Drug Patent Watch

DECEMBER 9, 2024

These large, complex molecules are made inside living cells, which can lead to small variations in the manufacturing methods that can have a significant impact on the final product.

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Pharmaceutical Technology

AUGUST 15, 2022

MHRA chief executive Dr June Raine said: “I am pleased to announce the approval of the Moderna bivalent booster vaccine, which was found in the clinical trial to provide a strong immune response against the Omicron BA.1 1 variant as well as the original 2020 strain.”.

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Pharmaceutical Technology

OCTOBER 6, 2022

Intended for intranasal administration, NGoXIM was demonstrated to be effective in animal models and elicited a durable and cross-protective immune response in proof-of-concept (PoC) studies. . Therapyx will develop and manufacture the IL-12-containing microspheres in the vaccine called GneX12.

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Pharmaceutical Technology

JANUARY 19, 2023

The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.

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pharmaphorum

JUNE 30, 2021

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing.”

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Pharmaceutical Technology

DECEMBER 6, 2022

In the partnership’s discovery phase, RAVEN, an artificial intelligence (AI) platform of Evaxion will be leveraged for designing a next-generation vaccine candidate that induces cellular as well as humoral/antibody responses. Using ExpreS 2 ion’s ExpreS2 platform, the company will manufacture the antigen constructs obtained from RAVEN.

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The Pharma Data

MAY 16, 2021

Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups. High immune response after a single dose in patients with prior infection shows strong booster potential. For media and investors only. Issued: London UK. About the Phase 2 study.

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pharmaphorum

JANUARY 12, 2021

For instance, oral vaccines could allow repeat dosing without a treatment-limiting anti-vector response – where the body generates an immune response against the harmless, non-replicating viruses used to deliver the COVID-19 antigens. There are other theoretical advantages as well.

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pharmaphorum

OCTOBER 5, 2022

Called NGoXIM, the vaccine is based on gonococcal OMVs combined with sustained-release microspheres containing recombinant human IL-12, supplied Intravacc’s US partner Therapyx, which are designed to boost the immune response to the antigens.

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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. Last year, Merck said due to increasing global demand for TICE BCG, the company could not keep up with manufacturing enough of it.

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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. Last year, Merck said due to increasing global demand for TICE BCG, the company could not keep up with manufacturing enough of it.

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Pharmaceutical Technology

AUGUST 26, 2022

A 2015 study showed that both routes of administration (ROA) produce similar immune responses but that intradermal ROA produced more swelling at the injection site.) On July 26, 2022, the FDA extended the biologics license for Jynneos to allow for additional manufacturing at one of Bavarian Nordic’s plants.

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XTalks

NOVEMBER 6, 2020

We are exceptionally pleased to commence dosing of our oral DNA vaccine for COVID-19 as we continue scale-up and manufacturing activities for future clinical development,” Symvivo’s chief medical officer Eric Sievers said in a press release from the company. Related: Red Meat Allergy Test Gets FDA Clearance. “We

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Cloudbyz

MARCH 5, 2024

Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability. The conditions affecting the living system can influence the final product, making the manufacturing process more sensitive and challenging.

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pharmaphorum

JULY 18, 2022

It then elicits an immune response against that spike protein. You have a response with immunoglobulins type G (antibodies) and robust cellular response with both CD4 and CD8 T-cells being activated,” Morgon states. We get a higher immune response with the inhaled compared to the injectable,” Morgon relays.

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Camargo

DECEMBER 13, 2021

A 351(k) application is a BLA process submitted by a manufacturer to get a product reviewed as a biosimilar or interchangeable, which is considered to be “highly similar” to an FDA-licensed reference product. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

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The Pharma Data

APRIL 15, 2022

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

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STAT News

NOVEMBER 3, 2022

The early-stage study, which is being sponsored by BioNTech, aims to evaluate safety, tolerability, and immunogenicity, or the ability to generate an immune response. The trial is being conducted in the U.S. and the companies aim to enroll 180 volunteers between the ages of 18 and 64.

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pharmaphorum

SEPTEMBER 15, 2020

Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand.

