Drug Target Review

FEBRUARY 21, 2024

Stem cell transplants primarily help the immune response through the “graft-versus-leukaemia effect,” and we have to manage the “graft versus host effect.” What is the efficacy and safety of bispecific T-cell engager (BiTE) therapy, and how do these findings inform its potential application in cancer treatment?

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The Pharma Data

AUGUST 16, 2021

Pfizer and BioNTech plan to seek licensure of the third dose via a supplemental Biologics License Application (BLA) in individuals 16 years of age and older, pending FDA approval of the primary BLA submitted in May 2021. today announced that they have submitted Phase 1 data to the U.S. In the U.S., Source link: [link].

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The Pharma Data

DECEMBER 16, 2020

It is worth noting that this is not the same as a full approval, which requires additional information. To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval.

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The Pharma Data

NOVEMBER 12, 2020

The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 Calquence® (acalabrutinib) [prescribing information]. Further information.

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The Pharma Data

OCTOBER 26, 2020

News information is not all-inclusive and updates are published once a week on Tuesdays. . . 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).

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. For more information, please visit our website: www.cloverbiopharma.com. For more information, visit www.dynavax.com. CHENGDU, China , Feb.

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The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. and its affiliate NantKwest, Inc.

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The Pharma Data

NOVEMBER 9, 2020

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax Forward-Looking Statements.

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The Pharma Data

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. Director of the FDA’s Center for Biologics Evaluation and Research. SILVER SPRING, Md. , 18, 2020 /PRNewswire/ — Today, the U.S. ModernaTX, Inc.

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The Pharma Data

NOVEMBER 30, 2020

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein adjuvanted with Novavax’ patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax Forward Looking Statements. Source link.

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The Pharma Data

FEBRUARY 18, 2022

“With our heritage in transformational science for immune-mediated diseases – and our commitment to inflammatory bowel disease research – we are seeking to find solutions that have the goal of redefining treatment outcomes and elevating standards of care for the gastroenterology community.”. About Ulcerative Colitis.

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The Pharma Data

DECEMBER 28, 2020

Moleculin is also engaged in preclinical development of additional drug candidates, including other Immune/Transcription Modulators, as well as WP1122 and related compounds capable of Metabolism/Glycosylation Inhibition. For more information about the Company, please visit [link].

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The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., Casirivimab and imdevimab injection is not FDA approved for any use. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

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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. About one year after its initial publication, FDA updated the guidance in February 2021. supplemental oxygen, mechanical ventilation).

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The Anticancer Fund

JUNE 23, 2023

Among 16 patients evaluable for best response, there were one complete response (Ewing sarcoma), three partial responses (Ewing sarcoma, glioblastoma multiforme, and alveolar rhabdomyosarcoma), and five patients with stable disease. However, this was not an efficacy trial and similar responses have been seen from chemo alone.

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The Pharma Data

DECEMBER 11, 2020

Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine.com. With the vaccine being authorized for emergency use in the U.S., the companies will begin delivering the first doses in the U.S.

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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

To give you just one example of how much these expert bodies have accomplished in record time, the Therapeutics Clinical Working Group got to work immediately evaluating some 400 candidate therapeutics using multiple publicly available information sources.

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The Pharma Data

DECEMBER 17, 2020

AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION. Authorized Emergency Use Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

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The Pharma Data

DECEMBER 10, 2020

Data from this study, including longer term safety, comprehensive information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and immunogenicity in adolescents 12 to 15 years of age will be gathered in the months ahead. The information contained in this release is as of December 10, 2020.

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The Pharma Data

MARCH 16, 2021

TREMFYA is the first and only treatment approved for both adults with moderate to severe plaque PsO and for adults with active PsA that selectively inhibits IL-23, a cytokine that is a key driver of the inflammatory immune response associated with the symptoms of these chronic autoimmune diseases. Important Safety Information.

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The Pharma Data

DECEMBER 27, 2020

As a reminder, there currently is no FDA approval pathway to develop a generic or biosimilar copy of a cell therapy product, which provides a significant barrier-to-entry from generic competition. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell. Forward-Looking Statements.

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The Pharma Data

OCTOBER 14, 2020

Additionally, immunogenicity, duration of immune response and occurrence of symptomatic COVID-19 will be measured. For more information, please visit www.nantkwest.com. The study’s primary objective is to examine the safety and reactogenicity of two-doses of the vaccine. Forward-Looking Statements.

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The Pharma Data

DECEMBER 31, 2020

The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. In mid-December, the FDA approved Orgovyx (relugolix), the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer.

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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. AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION.

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The Pharma Data

APRIL 4, 2023

For more information, see “Selected Important Safety Information” below. after the Selected Important Safety Information. The Merck Access Program provides reimbursement support for patients receiving KEYTRUDA, including information to help with out-of-pocket costs and co-pay assistance for eligible patients.

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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. AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION.

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The Pharma Data

JULY 6, 2021

Decreased levels of PGRN, a key regulator of immune response, lysosomal function, and neuronal survival in the brain, are genetically linked to many neurodegenerative disorders. There are currently no FDA-approved treatment options for FTD. Alector Conference Call Information.

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The Pharma Data

JANUARY 4, 2021

Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is based on randomized data from the Phase II CITYSCAPE trial. CITYSCAPE provides the first evidence that targeting both immune inhibitory receptors, TIGIT and PD-L1, may enhance anti-tumor activity by potentially amplifying the immune response.

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The Pharma Data

APRIL 27, 2021

At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. Developed as part of a joint-partnership between Sanofi and Merck, Vaxelis ® is the first and only hexavalent combination vaccine approved in the U.S. First-quarter sales in the U.S.

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The Pharma Data

OCTOBER 26, 2020

In addition, the observed median PFS shows that the regimen can induce a sustained and durable response, which is also shown consistently by the induction of a specific immune response. More information on the trial is available on clinicaltrials.gov. Avelumab Important Safety Information from the US FDA-Approved Label.

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The Pharma Data

JULY 23, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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The Pharma Data

MARCH 11, 2021

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) In addition, the T-cell responses are especially strong and stable over time, which is also potentially important for activity against these variants.”.

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The Pharma Data

AUGUST 11, 2020

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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The Pharma Data

AUGUST 11, 2020

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

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