pharmaphorum

JUNE 28, 2022

billion partnership with US biotech Sutro Biopharma for a series of antibody-drug conjugates for cancer, focusing on applications in patients who don’t respond to current immunotherapies. Astellas has agreed a $1.36 The alliance includes an upfront payment of $90 million, backed by $422.5

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Antibody Immune Response Gene Therapy Drugs 105

XTalks

JULY 31, 2024

The US Food and Drug Administration (FDA) has just approved Leqselvi (deuruxolitinib), a new oral medication by Sun Pharmaceutical Industries Limited, offering significant hope for those suffering from severe alopecia areata, a condition causing sudden hair loss.

Immune Response 105

Immune Response Dermatology Clinical Trials Clinical Trials 105

The Pharma Data

NOVEMBER 30, 2020

Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA). Additional clinical data from the Phase 2 trial conducted in the U.S. and Australia are expected to be unblinded in Q1 and will be targeted for publication.

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Clinical Development Vaccination Vaccine Development 52

pharmaphorum

AUGUST 5, 2022

It reckons that its antibodies will be able to target the underlying cause of autoimmune diseases, unlike current therapies such as steroids or TNF and interleukin inhibitors that while effective are non-selective, so suppress both appropriate and inappropriate immune responses.

Antibody 105

Antibody Immune Response Development Medicine 105

pharmaphorum

SEPTEMBER 24, 2020

That vaccine is top of the World Health Organization’s list of vaccines in clinical development, which shows there are 38 potential shots in human trials. Although controversial, as the subjects would be exposed to a potentially lethal virus, the trial could provide data about the immune response for any vaccine.

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Vaccination Vaccine Trials Immune Response 98

pharmaphorum

FEBRUARY 10, 2022

AstraZeneca confirmed today that it has discontinued clinical development of a follow-up to its COVID-19 vaccine Vaxzevria targeted at the Beta variant of the virus, which started development before the emergence of the Delta and Omicron strains. ” Vaxzevria added almost $4 billion to its revenues last year, including $1.8

Vaccination 52

Vaccination Vaccine Development Immune Response 52

The Pharma Data

JANUARY 12, 2021

. “The emphasis in the development of cancer immunotherapies has been placed so far mainly on drugs that stimulate the adaptive immune system to attack malignant cells, in particular T lymphocytes. Unfortunately, many advanced cancer patients do not derive a durable benefit from these drugs,” said Tehila Ben-Moshe, Ph.D.,

Immune Response 52

Immune Response Clinical Trials Clinical Trials Development 52

XTalks

SEPTEMBER 5, 2023

Xtalks spoke with Maria Reyes Boceta-Muñoz, Clinical Operations Head of Development R&D at GlaxoSmithKline in Spain, Portugal & Israel, to understand the current vaccine development climate and where the sector is headed. However, guidelines do not provide matters specific to each vaccine type.

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Vaccination Vaccine Development Clinical Trials 96

The Pharma Data

DECEMBER 3, 2020

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

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.

Antibody 130

Antibody Engineer FDA Approval Development 130

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. The VAERS toll-free number is 1?800?822?7967

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Vaccination Vaccine Protein Immune Response 111

The Pharma Data

JANUARY 12, 2021

“KSQ’s CRISPRomics discovery platform is a powerful technology to help us identify novel targets in line with our immuno-oncology strategy,” said Loïc Vincent, Head, Oncology Drug Discovery Unit and Immunology Unit at Takeda. Takeda will assume responsibility for funding all development and commercialization activities.

Development 52

Development Research In-Vivo Genome 52

pharmaphorum

JANUARY 31, 2022

The digital transformation is allowing pharmaceutical companies to expand their drug discovery capabilities and accelerate drug development. Partly as a result of these developments, vaccine innovation has grown by leaps and bounds in just the past year. Innovation at Pfizer.

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Vaccination Vaccine Development Marketing 97

The Pharma Data

DECEMBER 13, 2020

Nasdaq: SYBX ), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced SYNB1891 has advanced into the combination therapy stage of the ongoing Phase 1 trial. SYNB1891 is being evaluated in a Phase 1 clinical trial. CAMBRIDGE, Mass. , 14, 2020 /PRNewswire/ — Synlogic, Inc.

