XTalks

SEPTEMBER 30, 2020

The research shows that the activity of the immune messenger type 1 interferon (IFN) protein is diminished, either by genetic mutations or an autoimmune attack by neutralizing antibodies against it, in a subset of COVID-19 patients. According to the study, patients had auto-antibodies against IFN-? (13 We said, ‘bingo!’”

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Antibody Genetics Research In-Vitro 135

Pharma in Brief

DECEMBER 17, 2023

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. The Court found that this publication disclosed adalimumab and self-buffering protein formulations. A-203-22).

Antibody 52

Antibody Production Regulation Marketing 52

pharmaphorum

MAY 10, 2021

The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU. . At the moment the regulator is looking at the first batch of data from lab and animal studies as well as quality studies. Intramuscular injection.

Antibody 52

Antibody Protein Trials Clinical Trials 52

Advarra

JANUARY 11, 2024

Adoptive T Cell therapies, therapeutic antibodies, and immunomodulatory proteins represent just some of the potentially beneficial treatment strategies for successful mRNA cancer trials. One strategy proposed the use of synthetic mRNA or modified mRNA analogs, which can enhance the stability and protein expression of mRNA.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

The Pharma Data

SEPTEMBER 30, 2021

Scientists from the German Cancer research facility (DKFZ) and therefore the Medical Faculty Mannheim, Heidelberg University, have now identified a replacement protein produced by blood vessels that permits tumor cells to metastatically colonize organs.

Protein 52

Protein Scientist Antibody Research 52

pharmaphorum

JUNE 24, 2021

Just a few days after Biogen abandoned its tau-targeting Alzheimer’s disease candidate gosuranemab, Bristol-Myers Squibb has opted into a rival drug, paying $80 million for rights to Prothena’s PRX005 antibody in phase 1 testing. . The deal – which could be worth up to $2.2

Antibody 45

Antibody Protein Drugs Trials 45

Drug Discovery World

NOVEMBER 2, 2022

UbiSite technology uses an antibody specific to the C-terminal of ubiquitin for the capture and further identification of protein ubiquitylation sites in cell and tissue samples. . UbiSite will form a new component in Ubiquigent’s deubiquitylase (DUB) and ubiquitin-proteasome system (UPS) focused drug discovery platform.

Licensing 52

Licensing Licensing Protein Antibody 52

Pharmaceutical Technology

MARCH 10, 2023

Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity.

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Manufacturing Production Containment Antibody 147

Drug Discovery World

MARCH 26, 2024

For example, progress made in developing gene mutant-specific inhibitors, antibody-drug conjugates (ADC), or cellular therapies. OR: The presentations at ESMO TAT 2024 highlighted our advances in targeted and more personalised anti-tumour therapies.

RNA 64

RNA In-Vivo In-Vitro DNA 64

pharmaphorum

JANUARY 5, 2022

The new vaccine differs from the currently approved shots because it delivers antigens for both the spike protein and other proteins found in SARS-CoV-2. That could mean it is less susceptible to the loss of efficacy to vaccines that can occur when there are changes in the spoke protein – as witnessed with the new Omicron variant.

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Protein Vaccination Vaccine Immune Response 127

XTalks

JULY 10, 2023

Rystiggo received FDA approval under the Priority Review designation, specifically for the treatment of gMG in adult patients who have tested positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. The active ingredient in Rystiggo is rozanolixizumab, a humanized IgG4 monoclonal antibody.

FDA Approval 98

FDA Approval Antibody Protein Engineer 98

The Pharma Data

MARCH 22, 2021

Investigational antibody cocktail of casirivimab and imdevimab also significantly shortened the duration of symptoms by four days. The combination of casirivimab and imdevimab is the only monoclonal antibody treatment to retain potency against key emerging variants, based on the recently updated EUA guidance from the U.S.

Antibody 52

Antibody Trials Clinical Trials Clinical Trials 52

pharmaphorum

NOVEMBER 23, 2020

AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. AZ made the announcemen t as the UK regulator reportedly gears up to make a decision on the rival vaccine from Pfizer and BioNTech, ahead of counterparts in the US and Europe.

