The Pharma Data

APRIL 11, 2023

Bayer will present the first clinical Phase 1 results on aryl hydrocarbon receptor (AhR) inhibitor BAY 2416964, the company’s most advanced Immuno-Oncology program. The company has the passion and determination to develop innovative medicines that help improve and extend the lives of people living with cancer.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The committee also made recommendations regarding pharmacokinetic and safety assessments. hours, the drug is no longer physiologically active.

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The Pharma Data

NOVEMBER 8, 2020

The active ingredient is violaxazine hydrochloride, which has an extensive safety record in Europe, where it was previously marketed as an antidepressant. SPN-812 is a serotonin norepinephrine modulating agent (SNMA).

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The Pharma Data

AUGUST 19, 2021

Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. “We 7 Janssen has filed regulatory submissions for RYBREVANT TM with health authorities in Europe and other markets. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

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The Pharma Data

AUGUST 29, 2020

3,4 LNP023 is currently in clinical development for PNH and a number of renal conditions with complement system involvement where significant unmet needs exist, including IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome and membranous nephropathy.

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The Premier Consulting Blog

JULY 31, 2024

Clinical Pharmacology in Drug Development Clinical pharmacology in drug development covers all aspects of interaction between humans and drugs. Clinical pharmacology studies include both in vitro studies using human biomaterials and in vivo human studies and are focused on characterizing pharmacokinetics (PK) (e.g.,

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The Pharma Data

JULY 21, 2021

As part of our commitment to understanding the potential for our HIV medicines in a broad range of patients, we focused on the enrollment of diverse patient populations at risk for HIV, including women, who have one of the highest unmet needs in HIV prevention.”.

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The Pharma Data

NOVEMBER 4, 2020

Unrealized gain (loss) on marketable equity securities. Concert Pharmaceuticals is a clinical stage biopharmaceutical company that is developing small molecule drugs that it discovered through the application of its DCE Platform® (deuterated chemical entity platform). . . .

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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 addition, COVID-19 may impact market conditions and the Company’s ability to seek additional funding or enter into partnerships.

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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

APRIL 11, 2021

Retevmo (marketed as Retsevmo ® outside the U.S.) The Phase 1/2 LIBRETTO-001 trial is the largest clinical trial of patients with RET -driven cancers treated with a RET inhibitor. Our approach centers on creating new oncology medicines that unequivocally work early in clinical development and will matter to patients.

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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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Drug Discovery World

DECEMBER 13, 2023

Fortis Life Sciences offers custom antibody discovery and manufacturing services for antibodies and single-domain antibodies, supporting the drug discovery market. View all of our offerings for the therapeutics and diagnostics markets. Moreover, custom antibodies are a key reagent in companion diagnostics for these novel therapeutics.

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Drug Target Review

JULY 1, 2024

Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. It addresses both acute and chronic pain, avoiding the addiction risks associated with opioids.

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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

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. Author: Minton. Presentation Number: P1133. Presentation Topic: Reproductive Aspects and Pregnancy.

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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. SHANGHAI , Jan.

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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). Consider Fig.

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Alta Sciences

APRIL 17, 2024

The FDA approved the first gene therapy in 2017 for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL), and as of December 2023, there are over 30 approved cell and gene therapies on the market in the U.S.A. Several bioanalytical strategies for the quantitation of ASOs are available at Altasciences.

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Conversations in Drug Development Trends

DECEMBER 20, 2023

In some cases, the FDA has had to remove approvals of oncology drugs based on single-arm trials after they came to market because confirmatory studies had found that the safety/tolerability profile was less acceptable in the wider population.

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PPD

JUNE 20, 2023

Biotech and biopharma companies with a dependable contract research organization (CRO) partner will derive strong value across all business cycles — ensuring project delivery excellence and continued speed to market. Does your CRO leverage data-backed intelligence to accelerate your clinical development strategy?

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Agency IQ

AUGUST 9, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. What about combination products?

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The Pharma Data

NOVEMBER 11, 2020

These data provide further evidence of efficacy and high potency of SLV213 against SARS-CoV-2 and support the clinical development of SLV213 as a potential oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “As Cofounder and Chief Scientific Officer of Selva Therapeutics.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

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Drug Discovery World

FEBRUARY 15, 2023

Rising demand The global immuno-oncology assay market is expected to grow at a compound annual growth rate (CAGR) of 11.87% from 2021 to 2030 to reach 11.74bn USD by 2030 7. These models have greatly contributed to the clinical development of several tumour immunotherapies. Science 271, 1734–1736 (1996). Korman, A.

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The Pharma Data

MAY 7, 2021

Review will support a formal Marketing Authorisation Application. The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The rolling review will continue until enough evidence is available to support a formal marketing authorisation application.

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Agency IQ

JULY 26, 2024

BY LAURA DIANGELO, MPH , RACHEL COE, MSC | JUL 23, 2024 9:54 PM CDT Biosimilarity and interchangeability: A quick recap The Biologics Price Competition and Innovation (BPCI) Act of 2009 intended to increase the number of biologic products on the market by creating two types of approvals for biosimilar products.

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Agency IQ

AUGUST 16, 2024

The guidance emphasizes that identification of an optimized dosage(s) can occur prior to or concurrently with the establishment of the drug’s safety and efficacy; however, this process should occur prior to the submission of a marketing application. Stay tuned for Part 2 of Agency IQ’s analysis of the final guidance.

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The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. Pipeline Updates. •. ?.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. A sponsor could conduct a study that is not initially viewed as pivotal but which ends up being so for its marketing application.

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The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML.

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The Pharma Data

MARCH 17, 2021

In adjuvant breast cancer trials, this includes the length of time before any cancer comes back, a new cancer develops or death. Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes. Across clinical trials (MONARCH 1, MONARCH 2, MONARCH 3), 3.3%

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Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. In general, regulatory nonclinical studies conducted in animals should mirror the conduct of clinical trials as closely as possible.

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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The Pharma Data

DECEMBER 15, 2020

Anokion is responsible for preclinical activities and Phase I clinical development of partnered programs, and Bristol Myers Squibb will fund subsequent trials and commercial activities at clinical proof-of-concept. The secondary outcome involves pharmacokinetic endpoints. Receptor Inhibitors. Oral, Small Molecules.

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The Pharma Data

SEPTEMBER 15, 2020

The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval.

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Agency IQ

DECEMBER 11, 2023

In addition, it may also be unethical to operate a control arm in some cases, such as when there is no currently marketed treatment option for a life-threatening disease. In other cases, patients may not wish to enroll in a study if there is a chance they would not benefit, as would be the case if they might receive a placebo.

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