Pfizer

JULY 8, 2022

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial.

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XTalks

JANUARY 20, 2025

Sasanlimab, a subcutaneous anti-PD-1 therapy, offers a novel immunotherapy approach that enhances the anti-tumor immune response. Having its own checkpoint inhibitor to combine with its ADCs rather than from other companies would make things easier to coordinate in clinical trials.

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XTalks

JANUARY 20, 2025

Sasanlimab, a subcutaneous anti-PD-1 therapy, offers a novel immunotherapy approach that enhances the anti-tumor immune response. Having its own checkpoint inhibitor to combine with its ADCs rather than from other companies would make things easier to coordinate in clinical trials.

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XTalks

NOVEMBER 22, 2022

Provention Bio’s Tzield (teplizumab) has won US Food and Drug Administration (FDA) approval to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years of age and older who have stage 2 type 1 diabetes.

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Insulin Drugs FDA Approval Immune Response 97

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases. All except for Adstiladrin were cleared for rare disease indications.

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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. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

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XTalks

JULY 31, 2024

Alopecia areata can be triggered by genetics, immune system dysfunction and environmental factors. Leqselvi works by selectively inhibiting the Janus kinases (JAK) JAK1 and JAK2, pathways that play a key role in this misguided immune response.

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Immune Response Dermatology Clinical Trials Clinical Trials 105

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. INTERCHANGEABILITY.

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Pharmaceutical Technology

APRIL 17, 2023

The Fc region interacts with the cell surface receptors to cause the protective immune response. In December 2021, the US Food and Drug Administration (FDA) approved argenx’s Vyvgart for the treatment of myasthenia gravis in December 2021, marking the company’s first approval.

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XTalks

JUNE 15, 2022

Adjuvants can help boost the effectiveness of a vaccine and elicit a stronger immune response. If approved, NVX-CoV2373 would become the first available protein-based vaccine against COVID-19 in the US. Clinical Trial Results. NVX-CoV2373 also includes an adjuvant called Matrix-M. The vaccine is given in two doses.

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The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

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The Pharma Data

NOVEMBER 9, 2020

“While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History. and globally.”.

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The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. Clover intends to initiate a separate pivotal clinical trial of the S-Trimer vaccine candidate in combination with Dynavax’s advanced CpG 1018 adjuvant plus alum in the first half of 2021.

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The Pharma Data

NOVEMBER 30, 2020

In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

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Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 1 as compared to the companies’ current COVID-19 vaccine. INTERCHANGEABILITY.

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XTalks

AUGUST 5, 2022

The Janssen Pharmaceutical Companies of Johnson & Johnson this week announced the US Food and Drug Administration (FDA) approval of Stelara (ustekinumab) to treat active psoriatic arthritis in pediatric patients six years and older. The featured speakers will discuss how to facilitate trial participation in rare disease.

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XTalks

SEPTEMBER 23, 2021

one month after administration of the second dose, which indicates a strong immune response. In the US, the companies expect to submit the preliminary data in a near-term submission for Emergency Use Authorization (EUA) as they continue to collect the safety and efficacy data needed to file for full FDA approval in this age group.

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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.

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Pfizer

JULY 8, 2022

In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. INTERCHANGEABILITY.

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Find Me Cure

OCTOBER 13, 2019

There currently are drugs that do just that but now they’re in clinical trials for metastatic breast cancer as well. There are antibody drugs targetting those cells that are already FDA approved and there are antibody drugs still in trials. In phase II clinical trial, led by Steven A. Rosenberg, M.D.

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Development DNA Clinical Trials Clinical Trials 52

XTalks

MAY 24, 2024

Tarlatamab Clinical Trial Insights In the DeLLphi-301 Phase II study, tarlatamb was administered biweekly at a dose of 10 mg to patients with advanced SCLC who had progressed after two or more prior lines of therapy, aiming to activate their immune responses against the tumor.

Antibody 52

Antibody Clinical Trials Clinical Trials Trials 52

The Pharma Data

AUGUST 16, 2021

Pfizer and BioNTech have submitted Phase 1 data – part of their Phase 1/2/3 clinical trial program – evaluating the safety, tolerability, and immunogenicity of a third dose of the COVID-19 vaccine in U.S. adult participants from the Phase 1 trial of the two-dose series. In the U.S.,

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XTalks

JUNE 10, 2024

Sotyktu (deucravacitinib) is a one-of-its-kind oral medication approved by the US Food and Drug Administration (FDA) indicated to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

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Immune Response Dermatology Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 28, 2020

. Moleculin recently announced that the FDA had allowed its request for Investigational New Drug (IND) status for Annamycin, allowing Moleculin to begin a Phase 1B /2 clinical trial in the US for patients with soft tissue sarcoma (STS) that has metastasized to the lungs after first-line therapy for their disease.

