Drug Discovery World

OCTOBER 4, 2022

million from the National Institute on Aging of the National Institutes of Health, the company plans to begin a Phase Ia clinical trial evaluating its lead tau self- association small molecule inhibitor OLX-07010. . Global dementia prevalence is expected to increase to 152 million in 2050, a 204% increase compared to 2018.

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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.

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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.

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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. .

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Drug Discovery World

APRIL 14, 2023

He is being recognised for his celebrated contributions to the understanding and targeting of pancreas cancer metastasis, including work that has assisted with the development of minnelide, a pro-drug of triptolide for the treatment of pancreas and gastrointestinal cancers that is currently in Phase II clinical trials.

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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.

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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).

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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.

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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.

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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.

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Drug Discovery World

AUGUST 10, 2023

Evident by the rapid enrollment in our clinical trial and survey findings of people who use e-cigarettes, many people want to quit and have difficulty in doing so successfully. Research in this emerging area is limited, and there are currently no treatments that are specifically approved by the FDA for e-cigarette cessation.

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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.

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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.

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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.

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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. This DNA Science post from 2018 traces the history of the efforts.

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Agency IQ

JANUARY 19, 2024

However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. approval was supported by the RATIONAL 302 study, which was a randomized, active comparator, open-label trial in the second-line setting.

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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.

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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.

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Agency IQ

JUNE 7, 2024

However, this means that substances that were already available as dietary ingredients prior to their sponsors submitting an IND or obtaining FDA approval may still be marketed as such. L-glutamine offers an example of a more recently approved drug product. FDA’s problems with supplement oversight go well beyond just NDIs.

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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.

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Agency IQ

JULY 21, 2023

BY RACHEL COE, MSC JUL 18, 2023 11:14 PM CDT Oncology endpoints: The growing pains of an evolving field FDA approval of a drug or biologic relies on whether there is “substantial evidence” of safety and effectiveness derived from “adequate and well-controlled clinical investigations” according to the Federal Food, Drug, and Cosmetic (FD&C) Act.

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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.

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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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Agency IQ

NOVEMBER 3, 2023

In fact, the FDA has even developed a guidance document for “early clinical trials with live biotherapeutic products [LBPs].” In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP.

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The Pharma Data

JANUARY 14, 2021

Food and Drug Administration (FDA) approved Pfizer ’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. Manuel Esteban/Shutterstock.

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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.

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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.

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The Pharma Data

DECEMBER 27, 2020

This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians.

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The Pharma Data

JANUARY 24, 2021

1 Sairiyo has an exclusive license from a research and development organization to develop and commercialize reformulated Cepharanthine for all diseases and exclusive rights to the patent, method of manufacturing, clinical supply, pre-clinical data and know-how to support FDA clinical trials.

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Drug Discovery World

JANUARY 17, 2024

Brett Swansiger, Chief Commercial Officer at ANGLE discusses the importance of liquid biopsies in precision medicine trials for cancer. Furthermore, oncology clinical trials are frequently challenged by low enrolment rates, failure to achieve primary endpoints, study design complexity and limited funding 5.

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Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. 2018) 4;8:163. 2018) 9(507). 2018) 18(1).

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The Pharma Data

JANUARY 11, 2021

based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The WEB System received its first PMA approval in late 2018.

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Agency IQ

OCTOBER 20, 2023

A study found that, of 23 FDA-approved biosimilar products, 21 had comparative efficacy established through one or more phase 3 clinical trials , which included “both an initial comparative efficacy period and additional follow-up, during which a subset of patients was switched between the biosimilar and reference products.”

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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]

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Drug Discovery World

SEPTEMBER 16, 2022

In 2021, the Cell and Gene Therapy Catapult estimated that there 168 ongoing clinical trials for advanced therapy medicinal products (ATMPs) taking place – representing 9% of all global trials in the space. The UK stands as one of the key markets for cell and gene therapies. billion in funding. . The potential is there though.

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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.

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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.

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