pharmaphorum

MARCH 23, 2022

Argenx only recently scored FDA approval for its intravenous anti-neonatal FC receptor (FcRn) antibody Vyvgart for generalised myasthenia gravis (gMG), but is already looking to defend its franchise with a new subcutaneous version of the drug. After 29 days’ treatment IgG levels were reduced by 66.4% in the IV arm.

Antibody 52

Antibody Sales FDA Approval Trials 52

pharmaphorum

DECEMBER 23, 2021

Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The post FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag appeared first on.

Drugs 70

Drugs Antibody Clinical Trials Clinical Trials 70

The Pharma Data

JANUARY 31, 2021

Both vaccines induced high levels of neutralizing antibodies comparable to or exceeding levels in human convalescent sera as well as a strong Th1-biased cell-mediated immunity. Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

JANUARY 5, 2022

The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. The post FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag appeared first on.

Antibody 109

Antibody Drugs Protein Gene 109

Pharmaceutical Technology

MAY 15, 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.

Antibody 130

Antibody DNA Development Vaccination 130

The Pharma Data

DECEMBER 3, 2020

S-Trimer adjuvanted with GSK’s pandemic adjuvant system induced neutralizing antibody titers (seroconversion) in 100% of participants at the selected 9 µg S-Trimer dose in both adult and elderly groups, with geometric mean titers (GMT) greater than 1:1,800. About Trimer-Tag © Technology. About COVID-19 S-Trimer Vaccine.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

pharmaphorum

APRIL 27, 2022

The coveted status has been awarded to the HER2-targeting antibody-drug conjugate (ADC) on the back of the DESTINY-Breast04 trial results, unveiled in February, which involved patients with HER2-low, unresectable and/or metastatic breast cancer previously treated with one to two prior lines of chemotherapy. .”

Sales 57

Sales Drugs Antibody Licensing 57

pharmaphorum

JANUARY 18, 2022

The hope is that they will harness and re-programme natural cellular mechanisms to selectively remove the disease driving proteins from human tissues, working by boosting interactions – gluing – between therapeutically relevant proteins and the machinery used by cells to naturally tag and destroy proteins.

Dermatology 52

Dermatology Protein Pharma Companies Research 52

pharmaphorum

DECEMBER 12, 2022

Vyvgart is already approved to treat generalised myasthenia gravis, getting a green light for that indication from the FDA a year ago, and launched with a $225,000 per annum price tag in competition with rival gMG drugs like AstraZeneca/Alexion’s C5 inhibitor Soliris (eculizumab).

Sales 52

Sales Trials Drugs Antibody 52

pharmaphorum

APRIL 20, 2021

The cost-effectiveness agency has said that anti-CD20 antibody Kesimpta (ofatumumab) can be prescribed via the NHS in England and Wales as a treatment for adults with RMS with active disease, as either a first-line therapy or after alternative drugs have been tried.

Sales 109

Sales Medicine Drugs Marketing 109

XTalks

JUNE 28, 2023

million price tag of Elevidys, a one-time gene therapy. It has taken Sarepta six years to develop Elevidys with several roadblocks in its journey, including two clinical holds due to safety concerns. It has taken Sarepta six years to develop Elevidys with several roadblocks in its journey, including two clinical holds due to safety concerns.

Gene Therapy 98

Gene Therapy Gene Protein FDA Approval 98

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

Development 52

Development Drugs Clinical Development Antibody 52

The Pharma Data

JANUARY 31, 2021

In its Phase 1 clinical trial, Clover’s protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either Dynavax or GlaxoSmithKline plc (GSK, London Stock Exchange: GSK) both performed well and induced high levels of neutralizing antibodies while demonstrating favorable safety and tolerability profiles.

Vaccination 52

Vaccination Vaccine Trials Protein 52

XTalks

APRIL 18, 2024

Previously, Roche secured an FDA breakthrough tag for another one of its Alzheimer’s blood tests that detects levels of pTau-181 and ApoE4 (apolipoprotein e4). However, the guidance doesn’t say whether it could serve as a study’s primary endpoint on its own.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

XTalks

JULY 12, 2021

The FDA’s rationale for granting the approval was based on the function of the drug as an amyloid beta targeting antibody. On the other hand, Biogen is being aggressively questioned over its tacking on of such a hefty price tag for the drug.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

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. While its headline revenue of $7.4

Trials 52

Trials Sales FDA Approval Production 52

The Pharma Data

OCTOBER 9, 2021

Roche (SIX RO, ROG; OTCQX RHHBY) now posted that gantenerumab, ananti-amyloid beta antibody developed for subcutaneous administration, has been granted Improvement Rectifier Designation by theU.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s fever ( Notice).

Antibody 52

Antibody In-Vitro Trials Development 52

Drug Discovery World

JUNE 14, 2023

We have now our lead product in a Phase I/II study, which is a HER-2 directed tag T cell product for patients with HER-2 positive solid tumours. I started as a cancer biologist and worked with small molecules and antibodies. I’ve been with a company for more than five years now. This is not how I started out.

Research 52

Research Engineer In-Vivo Production 52

XTalks

FEBRUARY 27, 2024

Addressing the high price tag, Iovance’s commercial chief Jim Ziegler said, “Payers have expressed their appreciation for the value proposition for Amtagvi.” Vogt said Iovance set Amtagvi’s price based on its value as the first drug approved in the post-PD-1 melanoma setting, and the company’s analysis of relevant benchmarks.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

XTalks

JUNE 9, 2021

Aducanumab is a human IgG1 monoclonal antibody that binds to aggregated forms of amyloid beta to help reduce its buildup. Aducanumab Controversy and Price Tag. Biogen developed aducanumab in partnership with Japanese pharmaceutical company Eisai. Evidence for aducanumab’s efficacy has been highly contested.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

Drug Discovery World

OCTOBER 3, 2022

She also works on her own research following her PhD in the digitisation of scientific research, smart labs and the lab of the future, and semantic tagging of scientific data, which she has continued as part of the Physical Sciences Data Infrastructure (PSDI) Project. Fellowship Programme.

