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 111

Drugs FDA Approval Trials Marketing 111

World of DTC Marketing

SEPTEMBER 24, 2021

Then, against the advisory panel’s advice, Aduhelm was approved, but insiders within the industry criticized both the FDA and Biogen weren’t sold on the drug or its price tag. 2wo: The new CEO needs to withdraw Aduhelm from the market until such a time that they have independent data that confirms efficacy.

Drugs 222

Drugs Pharma Companies Doctors Doctor 222

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

Rethinking Clinical Trials

NOVEMBER 1, 2022

The first trial undertaken by the HERO Program, HERO-HCQ, evaluated the efficacy of hydroxychloroquine (HCQ) to prevent COVID-19 in healthcare workers. Important issues early on included COVID-19’s effects on the workplace, vaccine access and willingness, and impact on home life. Over 1300 participants were recruited from the HERO Registry.

Trials 130

Trials Clinical Research Vaccination Vaccine 130

pharmaphorum

JANUARY 5, 2022

The FDA reserves breakthrough therapy status for therapies that could represent a significant improvement over standard of care – in this case platinum-based chemotherapy – in either efficacy, safety, or both. The post FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag appeared first on.

Antibody 111

Antibody Drugs Protein Gene 111

Rethinking Clinical Trials

DECEMBER 20, 2023

Diversity in clinical trials is important for generalizability of results, to provide equal opportunities, practice precision medicine, tailor practical guidelines, improve public health outcomes, detect potential differences in safety and efficacy, and to address health disparities. We need to think about removing some of this and evaluate.

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Clinical Trials Clinical Trials Trials Cardiology 169

Pharmaceutical Technology

FEBRUARY 10, 2023

This is not the first treatment to come with a high price tag. Access to oncology medicines varies across countries, and their cost against safety/efficacy is generally perceived as being low, such as in the US. million, according to GlobalData’s Price Intelligence (POLI), making it the most expensive drug in the world.

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Gene Therapy Marketing Gene Drugs 263

Rethinking Clinical Trials

JULY 22, 2022

Six agents showed really good results and either changed clinical practice or showed efficacy and improved patient care. The team reviewed 800 candidates over 2 years time. We selected 35 and completed testing of 27 of them. Five agents are still in testing. Each protocol has had many lessons learned. pctGR, @Collaboratory1.

Vaccination 130

Vaccination Vaccine Clinical Trials Clinical Trials 130

pharmaphorum

OCTOBER 3, 2022

Chief medical officer at the independent drug pricing watchdog, Institute for Clinical and Economic Review (ICER), David Rind said Relyvrio should have been priced closer to the cost of production until there is clear proof about its efficacy. The post Amylyx ALS drug draws criticism over $158,000 price tag appeared first on.

Drugs 52

Drugs Generic Drugs FDA Approval Trials 52

Rethinking Clinical Trials

MARCH 6, 2024

There were also surveys to assess program education, diet, a self-efficacy questionnaire, and a self-assessed physical and mental health questionnaire at 0, 6, and 12 months. Lab results for HbA1c, cholesterol, triglycerides, blood pressure, weight were taken at 0, 6 and 12 months. From a researcher standpoint, we need more information.

Clinical Trials 141

Clinical Trials Clinical Trials Medicine Trials 141

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).

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Drugs Antibody Clinical Trials Clinical Trials 72

pharmaphorum

OCTOBER 21, 2021

Vounatsos also insisted that Aduhelm’s price tag has not been a factor discouraging treatment with the drug. Many are still predicting multibillion-dollar sales for the drug, albeit with a longer runway, despite reservations about its clinical efficacy among doctors and payers.

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Sales Doctors Doctor Gene Therapy 122

Rethinking Clinical Trials

SEPTEMBER 13, 2023

After enrolling patients for 8 months, the data safety board recommended trial enrollment stop because the prespecified stopping criteria for efficacy had been met. Nearly 2,000 patients were assessed for eligibility and 1,417 patients were enrolled. Successful intubation on the first attempt occurred in 85.1%

Trials 141

Trials Clinical Trials Clinical Trials Medicine 141

Rethinking Clinical Trials

FEBRUARY 28, 2024

Was there complete ascertainment of primary and secondary efficacy data? Tags #pctGR, @Collaboratory1 The post Grand Rounds February 23, 2024: Virtual Vigilance: Monitoring of Decentralized Clinical Trials (Adrian Hernandez, MD; Christopher J. Did participants receive the assigned treatment and did they stay on the treatment?

Clinical Trials 141

Clinical Trials Clinical Trials Trials Clinical Research 141

Pharmaceutical Technology

JULY 14, 2022

The commercial investment required to research and develop an innovative drug, prove its safety and efficacy, and bring it to market is staggering. These countries will have a smaller patient pool due to population size and will likely carry a price tag that is significantly below that of higher GDP countries.”.

Drugs 147

Drugs Medicine Marketing Development 147

Pharmaceutical Technology

APRIL 13, 2023

Although the findings in the report are only preliminary, they shed light at the considerations behind the high price tags of gene therapies. Sickle cell disease is an inherited blood disorder that is caused by mutations in the HBB gene, which codes for the oxygen-carrying protein haemoglobin in red blood cells.

Gene Therapy 147

Gene Therapy Gene FDA Approval Licensing 147

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. About Trimer-Tag© Technology.

Vaccination 52

Vaccination Vaccine Trials Protein 52

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. .

Protein 52

Protein Sales Drugs 52

Drug Discovery World

JANUARY 9, 2023

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. . This dual-action cell therapy was safe, applicable, and efficacious in these models. .

