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 Pharma Data

DECEMBER 29, 2020

(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A., mL/min/ 1.73m 2 /year.

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Drug Target Review

SEPTEMBER 19, 2023

The chips can be modelled with primary cells, IPS derived stem cells or patient derived cells and potentiates to unlock molecular mechanisms that drive the disease pathophysiology, holding a greater promise. The first successful chip adaptation to a lung model was first described in 2010 by Donald Ingber, a bioengineer at Wyss institute.

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The ChEMBL-og

JUNE 13, 2023

The dataset is also available from the ChEMBL - Neglected Tropical Disease archive ([link] Literature data from EUbOPEN Chemogenomic Library (src_id = 65): 2,842 bioactivity measurements have been extracted from primary literature by the SGC consortium to complement their Chemogenomic library (src_id = 55).

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The Pharma Data

APRIL 4, 2023

The approval includes all indications covered by the reference medicine*: rheumatic diseases, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa. 1 “Living with a chronic disease can take a significant toll on a patient’s quality of life.

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Biosimilars Pharmacokinetics FDA Approval Packaging 40

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

Gene Therapy Gene therapy is currently considered for diseases, often rare, that have no other cures. We have conducted over 130 in-life studies in the last five years (over 95% conducted in NHPs), including IND-enabling studies for rare diseases and CRISPR gene editing therapeutics in NHPs.

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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. They discovered that cimetidine inhibits gene expression in tumor growth and metastasis, suggesting that it could effectively slow disease progression. 

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The Pharma Data

AUGUST 19, 2021

1 Disease response was evaluated using overall response rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1* (RECIST v1.1) RYBREVANT TM (amivantamab-vmjw) received accelerated approval by the U.S. Interstitial Lung Disease/Pneumonitis 7. RYBREVANT™ can cause interstitial lung disease (ILD)/pneumonitis.

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The Pharma Data

JUNE 28, 2021

If approved, Xarelto will be the only oral Factor Xa Inhibitor indicated in the U.S. There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. for use in pediatric patients. EINSTEIN-Jr. About the EINSTEIN-Jr.

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The Pharma Data

MAY 17, 2023

The study met its primary and secondary endpoints, showing oral fenebrutinib significantly reduced magnetic resonance imaging (MRI) markers of MS disease activity in the brain compared to placebo. T1 lesions, as measured by MRI, are a marker of active inflammation and T2 lesions represent the amount of disease burden or lesion load.

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The Pharma Data

AUGUST 30, 2021

Dupixent plus TCS reduced overall disease severity by 70% and itch by 49%. Results reinforce well-established safety profile of Dupixent – the first ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old. Yancopoulos, M.D., President and Chief Scientific Officer at Regeneron. “

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Trials Disease Treatment Clinical Trials 52

The Pharma Data

APRIL 8, 2021

OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs). Following U.S.

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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

SEPTEMBER 8, 2021

Evaluation of the Pharmacokinetic Interaction and Safety of Coadministered Atogepant and Topiramate. About BOTOX ® BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Abstract Lecture. September 12, 2021. 2:45-2:55 a.m. ePoster (on-demand only). Ubrogepant.

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The Pharma Data

APRIL 11, 2021

FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50 50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity. i Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

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Research Treatment Therapies Trials 52

The Pharma Data

DECEMBER 5, 2020

57% of evaluable patients (4 of 7 patients) were minimal residual disease (MRD) negative. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. 42% (n=8) had a CR or sCR. and the world, respectively, in 2020.

Production 40

Production Trials Treatment Disease 40

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

JANUARY 21, 2021

. Hepatotoxicity: Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors. Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected.

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FDA Approval Treatment RNA FDA 52

Drug Target Review

JUNE 5, 2023

It also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious. ZW191 also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious.

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The Pharma Data

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . Farxiga use expanded for reducing risks in patients with chronic kidney disease. The approval was based on results in a prespecified interim analysis of the first 264 patients of the ongoing KEYNOTE-811 trial.

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FDA Approval FDA Therapies Pharmacokinetics 52

The Pharma Data

SEPTEMBER 1, 2021

The FDA approval of INVEGA HAFYERA™ is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. have Parkinson’s disease or a type of dementia called Lewy Body Dementia. The Janssen U.S.

