Rethinking Clinical Trials

MARCH 1, 2023

S1800A was a Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for NSCLC patients previously treated with immunotherapy performed within the Lung-MAP platform. The study does not include tissue specimen collection, image submission, or patient-reported outcome instruments.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Packaging 130

Rethinking Clinical Trials

OCTOBER 2, 2023

The PROTEUS Consortium’s objective is to ensure that patients, clinicians, and other decision-makers have high-quality PRO data from clinical trials and clinical practice to make the best decisions they can about treatment options. In our research, we learned that patients actively do not want to see error bars and P values on graphs.

Clinical Trials 154

Clinical Trials Clinical Trials Research Trials 154

pharmaphorum

JANUARY 11, 2022

A prescription digital therapeutic (DTx) for leukaemia patients developed by Blue Note Therapeutics has been awarded breakthrough device status by the FDA. Breakthrough designations can speed up the development of new therapies, making them available to patients sooner.

Development 64

Development Production Drugs 64

Drug Discovery World

MARCH 2, 2023

A new paper has solved the 20-year mystery of how epigenetic modifications act as traffic lights to control gene expression and could ultimately speed up the development of a new class of epigenetic cancer drugs. Epigenetics is still largely unexplored and referred to as the ‘dark matter’ of the genome.

Gene Expression 52

Gene Expression Gene DNA RNA 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. At the moment, the prognosis for these heavily pre-treated patients is very poor. Daiichi Sankyo and AZ are close collaborators in the ADC arena.

Drugs 72

Drugs Antibody Clinical Trials Clinical Trials 72

pharmaphorum

APRIL 27, 2022

AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after showing the drug extended survival in patients with HER2-low metastatic breast cancer. The post Enhertu gets breakthrough tag in HER2-low breast cancer appeared first on.

Sales 59

Sales Drugs Antibody Licensing 59

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. Of these patients, seven have been treated at the recommended phase II dose (RP2D) and regimen.

Development 52

Development Drugs Clinical Development Antibody 52

XTalks

FEBRUARY 27, 2024

Melanoma is a type of skin cancer often caused by exposure to ultraviolet light, such as that from sunlight or indoor tanning. Despite accounting for only about one percent of all skin cancers, melanomas make up a significant proportion of cancer-related deaths. The cost is the highest of any cell-based cancer drug in the US.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

pharmaphorum

APRIL 5, 2022

Immunocore now has approval on both side of the Atlantic for Kimmtrak – the first cancer therapeutic based on T cell receptor (TCR) technology – after getting a green light from the European Commission. Uveal melanoma is a rare cancer of the eye, which in the majority of patients is localised.

Protein 52

Protein Sales Drugs Trials 52

Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. How can we better educate the patients? How has the field changed in recent years?

Gene Therapy 147

Gene Therapy Gene Engineer Production 147

XTalks

DECEMBER 13, 2023

Current treatments for sickle cell disease include blood transfusions but patients often have episodes of intense pain and an increased risk of stroke. It can also make patients more susceptible to complications like anemia, jaundice, infections and gallstones. Vertex-CRISPR’s Casgevy has a US list price of $2.2

Gene Therapy 98

Gene Therapy FDA Approval Gene In-Vivo 98

XTalks

JANUARY 28, 2022

Up to 50 percent of patients will develop metastatic disease, mainly spreading to the liver, making treatment difficult and limited. Kimmtrak has a price tag of $18,760 per vial, which amounts to a weekly dose. months), so the average cost per patient will be approximately $400,000.

FDA Approval 98

FDA Approval Development Licensing Licensing 98

World of DTC Marketing

DECEMBER 13, 2021

OPENING: American cancer patients spent more than $21 billion on their care in 2019. billion and patient time costs of $4.87 As cancer survival rates rise, so do the price tags of life-saving treatments. Some cancer patients may face out-of-pocket costs of nearly $12,000 a year for one drug.

Drugs 55

Drugs FDA Approval Medicine Containment 55

pharmaphorum

FEBRUARY 22, 2021

Bluebird Bio’s decision to hit pause on the launch of Zynteglo for beta thalassaemia after two cases of cancer were seen in a clinical trial could see fears over the safety of viral vectors used to deliver gene therapies resurface. . million in Europe.

