pharmaphorum

DECEMBER 24, 2021

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. The $56,000-a-year price tag for the drug, which has now been cut in half in the US, also hasn’t helped the drugmakers make a case for Aduhelm with US payers.

Drugs 109

Drugs FDA Approval Trials Marketing 109

pharmaphorum

JANUARY 5, 2022

Teliso-V (telisotuzumab vedotin) is pitching to become the first targeted cancer treatment for people with non-small cell lung cancer (NSCLC) whose tumours overexpress c-Met. The post FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag appeared first on. Preliminary results from that study showed a 53.8%

Antibody 109

Antibody Drugs Protein Gene 109

Pharmaceutical Technology

MAY 2, 2023

All currently approved CAR-Ts are autologous, with the patient’s T-cells being genetically engineered to target antigens expressed by the cancerous cells. IO therapies come with a hefty price tag, with ICI therapies in the US typically exceeding $100,000, while cell therapies can exceed $400,000.

Genetic Engineering 130

Genetic Engineering Antibody Clinical Trials Clinical Trials 130

Rethinking Clinical Trials

AUGUST 30, 2023

The treatment philosophy for RA is to treat-to-target based on PRO disease activity scores. There are 4 components to the treat-to-target approach: record disease activity using a composite measure every 3 months; specify disease activity target; adjust medications to target; and document shared decision making.

Trials 141

Trials Clinical Research Coordinator Medicine Clinical Trials 141

Pharmaceutical Technology

MAY 1, 2023

CTH-004 is developed by genetically altering patient T cells for inserting a chimeric antigen receptor (CAR) to target a marker (TAG-72) on ovarian cancer cells and delete genes which are involved in T cell function suppression. Shunxi will also hold an option to negotiate rights to other CAR-T products, which include the licenced IP.

Gene Therapy 130

Gene Therapy Gene Development Clinical Trials 130

Pharmaceutical Technology

NOVEMBER 9, 2022

BioMarin’s Roctavian has a target PDUFA action date of March 31 next year. million price tag. The post Can gene therapies for haemophilia defend their high price tags? CSL Behring has a commercialisation and license agreement to develop EtranaDez. After its approval, bluebird had set Zynteglo’s price at roughly EUR1.6

Gene Therapy 278

Gene Therapy Gene FDA Approval Medicine 278

Rethinking Clinical Trials

NOVEMBER 1, 2022

Participant feedback revealed that shorter more targeted surveys focusing on the most high-value information may have been less burdensome for participants. pctGR, @Collaboratory1.

Trials 130

Trials Clinical Research Vaccination Vaccine 130

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

Rethinking Clinical Trials

APRIL 18, 2023

The 5 platform protocols are integrated rather than siloed, disparate studies to achieve efficiencies, allow researchers to rapidly assess targeted therapeutics and pivot as needed to new treatment arms, maximize knowledge gained from patient participation, and to enable cross-trial analysis and accelerated knowledge acquisition.

Clinical Trials 219

Clinical Trials Clinical Trials Trials Immune Response 219

Rethinking Clinical Trials

JANUARY 9, 2024

Across these situations, treating certain aspects at zero would cause these examples not to be what we’re targeting. When we fit different model, we would look at the tool missing, the gamma parameter, or maybe the AGA parameter depending on the model and whether the individual outcome is missing or not.

Trials 275

Trials Clinical Trials Clinical Trials Research 275

Drug Discovery World

MARCH 2, 2023

New understanding of epigenetics It has been known for more than 20 years that the enzymes placing H3K4me3, a chemical tag added to DNA, are crucial for normal cell development, as well as being linked to leukaemia, breast, bowel and pancreatic cancers.

Gene Expression 52

Gene Expression Gene DNA RNA 52

Rethinking Clinical Trials

JULY 22, 2022

. – Foundation for NIH was involved from the beginning because we had successfully done the public-private partnerships for other initiatives, we had the stakeholder relationships to get everyone to the table, and our involvement allowed for rapid, targeted donations from private sector. pctGR, @Collaboratory1.

