pharmaphorum

NOVEMBER 16, 2021

The cost-effectiveness agency has backed Ontozry (cenobamate) as an option for treating focal onset seizures with or without secondary generalised seizures in adults with drug-resistant epilepsy that has not been adequately controlled with at least two prior antiseizure medicines.

Drugs 98

Drugs Medicine Clinical Trials Clinical Trials 98

XTalks

JUNE 28, 2023

The approval is restricted to ambulatory patients within this narrow age range due to uncertainty around its effectiveness in older children, which Sarepta hopes to clarify in a confirmatory trial. million price tag of Elevidys, a one-time gene therapy. He said an analysis suggested that the drug could be cost-effective at $5 million.

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Gene Therapy Gene Protein FDA Approval 98

World of DTC Marketing

JUNE 23, 2021

What’s more, 40 percent of those subjects suffered side effects, including severe brain swelling. Not to mention the $56,000 annual price tag. While it’s not clear that Aduhelm actually slows down Alzheimer’s, there was “convincing evidence” that it had a “robust” effect on amyloid plaques.

Drugs 218

Drugs FDA Approval Doctors Doctor 218

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. That could that patients would be able to administer their own injections instead of having to go to a healthcare facility every week or two.

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Sales Trials Drugs Antibody 52

pharmaphorum

APRIL 14, 2022

US cost-effectiveness watchdog ICER has handed bluebird bio some good news ahead of its FDA advisory committee meeting for rare blood disorder gene therapy beti-cel in June, by endorsing its proposed $2.1 million price tag. gene therapy is cost-effective appeared first on. The post ICER says bluebird bio’s $2.1m

Gene Therapy 64

Gene Therapy Gene Marketing Clinical Trials 64

pharmaphorum

JANUARY 31, 2023

Additionally, when patients are prescribed medication, they are often unaware of the mechanism of action, potential side effects, interactions, and contraindications. There are many reasons for patient non-adherence, including high medication costs, fear of potential side-effects, and forgetfulness, amongst others.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Vaccination 52

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. Vertex-CRISPR’s Casgevy has a US list price of $2.2

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Gene Therapy FDA Approval Gene In-Vivo 98

pharmaphorum

JUNE 8, 2021

ICER argues that Aduhelm was effectively approved on the strength of a biomarker – removing amyloid from the brain – rather than clinical outcomes, which is “puzzling” as other drugs have been shown to remove amyloid from the brain yet failed to help patients. — Dr. Patrizia Cavazzoni (@FDACDERDirector) June 7, 2021.

Drugs 98

Drugs Marketing FDA Approval Trials 98

pharmaphorum

JANUARY 11, 2022

Blue Note said the new status recognised the potential of BNT200 for the thousands of patients diagnosed with AML every year in the US who can find it challenging to cope with both the symptoms of the cancer and the debilitating side effects of treatment. The post Blue Note leukaemia DTx gets FDA breakthrough tag appeared first on.

Development 64

Development Production Drugs 64

pharmaphorum

APRIL 27, 2022

Last year, sales were $426 million, more than double the amount made in the previous year, on expanded indications and more confidence among physicians in the use of the drug, which can have serious side effects. The post Enhertu gets breakthrough tag in HER2-low breast cancer appeared first on.

Sales 59

Sales Drugs Antibody Licensing 59

pharmaphorum

JANUARY 11, 2021

Laying out the rationale for the spin-off, bluebird said that operating individually the two companies will be more effective at allocating capital. million price tag. The FDA is now due to make a decision on ide-cel as a treatment for multiple myeloma in late March.

Gene Therapy 66

Gene Therapy Gene Genetic Disease Manufacturing 66

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.” This is why the treatment can only be administered at an ATC with inpatient hospitalization, as patients must be monitored for side effects.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

pharmaphorum

SEPTEMBER 15, 2020

“Digitally native brands are typically agile businesses from the ground up, and agility and flexibility are part of their core makeup,” says Joe Holmes, vice president, marketing services, US at Tag. As part of this, a number of big pharma companies are also racing to develop a safe and effective vaccine for the coronavirus.

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Branding Marketing Pharma Companies Life Science 130

XTalks

APRIL 6, 2021

Where flour, pasta and other shelf-stable goods once sat in abundance quickly emptied to nothing but price tags. Hoarding, which is on the demand side, and supply side issues with labor, factories and logistics. The supply side recovered quickly, but the demand spike continued for months,” Mikhail said.

Production 104

Production Sales Vaccination Vaccine 104

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

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

JUNE 9, 2021

Aducanumab Controversy and Price Tag. Among notable side effects of the drug include temporary swelling in areas of the brain, which is generally symptomless and related to amyloid-related imaging abnormalities (ARIA). Evidence for aducanumab’s efficacy has been highly contested.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

XTalks

AUGUST 23, 2021

This approval also had an effect on the types of patients included in trials and changed the way in which outcomes were measured. Non-inferiority designs carry the troubling risk of demonstrating that a new drug is as good as the standard therapy without showing that either is actually effective,” warned Grill.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Drugs 52

pharmaphorum

NOVEMBER 16, 2022

The advancements made in drug development over the last decade have seen the arrival of a number of treatments that offer one-time cures and more effective therapies for conditions in smaller patient populations. However, with a price tag of €1.58 At more than $2.1

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Gene Therapy Gene Marketing Development 131

XTalks

APRIL 29, 2022

Obesity is a chronic disease that requires effective treatment options, and Lilly is working relentlessly to support people with obesity and modernize how this disease is approached. The medium-dose group (10 mg) had the most participants that dropped out (seven percent) due to side effects. billion in 2020 to $5.42 percent.

