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). * About VAT08 and VAT02 The Phase 3 trial, VAT08 is evaluating a 10µg antigen formulation of the SARS-CoV-2 adjuvanted recombinant protein-based vaccine?for

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The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

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The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. 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.

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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. Lastly, the revised guidance briefly discussed trials meant to assess drugs intended for prevention of Covid-19.

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The Pharma Data

JANUARY 12, 2021

“Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D. .

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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.

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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. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

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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. It is approved in the U.S. Manage patients according to routine clinical guidelines.

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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. Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., See the full Prescribing Information here.

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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

NOVEMBER 16, 2020

Since early January, we have chased this virus with the intent to protect as many people around the world as possible. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus.

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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. Monitor patients for TB during Olumiant treatment.

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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

DECEMBER 5, 2020

Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Regeneron Pharmaceuticals, Inc.

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Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. CAR T cells are T cells that have been trained to attack tumours.

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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].” According to the FDA, a recombinant LBP is distinctive from a standard LBP. 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

REGN-COV2 trial in the COVID-19 outpatient setting met primary and key secondary endpoints. 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). and non-GAAP diluted EPS (1) was $8.36 .

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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

JANUARY 21, 2021

Food and Drug Administration (FDA) has approved CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults.

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The Pharma Data

SEPTEMBER 15, 2020

New indication allows this first FDA-approved biomarker-based test to be used as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs. This latest expanded use approval gives laboratories access to the complete Roche Cervical Cancer Portfolio offering in the U.S.,

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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

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. “The Yancopoulos, M.D.,

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Advarra

AUGUST 8, 2023

These studies were previously considered to be highly experimental and limited to early phase trials at a handful of highly specialized academic medical centers. However, well-established safety profiles, promising research results, and the FDA issuing the first gene therapy approvals in recent years have led to dramatic growth.

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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. .” Yancopoulos , M.D.,

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The Pharma Data

MARCH 4, 2021

There are currently no FDA-approved treatments for AA. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. associate professor of Dermatology at Yale School of Medicine.

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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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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. .

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The Pharma Data

JANUARY 13, 2021

Germany-based Cevec Pharmaceuticals GmbH signed a licensing agreement with Biogen for the use of its proprietary ELEVECTA Technology for the manufacturing of adeno-associated virus (AAV) vectors for gene therapy applications. Vivity received FDA approval in February 2020. A second liver biopsy will be performed after 18 months.

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The Pharma Data

JANUARY 26, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. In the trial, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. INDIANAPOLIS, Jan. have reached record highs.

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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. Therapeutic neutralizing monoclonal antibody administration protects against lethal yellow fever virus infection. ” Clinical trials are underway. Nature Neuroscience.

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The Pharma Data

FEBRUARY 13, 2022

director of the FDA’s Center for Drug Evaluation and Research. This authorization is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge.”. The issuance of an EUA is different than an FDA approval. 2 omicron subvariant. Related Information.

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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

OCTOBER 26, 2020

The purpose of this exploratory Phase 1b/2 trial was to evaluate the safety and efficacy of the combination of TG4001 and an immune checkpoint inhibitor in a heterogeneous group of patients with aggressive, recurrent and/or metastatic HPV16-positive cancers. Key findings of the trial: .

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Agency IQ

SEPTEMBER 29, 2023

July 2023 (Under OIRA Review) Medical Devices; Laboratory Developed Tests (Proposed Rule) This proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.

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The Pharma Data

AUGUST 22, 2021

“We are proud to make these new options available in the EU as Pfizer continues to advance the science and understanding of medicines like XELJANZ, which has been studied in more than 50 trials across clinical programs worldwide.”. FDA-APPROVED INDICATIONS. Rheumatoid Arthritis.

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