The Pharma Data

JUNE 26, 2021

Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit. director of the FDA’s Center for Drug Evaluation and Research.

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The Pharma Data

NOVEMBER 18, 2020

. “I think it would make my mother so happy to know that I’m doing something to help other families who are going through what my family went through because it was the greatest trial of our lives,” Kaling said. Since 2003, the organization has invested $126 million in pancreatic cancer research.

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The Pharma Data

JANUARY 18, 2021

The forward-looking statements contained in this press release are also subject to risks not yet known to Biophytis or not currently considered material by Biophytis.

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The Premier Consulting Blog

DECEMBER 28, 2023

3] Understanding Medicare Coverage for IDE Studies The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) allows for Medicare coverage of the routine costs of care provided to Medicare beneficiaries in certain categories of Investigational Device Exemption (IDE) studies. [4]

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The Pharma Data

NOVEMBER 23, 2020

The study is an open-label, exploratory phase I/II trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and second- (and later) line treatment of MPM to assess safety, immune activation and efficacy versus SoC only. 1 Vogelzang 2003, Ceresoli 2006, Zalcman 2015, Tsao 2019, Scagliotti 2019, Baas 2020 SITC 2020 poster.

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The Pharma Data

JULY 22, 2021

Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Biogen Inc.

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The Pharma Data

OCTOBER 19, 2020

Promising results have been observed in the phase I trial regarding local control. In the United States, the Company has started the regulatory process to commence a phase III clinical trial in locally advanced head and neck cancers. About NANOBIOTIX: www.nanobiotix.com.

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NIH Director's Blog: Drug Development

MARCH 18, 2021

He’s also a member of the international research team that identified a human antibody, called S309, from a person who’d been infected with SARS in 2003. This antibody is showing promise for treating COVID-19 [3], now in a phase 3 clinical trial in the United States.

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Drug Discovery World

FEBRUARY 26, 2024

Xolair was originally approved in 2003 for the treatment of moderate to severe persistent allergic asthma. Omalizumab clinical trial The FDA approval is based on data from a planned interim analysis of a Phase III clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH.

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The Pharma Data

OCTOBER 1, 2021

The phase IV clinical trials , multicenter, controlled, cross-over study with corresponding blinded image evaluations met its primary endpoint, showing that a 75 percent dose of gadobutrol (0.075 mmol/kg) is non-inferior to a one hundred pc dose of gadoterate (0.1 mmol/kg) for CNS imaging. it had been further approved within the U.S.

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The Pharma Data

NOVEMBER 9, 2020

The primary endpoint of the trial is recommended phase II dose (RP2D); the secondary endpoints are objective response rate (ORR), safety and feasibility, and body-kinetics; and the exploratory endpoints are survival outcomes, duration of response, and biomarkers of response.

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NIH Director's Blog: Drug Development

MAY 21, 2020

In work described in the journal Nature , an international research team started with a set of neutralizing antibodies previously identified in a blood sample from a person who’d recovered from a different coronavirus-caused disease, called severe acute respiratory syndrome (SARS), in 2003 [3]. In the U.S.

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Agency IQ

SEPTEMBER 15, 2023

The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. Both trials showed no difference between phenylephrine and placebo.

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PLOS: DNA Science

JULY 27, 2023

That information led, thanks to vaccine shelved from the first SARS circa 2003, to the rapid development and deployment of mRNA vaccines against the new infectious disease. Next up: testing in real-world settings and submission of clinical trial findings to the FDA.

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Drug Discovery World

FEBRUARY 20, 2024

Industry experts explain how blockchain can fundamentally enhance clinical trials. Obtaining consent from patients or healthy volunteers is a fundamental requirement for enrolling participants on to clinical trials. Along the study, patients are usually reconsented multiple times following a change in the trial protocol, eg.

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Drug Discovery World

FEBRUARY 20, 2024

Industry experts explain how blockchain can fundamentally enhance clinical trials. Obtaining consent from patients or healthy volunteers is a fundamental requirement for enrolling participants on to clinical trials. Along the study, patients are usually reconsented multiple times following a change in the trial protocol, eg.

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The Pharma Data

DECEMBER 15, 2020

Founded in 2003, Athenex, Inc. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, through 13 subsidiaries, with about 1,800 employees. Total revenues in 2019 were 908.4 million euros. For more information, please visit almirall.com. About Athenex, Inc.

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The Pharma Data

NOVEMBER 5, 2020

Sussman has also had leadership experience in industry as the founder and vice president of both Amphioxus Cell Technologies from 1995 to 2003 and Hepatix, Inc. O’Day has been a principal investigator for more than 200 clinical trials. from 1993 to 1995. FAST BioMedical – Privately-held FAST named Jim Dillon to its board of directors.

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The Pharma Data

MAY 5, 2021

Active LN was confirmed by renal biopsy during screening visit using the 2003 International Society of Nephrology/Renal Pathology Society criteria within the past 6 months, and clinically active kidney disease requiring induction therapy. [1]. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. N Engl J Med.

