Drug Discovery World

DECEMBER 22, 2023

In other news, the FDA approved a promising antibody-drug conjugate for bladder cancer and trial results demonstrated that psilocybin could reduce depression symptoms in cancer patients. In the study, trial participants treated with psilocybin not only experienced a lessening of depressive symptoms but also spoke highly of the therapy.

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Drug Discovery World

AUGUST 24, 2023

It is approved in adult patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. The most common adverse event (AEs) observed in the study was cytokine release syndrome (77%, 1.5%

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The Pharma Data

JANUARY 18, 2021

This technology has received a lot of attention in our facility, and, likely, many of the patients who need and then receive CCM therapy will ultimately require MRI procedures,” said Dr. Robert W. CCM therapy is the first approach designed to optimize heart contraction, allowing more oxygen-rich blood to reach the body.

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Drug Discovery World

SEPTEMBER 13, 2022

The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2022 by Professor Robin Jones, MD, Head of the Sarcoma Unit at The Royal Marsden Hospital, London. Desmoid tumours are rare, connective tissue tumours that can have aggressive infiltrative growth and a high risk of local recurrence.

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The Pharma Data

AUGUST 13, 2020

NS Pharma has claimed a tentative FDA approval for its Viltepso (viltolarsen) injection in the treatment of Duchenne muscular dystrophy (DMD) in patients who are suitable to receive exon 53 skipping therapy. Mutations in the DMD gene can lead to an absence of the muscle cell protein dystrophin. of normal at baseline to 5.9%

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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

MAY 5, 2021

AstraZeneca’s Farxiga (dapagliflozin tablet) has received an expanded indication for lowering the risk of kidney function decline, kidney failure, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease and risk of progression. . . Patients in the multicenter, double?blind, blind, placebo?controlled

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The Pharma Data

DECEMBER 3, 2020

In the long-term APeX-S trial, those who completed 48 weeks of therapy had an average attack rate of 0.8 ORLADEYO is the first and only oral therapy that was designed to prevent attacks of HAE in adults and pediatric patients age 12 and older. attacks per month at baseline, to a mean of 1.0 attacks per month. attacks per month.

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The Pharma Data

FEBRUARY 24, 2022

Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Today, the U.S.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalization after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalization. KENILWORTH, N.J.–(BUSINESS

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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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Drug Discovery World

SEPTEMBER 7, 2023

4 Recent regulatory initiatives in the United States and Europe have aimed to increase the study of novel anti-cancer therapies in children. 4 Recent regulatory initiatives in the United States and Europe have aimed to increase the study of novel anti-cancer therapies in children.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. PALO ALTO, Calif.,

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The Pharma Data

DECEMBER 21, 2020

Now, all that being said, with the Covid-19 pandemic, there is a recommendation from the National Comprehensive Cancer Network for patients with cancer to avoid hospitals and clinics as much as possible. It’s, we believe, one of the reasons we were granted priority review by the FDA.” .

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The Pharma Data

SEPTEMBER 11, 2021

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. The benefit was independent of ejection fraction or diabetes status.

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Drug Discovery World

JULY 2, 2024

In another example, university of Basel spin-off T3 Pharma reached Phase I development of a cancer therapy that harnesses the natural behaviours of live bacteria before being acquired by Boehringer Ingelheim for $509m at the end of 2023. Three years ago, we started our venture into the radiotherapy space.

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The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir. percent (24/515) for baricitinib plus remdesivir versus 7.1 Wesley Ely, M.D.,

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The Pharma Data

DECEMBER 17, 2020

(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic.

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The Pharma Data

JULY 12, 2021

Finerenone 10 mg or 20 mg is indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

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The Pharma Data

AUGUST 28, 2020

In other news, the FDA has approved a request from American Gene Technologies to begin a clinical study of its HIV gene therapy and a 75-year-old woman from Nottinghamshire is thought to be the first British case and victim of COVID-19. FDA approves Phase 1 trial for HIV gene therapy.

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Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

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MARCH 24, 2021

of women who continued on relugolix combination therapy remained responders (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who continued relugolix combination therapy remained responders through Week 104. of women who discontinued treatment at Week 52 (p < 0.0001). weeks after discontinuation.

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The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) has approved Benlysta to treat lupus nephritis (lupus-related kidney disease) in adults. The approval is for both the intravenous and subcutaneous formulations. The decision makes Benlysta the first lupus therapy authorized to treat this potentially life-threatening complication of the disease.

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The Pharma Data

JULY 8, 2021

Patients should call their healthcare provider or go to the nearest hospital emergency room right away if they have any of the symptoms listed above. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies.

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Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

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The Pharma Data

MAY 4, 2021

An initial donation of 400,000 baricitinib tablets is being made immediately available to the Indian government for eligible hospitalized COVID-19 patients in India and Lilly will work urgently to increase the quantity of donated product multifold over the coming weeks. Ricks , Lilly chairman and CEO.

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Eye on FDA

DECEMBER 6, 2023

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. The Antimicrobial and the Cellular, Tissue, and Gene Therapy each met three times.

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The Pharma Data

MAY 17, 2021

. In a Viewpoint, Bishal Gyawali, MD, PhD, and colleagues at the Program on Regulation, Therapeutics and Law (PORTAL) research group at Harvard Medical School and Brigham & Women’s Hospital suggested improving FDA’s authority to modify drug package insert for situations such as drug repurposing and de-escalation of therapy.

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The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Testing Therapies, Antivirals and Vaccines. Days after the U.S. Please read more here. . Typically, the U.S.

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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

hospitals are stretched to the limit trying to help people battling serious cases of COVID-19. This improvement stems from several factors, including the FDA’s emergency use authorization (EUA) of a number of therapies found to be safe and effective for COVID-19. Credit: NIH Right now, many U.S.

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Drug Discovery World

SEPTEMBER 16, 2022

Here, DDW Editor Reece Armstrong explores the global hubs of innovation for cell and gene therapies. Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. .

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The Pharma Data

OCTOBER 22, 2020

With today’s FDA approval, and regulatory approvals or temporary authorizations in approximately 50 additional countries around the world, Veklury® (remdesivir) is one of the tools available today. Rapid Mobilization While Navigating Unknowns The development pathway for Veklury as a COVID-19 treatment has been extraordinary.

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The Pharma Data

JANUARY 12, 2021

Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. Regeneron Pharmaceuticals, Inc. NASDAQ: REGN ) today announced that the U.S. Yancopoulos , M.D., In the U.S.

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The Pharma Data

OCTOBER 25, 2020

When used with the Impella heart pump it can unload the heart and oxygenate the body, a combination therapy known as ECpella. This ECMO technology will allow us to support new patient populations, such as COVID-19 patients and others who need lung support, and provide combination ECpella therapy to Impella patients who need oxygenation.

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The Pharma Data

OCTOBER 25, 2020

We are pleased to continue pursuing additional neuroscience opportunities with BXCL501, targeting agitation associated with delirium, a fifth potential indication for this candidate and a condition for which there is no FDA-approved treatment,” commented Vimal Mehta, Chief Executive Officer of BTI. NEW HAVEN, Conn.,

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