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

DECEMBER 21, 2020

Food and Drug Administration (FDA) has now approved the very first oral drug to treat the millions of men affected. . 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.

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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. Lupus is an unpredictable and misunderstood autoimmune disease that ravages different parts of the body.

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The Pharma Data

JANUARY 5, 2021

RAD011 is a pivotal-trial ready synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases. Prader-Willi syndrome (“PWS”) will be the initial indication, which has been granted Orphan Drug and Fast Track Designation by the FDA. Disease Highlights.

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The Pharma Data

DECEMBER 3, 2020

The addition of berotralstat through the EAMS will bring a much needed option for HAE patients suffering with this debilitating disease,” said Dr. Sorena Kiani, Consultant Immunologist at Royal London Hospital, London. “There are many patients in the UK that don’t have a realistic option for effective HAE prophylaxis.

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The Pharma Data

JANUARY 15, 2021

13 in the New England Journal of Medicine , involved patients with high blood pressure in the lungs caused by interstitial lung disease (ILD). It can have a range of causes, from smoking, to occupational exposure to toxins like asbestos, as well as autoimmune diseases like rheumatoid arthritis. The study, published online Jan.

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The Pharma Data

JULY 8, 2021

ADUHELM should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. Food and Drug Administration (FDA) has approved an updated label for ADUHELM (aducanumab-avwa) injection 100 mg/mL solution. ADUHELM is indicated for the treatment of Alzheimer’s disease.

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The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”

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PPD

AUGUST 5, 2024

Pulmonary arterial hypertension (PAH) is a progressive and fatal lung disease that is caused or influenced by multiple factors. Composite endpoints might include factors such as hospitalization, transplantation and worsening of clinical outcomes. Historically, the available drugs and U.S. None offers a cure for PAH.

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The Pharma Data

MAY 31, 2022

. “The approval of Evrysdi for pre-symptomatic babies is particularly important, as early treatment of SMA, before symptoms start to arise, can help babies to achieve motor milestones,” said Richard Finkel, M.D., Jude Children’s Research Hospital. There were no treatment-related adverse events leading to withdrawal.

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The Pharma Data

OCTOBER 30, 2020

(NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. About the REGN-COV2 Trial in Hospitalized Patients. Cohort 1A: patients not requiring oxygen.

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The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Food and Drug Administration (FDA)-approved for this use and there is limited information known about the safety or effectiveness of using Actemra/RoActemra to treat people in the hospital with COVID-19.

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The Pharma Data

OCTOBER 25, 2020

.” SQI’s RALI-dx COVID-19 Severity Triage Test measures five critical biomarkers including IL-6 in approximately 50-minutes to help clinicians determine severe inflammatory response in patients with COVID-19 and whether they require hospital admission or not. SQI Diagnostics, Inc.

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The Pharma Data

NOVEMBER 25, 2020

November 25, 2020 — Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). The approval of remdesivir ( Veklury ) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard.

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DrugBank

DECEMBER 18, 2024

These interventions target a broad spectrum of medical conditions, encompassing chronic diseases and even substance abuse. However, non-adherence to medication regimens remains a pervasive problem, leading to suboptimal outcomes and increased hospitalizations.

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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. Does this signal a return in 2024 to in-person meetings? ” Volume of Meetings and Outcomes.

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The Pharma Data

NOVEMBER 16, 2020

and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. principal investigator of the NIAID-funded Infectious Diseases Clinical Research Consortium site at Baylor College of Medicine in Houston; Lindsey R. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

FEBRUARY 23, 2022

. * In the VAT08 Phase 3 primary series trial, two doses of the Sanofi-GSK vaccine in seronegative populations demonstrated: * 100% efficacy against severe COVID-19 disease and hospitalizations * 75% efficacy against moderate or severe COVID-19 disease * 57.9% Geometric Mean Titers (GMT) (95% CI).

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The Pharma Data

OCTOBER 15, 2020

John Hospital, researchers compared 649 patients from two cohorts: a recent cohort (2017–2019) from the RECOVER III post-market approval (PMA) study, after the widespread adoption of the best practice of placing Impella pre-PCI, and a cohort from before PMA (2008–2014) when the practice of placing Impella pre-PCI was not yet widely adopted.

