The Pharma Data

AUGUST 7, 2021

Nexviazyme has been shown in clinical trials to provide patients with improvements in respiratory function and walking distance. LOPD symptoms may present at any age. A key secondary endpoint in the trial measured functional endurance with the 6-minute walk test (6MWT). Nexviazyme demonstrated improvements in pivotal study.

FDA Approval 52

FDA Approval Disease FDA Treatment 52

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

FDA Approval 52

FDA Approval FDA Clinical Trials Treatment 52

The Pharma Data

JANUARY 7, 2021

Hosts a Panel Discussion on Clinical Trials with Neil Solomons, M.D., The Company is currently seeking FDA approval of voclosporin for the potential treatment of lupus nephritis (LN). Wainwright Virtual BioConnect 2021 Conference. On-demand fireside chat available beginning Monday, January 11, 2021 at 6:00 a.m. EST; and.

Pharmaceuticals 52

Pharmaceuticals FDA Approval Clinical Trials FDA 52

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Haematologica.

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 52

The Pharma Data

SEPTEMBER 28, 2021

The presentations included additional results from the RAINBOWFISH study, evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA) from birth to 6 weeks aged and data supporting the continued clinical investigation of gene therapy, SRP-9001, in Duchenne dystrophy (DMD).

Clinical Trials 52

Clinical Trials Protein Expression Therapies FDA 52

The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. Orgovyx (relugolix) FDA Approval History.

FDA Approval 52

FDA Approval FDA Science Therapies 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. DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

FEBRUARY 1, 2021

In clinical trials, the most common adverse events associated with Plegridy were injection site reactions and flu-like symptoms. A list of adverse events can be found in the full Plegridy product labeling for each country where it is approved. You should not place undue reliance on these statements or the scientific data presented.

FDA Approval 40

FDA Approval FDA Clinical Trials Treatment 40

The Pharma Data

NOVEMBER 12, 2020

12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.

Trials 52

Trials Clinical Trials Immune Response FDA Approval 52

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119

Therapies FDA FDA Approval Treatment 119

Drug Target Review

MAY 14, 2024

How do hydrophobicity, electrostatic charge, and secondary confirmation of helical polypeptides influence the stimulation of innate immune pathways in antigen-presenting cells (APCs)?

Engineering 59

Engineering Immune Response FDA Approval Clinical Trials 59

The Pharma Data

NOVEMBER 18, 2021

Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’santi-PD-1 remedy, for the adjuvant treatment of cases with renal cell melanoma (RCC) at intermediate-high or high threat of rush following nephrectomy, or following nephrectomy and resection of metastatic lesions. 0.87); p = 0.0010) compared to placebo. About Merck.

FDA Approval 52

FDA Approval FDA Therapies Treatment 52

The Pharma Data

JULY 12, 2021

Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and principal investigator of the FIDELIO-DKD trial. The clinical data from FIGARO-DKD are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on August 28th.

FDA Approval 52

FDA Approval Disease FDA Treatment 52

The Pharma Data

OCTOBER 15, 2020

The findings were presented at TCT Connect , the 32nd annual scientific symposium of the Cardiovascular Research Foundation. In the first study, presented by Hemindermeet Singh, MD, of Ascension St. Since FDA PMA approval, Abiomed (NASDAQ: ABMD) has collected data on nearly 100% of U.S. View the full release here: [link].

Hospitals 52

Hospitals FDA Approval FDA Treatment 52

DrugBank

MAY 6, 2024

A Wave of Innovations The year 2024 has already proven to be significant for the field of biologics, witnessing a notable increase in FDA approvals. In the first quarter alone, the FDA approved 9 new biologics, a substantial rise from the 5 approvals during the same period in 2023.

FDA Approval 65

FDA Approval Therapies Treatment Clinical Trials 65

Pharmaceutical Development Group

DECEMBER 19, 2021

Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services , expedite a FDA Pre-Submission Review, and lead to FDA Approval. Author Information William E. Spanogle, Ph.D. Spanogle, Ph.D.

FDA Approval 52

FDA Approval FDA Clinical Trials Drug Development 52

The Pharma Data

APRIL 8, 2022

NYSE: PFE) announced updated results from the Phase 3 CROWN trial, which evaluated LORBRENA® (lorlatinib, available in Europe under the brand name LORVIQUA) versus XALKORI® (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Pfizer Inc.

Trials 52

Trials FDA Approval Treatment Disease 52

The Pharma Data

FEBRUARY 18, 2022

These data (Presentation #DOP44) will be presented at the 17 th Congress of the European Crohn’s and Colitis Organisation (ECCO), taking place February 16-19, 2022. Additional Bristol Myers Squibb-sponsored abstracts presented at the ECCO 2022 Congress can be accessed online here. About Bristol Myers Squibb.

