pharmaphorum

NOVEMBER 1, 2021

Novartis has claimed FDA approval for one of its ‘wild card’ drugs – Scemblix – a first-in-class STAMP inhibitor for patients with previously-treated chronic myeloid leukaemia (CML). The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on.

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Pharmaceutical Technology

MAY 24, 2023

The therapy has also received orphan drug and fast-track designations. It is also licensed by Spain’s Centro de Investigación Biomédica en Red de Enfermedades Raras, the Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz and the Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas.

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Drug Discovery World

MARCH 7, 2024

Following closing, the company will have an expanded pipeline that contains multiple assets spanning early and late development stages. The merged pipeline features an antibody-drug conjugate (ADC) toolkit with novel payload and linker technologies.

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Drug Discovery World

NOVEMBER 25, 2022

Cancer Research UK, The University of Manchester and Roche have opened a multi-drug, precision medicine trial for people with rare cancers. . The trial is set up to recruit both paediatric and adult patients with any rare cancer type and is one of very few precision medicine platform trials in the world targeting these populations.

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Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based based sites.

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Druggist

DECEMBER 31, 2020

Vibegron (brand name: Gemtesa) is the latest drug used to treat overactive bladder that has been approved by the FDA in the USA. Licensed use and legal status of vibegron (US). The effectiveness of vibegron: summary of clinical trial . The effectiveness of vibegron: summary of clinical trial . How does Vibegron work? .

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Drug Discovery World

FEBRUARY 1, 2023

Big pharma is helping to shape the focus The good news is that clinical trials are on the increase and market education is upping pace. Nothing is definitive yet, and these are complicated trials, but the world wants to move to safer alternatives that don’t impede daily life or cause further issues.

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pharmaphorum

APRIL 27, 2021

The Oncologic Drugs Advisory Committee (ODAC) is scheduled to look at the data for the three drugs – Merck & Co’s Keytruda (pembrolizumab), Bristol-Myers Squibb’s Opdivo (nivolumab) and Roche’s Tecentriq (atezolizumab) – across six types of cancer.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Drug Discovery World

AUGUST 4, 2023

The US Food and Drug Administration (FDA) approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent. Based on the results from the RUBY clinical trial, I look forward to the addition of Jemperli to chemotherapy becoming a new standard of care for patients.”

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) on Friday, December 11, 2020. The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

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Drug Discovery World

JULY 20, 2023

What are benefits of drug repurposing and why do clinical drug trials so often fail? Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023.

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The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development. View source version on businesswire.com: [link].

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Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

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World of DTC Marketing

MAY 24, 2022

To make matters worse, a former executive at Cerebral, a well-funded online mental health startup, claims in a labor lawsuit that the company fired him after he complained that the company was too quick to prescribe powerful stimulant drugs. Do online mental health apps work? Mental wellness apps are basically the Wild West of therapy.

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The Pharma Data

DECEMBER 13, 2020

RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). RLY-1971 is currently being evaluated in a first-in-human trial designed to treat patients with advanced or metastatic solid tumors. To learn more about the first-in-human clinical trial of RLY-1971, please visit here.

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The Pharma Data

MARCH 30, 2021

These targeted drugs bind to markers or proteins over-expressed by certain tumors, or tumor-associated tissue, such as stroma. This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Disclaimer. Source link:[link].

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The Pharma Data

OCTOBER 19, 2020

manufacturer, Pharmaceutics International, Inc. (“Pii”), has completed the manufacturing process for Berubicin Drug Product, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer currently considered incurable. About CNS Pharmaceuticals, Inc.

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Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account. Product Type-Specific Analysis.

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The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing.

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The Pharma Data

JANUARY 3, 2021

Food and Drug Administration cleared Investigational New Drug Application. United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. About the INZ701-101 Phase 1/2 Clinical Trial of INZ-701 in Adults with ENPP1 Deficiency. BOSTON, Jan. About INZ-701.

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Drug Discovery World

AUGUST 21, 2023

Medications containing semaglutide such as Ozempic, licensed for diabetes, and Wegovy, for weight loss, are being studied to see if they can treat a range of different conditions, including addiction and dementia. The drugs are currently approved as treatments for type 2 diabetes and weight loss.

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The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. and 2 trials planned by our sublicensee WPD in Poland. . and 2 trials planned by our sublicensee WPD in Poland. About CNS Pharmaceuticals, Inc.

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Drug Discovery World

FEBRUARY 6, 2023

Mesoblast has resubmitted its biologics license application (BLA) to the US Food and Drug Administration (FDA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Medicine 52

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XTalks

MAY 1, 2023

Last week, the US Food and Drug Administration (FDA) granted accelerated approval to Biogen’s Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 ( SOD1 ) gene. This makes Qalsody the first approved treatment to target a genetic cause of ALS.

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Druggist

SEPTEMBER 30, 2020

Buscopan and mebeverine are two common drugs used for symptomatic treatment of irritable bowel syndrome (IBS). Both drugs can be prescribed by a doctor or purchased over the counter from pharmacies and in case of Bucopa IBS relief from supermarkets. Buscopan vs Mebeverine lists similarities and differences between both drugs.

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Druggist

DECEMBER 28, 2020

Fexofenadine belongs to a group of drugs called antihistamines. Fexofenadine over the counter will be available as a branded product – Allevia 120mg tablets (each tablet contain 120mg of fexofenadine hydrochloride). The decision to make fexofenadine available without a prescription is based on the safety profile of this drug.

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The Pharma Data

AUGUST 17, 2020

Food and Drug Administration clearance in May 2020 for its investigational new drug application to develop DF6002. In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. Dragonfly received U.S.

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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. Novartis today announced that the U.S. SVP, Chief Medical Officer, Novartis Gene Therapies. “We

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The Pharma Data

NOVEMBER 30, 2020

The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. Chief Executive Officer of Biohaven, said: “We are excited to enter into this agreement with Sosei Heptares, a world leader in GPCR drug discovery.

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XTalks

APRIL 26, 2021

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. Malaria Vaccine Phase II Trial.

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Druggist

MAY 12, 2021

Celevac is a brand of tablets containing methylcellulose. Each Celevac tablet contained 500mg of methylcellulose. Celevac tablets were licensed as general sale list medicines (GSL), which means they could be sold in any retail outlet, including pharmacies, over the counter without a prescription. . What is Celevac?

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The Pharma Data

APRIL 27, 2023

The positive opinion is supported by data from the pivotal AReSVi-006 ( A dult R espiratory S yncytial V irus) phase III vaccine efficacy trial. In the trial, the vaccine candidate showed 82.6% (96.95% CI, 57.9–94.1, Across multiple trials, the vaccine candidate was generally well tolerated with an acceptable safety profile.

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The Pharma Data

DECEMBER 22, 2020

Approximately 74 patients are planned for this trial in Head and Neck Squamous Cell Carcinoma (HNSCC) and Cutaneous Squamous Cell Carcinoma (CuSCC). The trial will enroll three cohorts of patients within distinct populations – all with locally advanced, recurrent and/or metastatic HNSCC or locally advanced or metastatic CuSCC.

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The Pharma Data

JANUARY 13, 2021

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS).

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