The Pharma Data

JANUARY 6, 2021

“Further, PDE4-inhibition is a well-documented pharmacological target for a number of other inflammatory indications, and we look forward to advancing our clinical research to realize the full potential of orismilast for the benefit of the millions of patients living with inflammatory conditions globally,” adds Professor Sommer.

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KIF1A

JULY 1, 2023

But drug R&D is an uncertain process, and many therapeutics get shelved during preclinical or clinical research, before they ever reach a patient. Taking a drug that shelved during development or didn’t receive FDA approval, and assessing its application for another disease, is called drug repositioning.

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Advarra

JULY 5, 2022

Individuals invest a great deal to participate in clinical research, undertaking risks and burdens, while giving of their time and energies to advance scientific knowledge and the public good. Conversely, a CGM not yet FDA-approved assessed in the study for reliability, would yield an investigational result.

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The Pharma Data

AUGUST 20, 2020

Current FDA-approved meningitis vaccines help protect young persons who complete a four-injection regimen during adolescence but unfortunately, only a small percentage receive all four,” said Dr Charles Andrews, one of the study’s investigators and director of Clinical Research at the Diagnostic Research Group in San Antonio, Texas.

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The Pharma Data

MARCH 30, 2021

“KEYTRUDA has become an important treatment option for certain patients with locally advanced or metastatic bladder cancer in the European Union and other countries around the world,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We 1] as determined by an FDA-approved test.

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The Pharma Data

JULY 6, 2021

accelerated approval indication for KEYTRUDA for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [combined positive score (CPS ?1)] Merck has the industry’s largest immuno-oncology clinical research program.

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Advarra

AUGUST 8, 2023

As of June 2023, 416 Phase III studies are listed, representing a growing pipeline of gene therapy products preparing to undergo consideration for FDA approval. Risks and Regulatory Requirements Most clinical researchers are familiar with the regulatory requirements pertaining to the FDA phases of review as well as with IRB review.

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The Pharma Data

NOVEMBER 16, 2020

The partnership brings NIH together with other HHS agencies and government partners and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. El Sahly, M.D.,

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Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated.

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Advarra

NOVEMBER 17, 2022

In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). While the FDA’s approval of nusinersen may not seem extraordinary, it was. Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children. Why This Guidance Now?

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Advarra

SEPTEMBER 30, 2022

Is the clinical research industry winning or failing at innovation? Despite the fast pace of medical innovation, the lack of consistency between technology systems managing these advancements ultimately inhibits research progress. . Has innovation really succeeded in clinical research if this is the state we’re currently in?

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Drug Target Review

FEBRUARY 21, 2024

There is more to come for CAR-T cell treatments, and I would expect that perhaps in five years, oncologists and hematologists may have to rethink how they approach their fields since clinical research is moving at lightning speed.

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Conversations in Drug Development Trends

FEBRUARY 26, 2024

From a combined perspective, somewhere along the way, we tend to be able to land at what is the true design of clinical research,” says Perez. The research provides valuable data to sponsors and researchers regarding what is most important to patients with these conditions. And, frankly, none of them are wrong.

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Advarra

JUNE 20, 2023

According to a 10-year oncology research study conducted by the Biotechnology Innovation Organization (BIO), only 5.1% of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval.

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Vial

DECEMBER 5, 2023

In 2017, the Food & Drug Administration (FDA) approved the first gene therapy for cancer and for inherited diseases, the first multiplex NGS panel for companion diagnostics (CDx), and the first drug targeting a genetic signature though not a disease. Satam et al.

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The Pharma Data

MARCH 11, 2021

Session Category: Clinical Research (Excluding Trials). Session Title: Disease-Oriented Innovative Clinical Research and Trials. Session Type: Clinical Trials Minisymposium. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50 Abstract Number: 442.

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The Pharma Data

MARCH 23, 2021

Merck has the industry’s largest immuno-oncology clinical research program. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

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Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines.

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The Pharma Data

APRIL 4, 2023

Merck has the industry’s largest immuno-oncology clinical research program. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

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The Pharma Data

OCTOBER 22, 2020

With today’s FDA approval, and regulatory approvals or temporary authorizations in approximately 50 additional countries around the world, Veklury® (remdesivir) is one of the tools available today. ii] The ACTT-1 study sets a high bar for clinical evidence that must be considered as new data emerge. Posted: October 2020.

