The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion and $86.01

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The Pharma Data

AUGUST 24, 2020

The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases. The Phase 1 trial is expected to be conducted at sites in Baltimore, Maryland and Washington, DC.

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Drug Target Review

AUGUST 28, 2024

The preclinical findings, together with the early evidence of tolerability and efficacy coming from the MATCH Phase I study, laid the foundations for our characterisation and engineering platform, used to develop Resolution Therapeutics’ lead product, which will be tested in patients starting later this year.

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

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The Pharma Data

MARCH 8, 2021

We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

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Drug Target Review

OCTOBER 10, 2024

What are the risks of over-reliance on healthy donor material in early-stage research, and how can decision-makers ensure a balanced integration of diseased material to avoid potential gaps when transitioning to clinical trials?

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic.

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The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.

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The Pharma Data

MARCH 23, 2023

Head of Global R&D ad interim and Chief Medical Officer at Sanofi “Change cannot come quick enough for people living with uncontrolled COPD but , unfortunately , many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limited treatment options.

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The Pharma Data

JANUARY 21, 2021

The rest are in Phase I trials for ovarian cancer, AML, MDS, heart failure, HPV+ solid tumors and recurrent respiratory papillomatosis (RRP). Food and Drug Administration (FDA) gave the go-ahead for the company to initiate a Phase I trial of PRGN-2012 in adults with recurrent RRP. On January 5, 2021, the U.S. Most Read Today.

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Precision for Medicine

MAY 24, 2023

The CRO Leadership Awards recognize top CRO partners, determined by feedback from sponsor companies who outsource clinical trials. Precision applies novel biomarker approaches to clinical research that integrate clinical trial design and execution with deep scientific knowledge, laboratory expertise, and advanced data sciences.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e.,

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The Pharma Data

JUNE 2, 2023

This approval was based on an exploratory subgroup analysis of the Phase 3 PROpel trial which showed that LYNPARZAplus abi/pred demonstrated clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR=0.24 [95% CI, 0.12-0.45]) These approvals were based on the data from the Phase 3 PROfound trial.

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The Pharma Data

SEPTEMBER 21, 2020

This came after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave the recommendation based on a positive opinion of the PAOLA-1 Phase 3 trial which was published in The New England Journal of Medicine. .

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Agency IQ

JUNE 26, 2023

While the pilot has been in development for a while, the move comes as the FDA is looking towards a broader shift in its approach to LDTs. Further, footnote 7 in the document explains: “Examples of such clinical laboratory tests are commonly used and well understood biochemical assays (e.g.,

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PPD

NOVEMBER 14, 2023

In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development. Risk-Based Training Clinical trials are complex, so one-size-fits-all training may not always fit the bill.

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PPD

MARCH 13, 2024

In every early phase clinical trial, the transportation, chain of custody, environmental monitoring and subsequent analysis of biological samples are the cornerstones of a successful, robust and quality outcome. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

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The Pharma Data

AUGUST 31, 2021

Continued approval was contingent upon verification and description of clinical benefit in confirmatory trials. This indication was approved under accelerated approval based on tumor response rate and duration of response.

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The Pharma Data

APRIL 28, 2023

In August 2022, the FDA accepted the supplemental New Drug Application (sNDA) for Lynparza based on positive results from the pivotal PROpel trial, also published in NEJM Evidence. The Committee voted 11 to 1, with 1 abstaining, that the indication should be limited to patients whose tumours have a BRCA mutation. 0.81; p<0.001).

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The Pharma Data

NOVEMBER 9, 2020

and Canada, announced along with Eisai today that it has new investigational data demonstrating positive top-line results from the Phase III KEYNOTE-581/CLEAR trial (Study 307). The trial looked at a combination of Keytruda from Merck and Lenvima from Eisai for the treatment of advanced renal cell carcinoma (RCC).

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The Pharma Data

OCTOBER 1, 2021

Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials show that response rates for deucravacitinib continued to extend through Week 24 and were maintained through Week 52 in patients with moderate to severe plaque psoriasis. CESTidentified through 52 weeks of knowledge.

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The Pharma Data

JANUARY 19, 2021

TC-210 is currently in a Phase I/II trial for mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. TC-110 is in a Phase I/II trial for CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL).

