Drug Discovery World

JANUARY 3, 2023

AstraZeneca has initiated the SUPERNOVA Phase I/III trial of AZD5156 (a combination of AZD3152 and cilgavimab) in pre-exposure prophylaxis of Covid-19, following the company licensing AZD3152 from RQ Bio in May 2022. .

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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. See Table 1). (See

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XTalks

APRIL 18, 2022

In a joint news release , Matinas and BioNTech said they’ve also started discussions on a license agreement for Matinas’ LNC platform. Related: BioNTech Unveils the BioNTainer, a Modular mRNA Vaccine Factory to Help Production in Africa. “We

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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pharmaphorum

OCTOBER 21, 2022

Swiss pharma giant Roche has moved to strengthen its position in the KRAS-mutated cancer space through a $25 million licensing and collaboration agreement with Austrian arenaviral technology firm Hookipa Pharma. Roche also has the option to license a second, undisclosed, novel arenaviral immunotherapy.

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The Pharma Data

DECEMBER 17, 2020

In preclinical studies, Janux TRACTr drug candidates have demonstrated comparable anti-tumor efficacy relative to standard T cell engagers but lack the associated liabilities related to cytokine release, healthy tissue toxicities, or systemic immune activation, the company said. “At

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The Pharma Data

APRIL 8, 2022

The mere motions of breathing are known to influence vital functions of the lungs, including their development in babies, the production of air-exchange-enhancing fluid on their inner surfaces, and maintenance of healthy tissue structure. a Wyss Technology Development Fellow at the Institute. During his Ph.D.

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pharmaphorum

MAY 18, 2021

.” The interim phase 2 results show that two doses of the plant-derived jab stimulated neutralising antibody levels that are around 10 times higher than those in a panel of sera from patients recovering from COVID-19, with a similar response seen in adults and the elderly.

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The Pharma Data

NOVEMBER 17, 2020

Lead Pharma has entered into a collaboration and license agreement with Roche , hoping to lead the way in the development of oral small molecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. . This includes therapies against the nuclear receptor ROR?t,

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pharmaphorum

JANUARY 4, 2023

They both also include tiered royalties on sales of any products emerging from the partnerships. 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.

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XTalks

DECEMBER 20, 2021

It has also applied for regulatory licensing in the UK, European Union (EU), Australia, Singapore, India, United Arab Emirates (UAE), New Zealand and Japan. It contains Novavax’s Matrix-M adjuvant to enhance the immune response. So far, Novavax’s Covovax has been authorized in Indonesia and the Philippines.

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pharmaphorum

JUNE 2, 2021

Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a new production line at contract manufacturer Lonza. Sinovac’s vaccine has already been approved by China’s drugs regulator and in December company raised $515 million to expand production.

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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. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. In the U.S.,

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The Pharma Data

JUNE 24, 2021

Secondary objectives are to describe immune responses produced by each of the vaccines. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech

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The Pharma Data

AUGUST 15, 2021

About TBE TBE is a viral infection of the brain and spine, 2 transmitted to humans through the bite of an infected tick, 3 and less frequently by ingestion of unpasteurized milk or milk products from infected animals. 4 It may initially be mistaken for summer flu, 15,16 but can be a serious condition with possible long-term consequences.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. Efforts are also underway to enable the product to be stable at routine refrigerator temperature (2-8°C). Expected to enroll 415 participants; interim results expected in Q3 2021.

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The Pharma Data

AUGUST 28, 2020

There are also plans to strengthen the Medicines and Healthcare products Regulatory Agency (MHRA)’s powers to roll out an unlicensed vaccine rapidly if one becomes available before the new year. Oxford coronavirus vaccine triggers immune response. UK signs deals for 90 million virus vaccine doses.

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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. among adults 65 years of age or older.

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The Pharma Data

DECEMBER 23, 2020

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. About INOVIO.

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The Pharma Data

AUGUST 6, 2020

AstraZeneca reached a licensing deal with Chinese firm BioKangtai to help provide its adenovirus vector-based COVID-19 vaccine candidate, created by the University of Oxford, to China, AstraZeneca said (Chinese) in a social media post on Thursday. That has changed. The vaccine was moved into phase 2/3 in May. year over year. Source link.

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The Pharma Data

MAY 27, 2022

The authorisation is based on a review by the Committee for Medicinal Products for Human Use (CHMP) of the substantial body of evidence demonstrating an increased immune response after a third dose booster with Vaxzevria following a primary vaccine schedule of either Vaxzevria or an mRNA COVID-19 vaccine.(1-5).

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The Pharma Data

OCTOBER 26, 2020

based company said the preventative medication boosts immune responses in older and younger adults against the novel coronavirus. Food and Drug Administration greenlit the restart of AstraZeneca’s Phase III COVID-19 vaccine trial, the U.K.-based They expect to launch a Phase III trial of the drug in the first quarter of 2021. .

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The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

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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., The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.

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The Pharma Data

JANUARY 17, 2021

By inhibiting calcineurin, the drug blocks IL-2 expression and T-cell mediated immune responses. On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co. The bone marrow suppression inhibits the production of blood cells.

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pharmaphorum

AUGUST 27, 2020

Conventional vaccines introduce an inactivated sample of a disease to patients with the aim of stimulating an immune response. This precision has significant advantages in efficacy and production. Because they are relatively new, these techniques have not yet yielded licensed products for human use.

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XTalks

MAY 2, 2024

The Prescription Drug User Fee Act (PDUFA) date is the deadline that the FDA sets for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. Alexion, AstraZeneca Rare Disease is serving as a licensing partner of BridgeBio’s affiliate, Eidos Therapeutics, Inc.,

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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. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.

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The Pharma Data

MARCH 25, 2022

Evusheld has also been granted conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain for pre-exposure prophylaxis of COVID-19. People not adequately protected by a COVID-19 vaccine may particularly benefit from pre-exposure prophylaxis with Evusheld.

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review.

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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The Pharma Data

JULY 21, 2021

At full operational capacity, the annual production will exceed 100 million finished doses annually. This is why we will continue to evaluate sustainable approaches that will support the development and production of mRNA vaccines on the African continent.”. “We Procedures should be in place to avoid injury from fainting.

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The Pharma Data

JUNE 24, 2021

This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

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The Pharma Data

DECEMBER 17, 2020

Regeneron continues to increase in-house production of casirivimab and imdevimab, and the company has partnered with Roche to increase the global supply beginning in 2021. Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication.

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The Pharma Data

DECEMBER 20, 2020

The primary endpoints of the study include safety and overall response rate, while secondary endpoints include progression-free survival, overall survival and immune response correlates. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products. Kenilworth, N.J.,

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The Pharma Data

MARCH 29, 2022

Evusheld is authorised for emergency use for pre-exposure prophylaxis of COVID-19 in the US and has been granted conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain for pre-exposure prophylaxis of COVID-19.

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