Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. The Altascientist : Issue No. Read or listen now. Watch the video. Read the fact sheet. Read or listen now.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

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

Clinical Pharmacology 40

Clinical Pharmacology Clinical Trials Drug Development Clinical Research 40

New Drug Approvals

DECEMBER 24, 2023

“Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen” Neurology and Therapy. 12 (1): 267–287. doi : 10.1007/s40120-022-00414-z. PMC 9837340. PMID 36525140. Coelho, Teresa; Marques, Wilson; Dasgupta, Noel R.; PMID 35869634.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology FDA Approval 62

The Pharma Data

FEBRUARY 15, 2022

“The initial findings from EV-103 Cohort H are encouraging, and we look forward to learning more from the Phase 3 studies evaluating enfortumab vedotin in muscle-invasive bladder cancer in combination with the anti-PD-1 therapy pembrolizumab,” said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development at Seagen.

Clinical Pharmacology 52

Clinical Pharmacology Trials Treatment Therapies 52

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).

FDA 62

FDA Clinical Trials Treatment Trials 62

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.

Clinical Pharmacology 40

Clinical Pharmacology Drug Development Science Clinical Trials 40

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. Food & Drug Administration.

Treatment 52

Treatment Clinical Pharmacology Drugs Clinical Development 52

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]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. A combination therapy of glecaprevir and pibrentasvir has recently been implicated in a case of liver injury. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION.

Drugs 52

Drugs Metabolic Stability FDA Approval Treatment 52

Metabolite Tales Blog

JULY 5, 2023

Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. A combination therapy of glecaprevir and pibrentasvir has recently been implicated in a case of liver injury. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

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. Both trials showed no difference between phenylephrine and placebo.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

FEBRUARY 23, 2024

Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. LILLIAN SIU, an oncologist and clinical trialist at Toronto’s Princess Margaret Cancer Centre, was a panelist on the day’s second session.

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

FDA 40

FDA Science Regulations Production 40

Eye on FDA

AUGUST 4, 2021

Below is a chart that looks at 3 numbers – the number of AdComms; the number of new molecular entities approved each year, and the number of drugs that had breakthrough therapy designation. The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee.

FDA 122

FDA Clinical Pharmacology FDA Approval Therapies 122

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.

FDA 40

FDA Science Clinical Trials Trials 40

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.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

Alta Sciences

AUGUST 28, 2023

There are no TBI-specific therapies approved for the treatment of patients suffering brain injury, yet it is estimated that in the U.S. We are proud to support Ischemix in advancing this vital new therapy.” “There were no serious adverse events, and all treatment-emergent adverse events were mild and self-limiting.

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

Alta Sciences

MAY 15, 2023

Starting at formulation, through to preclinical testing, clinical manufacture, early phase clinical trials, and bioanalysis up to Phase IV, Altasciences' Proactive Drug Development Solution offers an innovative and seamlessly integrated drug development journey, with mulitple points of entry.

Drug Development 52

Drug Development Clinical Trials Laboratories Compounding Pharmacies 52

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, (..)

FDA 40

FDA Science Biosimilars Clinical Trials 40

Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. The trend of incorporating clinical trial diversity into PMRs continued in FY 2023. CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics.

FDA 52

FDA Biosimilars Science Drugs 52

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.

FDA 40

FDA Science Regulations Production 40

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 (..)

FDA 40

FDA Science Regulations Production 40

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.

Science 40

Science Biosimilars FDA Production 40

The Anticancer Fund

JUNE 7, 2022

This is another study that is strongly supportive of replication and further development, including clinical trial development. Gauthier Bouche & Pan Pantziarka Gauthier Bouche (MD) is Director of Clinical Research at the Anticancer Fund. Pan Pantziarka is Programme Director Drug Repurposing of the Anticancer Fund.

Drugs 40

Drugs Clinical Trials Trials Treatment 40

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 (..)

FDA 40

FDA Science Regulations Clinical Trials 40

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 (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 2, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

MARCH 1, 2024

District Court March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires. FDA) FDA required to have resolved dispute with Vanda Pharmaceuticals or hold a hearing.

FDA 40

FDA Science Clinical Trials Regulations 40

The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). 1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). percent in the control arm. 10 months. [iv]

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Agency IQ

DECEMBER 1, 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.

FDA 40

FDA Science Regulations Production 40

Drug Target Review

MARCH 25, 2025

The convergence of advanced research tools, a growing understanding of tumour biology, and urgent unmet patient needs makes this the perfect moment to reignite focus on DNA Damage Response in cancer therapy. scientists can develop therapies tailored to specific molecular signatures, ultimately expanding the reach and impact of this approach.

DNA 52

DNA Therapies Clinical Trials Clinical Pharmacology 52

Conversations in Drug Development Trends

JANUARY 6, 2025

Transforming Drug Development with Biomarkers and Streamlined Regulatory Pathways The growing focus on addressing unmet medical needs has prompted regulatory agencies to streamline pathways to expedite access to transformative therapies. As a cornerstone of the 4P model, PGx plays a transformative role in advancing personalized care.

Clinical Trials 52

Clinical Trials Trials Drug Development Therapies 52

Drug Target Review

JANUARY 20, 2025

The oncology drug development landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. Molecular factors Molecular markers, such as protein expression and signalling pathway activation, also guide therapy choices.

Clinical Trials 52

Clinical Trials Trials Drugs Drug Development 52

FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

This Guidance explicitly excludes gene therapies (a change from the draft guidance), but instead makes reference to a separate guidance that has been in place since 2020 titled Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.

Production 64

Production FDA Therapies Clinical Pharmacology 64

Drug Target Review

NOVEMBER 27, 2024

As precision medicines, including RNA interference (RNAi) and oligonucleotide therapies, become more prominent, the importance of advanced techniques in streamlining biomarker validation and expediting the regulatory review process becomes even clearer. Clinical Pharmacology & Therapeutics. 2022 Mar 5;112(1):69–80.

Drug Development 52

Drug Development Regulations Laboratories FDA 52

New Drug Approvals

APRIL 21, 2025

6] Clinical trials Phase I data indicated acoramidis achieved near-complete (>90%) TTR stabilization across the entire dosing interval at steady state. [12] New Drug Therapy Approvals 2024 (PDF). In wATTR-CM, there is no variant in the transthyretin gene. [6] 25 November 2024. Retrieved 25 November 2024. ^ January 2025.

FDA Approval 62

FDA Approval FDA Production Treatment 62