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.

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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

MARCH 1, 2023

For the standard of care arm, treatment is determined by the treating investigator and participant, with the recommendation that the choice of drug is based on NCCN guidelines and dosing administration based on the participant’s previous therapy and disease. – What was the rationale for the choice of study treatments (i.e.,

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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.

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Pharmaceutical Technology

MAY 2, 2023

Immuno-oncology (IO) agents have transformed the cancer therapeutics landscape, driving long-term remissions in a subset of patients who historically had limited options. All currently approved CAR-Ts are autologous, with the patient’s T-cells being genetically engineered to target antigens expressed by the cancerous cells.

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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.

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Clinical Trials Clinical Trials Trials Research 130

pharmaphorum

JANUARY 11, 2022

It has since been joined by other products in the software as a medical device (SaaMD) category, including Pear Therapeutics’ alcohol-use disorder candidate Pear-009 and another Blue Note DTx, codenamed BNT001, which is also being tested for anxiety and depression in cancer patients.

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Rethinking Clinical Trials

OCTOBER 26, 2023

Untreated, chronic Hepatitis C infection leads to liver damage, liver cancer, and death. There is a lack of point-of-care diagnostics; it can take up to 3 steps to treatment initiation. There is high cost of treatment and insurance prior-authorization requirements.

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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.

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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.

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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. Salvage therapies after the failure of both treatments fare even worse, with a progression-free survival rate of around three months.

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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.

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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. Zynteglo’s hefty price tag of $2.8

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XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Up to 50 percent of patients will develop metastatic disease, mainly spreading to the liver, making treatment difficult and limited. The new treatment will thus help address the unmet need for the disease.

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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. It’s the first treatment for mUM in the EU, as well as the first BiTE drug to treat a solid tumour.

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XTalks

DECEMBER 13, 2023

The US Food and Drug Administration (FDA) has approved the first gene therapies for the treatment of sickle cell disease, approving two on the same day. Current treatments for sickle cell disease include blood transfusions but patients often have episodes of intense pain and an increased risk of stroke.

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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. The Advisory Group identified 47 different potential solutions to address the top barriers.

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Clinical Trials Clinical Trials Research Trials 152

pharmaphorum

JANUARY 24, 2022

IBM said the sell-off is tagged as “a clear next step” as it focuses on its platform-based hybrid cloud and artificial intelligence strategy, but it’s no secret that Watson Health has failed to live up to its early promise. .”

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World of DTC Marketing

DECEMBER 13, 2021

OPENING: American cancer patients spent more than $21 billion on their care in 2019. 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. What makes cancer such a financial killer?

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pharmaphorum

OCTOBER 29, 2021

Take two recently-approved immunotherapies for triple negative breast cancer (TNBC), put them together, and what do you get? Gilead is sponsoring the new study to see if adding Trodelvy can be an alternative chemo when added to Keytruda in the first-line treatment of advanced TNBC, in the hope of moving the ADC up the treatment pathway.

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XTalks

JANUARY 19, 2024

Radiobiological and Clinical Considerations from CRO and Emerging Biotech Radiopharmaceuticals are medicinal formulations containing radioisotopes that are used in the field of nuclear medicine primarily for the diagnosis and treatment of various diseases, particularly cancer.

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DNA Radiology FDA Approval Development 66

Pharmaceutical Technology

MAY 15, 2023

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence.

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Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. This approach remains logistically complex, which builds the desire for allogeneic treatments that can be manufactured from unrelated donors on a larger scale. We also have the challenge of delivery.

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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. 22 in the New England Journal of Medicine , could lead to an effective — and chemo-free — treatment for the cancer. WEDNESDAY, Oct.

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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. 22 in the New England Journal of Medicine , could lead to an effective — and chemo-free — treatment for the cancer. WEDNESDAY, Oct.

Drugs 52

Drugs Genetics Trials Research 52

XTalks

OCTOBER 26, 2021

After initial rejection from the National Institute for Health and Care Excellence (NICE) last year, the non-departmental public body of the Department of Health in England has now given the green light to the gene silencing treatment Givlaari (givosiran) for the treatment of the rare metabolic disorder, acute intermittent porphyria (AIP).

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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.

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Protein Sales Drugs 52

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.

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Immune Response FDA Approval Drugs Sales 52

pharmaphorum

JUNE 12, 2022

Cases of cancer associated with insertional mutagenesis, caused when the viral vectors used to deliver the gene therapy to host cells, have been seen with bluebird’s gene therapies but have been more apparent in trials involving its CALD and sickle cell disease candidates than beti-cel.

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XTalks

DECEMBER 21, 2022

Additionally, advanced technologies like artificial intelligence (AI) and the adoption of digital tools in healthcare are allowing for improved treatments and care, and powerful research insights. Some experts say the high cost of gene therapies is justified as many are single-dose treatments with curative intent.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 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.

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FDA Approval Marketing Research Protein 52

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.

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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. It is estimated there are around 1,500 people in the US who could be eligible for treatment with the therapy.

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Gene Therapy FDA Approval Gene Clinical Trials 52

pharmaphorum

JANUARY 11, 2021

While bluebird has conducted pioneering work in gene therapy for blood disorders and in cancer cell therapy, products have been delayed by issues with filing data for the FDA. The FDA is now due to make a decision on ide-cel as a treatment for multiple myeloma in late March. million price tag.

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Gene Therapy Gene Genetic Disease Manufacturing 61

XTalks

SEPTEMBER 27, 2022

Skysona received FDA approval for the treatment of the rare neurological disorder cerebral adrenoleukodystrophy (CALD). About half of patients who do not receive any treatment die within five years of symptom onset. The record-breaking price tag of Skysona is not surprising for one-time gene therapies like it.

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FDA Approval Gene Therapy Drugs Gene 52

pharmaphorum

JANUARY 21, 2022

Medical science is accelerating at a tremendous rate, leading to profound changes in the treatment landscape for many diseases over the last decade. “It This evolution is leading to additional health benefits and health gains, but they are accompanied by major concerns, as very high price tags raise questions about their affordability.”.

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pharmaphorum

DECEMBER 12, 2022

“This is exciting news because existing treatments fail to improve platelet counts for as many as 30% of adults with chronic ITP,” commented said Catherine Broome of Georgetown Lombardi Cancer Centre in Washington DC, the trial’s lead investigator. All told, 51.2%

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