The Pharma Data

MAY 22, 2023

Teva to Present Data Demonstrating UZEDY™ (risperidone) Extended-Release Injectable Suspension Significantly Prolonged Time to Impending Relapse for Adults with Schizophrenia at the American Psychiatric Association’s 2023 Annual Meeting Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. once-monthly dosing) and 2.7

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov. Contraindications.

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The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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The Pharma Data

MARCH 11, 2021

Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinical trial.

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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.

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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.

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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.

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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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.,

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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.

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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.

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Vial

JUNE 12, 2024

PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. Food and Drug Administration (FDA) increasingly look to patients to understand how they describe their health status. What are PROs in clinical trials?

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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.

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The Pharma Data

SEPTEMBER 8, 2021

Amgen (NASDAQ: AMGN) today announced results from two analyses of the Phase 2 CodeBreaK 100 clinical trial evaluating LUMAKRAS™ (sotorasib), the first and only KRAS G12C inhibitor approved in the U.S., ” New Analyses From the LUMAKRAS Phase 2 CodeBreaK 100 Clinical Trial. Reese, M.D.,

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The Pharma Data

SEPTEMBER 8, 2021

–Results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluate the use of BOTOX® (onabotulinumtoxinA) for chronic migraine –These data further demonstrate AbbVie’s commitment to harnessing and sharing innovative science and working to advance treatment options for people with migraine across the migraine spectrum.

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The Pharma Data

NOVEMBER 12, 2021

Treatment is First FDA-Approved Option Patients Can Take Regardless of Previous Therapies. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. Today, the U.S.

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The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase IIIb OCREVUS higher dose clinical trial programme and Phase IV study evaluating OCREVUS in minority populations. Other data to be presented will show high treatment persistence and strong adherence for patients treated with OCREVUS compared to other DMTs in real-world settings.

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Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. This means presenting the growth factors, cytokines, and hormones in the right sequence in an environment that’s low in oxygen. The results of the trial are expected at the end of 2024. Data from Rousseau G.F.

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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.

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The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. 1) “Great advancements have been made in the fight against COVID-19, yet the virus remains a present and unpredictable concern. NYSE: PFE) announced today that the U.S. More than 11.6

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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).

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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.

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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.

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The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019.

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Broad Institute

OCTOBER 11, 2023

His mother had a presentation of the disease that suggested her immune system was already on the job. By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA. Using CRISPR screening in mice presented additional challenges.

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The Pharma Data

DECEMBER 8, 2020

The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the Phase III UK and Brazil trials conducted by Oxford University. We are hugely grateful to our trial volunteers for working with us over the past eight months to bring us to this milestone.”.

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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].

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The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Roche’s Chief Medical Officer and Head of Global Product Development. “In

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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.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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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.

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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.

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The Pharma Data

AUGUST 30, 2021

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. The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis. Yancopoulos, M.D., In 2016, the U.S.

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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.

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The Pharma Data

APRIL 11, 2021

Opdivo- based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma. Surgery was rarely canceled due to adverse events, only affecting two patients in each arm of the trial.

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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.

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The Pharma Data

MARCH 4, 2021

There are currently no FDA-approved treatments for AA. Detailed results from the BRAVE program will be presented at an upcoming medical conference and published in a peer-reviewed journal later this year. Reported infections include: Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease.

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