Drugs 52

Drugs Scientist Bioinformatics Medicine 52

Drug Discovery World

NOVEMBER 9, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Kielczewska will present: ‘Discovery of antibody-based therapeutics to challenging targets: Platform considerations’.

Engineer 52

Engineer Antibody Protein In-Vivo 52

XTalks

AUGUST 17, 2020

Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells. The design of the immune biologic puts these elements together on an antibody scaffold. With the Neo-STAT platform, “it’s like making a separate antibody molecule for each one of those. Immune system modulators (i.e.

Protein 98

Protein Engineer Immune Response In-Vivo 98

The Pharma Data

APRIL 22, 2023

Cocktail of modified antibodies provides strong effect against SARS-CoV-2 Is it possible to improve the antibodies that the body produces to fight SARS-CoV2? In a study led by researchers from Lund University in Sweden, this was investigated by redesigning antibodies and combining them against the virus.

Antibody 40

Antibody Immune Response Protein Research 40

Drug Discovery World

NOVEMBER 13, 2023

Ahead of protein and antibody engineering conference PEGS Europe 2024 in Lisbon, DDW’s Megan Thomas looks at what to expect from each track of the annual biologics technology meeting. Hiroki Shirai, PhD, Coordinator, RIKEN Center for Computational Science, on: ‘Applying deep learning anomaly detection to antibody structures’.

Protein 59

Protein Antibody Engineer Scientist 59

pharmaphorum

AUGUST 26, 2022

The US biotech claimed conditional marketing approval from the European Commission for Roctavian (valoctocogene roxaparvovec) as a treatment for adults with severe haemophilia A, who don’t have a history of developing the antibodies that inhibit the activity of blood-clotting protein Factor VIII. million spread over five years.

Gene Therapy 109

Gene Therapy Gene Antibody Marketing 109

Roots Analysis

SEPTEMBER 13, 2023

Conjugation is the process of formation of a single, stable hybrid, wherein one of the entities is a molecule, such as protein, antibody, peptide and small molecule. Bioconjugation is a subset of conjugation where one of the entity is a biomolecule, such as protein or an antibody.

Development 40

Development Antibody Protein Drug Delivery Systems 40

pharmaphorum

MARCH 27, 2022

The KarMMa trial of Abecma involved a similar patient group – treated with at least three lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody such as J&J’s Darzalex (daratumumab) – with an overall response rate of 72% and 28% complete responses.

Antibody 84

Antibody Clinical Trials Clinical Trials Sales 84

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. .”

Vaccination 52

Vaccination Vaccine Manufacturing Life Science 52

Drug Discovery World

OCTOBER 28, 2022

Click’ chemistry used to tag proteins made by cancer cells . Experimental monoclonal antibodies block EBV infection . A panel of investigational monoclonal antibodies (mAbs) targeting different sites of the Epstein-Barr virus (EBV) have been shown to block infection when tested in human cells in a laboratory setting. . .

Drugs 52

Drugs Antibody Protein RNA 52

XTalks

AUGUST 23, 2021

But studies investigating both classes of drugs in combination must also consider the potential that the tau-targeting agent might only receive approval to be prescribed alongside an anti-amyloid antibody like aducanumab. With a $56,000 price tag for a year’s worth of treatment, Aduhelm is far from the most expensive drug on the market.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

Delveinsight

DECEMBER 3, 2020

Roche receives FDA authorization for the quantitative COVID-19 antibody test. Roche has got an authorization from the FDA for a more accurate COVID-19 blood test capable of measuring the levels of specific antibodies, which target the cell-unlocking spike protein of coronavirus. Merck chooses TriNKET cancer immunotherapy program.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

Drug Discovery World

OCTOBER 21, 2022

The main principle involves a well-defined light source such as that produced by lasers that excites fluorescent tags bound to the cells or particles present in a sample. Best antibody development practices are summarised in Fig. Figure 1: Best practices followed by reliable, best in class antibody developers.

Reagent 52

Reagent Antibody Drugs Protein 52

pharmaphorum

DECEMBER 2, 2020

The New York-based firm has requested approval for the combination of its anti-CD20 antibody ublituximab and umralisib, an oral drug that inhibits PI3K-delta and CK-1 epsilon. US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche.

Drugs 52

Drugs Trials Antibody Marketing 52

XTalks

JANUARY 19, 2024

To specifically target cancer cells, alpha-emitting radionuclides are often attached to molecules that have a high affinity for cancer cells, such as antibodies or peptides (ligands). Due to their short range, alpha particles can destroy cancer cells while minimizing damage to surrounding healthy tissue.

DNA 66

DNA Radiology FDA Approval Development 66

The Pharma Data

MAY 5, 2021

India approves Roche/Regeneron antibody cocktail to treat COVID-19 ( Reuters ). Adagio offers first peek at Covid-19 antibody data, with preventative numbers that may rival mRNA vaccines ( Endpoints ). FDA approves 100th monoclonal antibody product ( Nature Reviews Drug Discovery ).

Vaccination 52

Vaccination Vaccine Gene Therapy Contract Packaging 52

The Pharma Data

MAY 4, 2021

Biosimilars, which grew 79% operationally to $530 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) globally, as well as continued growth from Retacrit (epoetin) in the U.S.; View source version on businesswire.com : [link].

Vaccination 40

Vaccination Vaccine Production Sales 40