Precision for Medicine

DECEMBER 1, 2023

December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinical research organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,

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Conversations in Drug Development Trends

MAY 1, 2024

By: Sarah Bly and Aman Khera, Regulatory Science and Innovation The journey of bringing a new therapeutic agent from the laboratory to the marketplace is fraught with challenges, not least of which is navigating the complexities of regulatory feedback, which do not always converge but can diverge.

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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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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

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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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The Pharma Data

JUNE 24, 2025

By aligning their research priorities, Bayer and Tsinghua are aiming to bridge the gap between academic research and industrial development. The goal is to transform laboratory discoveries into clinically relevant therapies that can reach patients faster and more efficiently.

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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

JANUARY 13, 2021

Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinical development, such as priority review and accelerated approval. Brilacidin antiviral research to date has been limited to laboratory-based experiments.

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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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Conversations in Drug Development Trends

MAY 15, 2025

Food and Drug Administration (FDA) within 30 days, providing a structured timeline for progressing with clinical trials. Early engagement with the FDA can help set expectations for future regulatory steps and ensure that non-clinical and clinical trial data meet global regulatory requirements.

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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 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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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

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

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

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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NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

These body-on-a-chip (BOC) devices place each tissue type in its own pea-sized chamber and connect them via fluid-filled microchannels into living, integrated biological systems on a laboratory plate. 2] Clinical development success rates for investigational drugs. Sci Transl Med. 2019 Jun 19;11(497). [2] Nat Biotechnol.

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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. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. Hillier et al.

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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

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

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

MARCH 5, 2021

The publication includes safety and efficacy data for 323 relapsed or refractory patients (including 170 with CLL/SLL, 61 with MCL, 26 with Waldenström’s macroglobulinemia and 66 with other B-cell lymphomas) that were enrolled to the BRUIN Phase 1/2 trial as of September 27, 2020. About the BRUIN Phase 1/2 Trial.

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The Pharma Data

OCTOBER 14, 2020

The CTS Rotea system is the first Gibco instrument for cell therapy processing applications and facilitates workflows from research through GMP clinical development and commercial manufacturing.

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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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Drug Target Review

OCTOBER 3, 2024

Moreover, ethical considerations regarding the use of laboratory animals further complicate the use of primate polyclonal serum, and successful immunisation is not always guaranteed. FDA no longer needs to require animal tests before human drug trials [Internet]. 1975 Aug;256(5517):495–7. Crescioli S, Kaplon H, Chenoweth A, et al.

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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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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

JUNE 26, 2021

Approval based on data from the largest trial to date in patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor Libtayo now approved by the European Commission for three advanced cancers. Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. “We

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NIH Director's Blog: Drug Development

SEPTEMBER 29, 2015

of Bioengineering, University of Wisconsin-Madison A lot of time, money, and effort are devoted to developing new drugs. Yet only one of every 10 drug candidates entering human clinical trials successfully goes on to receive approval from the Food and Drug Administration (FDA) [1]. Nat Biotechnol. 2014 Jan;32(1):40-51. [2]

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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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The Pharma Data

NOVEMBER 10, 2020

This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. In addition to Milciclib, the Company is also developing Foralumab for liver diseases.

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Precision for Medicine

JANUARY 23, 2023

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. This convergence of trials, labs and data sciences is driving faster clinical development and approval.

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The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.

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New Drug Approvals

JANUARY 3, 2023

1] It is being developed by Mirati Therapeutics. [1] 1] It is being developed by Mirati Therapeutics. [1] Identification of the Clinical Development Candidate MRTX849, a Covalent KRASG12C Inhibitor for the Treatment of Cancer.” 2] Research It is undergoing clinical trials. [5] 1] It is taken by mouth. [1]

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The Pharma Data

NOVEMBER 18, 2021

Senior Vice President, Early Clinical Development, Hematology/ Oncology and Cell Therapy and San Francisco point head. “ LabCentral offers completely permitted laboratory and office space for as numerous as 70 startups comprising roughly 500 scientists and entrepreneurs. AboutBioLabs@NYULangone( New York, NY).

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The Pharma Data

APRIL 11, 2021

” In the Phase 1/2 LIBRETTO-001 trial, 32 adult patients with 12 unique RET fusion-positive advanced cancer types were enrolled by the efficacy cutoff date of September 19, 2020 (with follow-up through March 19, 2021). Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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