Clinical Trials 40

Clinical Trials Treatment Immune Response Disease 40

The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

Drug Target Review

JANUARY 8, 2024

We hope to initiate the first human clinical trials with our lead indications in 2025, which would represent a monumental step forward for the field of cellular rejuvenation. What’s next for Life Bioscience’s preclinical studies? Most recently, Jerry was President and CEO for Neos Therapeutics, Inc.,

Science 145

Science Disease FDA Approval Clinical Trials 145

The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Source link: [link].

Trials 40

Trials Clinical Trials Licensing Licensing 40

The Premier Consulting Blog

DECEMBER 28, 2023

1] This exemption applies to the conduct of trials necessary for developing new medical devices. Clinical studies are often conducted to support a Premarket Approval (PMA) application, though some 510(k) submissions may require clinical data. 2 Existence of a predicate device. 2 Existence of a predicate device.

FDA 52

FDA FDA Approval Regulations Compliance 52

The Premier Consulting Blog

OCTOBER 11, 2022

Clinical trials for ultra-rare diseases can be particularly challenging to mount due to small, geographically-dispersed patient populations. For such trials, the US Food and Drug Administration (FDA) may allow the use of credible real-world data (RWD) and real-world evidence (RWE) in lieu of data collected in a Phase 3 trial.

Disease 52

Disease FDA FDA Approval Treatment 52

The Pharma Data

OCTOBER 22, 2021

In Brazil, the launch of its new Intacta 2 Xtend ® soy on roughly acres is presently underway, as the company upgrades its leading soybean particularity platform in South America. This time’s field trials brought to light the upgraded product’s better daises and stronger roots. is underway. added Condon. “ and Brazil alone.

FDA Approval 52

FDA Approval FDA Production Trials 52

Drug Target Review

MAY 27, 2024

Antibody-drug conjugates have seen explosive growth in the last few years which has materialised with numerous clinical trials demonstrating meaningful improvements in survival. At a base-layer, Caris’ comprehensive molecular profiling that we perform for patients today can identify predictive biomarkers for current FDA-approved ADCs.

Clinical Trials 59

Clinical Trials Science Molecular Biology Bioinformatics 59

The Pharma Data

MARCH 23, 2023

President and Chief Scientific Officer at Regeneron “ COPD is an urgent global health concern and a notoriously difficult-to-treat disease due to its heterogeneity, with no novel treatments approved in more than a decade. Detailed efficacy and safety results from this trial will be presented in a future scientific forum.

Trials 40

Trials Disease Treatment Therapies 40

The Pharma Data

AUGUST 25, 2020

The company will complete a full evaluation of the IDHENTIFY data and work with investigators to present detailed results at a future medical meeting. In August 2017, Bristol Myers Squibb received full approval in the U.S. Food and Drug Administration (FDA)-approved test. IDHIFA is also approved in Australia and Canada.

Trials 52

Trials FDA Approval Therapies Treatment 52

The Premier Consulting Blog

APRIL 15, 2024

However, when it comes to an IND and supporting a clinical trial, FDA’s primary focus is on healthy volunteer and patient safety. It is critical that the nonclinical program outlined in the PIND briefing document is presented in a manner that allows FDA to provide relevant input on the required IND-enabling studies.

FDA 52

FDA Pharmacokinetics Laboratories FDA Approval 52

The Pharma Data

APRIL 28, 2023

Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).

FDA 40

FDA FDA Approval Trials Treatment 40

The Pharma Data

APRIL 7, 2021

today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. Key AbbVie abstracts and presentation details for the 2021 AAN Annual Meeting program are outlined below. Presentation Details. All times CT.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. The GARNET trial is a multicentre, non-randomised, multiple parallel-cohort, open-label study.

FDA 52

FDA FDA Approval Treatment DNA 52

The Pharma Data

APRIL 6, 2022

Additional details of this trial will be presented at future medical congresses and will serve as the basis for a supplemental New Drug Application submission for an optional twice-daily administration to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022. . Robinson, M.D., ” About Presbyopia.

Trials 52

Trials FDA FDA Approval Clinical Trials 52

The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Food and Drug Administration greenlit the restart of AstraZeneca’s Phase III COVID-19 vaccine trial, the U.K.-based

Vaccine 52

Vaccine FDA Approval FDA Clinical Trials 52

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.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

The Pharma Data

JANUARY 13, 2021

I am pleased with the clinical progress we are making with this program and we are planning to present interim data from the ongoing Phase 1/2 dose escalation trial later this year.”. About the Phase 1/2 Trial for HPN217. Dose escalation for HPN217 in the Phase 1/2 clinical trial is progressing rapidly.

Treatment 52

Treatment FDA Clinical Trials Trials 52

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). of participants in the trial, respectively.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

Codon

AUGUST 26, 2024

One large-scale clinical trial found that it only reduces the relative risk of death by about ten percent in hospitalized patients. For this reason, developing broad-spectrum antivirals presents an enormous scientific challenge. As a result, it is classified as a “drug-free” product and does not require FDA approval.

RNA 87

RNA Virus DNA Vaccine 87