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

XTalks

AUGUST 17, 2020

Immune-based interventions can either amplify the immune system or suppress it, depending on the desired effect. However, issues of off-target effects and toxicities associated with cytokine release syndrome (the excessive or overproduction of cytokines from activated immune cells) have presented to be challenges for the therapies.

Protein 98

Protein Engineer Immune Response In-Vivo 98

Rethinking Clinical Trials

MARCH 21, 2023

Compared to standard care, 31% more patients in the self-reporting arm experienced QOL benefits; 7% fewer patients in self-reporting arm visited the ER with durable effects throughout the study; and median survival was 5.2 Quality of life (QOL) was assessed at 6 months. months longer among patients in the self-reporting arm.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

pharmaphorum

DECEMBER 2, 2020

Formulated initially at the Sandwich site in the UK as an anti-hypertensive, it was found have “unexpected” side effects that made the company rapidly change the indication to erectile dysfunction. For all the latest Pfizer news follow pharmaphorum’s Pfizer tag. The post A history of Pfizer appeared first on.

Sales 128

Sales Production Drugs Marketing 128

XTalks

JANUARY 19, 2024

There is a small but real risk of extravasation as well as a known systemic effect with intravenous administration. For example, non-target effects such as the release of damaged DNA into the cytoplasm of irradiated cells can lead to the activation of immune cells.

DNA 66

DNA Radiology FDA Approval Development 66

pharmaphorum

JUNE 15, 2021

The adoption of New Science – a unique combination of the best in science and health technology that address significant unmet patient needs – is delivering more precise and effective treatments, but often at a higher price tag, according to new research. A new economic reality is challenging profitability . billion and $6.7

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Clinical Trials Clinical Trials Development Marketing 90

pharmaphorum

NOVEMBER 19, 2021

Indeed, the price tags for Pfizer’s and Moderna’s jabs are substantial. This also comes in the wake of manufacturing and side effect issues. The market potential for any vaccine currently in trials is lower because the only markets really are the developing countries, which can’t pay the same prices.”.

Sales 137

Sales Vaccination Vaccine Marketing 137

XTalks

DECEMBER 21, 2022

As the world continues to experience the effects and aftermath of the COVID-19 pandemic, lessons learned from the biggest global health crisis in recent times spurred changes and adaptations in the life sciences and healthcare. On the medical device side, devices are offering patients greater options to personalize their care.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

Drug Discovery World

FEBRUARY 21, 2023

Less is more, and a centralised location for information helps users get up to speed faster and be more effective at their roles.” Focusing on the instrumentation and software side of things, he says: “There are so many tools to accomplish the same outcomes that it becomes a challenge to string together the right software tools and workflows.

Scientist 52

Scientist Gene Editing Engineer Bioinformatics 52

XTalks

FEBRUARY 11, 2021

Around the time of Franklin’s departure, the story goes that Watson went to Wilkins who sided with him and ended up showing him the coveted “Photo 51” that had been taken by Franklin and Gosling. She did write up three manuscripts on her findings before leaving. Emmanuelle Charpentier.

Genetics 119

Genetics DNA Genome Genomics 119

The Pharma Data

MAY 5, 2021

New Scottish Agency Would Ensure Supply Of Cost-Effective Drugs ( Pink Sheet ). Nasal spray shown to be effective in reducing COVID-19 transmission ( EPR ). The weird science of the placebo effect keeps getting more interesting ( Vox ). Coronavirus Pandemic. Medtech.

Vaccination 52

Vaccination Vaccine Gene Therapy Contract Packaging 52

Pharmaceutical Technology

NOVEMBER 30, 2022

In the past, obesity medications were often dismissed due to insufficient efficacy data and the fact that they were associated with a high occurrence of side effects. We’re using a combination of gut hormones to mimic the effectiveness of bariatric surgery. Evaluate the effects of COVID-19 on the sector. compared to a 5.1%

Drugs 264

Drugs Manufacturing Hormones Contract Manufacturing 264

Pharmaceutical Technology

NOVEMBER 30, 2022

In the past, obesity medications were often dismissed due to insufficient efficacy data and the fact that they were associated with a high occurrence of side effects. We’re using a combination of gut hormones to mimic the effectiveness of bariatric surgery. Evaluate the effects of COVID-19 on the sector. compared to a 5.1%

Drugs 246

Drugs Manufacturing Hormones Contract Manufacturing 246

Pharma Marketing Network

JUNE 8, 2020

Dave (HR): Yeah, I mean really everything we’re doing you know is about overturning the devastating effects of the status quo health plans. Well, to start, could you tell me a little bit about the Health Rosetta’s Mission and how you’re progressing towards that? So that individuals can realize their full potential.

HR 40

HR Marketing Doctors Doctor 40