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Drug Target Review

FEBRUARY 28, 2024

Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. from 2003 to 2006, covering the biotechnology and life-science tools sectors.

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Drug Target Review

NOVEMBER 17, 2023

Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. CAR-NK cell trials only commenced in 2017 and most are still recruiting patients.

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Drug Target Review

MAY 18, 2023

Results of the Multicenter Study of Hydroxyurea in Sickle Cell Anaemia published in the Journal of the American Medical Association in 2003, indicated that the use of hydroxyurea, the only drug approved at the time, reduced mortality as it reduced pain crises and increased foetal haemoglobin.

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Drug Target Review

NOVEMBER 30, 2023

Then I was approached to co-found AC Immune in 2003. We are the only company in the world including this population in any Alzheimer’s drug trial, and we are very proud of this! I accepted and I’ve been CEO ever since; our goal, from the beginning, was to pioneer new ways to diagnose, treat and prevent neurodegenerative diseases.

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The Pharma Data

APRIL 25, 2021

Nirsevimab demonstrate d protect ion against respiratory syncytial virus disease in healthy infants in Phase 3 trial. The overall safety profile of nirsevimab in the trial remains consistent with previously reported results. Lurie Children’s Hospital of Chicago, Illinois, US and primary investigator of the MELODY Phase III trial.

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The Pharma Data

DECEMBER 10, 2020

million (€40 million) to advance its clinical trial of NBTXR3 in the United States and Europe for the treatment of locally advanced head and neck cancers through an interim analysis of efficacy data, approximately $18.2 million (€15 million) to advance the development of its other clinical and pre-clinical programs, and.

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Agency IQ

APRIL 8, 2024

When the document was taken back to the drawing board again in 2003, it remained on hold for more than a decade until a final version was agreed upon in 2012, with the FDA officially adopting it in 2014. That revised version remains in use today ( more on this below ).

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Drug Target Review

DECEMBER 14, 2023

In 2003, Dr Richard Wood, distinguished Professor at the University of Texas MD Anderson Cancer Center, was a crucial part of the first characterisation of polymerase theta. His and Dr Stroik’s new research will help new cancer drugs called polymerase theta inhibitors, which are currently in clinical trials. Annual Review of Genetics.

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The Premier Consulting Blog

JANUARY 17, 2023

The Pediatric Research Equity Act (PREA) was signed into law in 2003 to increase pediatric use information in product labeling and close knowledge gaps regarding the safety, efficacy, and appropriate dosing of drugs to treat children.

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The Pharma Data

FEBRUARY 25, 2021

7 In clinical trials, the safety and immunogenicity of TicoVac was assessed across two age groups (1-15 years of age and 16-65 years of age). 2003 Dec 12;22(2):217-23. “If approved in the U.S., The BLA is based on results from more than 40 years of experience and evidence outside the U.S. 2011;29(43):7307-19. Ehrlich HJ, et al.

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Drug Discovery World

AUGUST 15, 2023

Consequently, electrophysiological techniques need to be developed that can provide better translation from small mammalian hearts into larger hearts and then on into human clinical trials. Figure 3: Electrograms (left panel) are recorded at increasingly short intervals between the stimuli (the ‘S1S2 interval’). 96(5): 549-558. Tisdale et al.

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New Drug Approvals

JULY 10, 2023

1] Zavegepant is an antagonist of the calcitonin gene-related peptide (CGRP) receptor currently in phase 3 trials in an intranasal formulation for the treatment of migraine. The clinical trial is expected to complete in September 2020. Zavegepant is indicated for the acute treatment of migraine with or without aura in adults. [1]

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Agency IQ

FEBRUARY 21, 2024

In 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the “strongly recommended format” for submission of applications to the FDA.

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Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). 2003), review denied (Cal.

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Drug & Device Law

JUNE 1, 2023

The linchpin of our proposed language, or anything similar, is – of course – the requirement that trial judges act as “gatekeepers” to preclude the admission of inadequately supported – under whatever test a particular jurisdiction applies – expert opinions. So we did it by state. Ex parte George , So.3d 3d , 2021 WL 68997, at *23 (Ala.

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Drug & Device Law

FEBRUARY 20, 2023

2003), aff’d , 810 N.Y.S.2d That the product had been approved in “other countries” could not create a triable issue of fact because, even for other uses that the FDA eventually allowed, the necessary clinical trials had not been completed in 2010. Lederle Laboratories recognized that courts, generally, are “reluctan[t]. . .

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Drug & Device Law

JANUARY 30, 2023

Moran , 536 U.S. Walsh , 538 U.S.

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Drug & Device Law

DECEMBER 18, 2023

The Tasigna decision addresses the defendant’s request that plaintiffs pay the costs of anonymizing clinical trial data prior to production. Plaintiffs claimed they needed the extensive clinical trial data so one of their statistician experts could utilize the data for signal analysis. 2003) supported their positions.

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