FDA Law Blog: Drug Discovery

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For many drugs, both a registry and an outcomes study are required.

Marketing 59

Marketing FDA Regulations Pharmacokinetics 59

Practical Cheminformatics

JANUARY 8, 2024

Picking up where we left off in Part I , this post covers several other ML in drug discovery topics that interested me in 2023. Most of the LLM activity in the drug discovery space in 2023 was reported as preprints from academic groups. Most of the drug discovery examples were underwhelming. Here’s the structure of Part II.

Drugs 140

Drugs Small Molecule Bioinformatics Packaging 140

Drug Target Review

NOVEMBER 15, 2023

Drug discovery is an interdisciplinary process that relies heavily on expert input from diverse and multifaceted teams, from medicinal, synthetic, and computational chemists to biologists and drug metabolism and pharmacokinetics (DMPK) scientists.

Pharmacokinetics 105

Pharmacokinetics International Laboratories Drugs 105

DrugBank

MARCH 7, 2024

The landscape of weight loss drugs has been rapidly evolving, and 2024 is poised to be another transformative year in this market. Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. Let’s delve into what lies ahead in the coming year.

Pharmaceutical Companies 80

Pharmaceutical Companies Pharmaceuticals Clinical Trials Therapies 80

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.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

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.

Clinical Trials 83

Clinical Trials Trials Pharmacokinetics FDA 83

PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. When imaged, the hiPSC showed a stable beating rate.

Drugs 52

Drugs FDA Approval Pharmacokinetics Drug Development 52

The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. Since there was no change in drug substance, the sponsor was able to reference the DMF.

Drugs 52

Drugs Clinical Pharmacology Packaging Small Molecule 52

New Drug Approvals

OCTOBER 12, 2024

After tramiprosate failed in Phase 3, its maker, NeuroChem, marketed it as a nutritional supplement. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease. Clin Pharmacokinet. 2016 ; Abushakra et al., 2018; 32(9): 849–861. [2].

Pharmacokinetics 62

Pharmacokinetics Small Molecule Disease Licensing 62

LifeSciVC

APRIL 24, 2024

Is a novel target at the inflection point where enough evidence is available to suggest it may prove to be a compelling drug? Directionality and Druggability: Does the proposed “direction” of insult and therapeutic intervention make sense, and can we drug our novel target with a compelling modality?

Production 114

Production Small Molecule Regulations Trials 114

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. In this complimentary webinar , Mel B. Watch the webinar.

Drug Development 40

Drug Development Clinical Trials Biosimilars Pharmacokinetics 40

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.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

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.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Pharma Data

JANUARY 26, 2021

Previous human pharmacokinetic (PK) study showed significantly better PK profile when compared to market leading product. US market for overdose rescue medications. Patent protection until 2039. UPPSALA, Sweden , Jan. Tel: +46 (0)18 780 88 00. About Orexo.

Drugs 40

Drugs Pharmacokinetics Production Marketing 40

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.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Click to enlarge At several steps during CGT development and testing, sensitive, accurate and precise quantitation of CGT drug vectors is required.

Laboratories 52

Laboratories Clinical Trials Protein Expression Pharmacokinetics 52

Drug Target Review

JULY 1, 2024

Can you explain the mechanism of action of SRP-001 and how it differs from traditional analgesics like acetaminophen (ApAP) and non-steroidal anti-inflammatory drugs (NSAIDs) in treating acute, chronic and neuropathic pain? We set out to improve health by developing a novel non-opioid that avoids potential abuse.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

Alta Sciences

SEPTEMBER 12, 2024

Each preclinical formulation development program has unique formulation goals; whether it be to maximize potency or bioavailability, to change the drug-release timing, to improve safety and stability, or to provide improved handling characteristics. We were required to develop a formulation from the ground up.

Pharmacokinetics 52

Pharmacokinetics Compliance Pharmaceuticals FDA 52

The Pharma Data

NOVEMBER 11, 2020

Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. While SLV213 can be dosed orally or intravenously, Selva is first advancing it as an oral drug candidate for COVID-19. About SLV213.

Treatment 52

Treatment Small Molecule Virus Pharmacokinetics 52

The Pharma Data

MARCH 9, 2022

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

Treatment 52

Treatment Pharmacokinetics Hospitals Trials 52

The Pharma Data

JANUARY 17, 2021

SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. Spero plans to initiate additional Phase 1 studies to assess the penetration of SPR206 into the pulmonary compartment and pharmacokinetics in subjects with renal impairment in 2021.

