The Pharma Data

DECEMBER 11, 2020

Food and Drug Administration is expected to approve emergency use of Pfizer’s coronavirus vaccine as early as Saturday after its advisory panel cleared the way for the start of a national campaign to inoculate Americans and stem the spread of COVID-19. Who is first in line? Centers for Disease Control and Prevention.

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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. The study findings have been submitted to a peer-reviewed journal for future print publication.

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The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * efficacy against any symptomatic COVID-19 disease, in line with expected vaccine effectiveness in today’s environment dominated by variants of concern.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration advisory panel will vote on Thursday whether to recommend emergency approval of Pfizer’s coronavirus vaccine, a decision that will come not a moment too soon as the country reported more than 3,000 new COVID-19 deaths on Wednesday. Meanwhile, U.S.

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The Pharma Data

MAY 7, 2021

. Pfizer-BioNTech files for US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) ( Politico ) ( Press ). Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ). Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ).

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The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. The interim analysis comprised 95 cases of symptomatic COVID-19 among volunteers.

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The Pharma Data

MARCH 2, 2021

Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older. The terms of the EUA allow use of the vaccine while more data are gathered.

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The Pharma Data

AUGUST 28, 2020

The top 10 news stories this week are focused on coronavirus vaccines and treatments, as China is set to move ahead with human testing of a potential vaccine that has been created using insect cells, while AstraZeneca has started a clinical trial of its antibody treatment designed to prevent and also treat symptoms of coronavirus.

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The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. Hahn , M.D.

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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. The approval marks the first drug approved by 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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The Pharma Data

APRIL 6, 2021

Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD). OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS.

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Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. It also stated that companies should consider whether an investigational product might interact with an administered vaccine for Covid-19.

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The Pharma Data

AUGUST 3, 2021

“As additional data from COV-BARRIER become available, it is increasingly evident that treatment with baricitinib may help prevent death in some of the most critically ill COVID-19 patients and that baricitinib represents an important treatment option for this vulnerable group of patients in this constantly evolving pandemic,” said E.

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The Pharma Data

MAY 4, 2021

This donation furthers both Lilly and Direct Relief’s charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries. ” The allocation of therapies will be based on the disease burden and hospitalization rates in each country.

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Drug Discovery World

APRIL 27, 2023

Recently, researchers at the Broad Institute of MIT Harvard, Boston Children’s Hospital, and Dana-Farber Cancer Institute have found that HSC are particularly vulnerable to ferroptosis, a kind of cell death triggered by iron. Previously, scientists have studied ferroptosis mostly in cancer cells.

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The Pharma Data

NOVEMBER 12, 2020

José Baselga, Executive Vice President, Oncology R&D, said: “Since the beginning of the year, AstraZeneca has been committed to doing everything we can to respond to COVID-19, including investigating existing medicines as potential treatments. Related Articles: Calquence (acalabrutinib) FDA Approval History. CALAVI US).

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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The Pharma Data

NOVEMBER 9, 2020

Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

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The Pharma Data

DECEMBER 20, 2020

Food and Drug Administration (FDA) is plenty busy with COVID-19 vaccine Emergency Use Authorizations (EUAs) this month, but they’re also wrapping up the year with a few PDUFA dates for other therapies. It was approved on December 15, 2020. The FDA completed a class 2 response in July 2020. Here’s a look.

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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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The Pharma Data

NOVEMBER 17, 2021

For the past year and a half, the COVID-19 pandemic has continued to engulf the globe, fueled in part by novel variants and the uneven distribution of vaccines. Noting that it would be unrealistic to give the drug as a preventative measure, they are especially interested in how patients hospitalized with severe COVID-19 fare on disulfiram.

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The Pharma Data

APRIL 26, 2022

This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population. director of the FDA’s Center for Drug Evaluation and Research.

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The Pharma Data

JULY 21, 2021

mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. Bayer also issued a news release earlier today announcing the EC approval. In the EU, VERQUVO (2.5

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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. Schleifer , M.D., ” The U.S.

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The Pharma Data

SEPTEMBER 1, 2020

The trial included 2,494 patients who had previously completed a Phase 1, 2 or 3 Zeposia clinical trial and who had an average treatment time of 35.4 Gaining insight into long-term therapeutic outcomes can enable clinicians to identify the most appropriate treatment approach for their multiple sclerosis patients. Author: Harris.

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The Pharma Data

MAY 15, 2023

Food and Drug Administration (FDA) approval of Dupixent in September 2022 and the European Medicines Agency approval of Dupixent in December 2022. Dupixent is the only approved biologic indicated for prurigo nodularis in the U.S. Results from the trials were the basis for the U.S. Source link: [link]

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The Pharma Data

MARCH 23, 2023

Head of Global R&D ad interim and Chief Medical Officer at Sanofi “Change cannot come quick enough for people living with uncontrolled COPD but , unfortunately , many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limited treatment options.

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The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S. Jansen, Ph.D.,

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The Pharma Data

OCTOBER 29, 2020

Interim analyses were conducted after patients completed 12 and 36 weeks of treatment, the latter for the primary endpoint of the Phase 2 part of the study. ” In March, the FDA granted Breakthrough Therapy designation to baricitinib for the treatment of AA based on positive Phase 2 results from BRAVE-AA1.

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The Pharma Data

JULY 29, 2021

The series of promising pipeline updates included the data from the landmark ZUMA-7 study for the treatment of second-line large B-cell lymphoma. Launch activities continue following the full FDA approval for second-line metastatic triple-negative breast cancer (“mTNBC”) and accelerated approval for metastatic urothelial cancer.

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The Pharma Data

APRIL 28, 2021

Second EU approval in less than 12 months for Sarclisa in combination with a standard of care regimen for the treatment of relapsed or refractory MM. This marks the second EC approval of Sarclisa in combination with a standard of care regimen in less than 12 months. “ This EC approval closely follows the U.S.

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The Pharma Data

JANUARY 26, 2021

While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence,” said Daniel Skovronsky, M.D., It remains under review by the FDA. INDIANAPOLIS, Jan. have reached record highs.

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Agency IQ

NOVEMBER 3, 2023

Because they focus on treatment of a specific condition, synthetic biotics must be studied under an investigational new drug application (IND). 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

MAY 16, 2021

Description: I’ve been a researcher for over 15 years at one of the biggest hospitals in Cleveland, Ohio. Before turning this formula into a supplement, I made sure that it is: with ingredients sourced from local growers that let plants naturally reach their full maturity and use no chemical treatments.

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Codon

JULY 14, 2024

The transfusion of platelets thus seems like an obvious treatment to stem bleeding. Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. As a clot forms, liquid blood becomes a solid plug that can stop bleeding in a matter of minutes.

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Drug Discovery World

AUGUST 1, 2023

In terms of breakthroughs and results, in July 2023, DDW reported that Alnylam Pharmaceuticals has revealed results from its Phase I study of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension.

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