Gene Therapy 52

Gene Therapy Gene Gene Sequencing Gene Expression 52

pharmaphorum

AUGUST 25, 2022

Johnson & Johnson has its first worldwide regulatory approval – in the EU – for Tecvayli, one of two much-anticipated bispecific antibodies the drugmaker has developed for patients with multiple myeloma. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

Antibody 98

Antibody Marketing Drugs Medicine 98

pharmaphorum

JUNE 12, 2022

The panel voted 13 to 0 on the question of whether beti-cel’s benefits outweighed the risks of the gene therapy in patients with beta thalassaemia who are dependent on blood transfusions, in a dream result for the biotech which just a few weeks ago was expressing doubts about its ability to continue as an operating concern.

Gene Therapy 59

Gene Therapy Gene Marketing Trials 59

pharmaphorum

JANUARY 5, 2021

The FDA’s breakthrough status is for tiragolumab plus Tecentriq is the first for a TIGIT drug, and covers the first-line treatment of patients with advanced-stage non-small cell lung cancer (NSCLC) that expresses high levels of PD-L1. The post Roche nabs breakthrough tag for TIGIT cancer immunotherapy appeared first on.

Immune Response 52

Immune Response FDA Approval Drugs Sales 52

The Pharma Data

OCTOBER 21, 2020

21, 2020 — A combination of two “targeted” therapies can beat back a rare form of blood cancer — without the toxic effects of chemotherapy, a new study has found. And at 18 months, 95% of patients were still alive. It is already approved in the United States for certain ALL patients. WEDNESDAY, Oct.

Drugs 52

Drugs Genetics Trials Research 52

The Pharma Data

OCTOBER 21, 2020

21, 2020 — A combination of two “targeted” therapies can beat back a rare form of blood cancer — without the toxic effects of chemotherapy, a new study has found. And at 18 months, 95% of patients were still alive. It is already approved in the United States for certain ALL patients. WEDNESDAY, Oct.

Drugs 52

Drugs Genetics Trials Research 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. In the MagnetisMM-3 trial, elranatamab was associated with an ORR of 60.6%

Antibody 52

Antibody Medicine Drugs Trials 52

Rethinking Clinical Trials

OCTOBER 26, 2023

Untreated, chronic Hepatitis C infection leads to liver damage, liver cancer, and death. Many people do not know they have Hepatitis C (about 40% of patients). Rates are the highest among 20-39-year-olds. There is now a cure for Hepatitis C, but many people are not able to access it.

Clinical Research 143

Clinical Research Clinical Trials Clinical Trials Research 143

pharmaphorum

OCTOBER 29, 2021

Take two recently-approved immunotherapies for triple negative breast cancer (TNBC), put them together, and what do you get? “This helps further our ambition of displacing chemotherapy with Trodelvy to improve outcomes for people living with cancer,” said Gilead’s chief medical officer Merdad Parsey.

Trials 52

Trials Sales FDA Approval Production 52

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. After 24 weeks, 21.8%

Sales 52

Sales Trials Drugs Antibody 52

The Pharma Data

AUGUST 18, 2020

The main focus of the deal is Dragonfly’s monovalent IL-12 immunoglobulin Fc fusion protein known as DF6002, which the company has been investigating in the treatment of both solid and blood cancers.

Protein 52

Protein Sales Drugs 52

Delveinsight

FEBRUARY 9, 2021

Deerfield and Dana-Farber Establish Links in USD 130 Million Cancer Research Deal. Deerfield Management has entered into a research agreement with Dana-Farber Cancer Institute to fuel the development of therapeutics and diagnostics for cancer. Breyanzi, BMS’ Blood Cancer CAR-T Therapy Receives FDA Nod.

FDA Approval 52

FDA Approval Marketing Research Protein 52

Delveinsight

FEBRUARY 25, 2021

GRAIL and Quest collaborate for the cancer blood test. Cancer detection company GRAIL has announced a collaboration with Quest Diagnostics that sees Quest proffering phlebotomy services to bolster GRAIL’s multi-cancer early detection blood test Galleri. Brain organoids grown in the lab mimic infant’s brains.

