Advarra

JUNE 20, 2023

cell and gene therapies), with other therapeutic areas then pushing it further. Because of this, oncology researchers may only have access to minimal existing scientific literature related to cell-based data and animal testing to predict an investigational therapy’s effect on human factors.

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Drug Discovery World

AUGUST 3, 2023

For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1. million for the STEP (Stratification & Treatment in Early Psychosis) programme, as part of its support for mental health research.

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The Pharma Data

APRIL 27, 2021

Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations. The review is being conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE), which provides a framework for concurrent submission and review of oncology products among international partners.

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New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] 1] [9] [10] Names Etrasimod is the international nonproprietary name. [11]

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Drug Discovery World

FEBRUARY 23, 2024

Voyager Therapeutics has announced new data from its two preclinical programmes targeting pathological tau for the treatment of Alzheimer’s disease. Recent third-party data with tau-targeted investigational therapies have demonstrated reduced spread of pathological tau, as measured by tau PET imaging, and favourable trends in cognition.

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Agency IQ

AUGUST 16, 2024

Many commenters took issue with the guidance’s statement that, “The contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized. In the clinical studies, this consisted of a four-month course of treatment with three doses of MDMA administered in supervised therapy sessions.

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Drug Discovery World

AUGUST 8, 2022

Earlier this year, pharmaceutical company Novo Nordisk announced positive results from Phase I & II clinical trials investigating its antibody treatment for haemophilia A. . Zero bleeds were reported in the eight participants treated with the therapy once monthly. . Mim8 works by mimicking activated Factor VIII (FVIII).

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The Pharma Data

JULY 29, 2021

P-tau217 in blood showed promise as additional biomarker of efficacy- Donanemab treatment led to 24% lowering of P-tau217 from baseline. Today at the Alzheimer’s Association International Conference © (AAIC © 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study.

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The Pharma Data

JULY 11, 2021

years with TAKHYZRO is Consistent with Initial Period of Treatment, Building on Growing Body of Evidence on the Long-term Safety and Efficacy Final Patient Subgroup Analysis Suggests Reductions of HAE Attacks Across Range of Patient Demographics and Disease Characteristics with TAKHZYRO. Analysis of Safety and Efficacy for up to 2.5

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The Pharma Data

SEPTEMBER 1, 2020

The trial included 2,494 patients who had previously completed a Phase 1, 2 or 3 Zeposia clinical trial and who had an average treatment time of 35.4 Gaining insight into long-term therapeutic outcomes can enable clinicians to identify the most appropriate treatment approach for their multiple sclerosis patients. Author: Zhang.

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Clinical Trials Treatment Trials Disease 52

The Pharma Data

AUGUST 29, 2020

Oral, investigational complement factor B inhibitor LNP023 substantially improved hematological response as add-on therapy to eculizumab. All patients required RBC transfusions prior to starting LNP023 treatment. “In Peffault de Latour.

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Treatment Disease Small Molecule Production 52

The Pharma Data

JULY 22, 2021

Takeda Pharmaceutical Company Limited ( TSE: 4502 /NYSE:TAK) (“Takeda”) today announced the results of a phase 3 trial investigating the efficacy and safety of recombinant von Willebrand factor (rVWF) prophylaxis, 1 one of the 12 abstracts being presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021.

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Laboratories Production Treatment Disease 52

The Pharma Data

JULY 27, 2021

” The acquisition will also add TNB-585, a Phase 1 bispecific T cell-engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term IND filings. ” In June 2021, AbbVie Inc. exercised its right to acquire TeneoOne, Inc.

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Production Clinical Trials Government Disease 52

Agency IQ

OCTOBER 20, 2023

FDA’s newest draft guidance lays out considerations for developing treatments for diabetic foot infections In a new draft guidance document released within weeks of a related clinical practice guideline, the FDA provides considerations for developing therapies to treat diabetic foot infections, focusing on Phase 3 efficacy trials.

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FDA Treatment Trials Therapies 40

The Pharma Data

DECEMBER 13, 2020

In patients with T2DM (41-47% of each group), the results observed showed treatment with PXL770 resulted in a -27% mean relative reduction in liver fat content at 500 mg QD (p=0.004) versus baseline. Currently no curative or specific therapies are available. 14, 2020 07:00 UTC. NASH Investor Event Information. About Poxel SA.

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Trials Disease Treatment Pharmacokinetics 52

The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata.

