FDA Law Blog: Drug Discovery

JANUARY 7, 2024

This review was limited to drugs with approved New Drug Applications (NDAs); biologics and vaccines were excluded. Additionally, this review excluded pharmacokinetic and animal studies. In that ten-year period, there were 67 drugs approved with a requirement to conduct a postmarketing pregnancy study, and 99 studies.

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The Pharma Data

APRIL 13, 2022

Takeda ( TSE:4502/NYSE:TAK ) today announced that the Phase 3 SHP643-301 study ( NCT04070326 ) evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO ® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives. We also make targeted R&D investments in Tube- Deduced Curatives and Vaccines.

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The Pharma Data

MARCH 16, 2021

Efficacy, safety, pharmacokinetic, immunogenicity and biomarker evaluations were performed in the study on a defined schedule. Clinical efficacy, radiographic efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker, and pharmacogenomics evaluations were performed in the study on a defined schedule.

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The Pharma Data

FEBRUARY 25, 2022

The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

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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. Although much of the U.S. Read on for this week’s. MacroGenics’ Margetuximab for Metastatic HER2+ Breast Cancer.

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The Pharma Data

APRIL 27, 2021

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). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. About the Phase 1/2 Trial.

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The Pharma Data

APRIL 14, 2021

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

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The Pharma Data

JANUARY 21, 2021

Hepatic Impairment: EDURANT ® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT ® have not been evaluated in these patients. . Please see full Prescribing Information for more details. Use in Specific Populations.

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The Pharma Data

JANUARY 3, 2021

The pharmacokinetics of nasally administered Foralumab will also be evaluated. Thus, our therapeutic approach to provide rapid relief to patients already suffering with the diseases is particularly important, because vaccination is primarily to prevent COVID-19 infection, but it may not be useful for treatment of COVID-19 patients.”.

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PPD

JUNE 20, 2023

Likewise, and particularly since partnering with Moderna on the development of its COVID-19 vaccine, we know that novel therapeutic platforms will continue to hold strong potential for priority therapeutic areas.

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Codon

APRIL 2, 2023

mRNA vaccines and hybrid immunity use different B cell germlines against Omicron BA.4 Read How well do different antibodies, created by people who got two or three doses of the COVID-19 mRNA vaccine, fight off new viral variants, such as BA.4 Andreano E. Nature Communications. Ricciardi M.J. Science Translational Medicine.

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Agency IQ

SEPTEMBER 22, 2023

The examples provided from the agency both relate to studies of infectious disease: the assessment of an antimicrobial agent or a preventive vaccine in well-established infection models. The guidance notes that this is separate from FDA’s Animal Rule pathway, which was originally developed to respond to bioterrorism.

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The Pharma Data

MARCH 8, 2021

For more than 100 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases. In addition to a combined portfolio of vaccines and antibacterial, antiviral and antifungal medicines, Merck has multiple programs that span discovery through late-stage development.

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Alta Sciences

SEPTEMBER 27, 2024

Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic , and safety data in clinical trials. Each class of immunomodulator has a defined complexity and mechanism of action.

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DrugBank

FEBRUARY 5, 2025

Conversely, conjugation involves chemically attaching the drug to the nanoparticle surface, allowing for targeted delivery and improved pharmacokinetics. Nanoparticles are being explored as innovative carriers for antibiotics, antivirals, and vaccines, with the potential to significantly enhance their effectiveness.

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Agency IQ

JUNE 9, 2023

Cell and gene therapy products, adjuvanted vaccines, and blood products all fall outside the scope. The guidance contains recommendations for small molecule drugs, as well as any biological products that fall within CDER’s purview.

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BMG Labtech

MARCH 11, 2024

biomarker discovery), blood typing, autoimmune diseases, food science (including allergy testing), infectious disease surveillance, drug discovery and development as well as vaccine development. ELISAs can also be used to measure the antibody responses elicited by vaccines.