Immune Response 40

Immune Response Engineer Medicine Clinical Trials 40

pharmaphorum

JANUARY 4, 2023

The hypothesis is that it will induce immune tolerance by stimulating anti-inflammatory regulatory T- (Treg) cells and cytokines that dampen down the immune response. It already has a pipeline of drug candidates in this area, including IRAK4 inhibitor GS-5718 that has advanced into early clinical development for lupus and RA.

Immune Response 52

Immune Response Engineer Licensing Licensing 52

The Pharma Data

JANUARY 21, 2021

Food and Drug Administration (FDA) gave the go-ahead for the company to initiate a Phase I trial of PRGN-2012 in adults with recurrent RRP. The drug is a first-in-class, off-the-shelf AdenoVerse immunotherapy. The National Institutes of Health (NIH) is planning on taking over manufacturing and clinical development.

Immune Response 52

Immune Response Trials Development Drugs 52

The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. About Fast Track Designation.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 3, 2021

We are very honored to have someone of Dr. Zeldis’ caliber lead our scientific research and clinical development teams. At NexImmune, he will oversee all aspects of research and development. The backbone of NexImmune’s approach is its proprietary Artificial Immune Modulation (AIM TM ) nanoparticle technology platform.

Immune Response 40

Immune Response Clinical Trials Clinical Trials Development 40

The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. About Moderna.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Development 52

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.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

OCTOBER 21, 2020

(Nasdaq: ACET), a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-001, an allogeneic gamma delta (??)

Immune Response 40

Immune Response Engineer Clinical Trials Clinical Trials 40

The Pharma Data

OCTOBER 27, 2020

The company plans to tackle the existing challenges of precision medicine with a three-prong approach – developing better medicines for known cancer-driving mutations, developing drugs for targets previously thought to be undruggable, and finding new, untapped targets that could lead to even better drugs.

Gene 52

Gene Gene Therapy Medicine Development 52

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.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

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. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.”

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 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. The drug was well-tolerated by patients except for two adverse events that were deemed unrelated to the therapy. Ongoing and Future Studies.

Trials 52

Trials Antibody Genetics Gene 52

The Pharma Data

JANUARY 19, 2021

The company is using its pioneering FasTCAR and TruUCAR technology platforms to discover and develop breakthrough cell therapies. The compound was developed in the laboratory of Richard Childs, chief of the Laboratory of Transplantation Immunotherapy with the National Heart, Lung, and Blood Institute (NHLBI).

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In-Vitro Production Trials Manufacturing 52

The Pharma Data

OCTOBER 27, 2020

Mirati Therapeutics is a San Diego -based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer. About Mirati Therapeutics.

Sales 52

Sales Immune Response Clinical Development Development 52

The Pharma Data

MAY 15, 2023

The acquisition complements Gilead’s existing clinical development priorities by adding additional pipeline assets for well-validated targets in oncology and inflammation. Both programs have the potential to address multiple indications, offering broad development opportunities alone and in combination with Gilead’s portfolio.

DNA 40

DNA Immune Response Medicine Development 40

The Pharma Data

JULY 6, 2021

The collaboration brings together Alector’s leading immuno-neurology expertise with GSK’s R&D focus on the science of the immune system and human genetics, proven late-stage drug development capabilities and global footprint. billion in clinical development, regulatory and commercial launch-related milestone payments.

Genetics 52

Genetics Gene Antibody Development 52

The Pharma Data

DECEMBER 15, 2020

Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. Scientists will be testing a drug class targeting the C-reactive protein (CRP) marker of acute inflammation in the body. They’ll use software that searches available drugs, as well as drug-like compounds.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Trials 52

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. The VAERS toll-free number is 1?800?822?7967

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Vaccination Vaccine Medicine Clinical Trials 100

Roots Analysis

OCTOBER 30, 2023

The next generation RNA therapeutics and RNA vaccines pipeline currently features the presence of more than 20 circular RNA therapeutics and vaccines, being developed across initial stages of drug development (discovery and preclinical).

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RNA Vaccination Vaccine Development 40

The Pharma Data

JANUARY 31, 2021

Delivery of viral antigens in potent vaccine vectors to elicit a strong immune response is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

FEBRUARY 16, 2023

Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025, pending successful completion of the Phase 3 studies and subject to the agreement of these regulatory agencies to proposed modifications of the clinical trial plan.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN?

Vaccination 52

Vaccination Vaccine RNA Clinical Trials 52

Pfizer

JULY 8, 2022

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. Food and Drug Administration (FDA) which granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine as a three 3-µg dose series in this age group on June 17.

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Vaccination Vaccine Clinical Trials Clinical Trials 81