XTalks

FEBRUARY 27, 2024

Iovance Biotherapeutics’ Amtagvi (lifileucel) won US Food and Drug Administration (FDA) approval last week for the treatment of advanced melanoma, making it the first individualized tumor-infiltrating lymphocyte (TIL) therapy and the first T-cell therapy for a solid tumor to win US regulatory approval.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

Drug Discovery World

MAY 22, 2023

Ryan Leahy , a science communication expert in cell and gene therapy, at Phacilitate, says there is a lot to celebrate but also much to assess, question and challenge in this sector. But are these price tags a barrier to access? Advanced Therapies Week highlights the dynamic landscape of CGTs. million per dose.

Gene Therapy 52

Gene Therapy Gene Drugs Contamination 52

Drug Discovery World

OCTOBER 31, 2022

The last month has seen huge strides forward in our understanding of cancers, particularly in how they develop resistance to therapies and how we can ‘outsmart’ them using gene editing or different therapeutic pathways, but also how we can better target drugs to individuals and accurately predict treatment outcomes.

Drugs 52

Drugs Research Gene Editing Protein 52

pharmaphorum

DECEMBER 23, 2021

The designation – which is awarded to therapies that could represent a significant improvement over standard of care in either efficacy, safety, or both – has been awarded on the strength of phase 1 results in patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer (NSCLC).

Drugs 72

Drugs Antibody Clinical Trials Clinical Trials 72

The Pharma Data

AUGUST 18, 2020

Since July, the company has been running the therapy through Phase 1/2 studies to evaluate its efficacy in generating anti-tumour responses in locally advanced or metastatic solid tumours when used as a monotherapy and in combination with PD-1 inhibitors. .

Sales 52

Sales Protein Drugs 52

Drug Discovery World

JANUARY 9, 2023

Harvard investigators have developed a new cell therapy approach to eliminate established tumours and induce long-term immunity. . The engineered tumour cells were also designed to express factors that would make it easy for the immune system to spot, tag, and remember them, priming the immune system for a long-term antitumour response.

Scientist 52

Scientist Gene Editing Gene Engineer 52

pharmaphorum

DECEMBER 23, 2022

There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives. Oral therapy data presented at ASH. CellCentric, a U.K-based CellCentric, a U.K-based

Development 52

Development Drugs Clinical Development Antibody 52

XTalks

APRIL 18, 2024

The Elecsys pTau217 assay is being developed for various use case scenarios, including clinical trials or determining eligibility for approved disease-modifying therapies. The approval of amyloid-beta-targeting therapies like Leqembi and recently discontinued Aduhelm (aducanumab) have come with controversy around their clinical effectiveness.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

pharmaphorum

OCTOBER 29, 2021

Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy (sacituzumab govitecan) will be paired with Merck’s PD-1 inhibitor Keytruda (pembrolizumab) in a new phase 3 trial in previously-untreated subjects with locally advanced or metastatic TNBC. billion for the full year. While its headline revenue of $7.4

Trials 52

Trials Sales FDA Approval Production 52

The Pharma Data

JANUARY 31, 2021

Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag© Technology. Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. —- End —-.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Delveinsight

FEBRUARY 23, 2021

The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform. The company, however, is optimistic and gearing up to find more opportunities to advance in the ALS market.

In-Vitro 52

In-Vitro Vaccination Vaccine Licensing 52

pharmaphorum

JANUARY 11, 2022

Breakthrough designations can speed up the development of new therapies, making them available to patients sooner. BNT200 and BNT100 are among a series of therapies that Blue Note is developing for specific cancer settings. The post Blue Note leukaemia DTx gets FDA breakthrough tag appeared first on.

Development 64

Development Production Drugs 64

pharmaphorum

DECEMBER 12, 2022

Updated results from the ADVANCE IV study of Vyvgart (efgartigimod alfa) showed that more than half of patients with ITP treated with Argenx’ drug showed an improvement in platelet counts, which are dramatically reduced in the disorder.