Vaccination 130

Vaccination Vaccine Clinical Trials Clinical Trials 130

Rethinking Clinical Trials

JUNE 14, 2023

When evaluating when and how RWE studies complement RCTs, it’s important to consider the target trial design that would best match the need or questions of the end users. 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?

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

FEBRUARY 7, 2024

How do people want to hear that science is a moving target? Tags #pctGR, @Collaboratory1 The post Grand Rounds February 2, 2024: Strategies for Improving Public Understanding of FDA and the Products It Regulates…Why Should We Care, and What Might We Do?

Regulation 152

Regulation Production Clinical Trials Clinical Trials 152

The Pharma Data

MARCH 23, 2022

Drugs that target polymerase could potentially treat Ebola virus infections and save lives. Their investigation reveals that an experimental drug that targets GSPT1 for degradation can also halt Ebola virus infection in human cells. But targeting Ebola virus polymerase has proven tough. Many viruses encode their own polymerase.

Protein 52

Protein Genome Genomics Research 52

Rethinking Clinical Trials

OCTOBER 18, 2023

It may be suitable for studies on targeted populations but will depend on collection practices at a given health system. Tags #pctGR, @Collaboratory1 The post Grand Rounds October 13, 2023: Incorporating Social Determinants of Health Into PCORnet (Keith Marsolo, PhD) appeared first on Rethinking Clinical Trials.

Clinical Trials 117

Clinical Trials Clinical Trials Clinical Research Research 117

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. HER3 is expressed in more than 80% of EGFR-mutant NSCLC, and overexpression is associated with poor outcomes, but no HER3-targeted drugs have been approved to date.

Drugs 70

Drugs Antibody Clinical Trials Clinical Trials 70

pharmaphorum

JANUARY 18, 2022

The use of monovalent degraders, which enable the targeted degradation of disease-relevant proteins, offers a new avenue to reach tissue that cannot be targeted with conventional therapeutic agents. Researchers at Almirall have identified several proteins whose abnormal function is associated with inflammatory immune skin diseases.

Dermatology 52

Dermatology Protein Pharma Companies Research 52

World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. Although COVID-19 has slowed the growth of drug sales, the oncology market’s total growth is driven by the targeted drugs in oncology. ” The U.S.

Pharma Companies 210

Pharma Companies Marketing Drugs Production 210

XTalks

DECEMBER 13, 2023

The FDA’s decision on the therapies came earlier than the given December 20 target decision date. Casgevy comes with a warning about off-target editing in the “Warnings and Precautions” section of the therapy’s label, which is less serious than a boxed warning. Vertex-CRISPR’s Casgevy has a US list price of $2.2

Gene Therapy 98

Gene Therapy FDA Approval Gene In-Vivo 98

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. The trimeric S protein of SARS-CoV-2 is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry, making it the primary target antigen for vaccine development.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

AUGUST 25, 2022

The category is getting increasingly crowed, with Pfizer also anticipating approval of its BCMA-targeting bispecific elranatamab in the coming months, with several more multiple myeloma bispecifics coming through the pipeline from the likes of Regeneron, AbbVie, Amgen and Roche. and 18,3 months, respectively.

Antibody 97

Antibody Marketing Drugs Medicine 97

Drug Discovery World

JANUARY 10, 2023

Scientists purchase antibodies with the expectation that they will recognise their intended targets and produce reliable data, but the presence of improperly validated antibodies on the market can make this process both time-consuming and expensive. This pillar takes advantage of the unique biology associated with some protein targets.

Antibody 52

Antibody Protein Reagent Scientist 52

XTalks

APRIL 18, 2024

The approval of amyloid-beta-targeting therapies like Leqembi and recently discontinued Aduhelm (aducanumab) have come with controversy around their clinical effectiveness. 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).