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Vaccination Vaccine Regulation Protein 106

Roots Analysis

MARCH 6, 2022

This complete process is in association with a complex and highly regulated assembly of proteins which involve several soluble and surface-bound complement components, including receptors and regulators, which are majorly generated by the liver. Further, the complement system can be activated by three distinct pathways-.

Regulation 52

Regulation Protein Antibody Marketing 52

Drug Discovery World

MARCH 8, 2023

Dosing has begun in a Phase I clinical study evaluating BAT8008, an antibody-drug conjugate (ADC) that targets Trop2. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase II dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumours.

Trials 52

Trials In-Vivo In-Vitro Antibody 52

Drug Discovery World

NOVEMBER 27, 2023

As the significance of large molecules continues to broaden across diverse modalities, emphasis on bispecific and multispecific antibodies to treat various disorders such as rheumatologic diseases, cancer, diabetes, anaemia, and infectious diseases becomes paramount. Biotechnol Bioeng 2012;118:2326. Budge JD, Knight TJ, Povey J, et al.

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Production Engineer Gene Editing Gene 59

Pharmaceutical Technology

JUNE 24, 2022

1 variant, on 22 June, Moderna said its booster also showed a “potent” antibody response against Omicron subvariants BA.4 As per Rohde, the spike protein in the Omicron variant has “wicked alterations” in its antigenicity, shows a very high transmission ability and immune escape from those early vaccine induced immune individuals.

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Vaccination Vaccine Antibody Medicine 264

Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. The booster dose elicited a significantly higher neutralising antibody response against Omicron subvariants BA.4 Regulators are well-disposed to these boosters.

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Manufacturing Vaccination Vaccine Packaging 130

XTalks

JUNE 28, 2023

DMD is caused by the absence of dystrophin, a protein that helps maintain the integrity of muscle cells. Elevidys’ approval was based on data from a randomized trial that showed the therapy increased expression of the Elevidys micro-dystrophin protein, which was used as a surrogate endpoint, in DMD patients aged four to five years of age.

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. following the initial European Medicines Agency (EMA) approval, and conducting any additional studies specifically required for approval by regulators outside the U.S. and around the world.

Antibody 52

Antibody Clinical Trials Clinical Trials Manufacturing 52

pharmaphorum

AUGUST 19, 2020

But like the rest of this first generation of antibody-based drugs, Remicade has been hit by cheaper competition from biosimilars and the hunt is on for newer drugs that outperform standard therapy in terms of safety and efficacy. per share is expected to close in the second half of 2020, subject to clearance by US antitrust regulators.

Antibody 106

Antibody Drugs Protein Sales 106

The Pharma Data

JANUARY 16, 2021

Etta Biotech”), to set up a high titer transient protein expression platform for high quality protein production using JS Bio’s transient transfection media. JS Bio becomes the exclusive cell culture supplier for Etta Biotech’s transient transfection high titer protein expression platform. JS Bio’s parent company.

Protein 52

Protein Production Antibody In-Vitro 52

XTalks

SEPTEMBER 2, 2021

The AlzoSure Predict prognostic biomarker Alzheimer’s blood test detects levels of an unfolded conformational variant of the p53 protein in the blood using a proprietary antibody called U-p53AZ. The Diadem AlzoSure Predict assay uses a proprietary antibody, U-p53AZ, to measure blood levels of the unfolded conformational p53 variant.

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Protein DNA Antibody Genome 105

pharmaphorum

AUGUST 31, 2021

The move follows phase 1/2 results with SK bio’s GBP510, which found that it stimulated neutralising antibodies against SARS-CoV-2 in all 80 recipients, with no safety issues recorded. Neutralising antibody titres in the blood were five to eight times higher than people who recovered from COVID-19.

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Vaccination Vaccine Protein Immune Response 59

pharmaphorum

MARCH 9, 2022

Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new long-acting drug candidate can revitalise the franchise. The half life of the new drug – one of the main draws for Sanofi’s $11.6

Protein 98

Protein Sales Gene Therapy Regulation 98

XTalks

NOVEMBER 26, 2020

In addition to innovative new antibody drugs and mRNA vaccines, researchers have found that the sleep-regulating hormone melatonin may also offer protection against COVID-19. Melatonin, which regulates the body’s circadian rhythm and sleep-wake cycle, is also available in pill form for use as a sleep aid.