Clinical Trials 52

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 52

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). Pfizer Inc. NYSE: PFE) today announced that the U.S.

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

The Pharma Data

DECEMBER 27, 2020

(HKEX: 1672) and fully dedicated to the R&D and commercialization of new drugs in the field of NASH, announces today dosing of first subject with its NASH drug candidate ASC42, a Farnesoid X Receptor (FXR) agonist, in a U.S. Food and Drug Administration (FDA) for NASH. Phase I Trial. ASC42 is an in-house developed?novel

Trials 40

Trials Pharmacokinetics Clinical Trials Therapies 40

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.

Hospitals 52

Hospitals Pharmacokinetics Treatment Trials 52

The Pharma Data

JANUARY 17, 2021

a global leader in providing drug discovery animal model solutions, announces an expansion of its immuno-oncology portfolio. . One consideration in using syngeneic models is that some drug candidates can cause a negative immune response not seen in humans. RENSSELAER, N.Y., Source link.

Immune Response 40

Immune Response Pharmacokinetics Engineering Licensing 40

PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. The drug development industry is undoubtedly in a season of change. Does your CRO have a pulse on the issues?

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 52

New Drug Approvals

JANUARY 13, 2023

6] Peak plasma concentrations of the drug are reached within one hour. [6] 8] There are no drug interactions identified with forasartan. [6] a comprehensive resource for ‘omics’ research on drugs” Nucleic Acids Research. The dose administered ranges between 150 mg-200 mg daily. [6] “DrugBank 3.0:

Pharmacokinetics 52

Pharmacokinetics Drugs Production Research 52

The Pharma Data

NOVEMBER 8, 2020

Food and Drug Administration (FDA) in terms of PDUFA dates. The active ingredient is violaxazine hydrochloride, which has an extensive safety record in Europe, where it was previously marketed as an antidepressant. November is promising to be a busy month for the U.S. Supernus Pharmaceuticals’ SPN-812 for ADHD.

FDA 52

FDA Trials Therapies Pharmaceuticals 52

The Pharma Data

DECEMBER 29, 2020

“We anticipate that the BRIDGE study results will be used to support the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency, and having completed the analysis, we have taken an important step in the preparations for the application.” ” Additional Details about the BRIDGE Study.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

APRIL 27, 2021

FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with HER2 mutations or EGFR mutations including Exon20 insertion mutations. The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC).

FDA 52

FDA Treatment Pharmaceutical Companies Therapies 52

The Pharma Data

JANUARY 4, 2021

05, 2021 (GLOBE NEWSWIRE) — Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“ Innate ” or the “ Company ”) today announced that Sanofi has made the decision to progress IPH6101/SAR443579 into investigational new drug (IND)-enabling studies. . MARSEILLE, France, Jan. Cell 2019 ).

Drugs 40

Drugs Cell Biology Pharmacokinetics Clinical Trials 40

The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. . Galactosidase-A enzyme.

Disease 52

Disease Treatment Clinical Trials FDA 52

Agency IQ

JULY 28, 2023

First, an audit of communications and meeting management under the Prescription Drug User Fee Act (PDUFA) Quick background: As AgencyIQ has previously discussed, the FDA collects user fees as part of an essential bargain between regulators and industry. This week, FDA posted several new special notice contract opportunities on SAM.

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

The Pharma Data

APRIL 7, 2022

Food and Drug Administration (FDA). REVIRAL1 is a global three-part adaptive study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, antiviral effects, and clinical effect of single and multiple oral doses of sisunatovir in otherwise healthy infants between the ages of 1 and 36 months hospitalized with RSV LRTIs.

Virus 52

Virus Vaccine Clinical Development Hospitals 52

Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. One of the core goals of the GDUFA program has been to increase the efficiency of the generic drug review program.

Science 40

Science FDA Drugs Production 40

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.

Trials 40

Trials Clinical Trials Pharmacokinetics Small Molecule 40

The Pharma Data

JULY 11, 2021

Depending on regional marketing authorization, TAKHZYRO is available as a 300 mg dose in a vial or pre-filled syringe. No dedicated drug-drug interaction studies have been conducted. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected.

Treatment 52

Treatment Pharmacokinetics Disease Production 52