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FDA Approval FDA Treatment Clinical Trials 52

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. The FDA approval was based on the review of a comprehensive data package which demonstrated biosimilarity of ABRILADA to the reference product.

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Biosimilars FDA FDA Approval Small Molecule 52

The Pharma Data

APRIL 27, 2021

In April 2020, mobocertinib received Breakthrough Therapy Designation from the FDA for patients with EGFR Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy. About the Phase 1/2 Trial. Takeda’s Commitment to Oncology.

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The Pharma Data

MARCH 16, 2021

1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. PsA can be a chronically painful and debilitating disease, and many PsA patients are still searching for enduring relief of their symptoms,” said Philip J. Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC.

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Treatment Disease Pharmacokinetics Therapies 52

Agency IQ

SEPTEMBER 22, 2023

Since that time, the FDA’s use of single pivotal trials has become more common , especially due to FDA’s expanded reviews of products intended to treat, cure or prevent rare diseases or life-threatening conditions for which there is an unmet clinical need.

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The Pharma Data

MARCH 16, 2021

SUNFISH Part 2 study population includes broad range of ages and disease severities, representing a real-world spectrum of people living with Type 2 or 3 SMA. 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.

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Pharmacokinetics Treatment Clinical Trials Disease 52

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. Ricciardi M.J. Science Translational Medicine. Press release. 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. The FDA now states that “Studies to characterize the effect of extrinsic factors (e.g., supplemental oxygen, mechanical ventilation).

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FDA Law Blog: Biosimilars

MAY 21, 2024

The State of Current Scientific Knowledge Regarding Marijuana HHS found that marijuana’s pharmacokinetic profile varies depending on the route of administration. Basis at 18; NPRM at 44,605. Basis at 24. Basis at 63-64. Basis at 63; NPRM at 44,617.

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Regulations FDA Drugs Treatment 69

The Pharma Data

FEBRUARY 25, 2021

FIREFISH Part 1 data show treatment with Evrysdi at 12 months helped 90% of these infants survive without permanent ventilation and 33% sit without support, a key motor milestone not normally seen in the natural course of the disease. fold from baseline in the high-dose cohort at 12 months. mg/kg for Part 2.

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FDA Approval Pharmacokinetics Treatment Disease 52

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. Of the 17 infants treated with the therapeutic dose, two experienced fatal complications of their disease at 8 and 13 months of treatment and one infant was withdrawn from the study and sadly died 3.5 months of age.

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FDA Approval Pharmacokinetics Treatment Clinical Trials 52

The Pharma Data

MAY 4, 2021

Lilly will donate both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together – providing options to treat COVID-19 patients at different stages of the disease. ” The allocation of therapies will be based on the disease burden and hospitalization rates in each country.

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Therapies Hospitals Treatment FDA Approval 52

The Pharma Data

FEBRUARY 8, 2021

ACIS is a Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the efficacy and safety of ERLEADA ® and ZYTIGA ® plus prednisone compared to placebo and ZYTIGA ® plus prednisone in 982 patients with chemotherapy-naïve mCRPC disease who received ADT. The primary endpoint of the study was rPFS.

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Pharmaceutical Companies Treatment Clinical Trials Therapies 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. Bamlanivimab FDA Approval History.

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Hospitals Treatment Trials Long-Term Care Facilities 52

New Drug Approvals

APRIL 21, 2025

SNDX-50613 free base SNDX-5613 free base SNDX50613 free base SNDX5613 free base FDA APPROVED 11/15/2024, Revuforj , To treat relapsed or refractory acute leukemia N -ethyl-2-[4-[7-[[4-(ethylsulfonylamino)cyclohexyl]methyl]-2,7-diazaspiro[3.5]nonan-2-yl]pyrimidin-5-yl]oxy-5-fluoro- Food and Drug Administration (FDA) (Press release).

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New Drug Approvals

APRIL 2, 2025

The compounds of this disclosure may be used as medicaments for the treatment of human brain diseases associated with a cholinergic deficit, including the neurodegenerative diseases Alzheimer’s and Parkinson’s disease and the neurological/psychiatric diseases vascular dementia, schizophrenia and epilepsy.

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