Sygnature Discovery

NOVEMBER 29, 2023

Patients at a clinical cancer center in Michigan, USA, have been dosed with the experimental drug QN-302, a potential first-in-class novel treatment for advanced or metastatic solid tumors. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

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Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) ’s focus appears to be on Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines, as the year wraps up there are still some PDUFA dates on the agency’s calendar. MacroGenics partnered with Zai Labs, based in Shanghai, China and San Francisco, on the drug.

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The Pharma Data

OCTOBER 27, 2020

The company plans to tackle the existing challenges of precision medicine with a three-prong approach – developing better medicines for known cancer-driving mutations, developing drugs for targets previously thought to be undruggable, and finding new, untapped targets that could lead to even better drugs.

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Sygnature Discovery

NOVEMBER 29, 2023

Patients at a clinical cancer center in Michigan, USA, have been dosed with the experimental drug QN-302, a potential first-in-class novel treatment for advanced or metastatic solid tumors. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

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PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

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The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. JERSEY CITY, N.J., 1) L iposomal IV formulation of ibrexafungerp entering Phase 1 study.

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The Pharma Data

NOVEMBER 9, 2021

We ’re agitated to partake data from our robust clinical development programs at AASLD’s The Liver Meeting ®, including the rearmost data demonstrating the positive impacts of bulevirtide for people living with HDV.”. Food and Drug Administration (FDA). Bulevirtide is an investigational agent in theU.S.

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The Pharma Data

NOVEMBER 5, 2021

With presently no approved treatments, there’s a major unmet need for curatives that can delay progression to order failure, “ said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis. About Novartis Novartis is reimagining drug to ameliorate and extend people’s lives.

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The Pharma Data

NOVEMBER 8, 2020

Food and Drug Administration (FDA) in terms of PDUFA dates. The drug is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to improve the efficacy of olanzapine while decreasing olanzapine-associated weight gain. November is promising to be a busy month for the U.S.

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The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. ‘SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties.

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The Pharma Data

JANUARY 3, 2021

Food and Drug Administration cleared Investigational New Drug Application. United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. The European Medicines Agency has also granted orphan drug designation to INZ-701 for the treatment of ENPP1 deficiency.

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The Pharma Data

APRIL 11, 2023

A focus of the presentation will be on the target engagement results and pharmacokinetics from its ongoing monotherapy dose-escalation study to explore a potential optimal dose and schedule to effectively inhibit AhR.

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Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

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The Pharma Data

OCTOBER 25, 2020

Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. BXCL501 has been granted Fast Track Designation by the U.S. BioXcel Therapeutics, Inc.

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PPD

SEPTEMBER 19, 2023

During the drug development process, companies have a choice of different approaches based on their development plan requirements. Whichever route a company takes, deliberate decision-making around the nature and timing of early phase studies is important to manage risks in the clinical development process.

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The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 1 Dose interruptions occurred in 32 percent of patients.

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The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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Drug Target Review

OCTOBER 3, 2024

Since the 1970s, when hybridoma technology enabling the generation of monoclonal antibodies (mAbs) was first developed, 1 antibody-based therapeutics have become one of the most rapidly growing drug categories, with applications across cancer indications, immune disorders and infections.

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The Pharma Data

AUGUST 29, 2020

First-in-class LNP023 – which potently and selectively targets factor B, part of the immune system’s alternative complement pathway 3,4,5 – is also in development for several renal conditions with complement system involvement . The FDA and EMA have granted orphan drug designations to LNP023 for the treatment of PNH and C3G.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Speak with an expert today to discuss your next clinical program. Watch the webinar.

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The Pharma Data

JULY 21, 2021

Most adverse events (AEs) were mild and there were no serious drug-related AEs in people who received islatravir. There were no serious drug-related AEs in people who received islatravir. After 24 weeks, once-monthly oral islatravir was generally well tolerated versus placebo.

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The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

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The Pharma Data

DECEMBER 13, 2020

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. In its mid-to-late-stage pipeline, the Company is currently advancing three drug candidates as well as earlier-stage opportunities.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., CTP-543 for moderate to severe alopecia areata, which received U.S.

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The Pharma Data

APRIL 11, 2021

Monitor the QT interval more frequently when Retevmo is concomitantly administered with strong and moderate CYP3A inhibitors or drugs known to prolong QTc interval. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated. About Lilly Oncology.

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The Pharma Data

SEPTEMBER 1, 2020

Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod. with arrhythmias requiring treatment with Class 1a or III anti-arrhythmic drugs.

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The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

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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. No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and Islatravir.

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LifeSciVC

APRIL 24, 2024

There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). From the above genetics exploration, is the functional impact known?

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The Pharma Data

APRIL 7, 2022

Sisunatovir significantly reduced viral load in a phase 2 RSV human challenge study in healthy adults and is currently in phase 2 clinical development in infants. The development program for sisunatovir is expected to continue in both adult and pediatric populations. Food and Drug Administration (FDA).

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. ” About SPR206.

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Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. This constitutes an interesting subset of 9 drugs, constituting over 25% of the new small molecule drug approvals in 2023!

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Conversations in Drug Development Trends

DECEMBER 20, 2023

If two or more doses are discovered to have comparable efficacy, the lowest effective dose should be used in the registration trial to help minimize the toxicity effects when the drug is used in a broader heterogeneous patient population. Platform Trial: Incorporates multiple drugs and/or different tumor types in various study arms.

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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Tapinarof is metabolised by multiple pathways including oxidation, glucuronidation, and sulfation.

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