The Pharma Data

AUGUST 15, 2021

Food and Drug Administration were based on mRNA, more conventional protein-based vaccines have also shown promise in clinical trials. After characterizing the nanoparticles in vitro, they injected them into mice, along with separate polymersomes containing an adjuvant, in two doses that were three weeks apart.

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Protein Vaccination Vaccine Antibody 52

pharmaphorum

NOVEMBER 2, 2021

In 2019, there were 57 bsAb candidates in clinical trials, against both haematological and solid tumours. They are also designed to have a short in vitro half-life, meaning that they will be cleared from a patient’s system within several hours. Simplified schematic overview of the proposed mechanisms of action for bsAbs.

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The Pharma Data

OCTOBER 14, 2021

The trial showed that no patients experienced Grade 3 or higher infusion-related reactions during treatment cycle 2 with short duration infusion Gazyvaro, and no unexpected safety findings were found, supporting its use. The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Medicine 52

Medicine In-Vitro Antibody Genome 52

The Pharma Data

MAY 27, 2022

Glofitamab is being investigated in several clinical trials and explored in earlier lines of lymphoma treatment. It is engineered to have two ‘Fab’ regions which bind to CD20, and one ‘Fab’ region which binds to CD3. of patients refractory to their initial therapy and about one-third (33.1%) having received prior CAR T-cell therapy.¹

Antibody 52

Antibody In-Vitro Medicine Engineer 52

The Pharma Data

DECEMBER 14, 2020

Many drugs fail in clinical trials because of their low blood brain barrier permeability. engine along with algorithms tuned to predict BBB permeability played an important role in helping determine which CNS cancers and which genomically-defined subtypes of CNS cancer should be prioritized for development. . Lantern’s A.I.

Drugs 52

Drugs Genome Genomics DNA 52

XTalks

JUNE 12, 2023

Medtronic’s proactive stance towards R&D is evident from the over 230 clinical trials it conducted and the more than 200 regulatory approvals it received in the US, Europe, Japan and China in the 2022 fiscal year. Join us as we explore the inspiring journey and significant contributions of these top 10 medical device companies.

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XTalks

SEPTEMBER 20, 2024

XTALKS CLINICAL EDGE: Issue 3 — Interview with CTTI Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. Such challenges highlight a significant unmet need and call for further advancements in the field.

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Gene Editing Manufacturing Gene In-Vivo 52

Roots Analysis

DECEMBER 12, 2022

Due to this biological mismatch, several toxic drugs are subjected to costly clinical trials, while potentially useful drugs do not get commercialized. In order to fasten the discovery of innovative drugs and personalized medication, improved in vitro simulation of human biology and pathologies is required.

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Production In-Vitro Marketing Branding 40

The Pharma Data

MAY 15, 2023

1,2 Vabysmo’s safety profile was consistent with previous trials. The sBLA is based on results from the phase III BALATON and COMINO studies that demonstrated treatment with Vabysmo provided early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept.

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Antibody In-Vitro Clinical Development Medicine 40

XTalks

OCTOBER 1, 2020

The drug is currently in clinical trials for alcoholic hepatitis (AH), nonalcoholic steatohepatitis (NASH), as well as in COVID-19 patients with acute liver or kidney injury. However, this has since changed, and now, transitioning between academia and industry has become more commonplace. Key Moments. A life-changing moment came for Dr.

Scientist 52

Scientist In-Vitro Research Life Science 52

The Pharma Data

APRIL 12, 2023

The abstracts showcase the strength and breadth of Roche’s Ophthalmology portfolio, including post-hoc data from phase III Vabysmo® (faricimab) studies that support its benefit in drying retinal fluid in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).

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Antibody In-Vitro Development Trials 40

XTalks

MARCH 6, 2024

This includes discussions on cutting-edge technologies and methodologies in brain research, such as neuroimaging, genetic engineering and artificial intelligence. It also emphasizes the importance of brain health across the lifespan, advocating for strategies to maintain brain function, improve mental health and enhance quality of life.

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FDA Approval In-Vitro Research Marketing 69

Cloudbyz

AUGUST 19, 2024

European Medicines Agency (EMA): Regulates medical devices within the European Union through the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare.