Sales 52

Sales Trials Drugs Antibody 52

The Pharma Data

DECEMBER 3, 2020

Clover intends to initiate a separate pivotal clinical trial of the S-Trimer vaccine candidate in combination with Dynavax’s advanced CpG 1018 adjuvant plus alum in the first half of 2021. Utilizing Clover’s proprietary Trimer-Tag © technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

XTalks

OCTOBER 12, 2022

MRI may also be used to evaluate drug dosing regimens, to gain insight about the mechanism of drug action, and to collect imaging biomarker data which could provide an earlier indication of response to therapy than clinical outcomes. An Example of an Anti-Angiogenic Therapy in Oncology. Introduction to Perfusion Imaging.

Clinical Trials 93

Clinical Trials Clinical Trials Trials Drugs 93

The Pharma Data

JANUARY 31, 2021

Joshua Liang , Chief Executive Officer of Clover Biopharmaceuticals, said, “Given the encouraging results of our adjuvanted S-Trimer COVID-19 vaccine candidate to-date, we are enthusiastic about progressing to a global Phase 2/3 efficacy study utilizing Dynavax’s advanced adjuvant CpG 1018 plus alum. About Trimer-Tag© Technology.

Vaccination 52

Vaccination Vaccine Trials Protein 52

The Pharma Data

MARCH 16, 2022

The research scientist at the Max Planck Institute for Medical Research received the award in recognition of his ground-breaking work in establishing various approaches to protein labeling in living cells that have enabled far-reaching advances in chemical and cell biology. Protein labeling (e.g. He is also a co-founder of several companies.

Protein 52

Protein Scientist Gene Development 52

The Pharma Data

MARCH 7, 2022

Cas9 binds and uses RNA as an address-tag. The system allows scientists, by synthesizing a specific “address-tag” RNA, to bring Cas9 to a precise location in genome and therefore cut and splice genes at specific sites. Ruohola-Baker and Levy then fused this designed protein with a disabled version of a protein called Cas9.

Protein 52

Protein Gene Genome Genomics 52

pharmaphorum

NOVEMBER 16, 2022

The advancements made in drug development over the last decade have seen the arrival of a number of treatments that offer one-time cures and more effective therapies for conditions in smaller patient populations. However, alongside this progress, Ben Hargreaves finds that there is also a conundrum over how to price these therapies.

Gene Therapy 131

Gene Therapy Gene Marketing Development 131

XTalks

FEBRUARY 27, 2024

Rare Disease Day 2024, which falls on February 29 this year, is an opportunity to unite under a common cause: to bring attention to the challenges faced by those living with rare diseases and to push for advancements in research, treatment and policy. Both therapies were awarded their approvals on the same day in December 2023.

Research 59

Research Drugs Gene Therapy Clinical Trials 59

XTalks

JANUARY 19, 2024

In 2023, there have been pivotal trends shaping the landscape and application of alpha emitter therapy. The discussion centered on the evolving potential of alpha particle therapy for treating advanced and metastatic tumors. Common radionuclides used in alpha therapy include radium-223, actinium-225 and bismuth-213.

DNA 66

DNA Radiology FDA Approval Development 66

XTalks

AUGUST 19, 2022

Bluebird bio’s gene therapy Zynteglo (betibeglogene autotemcel, beti-cel) has been awarded a much anticipated approval from the US Food and Drug Administration (FDA) for the treatment of adult and pediatric patients with beta thalassemia who need regular blood transfusions. Bluebird has a total of three gene therapies in its pipeline.

Gene Therapy 95

Gene Therapy FDA Approval Gene Clinical Trials 95

XTalks

DECEMBER 21, 2022

The past year has been a strong one for life sciences industries, from pivotal gene therapy approvals to continued innovations in the biotech and medical device spaces. Gene Therapy Approvals. Bluebird bio is a notable mention as it secured FDA approvals for two of its gene therapies, Zynteglo and Skysona.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

Pharmaceutical Technology

JANUARY 27, 2023

In an email to Pharmaceutical Technology , he further described the therapy as “the most important advance for treatment of TTP since the documentation of effectiveness of plasma exchange in 1991”. With these therapies, there is the possibility of there being no clinical benefit and an emergence of adverse events.

Manufacturing 130

Manufacturing Drugs Research Analyst FDA Approval 130

The Pharma Data

NOVEMBER 15, 2020

Peng Liang , Founder and Chief Scientific Officer of Clover and inventor of the Trimer-Tag© technology, says, “A successful vaccine that can truly modulate the course of the COVID-19 pandemic must have four essential characteristics: safety, efficacy, scalability of manufacturing, and speed. About Cytiva.