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The Pharma Data

MARCH 23, 2021

Tackling the COVID-19 pandemic requires both prevention via vaccine and targeted treatment for those who contract the virus. Together, the two have the potential to create an end to end treatment paradigm that complements vaccination in cases where disease still occurs.”.

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Agency IQ

DECEMBER 1, 2023

It also stated that companies should consider whether an investigational product might interact with an administered vaccine for Covid-19. Regarding vaccination status: The new document expands upon a previously simple recommendation to determine vaccination status for patients enrolled in clinical trials.

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The Pharma Data

DECEMBER 23, 2020

The parties also agreed to develop scientific and business relations and explore the possibilities for joint use of the Sputnik V vaccine and the AZD1222 vaccine in order to create more effective and long-term immunization against potential new coronavirus infections.

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The Pharma Data

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. New stability, immunogenicity, and tolerability data for COVID-19 vaccine candidate, BNT162b2, presented. BNT162 mRNA-based Vaccine Program.

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Drug Target Review

OCTOBER 4, 2023

7 These inhibitors have faced challenges such as dose-limiting toxicity and poor pharmacokinetics, but geldanamycin ADCs have demonstrated increased survival in mice. HSP90 inhibitors HSP90, a major chaperone protein often overexpressed in tumours, has been targeted by inhibitors derived from the geldanamycin backbone.

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Agency IQ

AUGUST 16, 2024

Likewise, it still omits radiopharmaceuticals, cancer vaccines, cell and gene therapy products, and microbiota-related products from its scope. Pharmacokinetic (PK) sample and analysis planning: Generally, the recommendations in the final guidance are nearly identical to those contained in the draft, with a few exceptions.

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The Pharma Data

APRIL 16, 2021

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

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The Pharma Data

FEBRUARY 8, 2021

The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. About Pfizer Oncology.

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The Pharma Data

APRIL 7, 2021

The addition of the SC administration also offers people living with MS another option at a time when they are being encouraged to discuss considerations around COVID-19 vaccination and their MS treatment with their physicians.

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The Pharma Data

MARCH 9, 2022

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

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The Pharma Data

JULY 23, 2021

Outside Japan, the antibody combination has been authorised for emergency use or temporary pandemic use in additional territories and regions, including in the European Union, United States, India, Switzerland and Canada. On 16 March 2021 the SARS-CoV-2 variant test was launched, designed to detect key spike mutations.

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The Pharma Data

JANUARY 26, 2021

BLAZE-4 Additionally, initial results from the ongoing BLAZE-4 trial provide viral load and pharmacodynamic/pharmacokinetic data which demonstrated lower doses, including bamlanivimab 700 mg and etesevimab 1400 mg together, are similar to bamlanivimab 2800 mg and etesevimab 2800 mg together. patients who recovered from COVID-19. .

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The Pharma Data

MAY 4, 2021

” “Even as the world makes progress on vaccine roll-outs, it remains vital for treatments to be available that can make a meaningful difference for those fighting COVID-19,” said David A. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. Ricks , Lilly chairman and CEO.

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The Pharma Data

MARCH 5, 2021

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

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The Pharma Data

FEBRUARY 8, 2021

In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone. ZYTIGA ® is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8. Learn more at www.janssen.com.

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The Pharma Data

OCTOBER 6, 2021

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said” Vulnerable populations suchlike as the immunocompromised hourly are n’t suitable to mount a self-protective response following vaccination and continue to be at trouble of developing COVID-19. AZD7442 was well- let. Griffin MP, et al. Yu XQ, et al.

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PerkinElmer

JUNE 3, 2022

1 Although effective COVID-19 vaccines have been developed, variants of SARS-CoV-2 have already emerged for which vaccines are less effective, and many people remain unvaccinated due to certain medical conditions, personal choice, or global access challenges.

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The Pharma Data

AUGUST 22, 2021

AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial. More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination.

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The Pharma Data

MARCH 11, 2021

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

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The Pharma Data

APRIL 7, 2022

At Pfizer, we have a strong heritage in, and commitment to, fighting infectious diseases, most recently evidenced by our delivery of the first authorized vaccine and oral therapy to combat COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

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