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. Food and Drug Administration (FDA). .

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. CARMIEL, Israel and BOSTON , Dec.

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The Premier Consulting Blog

APRIL 15, 2024

From a business standpoint, these studies are critical for obtaining funding and being reassured that the drug will show promise once it enters the clinic. However, when it comes to an IND and supporting a clinical trial, FDA’s primary focus is on healthy volunteer and patient safety.

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Drug Target Review

SEPTEMBER 19, 2023

The US FDA Modernisation Act 2.0., puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out.

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PerkinElmer

JANUARY 7, 2022

With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. References Hingorani, A.D.,

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New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] “FDA Approves New Drug for Ulcerative Colitis” Medscape.

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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. Asia, and Europe.

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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. The FDA has streamlined its recommendations for sponsors enrolling patients in clinical trials.

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The Pharma Data

MAY 17, 2023

The safety profile of fenebrutinib was consistent with previous and ongoing fenebrutinib clinical trials across more than 2,400 people to date. The Phase III fenebrutinib clinical trial programme in RMS and primary progressive MS (PPMS) is ongoing. There were no new safety concerns identified in the FENopta study.

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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. In clinical studies, PRX–102 has been observed to have a circulatory half-life of approximately 80 hours. About Pegunigalsidase Alfa. Galactosidase-A enzyme.

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The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 months (95 percent CI, 6.9 – NE). [7].

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The Pharma Data

DECEMBER 15, 2020

SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites in the U.S. The secondary outcome involves pharmacokinetic endpoints. Receptor Inhibitors.

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The Pharma Data

AUGUST 30, 2021

These results add to the extensive LIBERTY AD clinical program – the largest Phase 3 clinical trial program in atopic dermatitis involving approximately 3,500 children, adolescents, and adults to date. Further, 81% of these patients had at least one concurrent type 2 inflammatory disease. Dupilumab Development Program.

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Agency IQ

SEPTEMBER 22, 2023

Traditionally, FDA has interpreted the need for “well-controlled investigations” to mean at least two clinical trials for new drugs, or applications for supplemental indications. The FDA has just elaborated on considerations for applications relying on a single clinical trial and confirmatory evidence in a new guidance document.

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The Pharma Data

OCTOBER 25, 2020

“We are pleased to continue pursuing additional neuroscience opportunities with BXCL501, targeting agitation associated with delirium, a fifth potential indication for this candidate and a condition for which there is no FDA-approved treatment,” commented Vimal Mehta, Chief Executive Officer of BTI.

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The Pharma Data

JANUARY 26, 2021

Across multiple clinical trials, Lilly has collected safety and efficacy data in more than 4,000 participants treated with Lilly’s neutralizing antibodies, either bamlanivimab alone or bamlanivimab and etesevimab together. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. Source link.

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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. .” ” Clinical trials are underway. Ricciardi M.J.

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The Pharma Data

SEPTEMBER 8, 2021

Evaluation of The Long-Term Safety and Tolerability of Oral Atogepant 60 mg Once Daily for Preventive Treatment of Migraine: A Phase 3, 40-Week, Multicenter Extension to the ADVANCE Trial. Evaluation of the Pharmacokinetic Interaction and Safety of Coadministered Atogepant and Topiramate. Abstract Lecture. September 12, 2021.

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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

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. v] ERLEADA ® is being studied in five Phase 3 clinical trials. 2 ERLEADA ® received U.S. To date, more than 10,000 patients worldwide have been treated with ERLEADA ®.

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The Pharma Data

APRIL 11, 2021

was approved by the European Commission in February 2021. The Phase 1/2 LIBRETTO-001 trial is the largest clinical trial of patients with RET -driven cancers treated with a RET inhibitor. The trial, which spans 16 countries and 89 sites, included a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2).

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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. Lactation: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission.

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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.

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The Pharma Data

APRIL 8, 2021

Data from the Phase III SAkuraStar and SAkuraSky clinical trials reinforce the favourable safety and efficacy of this therapy for those living with NMOSD, including patients with concomitant autoimmune diseases (CAIDs). P6: Neuromuscular Disorders and Clinical Trials. P6: Neuromuscular Disorders and Clinical Trials.

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The Pharma Data

JUNE 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. EINSTEIN-Jr. About the EINSTEIN-Jr. Study The randomized, open-label phase III EINSTEIN-Jr. UNIVERSE was conducted in two parts.

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The Pharma Data

FEBRUARY 25, 2021

The FDA approved Evrysdi in August 2020 as the first and only at home SMA treatment with proven efficacy in adults, children and infants 2 months and older. Evrysdi has been and continues to be studied in more than 450 people as part of a large and robust clinical trial program in SMA. mg/kg for Part 2.

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The Pharma Data

MARCH 16, 2021

Evrysdi is the first and only at home SMA treatment approved by the FDA, and has proven efficacy across adults, children and infants 2 months and older. More than 2,500 patients now treated with Evrysdi in clinical trial, compassionate use and real-world settings. The study met its primary endpoint.

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The Pharma Data

SEPTEMBER 1, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today announced interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS). Presentation Topic: Clinical Trials.

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Advarra

DECEMBER 14, 2022

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. However, in order to be eligible for extended coverage under a clinical trial, several requirements must be met. Clinical trial agreement. If an MCA is required, does this clinical trial qualify for Medicare coverage?

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The Pharma Data

SEPTEMBER 27, 2020

In August, the FDA approved Evrysdi for the treatment of SMA in adults and children 2 months and older. The FDA approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older. 59% of infants were able to sit without support for at least 5 seconds. No new safety signals were identified.

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