FDA Law Blog: Biosimilars

JULY 23, 2024

Design validation may be covered by clinical studies, pharmacokinetic/pharmacodynamic or bioequivalence/bioavailability studies, literature, simulated bench testing, and/or anthropometric data and should include endpoints that have the capability of validating device performance.

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DrugBank

OCTOBER 17, 2024

Computational chemistry and molecular modeling techniques can predict potential drug candidates' binding affinity and pharmacokinetic properties, enabling the selection of the most promising compounds for further development.

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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.

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Drug Target Review

APRIL 22, 2024

Despite excellent pharmacokinetic and stable antibody-linker connections, such ADCs have yet to receive market approval. How do the selection of linkers and conjugation sites impact the pharmacokinetics and therapeutic window of an ADC?

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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].

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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. Nick has previously held senior leadership positions with WuXi AppTec and Optibrium.

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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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The Pharma Data

JUNE 17, 2022

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe.

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The Premier Consulting Blog

JULY 31, 2024

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., Author: Jayesh Patel , Principal Scientist, Pharmacokinetics It is important to work with a partner with experience and who recognizes these opportunities.

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The Pharma Data

APRIL 4, 2023

With eight marketed biosimilars Sandoz is offering the broadest biosimilar portfolio and is the leading biosimilars company in Europe with more than two decades of experience. The study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the two concentrations.

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Drug Target Review

OCTOBER 3, 2024

These assays may include pharmacokinetic (PK) assays, which provide information on the drug’s properties, and immunogenicity assays for the detection of anti-drug antibodies (ADA), which can lead to adverse events and reduced efficacy. Prior to this, he worked at an in vitro immuno-diagnostic company as Strategic Marketing Manager.

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The Pharma Data

JULY 6, 2021

New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented. Sanofi’s two marketed extended half-life factor replacement therapies shifted a two-decades-old treatment paradigm when launched in 2014.

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Alta Sciences

OCTOBER 30, 2023

35: Critical Considerations for the Safe and Compliant Manufacture of Highly Potent Drugs Mainly driven by oncological research, the demand for highly potent active pharmaceutical ingredients (HPAPIs) has increased over the past 10 years—with over 25% on the market formulated with HPAPIs. Watch it now. The Altascientist : Issue No.

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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.

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PerkinElmer

JANUARY 7, 2022

There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. Furthermore, nearly one third of drugs get withdrawn from the market post approval due to safety concerns.

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LifeSciVC

APRIL 24, 2024

Consider anticipated time to market (not just time to the clinic), competitiveness of the mechanism itself and broader competition for the indication at large, and potential impact on patient lives should discovery and development be successful. Consider Fig.

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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.

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Drug Target Review

JULY 1, 2024

Could you elaborate on the potential market size for SRP-001 and how it fits into the broader landscape of pain therapies? The global pain management market is projected to reach about $87 billion by 2025, driven by rising chronic diseases, an ageing population and more surgical procedures. Reference 1 Bazan H A, et al.

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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. Human factors. The new formulation resulted in a drug product that was very viscous.

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Alta Sciences

SEPTEMBER 12, 2024

Their goal was to develop a robust formulation prototype at the maximum potency, for preclinical work, including efficacy, pharmacokinetics , and toxicology studies. Client Study Overview A client approached us with the need to get their API BSC Class II compound through the preclinical formulation development phase.

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DrugBank

APRIL 3, 2025

These studies typically include in vitro assays to evaluate cytotoxicity and in vivo models to study pharmacokinetics, pharmacodynamics, and toxicological profiles. Liver-on-chip models, for instance, have been instrumental in understanding drug-induced liver injury , a leading cause of market withdrawals.

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The Pharma Data

JANUARY 17, 2021

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. In addition, no evidence of nephrotoxicity was observed in the study.

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The Pharma Data

NOVEMBER 11, 2020

We now have compelling data showing SLV213 has potent antiviral activity against SARS-CoV-2 as well as data on the safety, tolerability, and pharmacokinetics and pharmacodynamics of SLV213 in several preclinical model systems, including nonhuman primates,” said Felix Frueh, Ph.D., Cofounder and Chief Scientific Officer of Selva Therapeutics.

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DrugBank

FEBRUARY 12, 2025

This approach capitalizes on prior investments in R&D, mitigates risk by leveraging established safety and pharmacokinetic profiles, and accelerates the delivery of treatments to patients. Animal Models In vivo studies in animal models assess drug activity, pharmacokinetics, and safety in a living organism.

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The Pharma Data

JANUARY 17, 2021

Because the Jh mouse cannot produce ADA, there is no neutralizing or pharmacokinetic impact on the therapeutic or anaphylaxis risk. Media Contact: Kelly Owen Grover Director of Marketing Communications 518-478-6095 kelly.grover@taconic.com . Source link.

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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.” Galactosidase-A enzyme. Protalix has licensed to Pfizer Inc.

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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. The study will be conducted in South Africa. For more information, visit www.scynexis.com.

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The Pharma Data

DECEMBER 27, 2020

phase I trial is a randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics (biomarkers – FGF19 and C4) of ASC42 in healthy subjects. Phase I Trial. This trial also investigates the food effect on ASC42 exposure.

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The Pharma Data

JUNE 28, 2021

Part A evaluated the single- and multiple-dose pharmacokinetic and pharmacodynamic properties of Xarelto while Part B evaluated the comparative safety and efficacy of Xarelto versus aspirin when used for thromboprophylaxis for 12 months. Xarelto is marketed outside the U.S. by Bayer and in the U.S. by Janssen Pharmaceuticals, Inc.

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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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New Drug Approvals

JANUARY 13, 2023

“SC-52458, an orally active angiotensin II-receptor antagonist: inhibition of blood pressure response to angiotensin II challenges and pharmacokinetics in normal volunteers” Journal of Cardiovascular Pharmacology. 29 (4): 444–50. doi : 10.1097/00005344-199704000-00003. PMID 9156352. 18 (24): 8418–56. doi : 10.1016/j.bmc.2010.10.043.

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The Pharma Data

AUGUST 19, 2021

7 Janssen has filed regulatory submissions for RYBREVANT TM with health authorities in Europe and other markets. 8] , [9] , [10] , [11] , [12]. 8] , [9] , [10] , [11] , [12]. **In In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

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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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The Pharma Data

JULY 27, 2021

“Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. ” In June 2021, AbbVie Inc.

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The Pharma Data

NOVEMBER 26, 2020

Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Galactosidase-A enzyme.

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The Pharma Data

AUGUST 9, 2021

Polivy is marketed in the US by Genentech as Polivy (polatuzumab vedotin-piiq), with piiq as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S.

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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. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected. TAKHZYRO is not intended for treatment of acute HAE attacks. Interactions.

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