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The Pharma Data

JULY 21, 2021

These data were shared as a late-breaking oral presentation during the virtual 11 th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021).

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Clinical Trials Pharmacokinetics Trials International 52

The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. In the U.S., Read full announcement here: [link].

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The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. The therapeutic dose of pirfenidone approved by the US Food and Drug Administration (FDA) for the treatment of IPF is 801 mg three times a day.

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Pharmacokinetics Treatment Production Small Molecule 52

New Drug Approvals

SEPTEMBER 13, 2024

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] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] nM vs. 24.0

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and Islatravir.

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Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

OCTOBER 27, 2020

Treatment with Tyvaso of up to 12 breaths per session, four times daily, in the INCREASE study was well tolerated and the safety profile was consistent with previous Tyvaso studies and known prostacyclin-related adverse events. our initial phase 1 study of OreniPro , which has since been completed. ADVANCE OUTCOMES.

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The Pharma Data

MARCH 17, 2021

In one analysis, the PRO data indicated that most patients (approximately 70-75%) in both arms reported being bothered “a little bit” or “not at all” by treatment-related side effects. Gallen International Breast Cancer Conference. Gallen International Breast Cancer Conference Poster Awards 2021.

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Trials Therapies Treatment Pharmacokinetics 52

The Pharma Data

SEPTEMBER 8, 2021

–Results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluate the use of BOTOX® (onabotulinumtoxinA) for chronic migraine –These data further demonstrate AbbVie’s commitment to harnessing and sharing innovative science and working to advance treatment options for people with migraine across the migraine spectrum.

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Doctors Treatment Trials Clinical Trials 52

The Pharma Data

NOVEMBER 26, 2020

an international research-focused healthcare Group (Chiesi Group), today announced that the U.S. Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. About Pegunigalsidase Alfa.

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Disease Treatment Clinical Trials FDA 52

The Pharma Data

AUGUST 9, 2021

Since 40% of people with DLBCL relapse after initial therapy, achieving meaningful treatment effects in the front-line setting has the potential to be transformative,” said Levi Garraway, M.D., Safety outcomes were consistent with those seen in previous trials. Roche’s Chief Medical Officer and Head of Global Product Development.

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International Treatment Pharmacokinetics Disease 52

The Pharma Data

SEPTEMBER 15, 2020

Of note, The Phase 1b study is a double-blind, placebo-controlled clinical trial evaluating the safety, tolerability and pharmacokinetics of PF-07304814, a phosphate prodrug that when administered intravenously is metabolized to the active compound PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.

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The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML. About CG-806.

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The Pharma Data

DECEMBER 23, 2020

The European Union (EU) authorized ViiV Healthcare ’s Vocabria (cabotegravir injection and tablets) in conjunction with Janssen’s Edurant (rilpivirine tablets) for the treatment of HIV-1 infection in adults who are virologically suppressed.

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The Pharma Data

DECEMBER 15, 2020

Treatment induced sustainable clinical responses and reduced systemic inflammation. Daratumumab already is approved for the treatment of multiple myeloma. The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. The secondary outcome involves pharmacokinetic endpoints.

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Disease Clinical Trials Small Molecule Trials 52

Agency IQ

FEBRUARY 15, 2024

AgencyIQ has analyzed the agency’s guidance agendas, user fee commitment letters, statutory obligations and international efforts to determine which guidance documents the agency is actively working on this year (and in some cases, in the years ahead as well). We have tried to sort guidance documents by topic area.

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Agency IQ

DECEMBER 11, 2023

The areas within oncology that have seen the most success in terms of new and effective treatment options are now entering a new paradigm where the terms “success” and “harm” are being redefined. As more data have been collected on products previously approved, regulators have started to look back at them with a more critical gaze.

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The Pharma Data

DECEMBER 29, 2020

an international research-focused healthcare Group (Chiesi Group), today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease. galactosidase-A product candidate under development for the treatment of Fabry disease.

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Clinical Trials Disease Treatment Trials 52

The Pharma Data

SEPTEMBER 27, 2020

In August, the FDA approved Evrysdi for the treatment of SMA in adults and children 2 months and older. After two years of treatment with Evrysdi, 71% (12/17 vs. 10/17 at 1-year) of infants achieved a CHOP-INTEND* score of 40 points or more and all infants increased their score from month 12 to month 24. months and the oldest was 45.1

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