PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Historically, the available drugs and U.S.

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PLOS: DNA Science

MARCH 28, 2024

The New Drug Duvyzat (givinostat), a type of drug called an HDAC inhibitor, has been in clinical trials to treat cancers and other disorders of the blood, Crohn’s disease, and a form of juvenile arthritis. Results from the study that led to the FDA approval appeared in The Lancet Neurology in April 2024 with commentary.

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Chemical Biology and Drug Design

OCTOBER 10, 2023

Later, a new type of non-nucleoside reverse transcriptase inhibitors (NNRTIs) were approved as anti-HIV drugs. Zidovudine, didanosine, and stavudine are FDA-approved NRTIs, while nevirapine, efavirenz, and delavirdine are FDA-approved NNRTIs.

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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). The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials.

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Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. For HF, Savarese et al.

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Conversations in Drug Development Trends

FEBRUARY 26, 2024

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. There are endpoints that can be easily measured, that are already standardized, and they are FDA-approved,” says Dr. Ojeda.

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The Pharma Data

JANUARY 21, 2021

Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America, ViiV Healthcare. In the trials, Cabenuva was as effective as a daily oral three-drug regimen. clinical practices.

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Alta Sciences

FEBRUARY 8, 2024

Altasciences’ ability to design and conduct specialized tests, combined with our partnership with CRC, allows us to seamlessly incorporate driving simulation elements into your clinical trials. Tags Clinical Trials Weight 12 View the Driving Simulation Fact Sheet for more information.

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The Pharma Data

AUGUST 4, 2020

. Janssen has received US Food and Drug Administration (FDA) approval for its Spravato (esketamine) CIII nasal spray, in combination with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behaviour.

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The Pharma Data

SEPTEMBER 7, 2020

While the approval has been awarded, the FDA warned that continued approval may be dependent on Genentech reinforcing these positive data with a future confirmatory clinical trial. In 27 treatment-naïve NSCLC patients, the ORR was found to be 70% and CRR was 11%. Matt Fellows. Source link.

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Advarra

NOVEMBER 17, 2022

In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). While the FDA’s approval of nusinersen may not seem extraordinary, it was. Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children.

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Vial

DECEMBER 5, 2023

In 2017, the Food & Drug Administration (FDA) approved the first gene therapy for cancer and for inherited diseases, the first multiplex NGS panel for companion diagnostics (CDx), and the first drug targeting a genetic signature though not a disease.

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The Pharma Data

AUGUST 10, 2020

Genentech’s Evrysdi (risdiplam) has secured FDA approval for the treatment of spinal muscular atrophy (SMA), making it the first oral therapy available for the rare hereditary genetic condition in US and the second overall to be approved for the disease.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved. The FDA granted approval under the accelerated approval regulation. NEW YORK, Nov.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. BOSTON, Nov. in the first quarter of 2021.

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PLOS: DNA Science

JUNE 1, 2023

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). The gene treatment has been a long time coming, but it differs from the handful of other approved gene therapies: it isn’t a one-and-done.

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The Pharma Data

AUGUST 27, 2020

The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies.

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The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.

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The Pharma Data

NOVEMBER 16, 2020

As part of the arrangement under OWS, representatives from NIAID, BARDA and Moderna are part of the oversight group that receives recommendations from the trial’s independent DSMB. The same DSMB also oversees the additional OWS-supported Phase 3 clinical trials evaluating COVID-19 vaccine candidates. El Sahly, M.D., Baden, M.D.,

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The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School.

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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).

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The Pharma Data

OCTOBER 30, 2020

Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

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The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

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The Pharma Data

OCTOBER 29, 2021

Novartis blazoned moment that the US Food and Drug Administration (FDA) approved Scemblix ® (asciminib) for the treatment of habitual myeloid leukemia (CML) in two distinct suggestions. Scemblix is the first FDA-approved CML treatment that binds to the ABL myristoyl pocket1.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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The Pharma Data

JANUARY 22, 2021

Approval was based on data from the Phase 3 ATLAS and FLAIR studies, two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults. Before initiating Cabenuva treatment, study participants were virologically suppressed (HIV-1 RNA <50 copies/mL).

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The Pharma Data

JUNE 26, 2023

FDA approves Pfizer’s LITFULO™ (ritlecitinib) for adults and adolescents with severe alopecia areata Pfizer Inc. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. Source link: [link]

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The Pharma Data

APRIL 19, 2022

The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer.

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Drug Target Review

JANUARY 8, 2024

With significant validation of our platform in hand, we are now rapidly advancing towards the clinic with our lead therapeutic, OSK. 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.

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JANUARY 31, 2021

The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” . CHENGDU, China , Feb.

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The Pharma Data

DECEMBER 16, 2020

We will now rapidly move to initiate our Phase 2 trial of Berubicin for adults with GBM and expect to begin enrolling patients in the first quarter of next year,” commented John Climaco , CEO of CNS Pharmaceuticals. and 2 trials planned by our sublicensee WPD in Poland.

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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. The FDA approval follows a priority review by the FDA, which is reserved for medicines that, if approved, would represent significant improvements in safety or efficacy in treating serious conditions.

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The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”

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The Pharma Data

JANUARY 22, 2021

The FDA also approved Vocabria (cabotegravir, tablet formulation), which should be taken in combination with oral Edurant (rilpivirine) for one month before starting treatment with Cabenuva, to ensure the medications are well-tolerated by patients before they switch to the extended-release monthly injection.

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New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Food and Drug Administration (FDA).

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Broad Institute

JULY 17, 2024

Still, more than 90 percent of drug candidates fail in clinical trials, with even more that never make it to the clinical stage. Many drugs fail because they simply aren’t safe. Seal began this work after wondering if more toxicology insights could be gleaned from a drug candidate’s chemical structure.

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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. Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. CARMIEL, Israel and BOSTON , Dec.

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