Compliance 52

Compliance Manufacturing Regulation Marketing 52

pharmaphorum

JUNE 9, 2022

Antimicrobial resistance (AMR) is an issue of global concern, killing roughly 1.2 million 1 people per year and projected to rise to 10 million people by 2050 2. It occurs when bacterial pathogens adapt over time to develop resistance to traditional antibiotics, resulting in “superbugs” that are near impossible to treat.

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Bacteria Development In-Vitro Drugs 104

Roots Analysis

MAY 21, 2024

In allogeneic cell therapies, the cells are engineered ( to elicit a desired therapeutic response ) and amplified in-vitro. According to the Alliance for Regenerative Medicine, the number of clinical trials being conducted for allogeneic cell-based cancer therapies increased by 30% over the past five years.

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In-Vitro Development Engineer Medicine 40

The Pharma Data

DECEMBER 9, 2020

With the launch of Overland, we are creating a robust research and development engine in parallel with the significant growth and opportunity presented by Asia’s evolving biotech industry. A solution could be at hand with Overland Pharmaceuticals.

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In-Vivo In-Vitro Antibody Development 52

The Pharma Data

JUNE 17, 2022

“The broadly neutralizing antibodies we described were more efficient in vitro than many anti–SARS-CoV-2 monoclonals previously approved by the FDA for treatment or prevention. A modified version of the Cv2.1169 antibody was also effective at treating SARS-CoV-2 infection in mice and hamsters.

Antibody 52

Antibody In-Vivo In-Vitro Immune Response 52

The Pharma Data

JANUARY 11, 2021

Our antibody clones in their original IgG format have shown potent neutralization activity in in vitro assays and, in the case of our lead clone, in an in vivo animal model. Headquartered in Mountain View, California, IGM Biosciences is a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies.

Antibody 52

Antibody Licensing Licensing Development 52

The Pharma Data

JANUARY 17, 2021

The year is starting to pick up in terms of clinical trial announcements. NeuroRx , Relief Therapeutics and Quantum Leap Healthcare Collaborative (QLHC) announced that NeuroRx and QLHC have signed a Clinical Trial Participation Agreement for the inclusion of Zyesami (RLF-100 aviptadil) in the I-SPY COVID-19 trial.

Immune Response 52

Immune Response Antibody Trials Clinical Trials 52

The Pharma Data

APRIL 23, 2021

Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia. Venclyxto combinations significantly improved complete response rates in people with newly diagnosed acute myeloid leukaemia in two key studies (VIALE-A and M14-358). The median OS was 14.7 months (95% CI: 11.9, months (95% CI: 7.4,

Medicine 40

Medicine In-Vitro Antibody Development 40

pharmaphorum

JANUARY 16, 2023

There were developments in the past 12 months, true – Biogen/Eisai’s lecanemab (now branded Leqembi) showed clear success in the Clarity AD trial and received approval by FDA on 6th January 2023. The hard problem: innovation for high prevalence, chronic diseases of ageing.

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Gene Therapy In-Vitro Gene Medicine 98

pharmaphorum

OCTOBER 5, 2022

It has been shown in vitro to cover all major influenza A strains that have arisen since the 1918 ‘Spanish flu’ pandemic and is designed as a universal prophylactic for influenza A. Additionally, the incorporated Xencor Xtend Technology is half-life engineered, meaning a single dose could potentially last an entire flu season.

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Antibody In-Vitro Radiology Development 110

The Pharma Data

JANUARY 24, 2021

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. Read on to see. COVID-19-Related. Non-COVID-19-Related.

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Trials Allergies In-Vitro Antibody 52

Pfizer

JANUARY 27, 2023

and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells. and around the world.

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Research Vaccination Vaccine Drugs 112

The Pharma Data

MARCH 26, 2021

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.

Antibody 52

Antibody Trials Vaccination Vaccine 52

XTalks

JANUARY 6, 2025

For example, antisense oligonucleotide (ASO)-based therapies have gained traction, with 100 Phase I clinical trials initiated and around 25 percent of these advancing to Phase II or Phase III trials in recent years. Related: Biotech IPOs in 2024: Navigating the New Wave of Innovation 1.

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Gene Therapy RNA Gene Editing Gene 111

XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. As of July, the company and its federal partner stated that it is on track to supply between 500 million to 1 billion doses a year at a dose of 100 µg now selected for their Phase III trial.

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Vaccination Vaccine Antibody Life Science 92