Vaccination 52

Vaccination Vaccine Manufacturing Life Science 52

Rethinking Clinical Trials

MARCH 21, 2023

At each practice up to 50 patients with metastatic cancer, receiving systemic therapy, not on a therapeutic trial, were randomized to an intervention arm with digital monitoring or a control arm with usual care. Technology has advanced during this time, and there are all kinds of ways for patients to communicate with providers.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Delveinsight

DECEMBER 3, 2020

The company anticipates the test can aid in tracking the success of vaccines and recognize people who have recovered from infection and could serve as convalescent plasma donors or help in the development of new therapies. Janssen buys a gene therapy asset. of the time and negative results 99.98% of the time, as per Roche.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

Drug Discovery World

NOVEMBER 9, 2023

Gail Calvert, Field Application Scientist, Sartorius UK, on: ‘Leveraging integrated and advanced technologies for successful cell line development’. These include: Samantha Bailey-Bucktrout, PhD, Senior Vice President, Akamis Bio, on: ‘Tumour specific immunogene therapy to deliver protein therapeutics to solid tumour microenvironments’.

Engineer 52

Engineer Antibody Protein In-Vivo 52

Roots Analysis

AUGUST 28, 2022

Recent advances in multi-omics approaches, including genomics, transcriptomics, proteomics, metabolomics, cytometry and imaging, in combination with bioinformatics and biostatistics, have been translated into several popular bioanalytical platforms, such as next-generation sequencing (NGS), single-cell analysis, flow cytometry and mass spectrometry.

Genome 52

Genome Genomics RNA Genome Project 52

Drug Discovery World

NOVEMBER 13, 2023

Jannick Bendtsen, CEO, PipeBio, on: ‘Accelerating antibody development: Advancing discovery through integrated bioinformatics and machine learning’. He will discuss selection technologies for membrane targets using advances in whole cell panning and comparative deep sequencing.

Protein 59

Protein Antibody Engineer Scientist 59

pharmaphorum

OCTOBER 4, 2022

The Biobank was launched in 2020, with an initial aim of enrolling at least 1,000 patients with locally advanced or metastatic solid tumours and haematologic malignancies undergoing standard of care therapy. Building a bank. The entire process takes place in the physician’s office, alongside a clinician.

Biobanking 105

Biobanking Clinical Trials Clinical Trials Trials 105

Drug Discovery World

OCTOBER 21, 2022

Accordingly, advances in flow cytometry technology – both in instrumentation and reagent offerings – are enabling researchers to decipher these questions, leading to new discoveries and diagnostic tools. . However, despite impressive advances in modern flow cytometry, many bottlenecks remain that require constant research and investment.

Reagent 52

Reagent Antibody Drugs Protein 52

Rethinking Clinical Trials

JUNE 14, 2023

How do we teach our students and colleagues how to use the target trial framework and use these emulation approaches to advance our comparative effectiveness studies? A lot of these analytics are about dealing with confounding in a better way, but if you can’t get the design right, then the analytics aren’t going to be closer.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

The Pharma Data

MAY 4, 2021

and developed Europe following the approvals in 2019 for combinations of certain immune checkpoint inhibitors and Inlyta for the first-line treatment of patients with advanced renal cell carcinoma; as well as. Inlyta globally, up 34% operationally, primarily reflecting increased demand in the U.S. mg and norethindrone acetate 0.5

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

NOVEMBER 30, 2022

In the first quarter since its launch as an approved therapy for type 2 diabetes, Mounjaro has proven to be a lucrative drug, making $97.3 The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. million in Q3. compared to a 5.1%

Drugs 264

Drugs Manufacturing Hormones Contract Manufacturing 264

Pharmaceutical Technology

NOVEMBER 30, 2022

In the first quarter since its launch as an approved therapy for type 2 diabetes, Mounjaro has proven to be a lucrative drug, making $97.3 The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. million in Q3. compared to a 5.1%

Drugs 246

Drugs Manufacturing Hormones Contract Manufacturing 246