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pharmaphorum

JULY 13, 2022

Bicycle’s bicyclic peptide drug discovery platform is designed to produce drug candidates that have targeting properties like antibodies but are much smaller molecules, making manufacturing and dosing easier. Genentech has been looking at the platform since 2020 under the terms of a deal worth up to $1.7

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XTalks

DECEMBER 14, 2021

Moderna revealed the first interim results from a small, Phase I study of its mRNA-based influenza vaccine, which showed that the vaccine had no significant safety concerns and elicited immune responses against four strains of the influenza virus. There were no significant safety findings reported through day 29. Mixed Results.

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XTalks

JANUARY 8, 2021

The depth of the immune response is associated with the duration of protection. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that healthcare providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine.”.

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pharmaphorum

FEBRUARY 8, 2021

It works by using inactivated viral particles to expose the immune system, which mounts an immune response that fights off the active virus in the event of an infection. Reuters reported that Sinovac is expanding its capacity to fill vaccine into vials and syringes, which is lagging behind manufacturing capacity.

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pharmaphorum

AUGUST 23, 2021

Ahmedabad-based Zydus Cadila has said it expects to launch ZyCoV-D in late September or early October, and expects to be able to manufacture around 100-120 million doses a year, with around 10 million available at launch. Proponents of the approach claim that DNA vaccines may have advantages over other technologies like mRNA.

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pharmaphorum

AUGUST 11, 2021

The vaccine – based on a self-assembling protein nanoparticle that displays 60 copies of the SARS-CoV-2 spike protein – is formulated with GlaxoSmithKline’s vaccine adjuvant, designed to boost the immune response.

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The Pharma Data

DECEMBER 20, 2020

In October, Scancell signed a manufacturing deal for SN14 with Cobra Biologics, a Cognate BioServices subsidiary, ahead of a planned phase 1 trial in 2021. SN14 works by targeting the coronavirus’ nucleocapsid and spike proteins to prevent viral replication using the company’s ImmunoBody DNA vaccine technology. Source link.

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pharmaphorum

FEBRUARY 24, 2021

As the virus is constantly evolving, there is need a to quickly develop and approve updated vaccines to neutralise new versions of the virus that may be able to evade the immune response from older vaccines. If vaccines need updating, the FDA expects that manufacturing information will remain generally the same.

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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.

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pharmaphorum

OCTOBER 2, 2020

Genentech, which is already well established as a player in cancer immunotherapy with its PD-L1 class drug Tecentriq (atezolizumab) , will be responsible for development and marketing thereafter. The Roche unit will also bear all costs for trials, filings, manufacturing and marketing after the completion of the phase 1b study.

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The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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pharmaphorum

JUNE 11, 2021

takeover of Bioverativ in 2018, is designed to block the complement pathway of the immune response, which becomes activated in CAD. In some cases patients can develop life-threatening blood clotting complications. Sutimlimab, which Sanofi acquired via its $11.6

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pharmaphorum

DECEMBER 22, 2020

There is no evidence to suggest the new strain causes more serious illness, but it does show variations in the “spike” protein that the virus uses to infect cells – the same protein that the Pfizer/BioNTech shot uses to confer immunity. Feature image copyright BioNTech SE 2020, all rights reserved.

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pharmaphorum

SEPTEMBER 15, 2020

The UK has also agreed to invest in Valneva’s manufacturing plant in Livingston, Scotland, to help scale up production of the vaccine, with the investment serving as a credit for future vaccine supply. The hope is that directly targeting the cells lining the airways may stimulate a more effective immune response against SARS-CoV-2.

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pharmaphorum

MARCH 4, 2021

Instead of large phase 3 trials, the MHRA will require studies showing immune responses for tweaked versions of previously approved vaccines, in line with similar guidance issued by the FDA late last month.

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The Pharma Data

SEPTEMBER 4, 2020

The data, published in Nature Medicine, show that the investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by neutralising antibodies and prevented severe clinical disease, including weight loss, pneumonia and mortality, the firm said. End of the line for pimodivir in flu.

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Worldwide Clinical Trials

JUNE 15, 2022

Consulting with regulatory experts and experts in toxicology, manufacturing, etc., There have been a few cases lately where patients receiving gene therapy had a severe adverse effect because of their immune response to the mechanism of the AAV viral vector, based on their own genomic markers.

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XTalks

NOVEMBER 23, 2020

Oxford-AstraZeneca COVID-19 Vaccine Induces Immune Responses in Early Clinical Trials. As a manufacturing partner for Oxford’s vaccine, AstraZeneca is ramping up its production capabilities as it plans to make up to three billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval.

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