Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial. The results of the trial are expected at the end of 2024. Data from Rousseau G.F.

Production 140

Production Clinical Trials Trials Therapies 140

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.

Vaccine 52

Vaccine FDA Approval FDA Disease 52

The Pharma Data

MAY 31, 2022

.” Evrysdi is approved in 81 countries and the dossier is under review in a further 27 countries. More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings. Food and Drug Administration in 2017.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

New Drug Approvals

SEPTEMBER 10, 2024

2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]

FDA Approval 62

FDA Approval FDA Clinical Trials Trials 62

The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

Clinical Trials 52

Clinical Trials Vaccine Trials Virus 52

The Pharma Data

NOVEMBER 2, 2020

This morning, California-based GW said it will launch the first Phase III trial studying nabiximols, which is known as Sativex outside the United States, as a potential treatment for multiple sclerosis-associated spasticity. Sativex is approved for use in parts of Europe for this indication. It also forced the U.S.

FDA Approval 52

FDA Approval Marketing FDA Drugs 52

The Pharma Data

MARCH 15, 2021

Trial enrolled patients with advanced cervical cancer regardless of PD-L1 status. The trial will be stopped early based on a unanimous recommendation by the Independent Data Monitoring Committee (IDMC), and the data will form the basis of regulatory submissions in 2021. This is reflected in the trial where the average age was 51.”.

Trials 52

Trials Disease FDA Treatment 52

The Pharma Data

OCTOBER 26, 2020

EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. The FDA approved EYSUVIS based on the positive results from one Phase II and three Phase III trials. It also increases your risk for inflamed cornea, cornea eye disease, corneal ulcers and injuries, and eye infections. .

Disease 52

Disease Treatment FDA FDA Approval 52

New Drug Approvals

SEPTEMBER 8, 2024

1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] 5] History The effectiveness of palopegteriparatide was evaluated in a 26-week, randomized, double-blind, placebo-controlled trial that enrolled 82 adults with hypoparathyroidism. [5]

FDA 62

FDA International Trials FDA Approval 62

New Drug Approvals

SEPTEMBER 6, 2024

2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 1 It was approved by the FDA on August 19, 2024. 1 It was approved by the FDA on August 19, 2024. Food and Drug Administration (FDA).

FDA Approval 48

FDA Approval FDA International Treatment 48

The Pharma Data

MARCH 3, 2021

Food and Drug Administration (FDA) approved Pfizer Inc.’s LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Treatment 52

Treatment FDA Approval FDA Disease 52

The Pharma Data

APRIL 7, 2023

Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. In the U.S., Ono Pharmaceutical Co.

FDA 40

FDA FDA Approval Small Molecule Drugs 40

Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. Why Clinical Trials Stop: The Role of Genetics. Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. Are drug targets with genetic support twice as likely to be approved?

Disease 111

Disease Clinical Trials Therapies Science 111

Drug Target Review

AUGUST 3, 2023

Clinical trials are now underway for various genetic subtypes of both rare and common diseases, on the understanding that medications utilising genetic biomarkers have a significantly higher chance of success. There are clinical trials underway for genetic subtypes of rare and common diseases.

DNA 52

DNA Clinical Trials Trials Disease 52

The Pharma Data

OCTOBER 18, 2020

The principal investigator Professor Christophe Le Tourneau will present results from a pooled analysis of the Phase 1b/2 trial, including response rate, median progression-free survival, as well as the impact of patient/disease characteristics on outcome and immunogenicity. Christophe Le Tourneau, M.D.,

Vaccine 40

Vaccine Trials Virus Treatment 40

The Pharma Data

JUNE 30, 2021

Approval based on Phase 2 CheckMate -142 trial results showing nearly two-thirds of patients responded to the Opdivo plus Yervoy combination with durable responses observed. Opdivo plus Yervoy is the first dual immunotherapy regimen approved in the European Union for colorectal cancer. CheckMate -142 Efficacy and Safety Results.

Treatment 52

Treatment Trials FDA Approval Disease 52

New Drug Approvals

AUGUST 26, 2023

Zuranolone CAS 1632051-40-1 Zurzuvae FDA APPROVED 8/4/2023, To treat postpartum depression Press Release WeightAverage: 409.574 Monoisotopic: 409.272927379Chemical FormulaC 25 H 35 N 3 O 2 SAGE 217 SAGE-217 SAGE217 Zuranolone , sold under the brand name Zurzuvae , is a medication used for the treatment of postpartum depression. [1]

FDA 52

FDA FDA Approval Clinical Trials Treatment 52

The Pharma Data

SEPTEMBER 28, 2021

Also, the info from SRP-9001 have helped to optimise the planning of the upcoming phase III clinical trial trial for DMD,” said Levi Garraway, M.D., quite 4,000 patients are treated with Evrysdi in clinical trials, compassionate use, and real-world settings. Roche’s Chief medic and Head of worldwide development.

