The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Food and Drug Administration (FDA) has approved Zokinvy (lonafarnib) for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL). .

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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

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. “The investigational cocktail is now available to indicated high-risk U.S.

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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. Regeneron Pharmaceuticals, Inc.

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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). In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 There was a 1.08 placebo; p=0.024).

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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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The Pharma Data

NOVEMBER 17, 2021

Now, new research led by investigators at Harvard Medical School and Boston Children’s Hospital points to a well-known and widely available drug called disulfiram as a possible treatment for COVID-19. If disulfiram’s effect against SARS-CoV-2 is confirmed, it could become a useful tool against the virus. A Pandemic Pivot.

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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

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.,

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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

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% Favorable safety profile following both primary series and booster vaccinations.

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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. Third of Americans live where hospitals are short of ICU beds.

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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. supplemental oxygen, mechanical ventilation). These topics were covered in the body of the guidance and were addressed in two new appendices.

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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

DECEMBER 11, 2020

Operation Warp Speed, the White House-led initiative to develop and distribute vaccines, has already said it plans to begin shipping the vaccine to all 50 states within 24 hours of an FDA approval. Third of Americans live where hospitals are short on ICU beds. Initially, a shipment of 2.9 The companies have negotiated a $2.1

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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. Hepatitis B virus (“HBV”) and hepatitis delta virus (“HDV”) product sales increased 8% to $237 million for the second quarter 2021 compared to the same period in 2020.

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The Pharma Data

DECEMBER 18, 2020

. “ With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn , M.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

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

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

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Regeneron Pharmaceuticals, Inc. Schleifer , M.D.,

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The Pharma Data

OCTOBER 14, 2020

based Hoag Hospital this month with adult subjects up to age 55. By targeting the nucleocapsid protein on the interior of the virus particle as well as the spike protein on the virus’s surface, we believe this vaccine can stimulate both T-cell-mediated and antibody-mediated immunity to SARS-CoV-2.”. Forward-Looking Statements.

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The Pharma Data

NOVEMBER 21, 2020

In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. SILVER SPRING, Md. , Hahn , M.D.

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The Pharma Data

NOVEMBER 20, 2020

Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . “The Yancopoulos, M.D.,

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Drug Discovery World

SEPTEMBER 16, 2022

According to the Cell and Gene Therapy Catapult, the campus acts as a “vital focal point for companies looking to develop and commercialise advanced therapy treatments, as well as attracting significant investment from pharmaceutical companies and venture capitals firms.” . billion in funding. .

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The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. Bebtelovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. Today, the U.S.

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The Pharma Data

NOVEMBER 21, 2020

21, 2020 /PRNewswire/ — First treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2. ” “REGEN-COV2 is designed to mimic what a well-functioning immune system does by using very potent antibodies to neutralize the virus,” said George D.

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The Pharma Data

OCTOBER 24, 2020

The country could soon be facing its worst stretch of the pandemic, with some hospitals in the West and Midwest already overwhelmed and death counts beginning to rise, the Post reported. Already, hospitals are reporting shortfalls of basic drugs needed to treat COVID-19 infections. Remdesivir gets full FDA approval to treat COVID-19.

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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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The Pharma Data

OCTOBER 23, 2020

Remdesivir gets full FDA approval to treat COVID. Remdesivir’s full approval Thursday by the FDA comes after the agency granted it emergency use authorization last spring. It is given intravenously to hospitalized patients. The drug works by blocking the ability of the virus to replicate itself.

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The Pharma Data

DECEMBER 8, 2020

“Our vision is to discover and deliver life-transforming treatments guided by our commitment to patients, our people and the planet,” said Christophe Weber, Takeda president and chief executive officer. To date, it has received both Breakthrough Therapy designation and Orphan Drug designation from the FDA.

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The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) for the treatment of AA. There are currently no FDA-approved treatments for AA. “This level of high-quality research is needed to advance our understanding and the treatment of this frequently devastating disease.”

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The Pharma Data

DECEMBER 23, 2020

While the overall understanding of the condition is as novel as the virus that causes it, a recent survey from the U.K.’s Leronlimab, which is a viral-entry inhibitor against the CCR5 receptor, is originally intended as an HIV drug, though it has yet to receive FDA approval in this disease area. said in a statement.

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The Pharma Data

AUGUST 22, 2021

today that the European Commission (EC) has approved XELJANZ ® (tofacitinib) for the treatment of active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA) in patients two years of age and older who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs).

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The Pharma Data

APRIL 27, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June 2020 and is listed on the NRDL (National Reimbursement Drug List) as of March 2021. reflecting lower treatment compliance during the COVID-19 pandemic. In February, Libtayo ® was approved in two new indications in the U.S.

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