The Pharma Data

AUGUST 28, 2020

The Phase 1 trial will be conducted by MindMed later this year and will be the first to investigate what happens when you mix the two drugs to work as a therapy. Coaster420. Researchers are set to investigate a combined dose of LSD and MDMA to treat patients undergoing psychotherapy.

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Conversations in Drug Development Trends

FEBRUARY 21, 2024

The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

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Drug Target Review

AUGUST 7, 2024

The preclinical role of often-overlooked artwork During preclinical stages, labelling decisions can significantly impact clinical trials and eventual drug commercialisation. This increases the chances of success in clinical trials and commercialisation, leading to better patient outcomes and a more competitive pharmaceutical industry.

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Drug Target Review

MAY 7, 2024

AI holds the potential to revolutionise different aspects of healthcare, particularly in the realm of clinical trials. By leveraging AI technologies, we could create a more accessible and equitable approach to clinical trials, breaking down barriers to participation and ensuring diverse representation among participants.

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Alta Sciences

JULY 25, 2024

Discover some of the nonclinical requirements for moving dermal studies into Phase I clinical trials, including formulation considerations, species selection, and ideal candidates for transdermal drug delivery systems (TDDS). Read or listen now. Watch the webinar. Because of this, considering other regulatory pathways is necessary.

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Alta Sciences

OCTOBER 30, 2023

Discover the considerations and assessments necessary for performing preclinical research for ophthalmic therapies in this new eBook, that covers everything you need to know, from species selection and routes of administration, to preparing for first-in-human trials. Read it now. The Altascientist : Issue No. Read or listen now. Listen here.

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New Drug Approvals

DECEMBER 24, 2023

“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. 88 (12): 5389–5398. doi : 10.1111/bcp.15468. PMID 35869634. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S.

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Alta Sciences

JANUARY 23, 2024

With close to a decade of experience in the healthcare and pharmaceutical sectors, including clinical pharmacology, James will apply his knowledge to oversee the day-to-day management of clinical operations at Altasciences’ 140-bed, Phase I clinical pharmacology unit in Kansas City. “It

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New Drug Approvals

APRIL 19, 2025

elimination half-life (min) cardio-selectivity (1/2) metabilization Landiolol 4 250 pseudocholinesterases Esmolol 9 30 ery-esterases Metoprolol 420 3 cytochrom P2D6 (Leber) History The beneficial effects of landiolol have been demonstrated in over sixty clinical trials (pubmed search -August 2018). IV -Blocker max. August 2000).

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The Premier Consulting Blog

JUNE 8, 2023

The goal is to minimize regulatory and execution risks through a well-defined clinical, clinical pharmacology, nonclinical, and CMC (chemistry, manufacturing, and controls) development plan and a time and cost analysis for market entry. This robust plan will form the foundation of your pre-IND meeting preparation and discussion.

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The Pharma Data

FEBRUARY 15, 2022

– La te-breaking data from Cohort H of EV-103 trial to be presented at the 2022 ASCO Genitourinary Cancers Symposium –. Activity, tolerability of enfortumab vedotin support ongoing investigation in Phase 3 trials–. Half (50%) of all patients had a pathological downstaging, or reduction in tumor size, a secondary endpoint of the trial.

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Alta Sciences

DECEMBER 14, 2023

Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Image GettyImages-897885148_pharmacy.jpg Tags Clinical Trials Regulatory Excellence - Licenses for Schedule I through IV drug substances. Fully equipped to support all types of IP administration forms.

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The Pharma Data

DECEMBER 17, 2020

Patient enrollment of EXCELLENCE pivotal trial reaches 98%. The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020, despite the worsening of the COVID-19 pandemic. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021.

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Alta Sciences

OCTOBER 9, 2024

Altasciences’ integrated, full-service solutions include preclinical safety testing , clinical pharmacology and proof of concept , bioanalysis , program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements.

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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.

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Agency IQ

SEPTEMBER 15, 2023

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. 25 mg)” — such doses had been suggested in the Citizen Petition.

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New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

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Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S).

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Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S).

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Agency IQ

FEBRUARY 23, 2024

On the first day, discussants looked at how to tackle first-in human trials, weighed the importance of the maximum tolerated dose, and looked at the evolving concept of the clinical utility index. Read AgencyIQ’s analysis of the draft guidance document here , and the two FDA-ASCO meetings here and here.]

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Agency IQ

JULY 8, 2024

Start Date End Date Event Event Type Center 07/10/2024 07/10/2024 Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method Webcast CDRH 07/10/2024 07/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Exploring Religious Literacy and Spirituality in Cancer Care” Webcast (..)

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Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

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Agency IQ

DECEMBER 11, 2023

So far in 2023, the Office has co-authored fifteen guidance documents—the majority of which were drafts—offering insight into the agency’s thinking on several key policy issues, such as clinical trial diversity and the accelerated approval pathway. These issues are especially apparent in treatments that are intended for chronic use.

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Eye on FDA

AUGUST 4, 2021

When Breakthrough Therapy (BT) designation is granted, then the drug gets Fast Track status and receives more intensive guidance – which can begin as early as Phase I clinical trials. The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee.

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Alta Sciences

AUGUST 28, 2023

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI) pmjackson Mon, 08/28/2023 - 14:04 Laval, Québec, August 30, 2023 – Altasciences is pleased to have completed a Phase I trial on Ischemix, Inc.’s

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The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinical trial and assigning patients to placebo may be unethical.

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Alta Sciences

MAY 15, 2023

New technology has given us adaptive trial designs; novel drug delivery mechanisms; better understanding and integration of biomarkers, surrogate markers, imaging; and more, all of which are constantly evolving the landscape. And integration with our CDMO ensures the clinical trial drug product is available on time.

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Agency IQ

OCTOBER 6, 2023

Under the 351(k) pathway, biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability.

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Agency IQ

FEBRUARY 12, 2024

A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. This is a topic that the agency has been keenly aware of for years, but it’s not clear from the title if it will refer to how the FDA will use A.I.

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Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. FDA is directed to issue new draft guidance or update existing guidance regarding Diversity Action Plans for clinical studies.

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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 both newly diagnosed and recurrent PDX models the drug was shown to be non-toxic and to have meaningful anti-GBM activity - including a survival benefit.

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Agency IQ

JUNE 2, 2023

Start Date End Date Event Event Type Center 06/05/2023 06/09/2023 Regulatory Education for Industry (REdI) Annual Conference 2023 Virtual CDER 06/07/2023 06/08/2023 Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development Public CDER 06/07/2023 06/08/2023 RDEA Pilot Program 2023 Public Workshop Workshop (..)

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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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Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process.

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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

DECEMBER 1, 2023

Furthermore, the guidance offered a list of updated clinical outcome measures and offered insight on FDA’s evolving view of decentralized clinical trials and the use of real-world data to supplement trials. Lastly, the revised guidance briefly discussed trials meant to assess drugs intended for prevention of Covid-19.

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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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