The Pharma Data

NOVEMBER 16, 2020

The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. The majority of adverse events were mild or moderate in severity.

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The Pharma Data

MARCH 23, 2023

President and Chief Scientific Officer at Regeneron “ COPD is an urgent global health concern and a notoriously difficult-to-treat disease due to its heterogeneity, with no novel treatments approved in more than a decade. Detailed efficacy and safety results from this trial will be presented in a future scientific forum. placebo, 1.5%

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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

JULY 29, 2021

Evaluation of baricitinib’s efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials. Essential safety information on the authorized emergency use of baricitinib includes warnings related to serious infections, thrombosis, abnormal laboratory values, vaccinations and hypersensitivity.

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The Pharma Data

MAY 31, 2022

The target action date for the FDA decision is September 30, 2022. The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with uncontrolled prurigo nodularis ( PRIME2 and PRIME ). Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

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The Pharma Data

APRIL 4, 2022

The target action date for the FDA decision on this investigational use is August 3, 2022. The sBLA is supported by data from two Phase 3 trials evaluating the efficacy and safety of Dupixent 300 mg weekly in patients aged 12 years and older with EoE ( Part A and Part B ), and data from an active long-term extension trial.

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The Pharma Data

AUGUST 3, 2021

announced today results from an additional cohort of 101 adult patients from the COV-BARRIER trial. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. Vaccinations: Avoid use of live vaccines with baricitinib. It is approved in the U.S. Serious Side Effects.

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The Pharma Data

FEBRUARY 19, 2022

A Phase 3 trial (CUPID STUDY B) evaluating Dupixent® (dupilumab) in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, will stop due to futility based on a pre-specified interim analysis. The safety data were generally consistent with the known safety profile of Dupixent in its approved indications.

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The Pharma Data

MAY 4, 2021

Abnormal Laboratory Values: Evaluate at baseline and thereafter according to local patient management practice. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. Manage patients according to routine clinical guidelines. patients with a history of diverticulitis).

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The Pharma Data

FEBRUARY 13, 2022

The sBLA is supported by data from the pivotal Phase 3 trial evaluating the efficacy and safety of Dupixent added to standard-of-care topical corticosteroids (TCS) in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. Source link: [link].

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The Pharma Data

JUNE 28, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The approved dose for RINVOQ in these indications is 15 mg. Tears in the stomach or intestines and changes in certain laboratory tests can happen.

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The Pharma Data

APRIL 3, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Tears in the stomach or intestines and changes in certain laboratory tests can happen.

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The Pharma Data

MAY 4, 2021

” “Even as the world makes progress on vaccine roll-outs, it remains vital for treatments to be available that can make a meaningful difference for those fighting COVID-19,” said David A. Abnormal Laboratory Values: Evaluate at baseline and thereafter according to local patient management practice.

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The Pharma Data

APRIL 6, 2021

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm 3 were reported in Olumiant clinical trials. Increases of ALT ?5x

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Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. Karl Landsteiner in his New York laboratory. In each case, megakaryocyte cells in the laboratory only produced on the order of tens of platelets, far short of the 1,000 platelets generated per megakaryocyte in the human body.

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The Pharma Data

JULY 21, 2021

Bayer also issued a news release earlier today announcing the EC approval. Food and Drug Administration (FDA) approved VERQUVO in the U.S. The approval of VERQUVO in the EU will provide doctors, health care professionals and patients with an important treatment option to complement currently available heart failure therapies.”.

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The Pharma Data

OCTOBER 29, 2020

Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 trial (BRAVE-AA2) were initiated and are ongoing to assess the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo. 10x ULN were observed in patients in Olumiant clinical trials.

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The Pharma Data

APRIL 1, 2021

” Recently, the European Commission (EC) approved RINVOQ (15 mg) for use in adults with active psoriatic arthritis. . ” The safety profile of upadacitinib was generally similar to results reported previously in rheumatoid arthritis trials. The long-term extension of the trial is ongoing. About RINVOQ (upadacitinib).

