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Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.
Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services pmjackson Wed, 11/13/2024 - 14:50 Greater Montréal, Québec, 11/13, 2024 — Altasciences , a trusted drug development research partner for over 30 years, continues its commitment to providing world-class bioanalytical services.
As more drugs are being approved, is FDA getting less advice than in the past? Within those focused on human drugs , there are 17 committees organized under therapeutic categories (Arthritis, Cardiovascular and Renal, Gastrointestinal, e.g.). Fewer meetings – more approvals. If they did want to hold more, are they ready?
As originally proposed, this new Committee could be convened in conjunction with the existing medical specialty area-focused advisory committees, akin to the Drug Safety and Risk Management Advisory Committee. clinicalpharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,
The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world.
All three laboratories across North America are uniformly designed and managed. Whether as a standalone bioanalytical service or as part of an integrated program, Altasciences provides top-quality data for TK, PK, and PD determinations to support preclinical and clinical studies.
Dr. Gunther Hartmann from the Institute of Clinical Chemistry and ClinicalPharmacology at the University Hospital Bonn, in cooperation with other members of the cluster of excellence ImmunoSensation2 at the University of Bonn, have shown this in mice. Researchers led by Prof. SARS-CoV-2 belongs to the genus Betacoronavirus. .
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. Researchers are set to investigate a combined dose of LSD and MDMA to treat patients undergoing psychotherapy.
With close to a decade of experience in the healthcare and pharmaceutical sectors, including clinicalpharmacology, James will apply his knowledge to oversee the day-to-day management of clinical operations at Altasciences’ 140-bed, Phase I clinicalpharmacology unit in Kansas City. “It
Small patient populations often result in difficulty in determining a significant effect of a therapy, given the low confidence power associated with the statistics. How do AI-enhanced approaches accelerate the drug development process for rare diseases?
This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.
TOP 5 WAYS INTEGRATED DRUG DEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY aasimakopoulos Mon, 05/15/2023 - 16:06 Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 Here are five ways an integrated drug development solution can simplify and accelerate your programs: 1.
Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Zuranolone is an investigational two-week, once-daily oral drug being developed for MDD and postpartum depression (PPD).
s novel, proprietary cytoprotective drug candidate, CMX-2043, for the treatment of acute TBI. The trial was performed at Altasciences’ clinical facility in Montréal. Importantly, the Principal Investigator determined that few adverse events were drug-related.” We are proud to support Ischemix in advancing this vital new therapy.”
Dr. Setnik made the list of 100 honorees for her hands-on leadership and nearly 20 years of experience in clinicaldrug development, with a focus on abuse potential studies. These honorees, from the clinic to the C-suite, are making meaningful contributions to their fields and striving to improve outcomes for patients around the world.
Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions.
“Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen” Neurology and Therapy. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA). Ionis Pharmaceuticals.
“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.
Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions.
Absorption Systems is a leading scientific, non-clinical CRO that provides pharmaceutical, biotech, medical device companies and regulatory agencies with research and testing for small and large molecules, cell and gene therapies, ocular and medical device products. www.pharmaron.com.
FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic. As a reminder, the U.S.
The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. Axovant – Kristin Vuori was named to the board of directors at Axovant Gene Therapies Ltd. Trevi Therapeutics – Shashank Rohatagi was named vice president of Pharmacology and Clinical Phrarmacokinetics.
10 June 2022 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. Below, we have listed recent findings about the repurposing of generic drugs in oncology. It is one of the focus areas of the Anticancer Fund.
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.
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]
1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. v] ERLEADA ® is being studied in five Phase 3 clinical trials. . ‡
By our count, the FDA’s Oncologic Drugs Advisory Committee held seven meetings in 2023; additionally, the Oncology Center of Excellence authored nine new (draft) and six final guidance documents. Read on for a deep dive into the major themes in oncology this past year.
Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.
Many of those activities are tied to various user fee program commitments; a few others are related to other major pieces of legislation like last year’s Food and Drug Omnibus Reform Act (FDORA). We’re expecting to get a better sense in October about which of these bills might eventually start to move forward and potentially become law.
FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.
Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.
Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinicalpharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process. million (IQR: $18-36.7
December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.
Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.
FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.
If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest. Priority A List.
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.
Dr. Löbenberg holds Health Canada licences for research and analytical testing of a wide range of psychedelic compounds under the Controlled Drugs and Substance Act and research and analytical testing licences for cannabis under the Cannabis Act. Psilocybin has recently been designated twice as a “breakthrough therapy” by the U.S.
On March 26, the Supreme Court will hear the case of Alliance for Hippocratic Medicine vs. FDA , a case which calls into question FDA’s authority to make regulatory changes, to be free from unreasonable scrutiny, and to ensure that the abortion drug mifepristone remains both approved and widely available.
December also has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may soon receive greater clarity about the FDA’s thinking about prescription drug importation plans. December also typically brings end-of-year perspectives on the agency’s accomplishments.
The documents describe all the guidance documents that are under development and that may be published in a given year. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)
39 Key Considerations for Nonclinical Dermal Studies—Advancing to Phase I An increasing number of advanced methods for dermal drug delivery can contribute to successful 505(b)(2) applications and extend the patent life of a drug for its sponsor. The Altascientist: Issue No. Read the eBook. View the podcast. Read or listen here.
Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance enumerates key considerations for selecting an animal species for both pharmacology and toxicology studies.
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. It also covers strategies for drug developers who have yet to identify a biomarker, helping them advance their programs effectively.
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