science policy and advocacy, and funding for cancer research.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

JULY 8, 2024

In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document. Medical Misinformation : FDA Commissioner ROBERT CALIFF has been heavily focused for much of the last two years on what he calls the negative health effects of medical misinformation.

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Agency IQ

SEPTEMBER 15, 2023

FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy.

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Agency IQ

JUNE 2, 2023

Title Type Comments Close Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act Guidance June 5 Patient Preference Information—Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in (..)

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DrugBank

FEBRUARY 9, 2023

Read the paper Jörn Lötsch Biomedical scientist at the Goethe - University Frankfurt am Main, Germany Research Focus: Knowledge discovery by combining artificial and human intelligence for information reduction of biomedical data with a focus on data science, pain, and clinical pharmacology.

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Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

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Agency IQ

MARCH 1, 2024

Date Group Event Notable FDA Speakers February 28 TransCelerate Rapid RWD Analyses to Support Safety Signal Assessments February 28 White House Rare Disease Forum Julie Tierney March 1 Foundation Fighting Blindness PFDD Meeting on Dry Age-Related Macular Degeneration (Dry AMD) March 4 America’s Blood Centers 2024 Annual Meeting Peter Marks March (..)

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The Pharma Data

NOVEMBER 1, 2020

The Company is managed by a team with broad international, commercial and clinical-science experience. Suhail’s initial industry experience was at Pfizer, where he spent 12 years, initially in Sandwich, UK and then at Global R&D Headquarters in Connecticut, USA.

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Eye on FDA

JANUARY 5, 2022

Here is where FDA currently has vacancies: Bone, Reproductive and Urologic Drugs Advisory Committee – 4 vacancies Gastrointestinal Drugs Advisory Committee – 1 vacancy Pharmaceutical Science and Clinical Pharmacology Advisory Committee – 4 vacancies Pharmaceutical Compounding Advisory Committee – 1 vacancy.

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The Pharma Data

MAY 2, 2022

Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package. Source link: [link].

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The Pharma Data

NOVEMBER 8, 2020

HK) (“Pharmaron”), a fully integrated contract research and manufacturing organization offering laboratory, CMC and clinical development services for the life science industry, announced today that it has acquired 100% of the equity of Absorption Systems for up to US$137.5 BEIJING–( BUSINESS WIRE )– Pharmaron Beijing Co.,

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The Pharma Data

FEBRUARY 15, 2022

Vice President, Medical Sciences-Oncology, Astellas. However, up to half of these patients with MIBC are ineligible for cisplatin treatment and typically must undergo surgery without that treatment,” said Ahsan Arozullah, M.D.,

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The Pharma Data

NOVEMBER 9, 2020

Löbenberg is a director of XPhyto and is the founder and director of the Drug Development and Innovation Centre, Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Canada.

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The Pharma Data

OCTOBER 1, 2021

The research, which spans clinical, health economics and outcomes research, translational, clinical pharmacology and preclinical presentations, highlights the breadth and depth of the company’s data on deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, also because the emerging dermatology pipeline.

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Agency IQ

JULY 28, 2023

In announcing the contract, ACMT explained that while FDA has held a contract for years to access the ToxIC Registry, that contract involved a more specific goal and a concerted effort between the association and CDER’s Office of Surveillance and Epidemiology (OSE) and Office of Translational Sciences (OTS).

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FDA Law Blog: Drug Discovery

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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Drug Discovery World

NOVEMBER 8, 2023

Kathrin Herbst, PhD, Director of Science & Business Development, Lightcast, on: ‘A new era of single-cell functional profiling for drug discovery’. David Mills, PhD, Senior Director, Preclinical Science, Ambrx, on: ‘Preclinical discovery of ARX622, a site-specific HER2-targeted TLR7 agonist immune-stimulatory antibody conjugate’.

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Drug Discovery World

NOVEMBER 9, 2023

Peter O’Callaghan, PhD, Head of Expression System Sciences, Biologics and Licensing, Lonza, on: ‘Solve bispecific heavy-light chain mispairing with bYlok technology’. James Cooke, PhD, Associate Director, Bicycle Therapeutics, on: ‘Engineering bicyclic peptides for precision targeted medicine’.

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Agency IQ

OCTOBER 6, 2023

Amanda Conti, AgencyIQ Looking downstream, a shift toward biologics could have ripple effects for the life sciences industry. For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules.

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Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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Agency IQ

FEBRUARY 23, 2024

I’m not going to say which one is better,” said JIANG LIU, scientific lead at the FDA’s Division of Pharmacometrics in the Office of Clinical Pharmacology. Then, a bit later but still in early-phase studies, developers can leverage this pharmacology information in innovative approaches that may incorporate modeling.

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Agency IQ

DECEMBER 1, 2023

Following this announcement, the FDA developed a transition plan that explained what would happen to its extensive catalogue of PHE-related guidance documents, 60 of which were related to life sciences policy. Regarding trial design: Most of the recommendations in the updated guidance are consistent with the February 2021 version.

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Agency IQ

DECEMBER 1, 2023

Comments on LDT Proposed Rule: On December 4, the comment period on the FDA’s Laboratory Developed Test proposed rule will close, and we will get a fuller picture of the extent to which the life sciences industry opposes the FDA’s proposal. This is already proving to be one of the FDA’s most-opposed actions in years.

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Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

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Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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Agency IQ

DECEMBER 11, 2023

Older adults: While certain age-associated factors like comorbidities, age, and weight can be adjusted using standard clinical pharmacology methods; reviewers have noted that these factors do not entirely adjust for the differences we see in older patient populations.

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Agency IQ

JUNE 16, 2023

The proposed rule, if finalized, would improve regulatory efficiencies by implementing petition data requirements that are specific to the requested action.

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Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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Eye on FDA

AUGUST 4, 2021

The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee. Also the vacancies on the Peripheral and Central Nervous System Drugs Advisory Committee largely reflect the protest of the FDA approval decision in Alzheimer’s.

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Drug Discovery World

AUGUST 15, 2023

The pre-clinical pharmacological effects observed in such experimental model systems need to translate meaningfully into human clinical data to guide effective decision making in drug discovery. Clinical Pharmacology & Therapeutics. Proceedings of the National Academy of Sciences (USA) 99(9): 6210-5.

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The Anticancer Fund

JUNE 7, 2022

This is another study that is strongly supportive of replication and further development, including clinical trial development. In particular this study focuses on the role of the arginine-ornithine-polyamine axis, which is highly upregulated in GBM.

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The Pharma Data

DECEMBER 17, 2020

The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021. Its pipeline will include TLC19 and other chronic lung disease programs with potential indications including childhood interstitial lung disease (ILD), rheumatoid arthritis associated ILD, and idiopathic pulmonary fibrosis.

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The Pharma Data

OCTOBER 15, 2020

Assembly Biosciences – Former Gilead Sciences CEO John McHutchison, currently president and CEO of Assembly, was named the recipient of the Advance 2020 Global Impact award. Prior to joining Genalyte, Hanna served as COO at Verily Life Sciences. Farrell Simon joins Trevi as head of U.S.

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