Clinical Trials 52

Clinical Trials Protein Expression Therapies FDA 52

The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

Vaccine 52

Vaccine Immune Response Virus RNA 52

The Pharma Data

OCTOBER 26, 2020

The purpose of this exploratory Phase 1b/2 trial was to evaluate the safety and efficacy of the combination of TG4001 and an immune checkpoint inhibitor in a heterogeneous group of patients with aggressive, recurrent and/or metastatic HPV16-positive cancers. Key findings of the trial: .

Vaccine 40

Vaccine Trials Treatment Virus 40

The Pharma Data

APRIL 8, 2021

New 2-year findings from Part 2 of the Phase II/III FIREFISH trial show longer-term efficacy and safety of EVRYSDI in infants with symptomatic Type 1 SMA treated with EVRYSDI. P6: Neuromuscular Disorders and Clinical Trials. P6: Neuromuscular Disorders and Clinical Trials. Multiple Sclerosis (MS).

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

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 In 2018, Janssen Biotech, Inc.

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

MARCH 30, 2021

About the Phase 3 ADVANCE Study The pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was designed to evaluate the efficacy, safety, and tolerability of oral atogepant for the preventive treatment of migraine in those with 4 to 14 migraine days per month.

Treatment 52

Treatment FDA Doctors FDA Approval 52

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. Roche is also deeply committed to addressing barriers to clinical trial participation and advancing inclusive research.

Clinical Trials 52

Clinical Trials Disease Treatment Therapies 52

Agency IQ

OCTOBER 6, 2023

There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. This is a significant jump from any previous year, with the former peak at 15 in FY 2018, followed by several years in the 10-14 range. of all NME approvals this year.

FDA 52

FDA Biosimilars Science Production 52

Dark Matter Blog

AUGUST 27, 2020

In early August, risdiplam, an orally available small molecule that binds to a stem-loop structure in the SMN2 pre-mRNA, received FDA approval for the treatment of spinal muscular atrophy , a devastating genetic disease. This compound, since renamed ‘branaplam’, is in clinical trials in SMA patients.

Small Molecule 52

Small Molecule RNA Clinical Trials Drugs 52

The Pharma Data

JUNE 18, 2021

BOTOX ® Cosmetic is the first and only product of its kind FDA-approved to treat three areas, temporarily improving the appearance of moderate to severe forehead lines, glabellar lines and crow’s feet in adults. Department of Health and Human Services FDA Approval Letter for BOTOX® Cosmetic for Glabellar Lines, 2002.

Doctors 52

Doctors FDA Approval Treatment Production 52

The Pharma Data

AUGUST 31, 2021

Prostate-Specific AntigenKinetics in Patients from TITAN and SPARTAN (oral presentation): Post-hoc analysis of PSA kinetics in 1,331 patients treated with ERLEADA ® from both the TITAN and SPARTAN trials (Abstract #PD34-11). 2] ERLEADA ® received U.S. For more information, visit www.ERLEADA.com.

Treatment 52

Treatment Trials FDA Approval Disease 52

The Pharma Data

JUNE 28, 2021

” Aimovig (erenumab-aooe) was approved as a preventive treatment for migraine in adults in the United States on May 17, 2018. As of May 2021, it has been approved in 71 countries or territories, including the European Union, the United Kingdom, Canada, and Australia, and is approved by many regulatory authorities worldwide.

Treatment 52

Treatment Disease Clinical Trials Hospitals 52

The Pharma Data

JUNE 18, 2021

lead study investigator of the Phase 3 RESONATE-2 trial, and Professor of Medicine at the Wilmot Cancer Institute, University of Rochester. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA ® was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

FDA Approval 40

FDA Approval Treatment Therapies FDA 40

The Pharma Data

MAY 18, 2021

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. Tecentriq’s indication was subsequently focused on PD-L1 high patients, who would benefit the most based on findings from the IMvigor130 study in 2018. J Clin Oncol.

FDA 40

FDA Treatment Pharmaceuticals Science 40

The Pharma Data

AUGUST 1, 2021

AbbVie also presented an updated analysis from the Phase 3 ARTEMIS studies assessing the efficacy and duration of Durysta (bimatoprost intracameral implant), the first and only FDA-approved dissolvable implant to reduce eye pressure in people with open angle glaucoma or high eye pressure. years in patients with RA.

FDA 52

FDA Treatment Trials Disease 52

The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

The Pharma Data

JUNE 18, 2021

May 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced The Lancet published primary analysis results from the pivotal global Phase 3 clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating RINVOQ ® (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment.

Treatment 40

Treatment Disease FDA Therapies 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. Finally, the committee came up with a list of recommendations for the structure of additional trials, listed in the meeting minutes.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

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. 6] ERLEADA ® is being studied in five Phase 3 registrational clinical trials. ASCO Answers: Prostate Cancer (2018). ERLEADA ® received U.S. All rights reserved.

Treatment 52

Treatment Pharmaceutical Companies Therapies Pharmaceuticals 52

Agency IQ

OCTOBER 6, 2023

While stimulant use disorder is increasing, there are currently no FDA-approved medications. The meeting discussed the challenges associated with running trials for substance use disorder medications, from medication nonadherence to trial enrollment.

FDA 40

FDA Treatment Production Trials 40