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Molecule Blog

AUGUST 13, 2021

v=uT2-0qoHjbc Who will be there: Molecule & VitaDAO Core Teams If you haven’t yet read up on the research project as well as the researchers behind it, find more about it below: About the Research Project What if therapeutics to slow down the ageing process and prevent age-related disease already existed? billion prescriptions from 4.8

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Drug Target Review

AUGUST 29, 2024

MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs. What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies?

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The Pharma Data

MARCH 4, 2021

They are also at risk for life-threatening severe asthma attacks that can lead to hospitalization and emergency room visits, and may require the use of systemic corticosteroids which carry significant risks when used long term. Dupixent is approved in the U.S. Outside of the U.S.,

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The Pharma Data

NOVEMBER 29, 2020

The FDA approved the drug on November 24. PH1 is an ultra-rare genetic disease marked by overproduction of oxalate, which causes deposits of calcium oxalate crystals in the kidneys and urinary tract and can lead to painful and recurrent kidney stones, nephrocalcinosis, progression to kidney failure, and system organ dysfunction.

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NIH Director's Blog: Drug Development

JULY 20, 2017

Credit: Brittany Mahoney As NIH Director, I often hear stories of how people with serious diseases—from arthritis to Zika infection—are benefitting from the transformational power of NIH’s investments in basic science. Caption: Two-year-old Avalyn is among the cystic fibrosis patients who may be helped by targeted drugs.

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The Pharma Data

JUNE 28, 2021

Migraine is a Disabling Neurological Disease that Affects More Than 8.4 Having this treatment approved in Japan will enable us to ultimately serve more patients and help them find the right treatment for this disabling, neurological disease.” 1,7 Although approximately 8.4 became a wholly owned affiliate of Amgen Inc.

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The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Additional pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1?,

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The Pharma Data

AUGUST 16, 2021

Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. This press release features multimedia. In the U.S.,

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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. BioXcel Therapeutics, Inc.

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The Pharma Data

DECEMBER 23, 2020

a Miami, Florida-based clinical-stage biopharmaceutical company focused on harnessing the power of nanoparticles for the treatment of degenerative diseases, is awaiting a decision from the FDA regarding an investigational new drug (IND) application for a clinical trial of its proprietary therapeutic, Zofin, in COVID Long-haulers. .

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The Pharma Data

FEBRUARY 18, 2022

“For clinicians treating patients with this serious, chronic disease, results from the True North extension study provide an understanding of long-term therapeutic outcomes and help to identify an appropriate treatment approach for their patients with ulcerative colitis,” said Silvio Danese, M.D., About Ulcerative Colitis.

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The Pharma Data

MARCH 27, 2022

Food and Drug Administration (FDA) granted priority review for OLUMIANT in severe AA as a potential first-in-disease medicine. “Whether people with alopecia areata suffer loss of all the hair on their body or bald spots and missing eyebrows or eyelashes, this autoimmune disease can be devastating. scalp hair loss, or 14.5%

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Broad Institute

JUNE 24, 2025

Based on a technology developed by Broad Institute core member David Liu’s laboratory, the treatment is the first in a series of new medicines being tested to treat rare diseases by repairing patients’ particular genetic misspellings. s to be produced at scale, making them the standard of care for life-threatening rare genetic diseases.

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The Pharma Data

OCTOBER 28, 2020

REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits). The Phase 3 portion of this trial continues in non-hospitalized patients. In total, 47% of participants were male and 53% were female. .

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The Pharma Data

NOVEMBER 16, 2020

The stability at refrigerated conditions allows for storage at most pharmacies, hospitals, or physicians’ offices. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History.

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Agency IQ

JUNE 7, 2024

Dietary supplement products may only make “structure/function” claims – claims that the product affects the structure or function of the body – or claims of nutritional support, and may not make any claim that a supplement treats or prevents a specific disease. See AgencyIQ’s in-depth analysis of the FDA’s approach to CBD regulation here.

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The Pharma Data

NOVEMBER 9, 2020

We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. Albert Bourla, Pfizer Chairman and CEO. “We

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The Pharma Data

OCTOBER 29, 2020

. “Our foundation for the future is stronger than ever, and by maintaining our focus on serving patients and delivering for shareholders, I am confident that we will continue to build on our success to date and further advance our mission of delivering life-changing therapies to people with rare diseases and devastating conditions.”

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