Scientist 52

Scientist Gene Editing Gene Engineer 52

The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. CHENGDU, China , Feb.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

pharmaphorum

AUGUST 25, 2022

J&J’s first-mover advantage is likely to translate into a market-leading position unless newer drugs can show a significant advantage in safety or efficacy, according to GlobalData, which says the new drug will probably encroach on some of the CAR-T therapies’ territory.

Antibody 98

Antibody Marketing Drugs Medicine 98

World of DTC Marketing

JUNE 23, 2021

I always thought if there were questions about efficacy or treatment, we should be overly cautious and inform our customers (patients). Not to mention the $56,000 annual price tag. When I didn’t understand something, I went to the medical people on the team to gain insights.

Drugs 218

Drugs FDA Approval Doctors Doctor 218

pharmaphorum

AUGUST 21, 2022

There’s no word yet on its pricing, but for comparison Spravato was launched with an annual price tag of around $32,400, which the Institute for Clinical and Economic Review (ICER) concluded was around 25% to 52% too high to be cost effective.

Drugs 98

Drugs FDA Approval Production Marketing 98

pharmaphorum

JUNE 12, 2022

Beti-cel has already been approved for marketing in Europe as Zynteglo, with a price tag of around $1.8 million price tag, saying its ability to help patients reach sustained transfusion independence justified its high price. Eli-cel was also previously approved in Europe as Skysona.

Gene Therapy 59

Gene Therapy Gene Marketing Trials 59

The Pharma Data

DECEMBER 3, 2020

A global Phase 2/3 efficacy study of the S-Trimer vaccine candidate in combination with GSK’s pandemic adjuvant system is expected to begin in December 2020. 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.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

pharmaphorum

DECEMBER 12, 2022

She told ASH that current therapies for ITP have limitations, including tolerability issues, lacklustre efficacy and a short duration of effect, as well as having a limited impact on quality of life.

Sales 52

Sales Trials Drugs Antibody 52

pharmaphorum

NOVEMBER 19, 2020

Because Roche has never applied for Avastin to be used in wet AMD, clinics in the US have had to choose between the peace of mind offered by the regulatory process and Lucentis’ higher price tag, or the unapproved off-label formulation of Avastin at a lower price.

FDA Approval 64

FDA Approval Marketing Drugs Clinical Development 64

XTalks

DECEMBER 13, 2023

Related: Roctavian Becomes First Gene Therapy for Severe Hemophilia A to Get FDA Nod Casgevy and Lyfgenia Pricing and Warnings The price tags of both gene therapies are steep, given the complexity of developing gene therapies and as therapies meant to be one-time treatments. million, despite both having similar efficacy.

Gene Therapy 98

Gene Therapy FDA Approval Gene In-Vivo 98

XTalks

APRIL 18, 2024

The drug is currently facing a regulatory hiccup as the FDA wants to convene an advisory committee meeting to further discuss issues about its safety and efficacy based on Phase II trial results. Alongside its partnership with Roche on diagnostics, Lilly is also developing an amyloid beta therapy of its own, donanemab.

Clinical Trials 52

Clinical Trials Clinical Trials In-Vitro Protein 52

pharmaphorum

DECEMBER 23, 2022

But along with strong efficacy come some considerable risks and costs: cytokine release syndrome (CRS), where a patient’s immune system becomes dangerously over-stimulated, and neurotoxicity are potential side effects that need to be managed.

Development 52

Development Drugs Clinical Development Antibody 52

pharmaphorum

JANUARY 31, 2023

Another factor that impacts trust in pharmaceutical companies is the discrepancy between the efficacy of medications in controlled clinical trials and their effectiveness in real-world use. Given the high price tags placed on many medications, it’s easy to understand why patients often feel that they are being taken advantage of.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Vaccination 52

pharmaphorum

JUNE 8, 2021

” “FDA approval closes the door on further placebo-controlled trials of aducanumab that might have helped to resolve disputes about efficacy quickly and cleanly,” he added. Though good luck taking the drug off the market if future data doesn't support the its efficacy.

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Drugs Marketing FDA Approval Trials 98

pharmaphorum

DECEMBER 17, 2021

Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

Trials 52

Trials Sales Marketing FDA Approval 52

XTalks

OCTOBER 26, 2021

The treatment came with an initial price tag of $39,000 per vial, which amounts to a total of $575,00 each year. NICE provides health guidelines based on evidence-based assessments of efficacy and safety, and also serves as England’s drug price watchdog.

Gene Silencing 98

Gene Silencing Gene Clinical Trials Clinical Trials 98

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. Moreover, Clover plans to initiate a global phase II/III efficacy trial for SCB-2019 (S-Trimer), its COVID-19 vaccine candidate, in the first half of 2021.

In-Vitro 52

In-Vitro Vaccination Vaccine Licensing 52

XTalks

JUNE 9, 2021

Aducanumab Controversy and Price Tag. Evidence for aducanumab’s efficacy has been highly contested. As a drug with “borderline efficacy,” the price is “taking advantage of the weak US pricing scheme,” he said. Clinical Evidence.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

pharmaphorum

MAY 17, 2021

C5 inhibitor Soliris – which has a list price in the US of more than $500,000 per year – has been a standard therapy for the rare disorder since 2007, and was joined on the market by longer-acting follow-up Ultomiris in 2018 which launched with a price tag of around $450,000 per year. billion and $1.1

Drugs 52

Drugs FDA Approval Marketing Clinical Trials 52