Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. This is due to generally more stringent criteria on approvals in the wake of the Aduhelm scandal. However, non-NME and biosimilar approvals increased in 2022.

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Drugs Manufacturing Contract Manufacturing FDA Approval 130

XTalks

DECEMBER 28, 2023

BillionToOne will provide its UNITY Fetal Antigen Non-invasive Prenatal Test Clinical Trial Assay (UNITY Fetal Antigen CTA) as a critical screening tool to determine the eligibility of pregnant participants. Currently, there are no approved non-surgical treatments for pregnancies at high risk of this condition.

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Trials Clinical Trials Clinical Trials Antibody 97

The Pharma Data

JULY 8, 2021

KEYTRUDA has shown meaningful efficacy in patients with locally advanced or recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by surgery or radiation,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. 1) as determined by an FDA-approved test.

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FDA Approval Containment Trials Genome 52

Worldwide Clinical Trials

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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Gene Clinical Trials Clinical Trials Gene Therapy 204

The Pharma Data

DECEMBER 16, 2020

Benlysta is a human monoclonal antibody sold by GSK. The FDA first approved Benlysta for lupus in 2011. Last year, GSK announced positive results from a two-year clinical trial involving several hundred people with active lupus nephritis treated with Benlysta. .”

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FDA Approval Clinical Trials Clinical Trials Research 52

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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Vaccine Vaccination Protein Antibody 52

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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FDA Approval Containment Trials Genome 52

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.

FDA Approval 52

FDA Approval Containment Trials Genome 52

XTalks

JULY 3, 2024

Previously approved for generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive, Vyvgart Hytrulo is now available for CIDP patients as weekly 30-to-90 second subcutaneous injections. Injection site reactions were also noted in over 15 percent of CIDP patients.

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Clinical Trials Clinical Trials FDA Approval Antibody 52

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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Clinical Trials Clinical Trials Vaccine Vaccination 52

Find Me Cure

OCTOBER 13, 2019

This Breast Cancer Awareness Month we’d like to talk about emerging areas in metastatic breast cancer treatment since clinical research has come so far in recent years. There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials.

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Development DNA Clinical Trials Clinical Trials 52

XTalks

NOVEMBER 7, 2022

“Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

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Clinical Trials Clinical Trials Trials FDA Approval 98

The Pharma Data

APRIL 4, 2023

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Merck has the industry’s largest immuno-oncology clinical research program.

FDA Approval 40

FDA Approval Containment Hormones Dermatology 40

XTalks

MAY 17, 2024

The therapy is the first and only US Food and Drug Administration (FDA)-approved treatment that reduces the loss of kidney function in adults with the disease. He also traced his personal journey from the clinic to leading a rare disease biotech and winning FDA approval for a rare disease drug.

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Development Drugs Clinical Trials Clinical Trials 52

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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Research Antibody FDA Approval Trials 52

XTalks

OCTOBER 7, 2024

In addition, recent clinical research and new therapeutic approvals bring promising advances in managing rheumatic and musculoskeletal diseases (RMDs). DC-9476 also showed no toxicity, making it a potential candidate as a novel oral monotherapy.

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Clinical Trials Clinical Trials Trials Research 52

XTalks

AUGUST 30, 2022

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies.

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Trials Drug Delivery Drugs Gene 83

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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Research Clinical Trials Clinical Trials Trials 52

The Pharma Data

MARCH 23, 2021

KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. 1] as determined by an FDA-approved test.

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HR FDA Approval Containment Genome 52

XTalks

DECEMBER 17, 2021

While researchers are still learning more about Omicron, what we know is that it has the ability to spread quickly, has over 30 mutations in its spike protein and can impact the effectiveness of current vaccines. One of the answers to this is personalization, it’s respecting the fact that every brain is different.”.

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Life Science Vaccine Vaccination Trials 98

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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HR Trials Clinical Development Clinical Research 52

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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Clinical Trials Clinical Trials Trials Medicine 52

XTalks

SEPTEMBER 17, 2020

While clinical researchers occasionally need to identify and validate a new surrogate endpoint for a given trial, choosing endpoints that have been previously used as the basis of NDAs and BLAs can clear the path to eventual approval. Nizoral is prescribed off-label, while the others are FDA approved.

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Trials Gene Hormones Clinical Trials 98

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. XARELTO ® is not for use in people with artificial heart valves.

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Doctor Doctors Medicine Clinical Trials 52

The Pharma Data

SEPTEMBER 1, 2020

study investigator and Professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. Food and Drug Administration (FDA) approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020.

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Trials Clinical Trials Clinical Trials Vaccination 52