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The Pharma Data

JANUARY 12, 2021

“Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials. Schleifer , M.D.,

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Agency IQ

NOVEMBER 3, 2023

In fact, the FDA has even developed a guidance document for “early clinical trials with live biotherapeutic products [LBPs].” 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

JUNE 18, 2021

May 24, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced The Lancet published primary analysis results from the pivotal global Phase 3 clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating RINVOQ ® (upadacitinib) in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic treatment.

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The Pharma Data

JUNE 30, 2021

More information on these trials can be found at www.clinicaltrials.gov (NCT02819635, NCT03653026, NCT03006068). FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The approved dose for RINVOQ is 15 mg.

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The Pharma Data

SEPTEMBER 15, 2020

Next-generation biomarker cytology test supports World Health Organization’s goal to eliminate cervical cancer, which is nearly 100 percent preventable with proper screening, vaccination and treatment. This latest expanded use approval gives laboratories access to the complete Roche Cervical Cancer Portfolio offering in the U.S.,

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. 6] ERLEADA ® is being studied in five Phase 3 registrational clinical trials. Laboratory Abnormalities — All Grades (Grade 3-4). ERLEADA ® received U.S. All rights reserved.

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The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Clinical status including laboratory parameters should be monitored and appropriate therapy should be initiated. Global Head, Janssen Research & Development, Johnson & Johnson.

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Drug Discovery World

SEPTEMBER 16, 2022

In 2021, the Cell and Gene Therapy Catapult estimated that there 168 ongoing clinical trials for advanced therapy medicinal products (ATMPs) taking place – representing 9% of all global trials in the space. The UK stands as one of the key markets for cell and gene therapies. billion in funding. .

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The Pharma Data

MARCH 15, 2022

The trial’s other dual primary endpoint, radiographic progression free survival (rPFS), was evaluated at an earlier interim analysis and did not demonstrate improvement compared to the control arm. In collaboration with AstraZeneca, Merck is evaluating LYNPARZA in combination with abiraterone in the Phase 3 PROpel trial.

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The Pharma Data

NOVEMBER 30, 2020

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

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The Pharma Data

JANUARY 13, 2021

However, before the Phase III program may begin, the FDA requested a meeting with Theratechnologies to discuss questions and comments received on certain aspects of the proposed trial design, to ensure alignment with the agency’s expectations with NASH trials. Vivity received FDA approval in February 2020.

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The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

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The Pharma Data

MARCH 4, 2021

There are currently no FDA-approved treatments for AA. LABORATORY ABNORMALITIES: Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm 3 ) compared to placebo. 10x ULN were observed in patients in Olumiant clinical trials.

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The Pharma Data

FEBRUARY 13, 2022

The issuance of an EUA is different than an FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of available scientific evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. 2 omicron subvariant.

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The Pharma Data

DECEMBER 8, 2020

During the call, Takeda provided a deep dive into TAK-721, which has the potential to be the first FDA-approved agent for the treatment of eosinophilic esophagitis (EoE), and TAK-003, which is a live attenuated tetravalent vaccine for prevention of dengue disease.

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Codon

APRIL 2, 2023

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. mRNA vaccines and hybrid immunity use different B cell germlines against Omicron BA.4 ” Clinical trials are underway. Nature Neuroscience. Read You love to see it!

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The Pharma Data

OCTOBER 18, 2020

The principal investigator Professor Christophe Le Tourneau will present results from a pooled analysis of the Phase 1b/2 trial, including response rate, median progression-free survival, as well as the impact of patient/disease characteristics on outcome and immunogenicity. Christophe Le Tourneau, M.D.,

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The Pharma Data

APRIL 4, 2023

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This marks the first time an anti-PD-1 therapy has been approved in combination with anantibody-drug conjugate in the U.S. confirmatory trial for the accelerated approval.

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The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Data from these trials will be used to support a future BLA submission.

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