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XTalks

FEBRUARY 3, 2021

COVID-19 vaccines have been a topic of conversation since the outbreak began, and last year’s US Food and Drug Administration (FDA) approval of the Pfizer/BioNTech and Moderna vaccines have given the world hope to defeat the COVID-19 pandemic. Herd Immunity and Equitable Access to COVID-19 Vaccines.

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XTalks

MAY 30, 2024

CIDP is a rare autoimmune disorder where the body’s immune system mistakenly attacks its own tissues. The exact cause of this immune response is unknown, and there appears to be no identifiable genetic predisposition to CIDP. In early 2021, the FDA approved Pfizer’s Panzyga for the treatment of CIDP.

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pharmaphorum

NOVEMBER 2, 2021

In 2019, there were 57 bsAb candidates in clinical trials, against both haematological and solid tumours. The BiTE platform is an innovative technology designed to engage the immune system against numerous stages and types of cancers. Engagement of immune cells to the tumour cell.

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XTalks

SEPTEMBER 17, 2020

Acromegaly Surrogate Endpoint: Serum growth hormone and serum insulin-like growth factor 1 (IGF-1) are acceptable surrogate endpoints for acromegaly clinical trials involving somatostatin analogs such as octreotide, lanreotide and pasireotide. Nizoral is prescribed off-label, while the others are FDA approved.

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The Pharma Data

DECEMBER 15, 2020

SetPoint Medical received FDA Investigational Device Exemption (IDE) approval for a multicenter, double-blind, randomized, sham-controlled pivotal trial that will enroll up to 250 patients at 40 clinical trial sites in the U.S. Small Molecule Inhibitors. Anti-CD40L Antibody.

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Clinical Trials Clinical Trials Antibody Trials 52

XTalks

JUNE 9, 2022

It is the first US Food and Drug Administration (FDA)-approved and European Commission-approved therapy that targets angiopoietin-like 3 (ANGPTL3) for patients aged 12 and older with HoFH. These antibodies bind strongly to their target and provide a robust immune response. Ongoing and Future Studies.

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Trials Antibody Genetics Gene 52

Delveinsight

SEPTEMBER 8, 2021

Hydroxychloroquine and BENLYSTA are the FDA-approved therapies for SLE treatment. With the approval of these therapies, the outlook for SLE patients improved from a 4-year survival rate of ~50% in 1950 to a 15-year survival rate of ~85% by 2013. The average annual drug cost is USD 38,000 per year.

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech appreciate the continued participation of the approximately 44,000 trial volunteers and remain committed to the companies’ pledge to always make their safety and well-being the companies’ top priority. About the Phase 2/3 Study. Germany, Turkey, South Africa, Brazil and Argentina.

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The Pharma Data

FEBRUARY 24, 2022

The positive opinion adopted by the CHMP is based on an evaluation of interim safety and efficacy data from a clinical trial of a booster dose of the vaccine in those aged 16 and over, together with published literature and post authorisation data plus real-world evidence from the use of booster doses in young patients in Israel.

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The Pharma Data

FEBRUARY 23, 2022

Sanofi and GSK today announce that they intend to submit data from both their booster and Phase 3 efficacy trials as the basis for regulatory applications for a COVID-19 vaccine. 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?

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The Pharma Data

FEBRUARY 18, 2022

“These findings demonstrate important and clinically meaningful responses across multiple key endpoints and build upon our current knowledge of the efficacy and safety profile of Zeposia.”. About Ulcerative Colitis. Symptoms include bloody stools, severe diarrhea and frequent abdominal pain. About Bristol Myers Squibb.

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The Pharma Data

JULY 6, 2021

AL101 is in a Phase 1a clinical trial and is designed to treat patients suffering from more prevalent neurodegenerative diseases, including Parkinson’s disease and Alzheimer’s disease. There are currently no FDA-approved treatment options for FTD. There are multiple heritable forms of FTD.

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