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The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4

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The Pharma Data

SEPTEMBER 28, 2021

Recommendation supported Data From Phase 3 KEYNOTE-355 Trial. Triple-negative carcinoma grows and spreads faster than other sorts of carcinoma and consequently features a worse prognosis,” said Dr. Vicki Goodman, vice chairman , clinical research, Merck Research Laboratories. About Triple-Negative carcinoma.

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The Pharma Data

JANUARY 3, 2021

The scientific approaches underlying this clinical study could potentially be effective against SARs, MERS, and all variants of coronaviruses. This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses. NEW YORK and LONDON, Jan.

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The Pharma Data

APRIL 8, 2021

Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA monotherapy demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint. KENILWORTH, N.J.–(BUSINESS

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PPD

OCTOBER 24, 2024

Coordinated efforts are needed to combat this disease and improve the clinical status of persons with HBV infection. Currently there is no cure for hepatitis B, however there are several drugs in clinical development to improve the lives and clinical outcomes for persons with chronic HBV infection, including functional cure strategies.

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The Pharma Data

NOVEMBER 1, 2020

Trial facilitated with coll a boration of Harvard Medical School and one of the world’s top Neurologist, Dr. Howard Weiner. Clinical Data Expected by End of Year. The clinical data from this trial is expected to available by the end of this year. Brazil has reported almost 5.5M

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Agency IQ

DECEMBER 1, 2023

Completed development of the EUDAMED Market Surveillance module Q4 2023 Designation of E.U. Reference Laboratories Proposal for five laboratories to receive E.U. Reference Laboratory designation Q4 2023 Critical medicines list [E.U.] Expected Action Description of action Date Eudamed Module: Market Surveillance [E.U.]

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The Pharma Data

MAY 31, 2022

The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with uncontrolled prurigo nodularis ( PRIME2 and PRIME ). The safety results from these trials were generally consistent with the known safety profile of Dupixent in atopic dermatitis.

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The Pharma Data

JUNE 7, 2023

Rubin, senior vice president, global clinical development, Merck Research Laboratories. Patients with stage III and IV melanoma can be at high risk of having their cancer recur or metastasize to other sites,” said Dr. Eric H. The safety profile of KEYTRUDA was consistent with findings from previous studies.

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The Pharma Data

APRIL 28, 2023

In August 2022, the FDA accepted the supplemental New Drug Application for LYNPARZA plus abi/pred for priority review based on positive results from the pivotal Phase 3 PROpel trial, which were also published in NEJM Evidence. AstraZeneca and Merck will continue to work with the FDA as the agency completes its review of the application.

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The Pharma Data

APRIL 15, 2022

A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St. Louis is being advanced toward Phase I human clinical trials to treat COVID-19. coli, making them more cost-effective to manufacture.

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The Pharma Data

JANUARY 21, 2021

Prior to joining Labcorp, she held multiple appointments with The Children’s Hospital of Philadelphia, including Patient Safety Officer, chief of the Division of Transfusion Medicine and Vice-Chief of Pathology and Laboratory Medicine. Abbott Laboratories and TAP Pharmaceuticals. a company previously known as miRagen Therapeutics.

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The Pharma Data

APRIL 4, 2022

The sBLA is supported by data from two Phase 3 trials evaluating the efficacy and safety of Dupixent 300 mg weekly in patients aged 12 years and older with EoE ( Part A and Part B ), and data from an active long-term extension trial. Dupilumab Development Program. In September 2020, the U.S. About Eosinophilic Esophagitis (EoE).

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The Pharma Data

OCTOBER 27, 2020

Clynes developed several novel therapeutic approaches in cancer and autoimmunity, including DC targeting for cancer vaccines and Syk and JAK mediated inhibition of DCs and T cells in autoimmunity therapy. He is an internationally recognized key opinion leader, clinical investigator and translational research in mesothelioma.

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The Pharma Data

NOVEMBER 11, 2021

Reclamation for the VICTOR trial has begun. Like the VICTORIA trial, Merck and Bayer AG will serve asco-sponsors for the VICTOR trial. VICTOR is anticipated to take 39 months to complete, and the trial will include cases from 34 countries at roughly 500 spots around the world. The study will be executed by Merck.

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