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 Furthermore, nearly one third of drugs get withdrawn from the market post approval due to safety concerns. link] New safety concerns identified for 1 in 3 FDA-approved drugs [Internet].

Drugs 52

Drugs FDA Approval Drug Development Pharmacokinetics 52

The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. was approved by the European Commission in February 2021. About LIBRETTO-001.

Research 52

Research Treatment Therapies Trials 52

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 4] , [5] , [6].

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

Drug Target Review

SEPTEMBER 19, 2023

The US FDA Modernisation Act 2.0., Prior to this European Union Parliament, in 2021, voted for animal testing phase out. Viable in vitro alternatives to animal Models: The European Medicines Agency has launched the new approach methodologies in 2021 promoting the use of animal experiment alternatives in drug discovery and development.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

New Drug Approvals

DECEMBER 24, 2023

“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. World Health Organization (2021). (December 2022).

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology FDA Approval 62

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

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

The Pharma Data

SEPTEMBER 8, 2021

today announced that data from its migraine portfolio will be presented at the International Headache Congress 2021, held jointly this year by the International Headache Society and the European Headache Federation, from September 8-12. AbbVie abstracts and presentation details for IHC 2021 are outlined below. September 11, 2021.

Doctors 52

Doctors Treatment Trials Clinical Trials 52

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

The Pharma Data

DECEMBER 29, 2020

“We look forward to the continued findings from our other ongoing Phase III studies of PRX-102, with the final results from the BRIGHT study expected in the first quarter of 2021, and interim results from the BALANCE study expected in the first half of 2021.” ” Additional Details about the BRIDGE Study.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

DECEMBER 15, 2020

The Phase I/IIa clinical trial is a randomized, double-blind, placebo controlled, single and multiple dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NMD670 in 79 male and female healthy subjects and patients with myasthenia gravis. The secondary outcome involves pharmacokinetic endpoints.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

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. billion, compared with retail sales of $0.5

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

DECEMBER 5, 2020

We are also expanding our odronextamab program with multiple pivotal trials in 2021.” Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

Production 40

Production Trials Treatment Disease 40

The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Regulatory reviews continue in Australia and Switzerland , and several additional submissions are planned throughout 2021. US Approval January 2021. TITUSVILLE, N.J. , Use in Specific Populations.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . © 2021 Regulatory Affairs Professionals Society. In the case of Kloxxado, the applicant used the agency’s safety and effectiveness findings for Narcan (injectable naloxone hydrochloride) to support its application.

FDA Approval 52

FDA Approval FDA Therapies Pharmacokinetics 52

The Pharma Data

MARCH 16, 2021

These data will be presented virtually in abstract, poster, and video form during the Innovations in Dermatology: Virtual Spring Conference, March 16–20, 2021. 1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. TREMFYA q4w is not currently FDA-approved. Clinically meaningful defined as ?3

Treatment 52

Treatment Disease Pharmacokinetics Therapies 52

The Pharma Data

MARCH 16, 2021

These data will be presented at the 2021 Muscular Dystrophy Association (MDA) Virtual Clinical & Scientific Conference taking place from March 15-18. Food and Drug Administration (FDA) approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older in August of 2020.

Pharmacokinetics 52

Pharmacokinetics Treatment Clinical Trials Disease 52

Agency IQ

SEPTEMBER 22, 2023

FDA includes the definitions of RWD and RWE according to the September 2021 draft guidance titled, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Product [ Read AgencyIQ’s analysis of that document here. ].

FDA 40

FDA Science Trials Clinical Trials 40

Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. from 2021 to 2022, up to $625 million. Ricciardi M.J. Press release.

DNA 52

DNA RNA Engineering Licensing 52

Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. About one year after its initial publication, FDA updated the guidance in February 2021.

FDA 40

FDA Clinical Trials Vaccine Drugs 40

The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. It is approved in the U.S.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

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. Posted: January 2021. INDIANAPOLIS, Jan.

Hospitals 52

Hospitals Treatment Trials Long-Term Care Facilities 52

The Pharma Data

FEBRUARY 8, 2021

[i] Results will be featured in an oral presentation at the American Society of Clinical Oncology’s Genitourinary (ASCO GU) Cancers Symposium, taking place virtually February 11-13, 2021 (Abstract #9; Oral Abstract Session: Prostate Cancer, February 11, 12:45 PM-2:00 PM EST). Accessed February 2021. Accessed February 2021. [iv]

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Trials 52

Metabolite Tales Blog

JANUARY 22, 2025

Metabolism of 2024 FDA approved small molecules part 1 By Julia Shanu-Wilson Involvement of active metabolites The number of small molecules approved by the FDA in 2024 totaled 31 out of 50 NMEs with 56% (28) of these comprising small molecule therapies. Clin Pharmacokinet. Cardiol Ther 10, 397406 (2021).

Small Molecule 52

Small Molecule FDA Approval FDA Pharmacokinetics 52

New Drug Approvals

MAY 14, 2025

5] Rezafungin was approved for medical use in the United States in March 2023, [1] [6] [5] and in the European Union in December 2023. [2] 7] This pharmacokinetic property has supported its investigation for the treatment of deep-seated Candida infections, including osteomyelitis. [8] Epub 2021 Oct 18. 2] [3] CAS No.

Pharmacokinetics 62

Pharmacokinetics FDA FDA Approval Treatment 62

New Drug Approvals

MAY 30, 2025

PATENT [link] PATENT CN112457267 [link] REF Satish Kumar RangarajuSatish Kumar Rangaraju The first FDA-approved treatment for Demodex Blepharitis, a common eyelid disease caused by microscopic mites living in the eyelashes’ hair follicles. Archived from the original on 5 August 2021. Retrieved 4 August 2021.

FDA Approval 70

FDA Approval FDA Production International 70

New Drug Approvals

APRIL 27, 2025

9] [10] [11] Pharmacokinetics After oral administration, less than 10% of the dose is absorbed. 13] [14] The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets. [15] 13] [14] The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets. [15]

FDA Approval 57

FDA Approval FDA Pharmacokinetics Licensing 57

New Drug Approvals

APRIL 5, 2025

Retrieved 25 January 2025. ^ “Health product highlights 2021: Annexes of products approved in 2021” Health Canada. Jump up to: a b “FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS” U.S. 4 July 2023. 3 August 2022.

FDA 62

FDA FDA Approval Production Treatment 62

New Drug Approvals

APRIL 21, 2025

6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] Jump up to: a b c d e f g h i j k “FDA approves drug for heart disorder caused by transthyretin-mediated” U.S. Food and Drug Administration (FDA). 61 (17): 78627876.

FDA Approval 62

FDA Approval FDA Production Treatment 62

Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates.

Clinical Trials 80

Clinical Trials Virus Vaccine DNA 80