Research 98

Research Hormones Protein Regulation 98

The Pharma Data

JANUARY 13, 2021

The patent application is titled “Anti-CD154 Antibodies and Uses Thereof” and published under International Publication No. TNX-1500 is a third generation anti-CD40-ligand mAb that has been designed by protein engineering to decrease Fc?RII antagonist receptor fusion protein. WO 2021/001458 A1. International Immunol. (11):1583

Antibody 52

Antibody Development Protein Vaccination 52

The Pharma Data

APRIL 7, 2021

Anti-p53 antibodies are antibodies that mistakenly target a patient’s own tissues, leading to a growth of solid tumors. today announced the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies. The assay is now available for all markets accepting the CE Mark.

In-Vitro 52

In-Vitro Antibody Genetics Protein 52

Pharmaceutical Technology

DECEMBER 9, 2022

Beyond our expertise in small molecules, we have built a solid reputation with biopharmaceutical companies for the characterisation and analysis of monoclonal antibodies, therapeutic proteins and biosimilars. Solvias is well equipped to provide stability testing for all stages of drug development. Quality control release testing.

Development 130

Development Manufacturing Production Vaccination 130

pharmaphorum

AUGUST 10, 2020

The FDA has set a decision date for March 27 next year, and Biogen said that the regulator could make a ruling before then. The other main method of action being investigated is targeting the tau protein tangles that are seen in brain cells of people with Alzheimer’s.

Drugs 106

Drugs Clinical Trials Clinical Trials Trials 106

Pharmaceutical Technology

JUNE 4, 2023

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin-1, which are now well established in the industry.

Genetics 130

Genetics Gene Expression DNA Antibody 130

pharmaphorum

SEPTEMBER 7, 2020

Preliminary results published in The Lancet are from a non-randomised phase 1/2 trial of 76 people aged 18-60, which found an antibody response within 21 days and no serious adverse events after 42 days. All participants in the phase 2 trials (40 participants) produced antibodies against the SARS-CoV-2 spike protein.

Immune Response 108

Immune Response Vaccination Vaccine Trials 108

pharmaphorum

MARCH 30, 2022

When the first generation vaccine CVnCoV failed its phase 2b/3 test last summer, the writing looked to be on the wall for the alliance, with multiple COVID-19 shots already available with more coming down the pipeline – including GSK and Sanofi’s recombinant protein candidate – and prospects looking slim in an increasingly crowded market.

Vaccination 65

Vaccination Vaccine Protein Antibody 65

The Pharma Data

AUGUST 24, 2020

It is hoped that using insect cells to grow proteins for the vaccine could speed up large-scale production. The news comes after China said that companies and organisations must prove to regulators that vaccines have 50% efficacy. Conor Kavanagh. Source link.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

pharmaphorum

SEPTEMBER 14, 2020

US-based Merck, known as MSD outside North America, will globally develop and market Seattle’s investigational antibody-drug conjugate (ladiratuzumab vedotin). The drug zeroes in on cancer cells expressing a protein known as LIV-1 and is in phase 1 development for breast cancer and other solid tumours.

Genetics 52

Genetics Development Drugs Protein 52

XTalks

JULY 2, 2021

This is because the processes that maintain the uterine lining, including the placenta, during pregnancy are different than those that regulate the normal menstrual cycle. However, the similarity between the two proteins is not great enough for anti-spike antibodies to cross-react with placental syncytin-1.

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Vaccination Vaccine Protein Immune Response 105

pharmaphorum

NOVEMBER 17, 2020

Pfizer is poised to file the vaccine with the FDA in the coming days, seeking an Emergency Use Authorization (EUA) after gathering enough safety data required by the regulator. The four states will not receive the vaccine earlier because of the pilot, according to Pfizer. Pfizer and BioNTech have a $1.95

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Vaccination Vaccine RNA Clinical Trials 78