DNA 52

DNA In-Vivo Genetics Medicine 52

XTalks

OCTOBER 26, 2021

The Phase III trial results show that Givlaari offers sustainable benefit to AIP patients and confirm its favorable safety profile. The treatment came with an initial price tag of $39,000 per vial, which amounts to a total of $575,00 each year. This is a huge development for patients.”. AHP affects 1 in 100,000 people in Europe.

Gene Silencing 98

Gene Silencing Gene Clinical Trials Clinical Trials 98

Drug Discovery World

JUNE 14, 2023

At the American Association of Cancer Research’s Annual Meeting in Orlando, Florida, DDW’s Megan Thomas met with industry experts to learn more about their research and careers in the field of cancer research. Thomas speaks with Andreas Bader, Chief Scientific Officer at Triumvira Immunologics.

Research 52

Research Engineer In-Vivo Production 52

pharmaphorum

AUGUST 18, 2022

bluebird bio’s Zynteglo has become the first cell-based gene therapy to be approved in the US, getting the nod from the FDA as a treatment for patients with beta thalassaemia who require regular blood transfusions. An FDA advisory committee recommended approval of Zynteglo on the strength of that data in June.

Gene Therapy 52

Gene Therapy FDA Approval Gene Clinical Trials 52

Drug Discovery World

MAY 22, 2023

But are these price tags a barrier to access? Its subsequent success with approval in the US shows us that some drugs will be unavailable to some markets and patients for now. The fact remains that the science behind the drugs is sound, there is direct patient need, and the medical benefits are pertinent. million per dose.

Gene Therapy 52

Gene Therapy Gene Drugs Contamination 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. Despite the feedback, the platform showed improvements in some ALS patients, and it presents a positive picture.

In-Vitro 52

In-Vitro Vaccination Vaccine Licensing 52

pharmaphorum

JANUARY 21, 2022

“It has become clear that the medicines of the 20 th century, the so-called blockbuster era, are gradually being replaced by drugs designed for smaller groups, specific indication, and even for individual patients,” said Jo De C**k, CEO of Belgium’s National Institute for Health and Disability Insurance. WHO is OMI?

Medicine 52

Medicine Marketing Manufacturing Production 52

XTalks

AUGUST 17, 2020

To learn more about innovations in the field, Xtalks spoke to Anish Suri, PhD, president and chief scientific officer of Cue Biopharma about the company’s initiatives in the development of immune-based biological compounds for the treatment of cancers and autoimmune diseases. Cell-Based Immunotherapy vs. Immune Biologics. asks Dr. Suri.

Protein 98

Protein Engineer Immune Response In-Vivo 98

XTalks

OCTOBER 12, 2022

Features of blood perfusion in the brain detected by MRI now have clinical applications in central nervous system (CNS) cancers, neurodegenerative disease, cerebrovascular disease and demyelinating disease. Each patient is represented as one data point. Figure from Liu et al., 2005 , courtesy of article co-author Edward Ashton, PhD.

Clinical Trials 93

Clinical Trials Clinical Trials Trials Drugs 93

Rethinking Clinical Trials

MARCH 21, 2023

Goldberg Distinguished Professor and Chief of Oncology Physician-in-Chief, North Carolina Cancer Hospital Director, Cancer Outcomes Research Program University of North Carolina Slides Keywords Patient-reported outcomes, Oncology, Clinical Trials Key Points Symptoms are common in cancer care.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

The Pharma Data

OCTOBER 9, 2021

This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies.

Antibody 52

Antibody In-Vitro Trials Development 52

Delveinsight

JULY 22, 2020

Today the tech-based healthcare industry is providing many unique solutions to the patient’s care which are more efficient and effective than the traditional services. IoT relies on the data collected from devices and provides valuable insights that help in providing the best possible healthcare solution to the patient.

Doctors 59

Doctors Doctor Marketing Production 59