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

Drug Discovery World

NOVEMBER 7, 2022

One enduring problem for the field has been the fact that some of these drugs bind tightly to cereblon, yet fail to cause sufficient degradation of their protein targets. . The structural data revealed that CELMoDs must bind to cereblon in a way that changes its shape, or conformation.

Scientist 52

Scientist Drugs Protein Research 52

XTalks

MAY 1, 2024

Walmart is specifically targeting millennials with preferences for oat milk, gluten-free options and trendy flavors like hot honey. With its expansive range and competitive pricing, bettergoods is poised to become a key player in the grocery sector, inviting customers to enjoy premium products without the premium price tag.

Branding 52

Branding Production Sales Marketing 52

pharmaphorum

JULY 25, 2022

The EMA’s human medicines committee has recommended approval of Johnson & Johnson’s Tecvayli as a fourth-line therapy for multiple myeloma , joining a growing group of BCMA-targeted therapies for the blood cancer.

Antibody 52

Antibody Medicine Drugs Trials 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

Drug Discovery World

NOVEMBER 28, 2023

Importance of healthy mitochondrial function Dysfunctional mitochondria are usually tagged for removal via mitophagy with a protein ‘flag’ called ubiquitin. This research provides compelling evidence that USP30 is a promising therapeutic target for PD, where there is a pressing need for disease-modifying treatments.”

In-Vivo 52

In-Vivo Protein Drugs Research 52

The Pharma Data

DECEMBER 3, 2020

Utilizing Clover’s proprietary Trimer-Tag © technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. The trimeric S protein of SARS-CoV-2 is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry, making it the primary target antigen for vaccine development.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

Rethinking Clinical Trials

APRIL 13, 2023

Tags #pctGR, @Collaboratory1 The post Grand Rounds April 7, 2023: A Nudge Towards Cardiovascular Health: Incorporating Insights From Behavioral Science to Improve Cardiovascular Care Delivery (Srinath Adusumalli, MD, MSHP, MBMI, FACC) appeared first on Rethinking Clinical Trials.

Medicine 100

Medicine Trials Cardiology Development 100

Rethinking Clinical Trials

AUGUST 23, 2022

– How do investigators target rural areas to increase diversity? In terms of untapped potential, the engagement with the community, taking the time to identify who folks are and speak face to face. Ask questions like here’s what we think are priorities; are we right? Ask and engage community partners. Learn more.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Medicine 130

pharmaphorum

APRIL 5, 2022

The therapy is a bispecific T cell engager (BiTE) molecule, consisting of a soluble TCR targeting gp100 expressed on cancer cells fused to a protein that binds CD3 receptors on lymphocytes. It’s the first treatment for mUM in the EU, as well as the first BiTE drug to treat a solid tumour.

Protein 52

Protein Sales Drugs Trials 52

pharmaphorum

JANUARY 5, 2021

Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Meanwhile, drugs targeting TIM-3, LAG3, VISTA and STING also coming through development.

Immune Response 52

Immune Response FDA Approval Drugs Sales 52

Drug Discovery World

OCTOBER 31, 2023

The children will continue to receive enzyme replacement therapy during treatment, but once the gene therapy begins to work, the research team say part of the trial aims to remove the need for weekly enzyme replacement therapy over the child’s lifetime, while the other aim is to safely target the brain disease suffered by these patients.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

pharmaphorum

DECEMBER 23, 2022

price tag of $475,000 when it was first launched in 2017 – and it becomes apparent that these may not be desirable treatment options for every patient and in every setting. Inobrodib works by targeting twin cancer proteins p300 and CBP, which impacts the expression of cancer drivers including MYC and IRF4.

Development 52

Development Drugs Clinical Development Antibody 52

Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. It’s a much more challenging environment in terms of immunosuppression and the choice of targets is not as clean as with CD19 or BCMA. We also have the challenge of delivery.

Gene Therapy 147

Gene Therapy Gene Engineer Production 147