LifeSciVC

OCTOBER 13, 2022

This summer, approvals on both sides of the Atlantic – for beta thalassemia and cerebral adrenoleukodystrophy in the United States and for severe hemophilia A and aromatic L-amino acid carboxylase deficiency in Europe – show that regulators are likely open to green-lighting a range of emerging gene therapies.

Therapies 40

Therapies Disease Treatment Marketing 40

Drug Target Review

SEPTEMBER 26, 2023

Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. Within the field of drug safety hiPSC-cardiomyocytes are now routinely used for early identification of cardiac liabilities in drug discovery.

Drugs 111

Drugs FDA Disease Animal Testing 111

The Pharma Data

JANUARY 13, 2021

Lancet Respir Med 2013. In addition, nebulized ensifentrine showed further improved lung function and reduced lung volumes in COPD patients taking standard short- and long-acting bronchodilator therapy, including maximum bronchodilator treatment with dual/triple therapy. Franciosi LG, et al., . .

Hospitals 52

Hospitals Clinical Trials Therapies Treatment 52

The Pharma Data

JANUARY 7, 2021

RMI), a global biotechnology company developing precision-targeted cancer therapies based on its proprietary, anti-cancer treatment platform, Illuminox , will present at the 39th Annual J.P. Outside of Japan, Illuminox therapies have not yet been approved as safe or effective by any regulatory authority. SAN MATEO, Calif. ,

Clinical Trials 40

Clinical Trials Therapies Trials Licensing 40

The Pharma Data

JANUARY 6, 2021

This is a landmark study in converting the power of lethal botulinum neurotoxins into therapies. The approach used to turn botulinum toxin into a kind of Trojan horse that delivers a cargo into neurons has enormous potential for future drug development,” noted Thomas C. Südhof, M.D., Südhof, M.D.,

Science 52

Science Molecular Biology Treatment Production 52

The Pharma Data

DECEMBER 27, 2020

As part of its broad development program, BeiGene expects to work with the NHSA for potential NRDL inclusion in future expanded indications for these medicines. As part of its broad development program, BeiGene expects to work with the NHSA for potential NRDL inclusion in future expanded indications for these medicines.

Production 52

Production Therapies Treatment Drugs 52

Codon

APRIL 9, 2024

falciparum to monotherapy with conventional drugs like chloroquine and sulfadoxine-pyrimethamine, that the WHO recommended treating malaria with drugs in combination with artemisinin. Department of Defense administered mefloquine, the synthetic drug developed at Walter Reed in the U.S.,

Drugs 139

Drugs Science Research Doctors 139

The Pharma Data

NOVEMBER 29, 2020

Antiviral therapies are used to help control disease, but they are limited by toxicity and the emergence of viral resistance. Participants receive either pre-emptive or prophylactic antiviral therapy post-transplant and are followed for a 12-month observation period. Human Cytomegalovirus Resistance to Antiviral Drugs.

Vaccine 40

Vaccine Clinical Trials Disease Therapies 40

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 12] Positron emission tomography imaging revealed that brain KORs were almost completely saturated by the drug 2.5 March 2013). Drug Discovery.

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

The Pharma Data

DECEMBER 15, 2020

A total of 43 patients initially diagnosed with unresectable stage IV metastatic PDAC, who had progressed following first-line gemcitabine-based therapy, were enrolled in the triple combination arm. BioLineRx plans to present the full data set at an upcoming medical conference. Kenilworth, N.J. , These results are being announced today.

Clinical Trials 40

Clinical Trials Trials Treatment Therapies 40

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.

FDA 40

FDA Treatment Trials Therapies 40

The Pharma Data

APRIL 25, 2021

Editor’s note: In January 2021, nirsevimab received the Promising Innovative Medicine (PIM) Designation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and was also granted the Breakthrough Therapy Designation (BTD) by the China Center for Drug Evaluation (CDE) under the National Medical Products Administration.

Virus 40

Virus Trials Disease Hospitals 40

Agency IQ

DECEMBER 15, 2023

This includes questions about the scope of the rule itself and the FDA’s plan for implementation and more granular questions about implications for specific product types, including companion diagnostics (CDx) or LDTs used in drug development as clinical trial assays.

Laboratories 40

Laboratories Science FDA Regulations 40

Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. EMA has now published a report on the workshop; read on for AgencyIQ’s analysis.

Clinical Trials 40

Clinical Trials Regulations Trials FDA 40

NIH Director's Blog: Drug Development

SEPTEMBER 18, 2014

Such knowledge would allow tailoring of therapy, thereby minimizing the broad-spectrum antibiotic approach used by many clinicians today, in which they take aim at a broad array of bacteria while awaiting culture results to identify a specific bacterial target. Note: Anthony S. Fauci, M.D.,

Clinical Trials 52

Clinical Trials Vaccine DNA Trials 52

Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

FDA 40

FDA Science Biosimilars Regulations 40

SugarCone Biotech

MAY 28, 2019

Learnings regarding immune geography and cell:cell contact are increasingly important as we consider how best to advance cell therapies for diverse hematologic malignancies and solid tumors ( www.aletabio.com ). This was an interesting finding and one that I think remains under-appreciated by the immuno-oncology drug development field.

Immune Response 52

Immune Response Therapies Engineering Drug Development 52