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Conversations in Drug Development Trends

MAY 30, 2024

From drugs previously FDA-approved for gallstone diseases, Parkinson’s disease, and even cancer, researchers are working tirelessly to test and establish whether these pharmacotherapies with well-defined safety profiles may have any potential for efficacy in treating ALS.

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The Pharma Data

MARCH 26, 2021

Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC. If approved, ponesimod will be the first therapy by Janssen for patients living with RMS with active disease defined by clinical or imaging features. 6]. ###.

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The Pharma Data

JANUARY 22, 2021

22, 2021 /PRNewswire/ — The Lupus Research Alliance (LRA) is excited to share that the U.S. Food and Drug Administration (FDA) approved the use of Aurinia Pharmaceuticals’ Lupkynis TM (voclosporin) as the first oral treatment developed specifically for adults with active lupus nephritis (LN) in combination with standard of care.

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The Pharma Data

APRIL 27, 2022

Migraine is often overlooked and undertreated, resulting in substantial disability with suboptimal care for patients,” commented Professor Peter Goadsby, Director of the National Institute for Health and Care Research (NIHR) Clinical Research Facility and Professor of Neurology at King’s College London.

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The Pharma Data

JUNE 24, 2021

Professor of Oncology at the University of Utah School of Medicine, Senior Director for Clinical Research Innovation at Huntsman Cancer Institute and member of the TALAPRO-3 steering committee. Selection of patients for therapy is based on an FDA-approved companion diagnostic for TALZENNA.

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The Pharma Data

SEPTEMBER 8, 2020

The findings are expected to improve current understanding of MS disease biology and treatment response, among African-American and Hispanic- and Latinx-American patients with MS, with the ultimate goal of increasing high-quality standard of care to traditionally underserved communities and enhancing equality through clinical research.

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The Pharma Data

JULY 15, 2021

“These highly anticipated event-free survival results in this TNBC population build upon earlier findings from the KEYNOTE-522 trial and further support the potential use of KEYTRUDA in these patients,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories.

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The Anticancer Fund

OCTOBER 18, 2023

The results show that enoxacin, an FDA approved antibiotic, was able to slow tumour growth compared to untreated controls and compared to etoposide alone. Gauthier Bouche & Pan Pantziarka Gauthier Bouche (MD) is Director of Clinical Research at the Anticancer Fund.

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Drug Target Review

AUGUST 3, 2023

Doctors and other healthcare professionals have very little time to devote to signposting patients to research, so we have to explore other ways to find participants and, crucially, keep them engaged. That needs to change. Could you provide insights into the process of developing the at-home DNA tests used by Sano?

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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

The program relies on four expert “working groups” with specific charges: Preclinical Working Group : Shares standardized preclinical evaluation resources and accelerate testing of candidate therapies and vaccines for clinical trials.

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The Pharma Data

JANUARY 24, 2021

Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to treat a variety of acute and chronic diseases. In clinical research, Cepharanthine exhibits multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic properties.

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The Pharma Data

JANUARY 17, 2021

The service is expected to become operational in 2021 and will be available for clinical research and clinical care — starting with private patients, followed by expansion into the public healthcare system over time. “We Guardant Health has achieved CE mark approval as well as U.S. This press release features multimedia.

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NIH Director's Blog: Drug Development

JULY 20, 2017

These results, along with data from another clinical trial expected to begin later this year, will be used by Vertex to select which next-generation targeted drug or combination of drugs will move forward into larger scale Phase III studies. About 30,000 Americans have CF.

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Agency IQ

NOVEMBER 3, 2023

In simpler terms, these are live microbes that have actually demonstrated health benefits in clinical research. Keep in mind that this is the definition developed by ISAPP – there is no regulatory body confirming that any product on the market referred to as a “probiotic” has actually demonstrated benefits in clinical research.

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The Pharma Data

JULY 29, 2021

Launch activities continue following the full FDA approval for second-line metastatic triple-negative breast cancer (“mTNBC”) and accelerated approval for metastatic urothelial cancer. Gilead welcomed William Grossman, MD, PhD, as Senior Vice President, Oncology Clinical Research.

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The Anticancer Fund

JUNE 23, 2023

They screened 20 FDA approved AEDs against a panel of six patient-derived IDHmut glioma stem-like cells. Gauthier Bouche & Pan Pantziarka Gauthier Bouche (MD) is Director of Clinical Research at the Anticancer Fund. Of the screened drugs two, oxcarbazepine and perampanel, demonstrated an antiproliferative effect.

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The Pharma Data

JUNE 26, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure, a surgical procedure that redirects blood flow from the lower body to the lungs.

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