Vicore’s lung disease digital therapy gets breakthrough tag
pharmaphorum
MARCH 20, 2024
Vicore gets FDA breakthrough status for Almee, a cognitive behavioural therapy (CBT) digital health therapy used to support people with pulmonary fibrosis
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pharmaphorum
MARCH 20, 2024
Vicore gets FDA breakthrough status for Almee, a cognitive behavioural therapy (CBT) digital health therapy used to support people with pulmonary fibrosis
pharmaphorum
APRIL 11, 2024
Roche and Eli Lilly have been granted breakthrough status by the FDA for their pTau217 blood test for Alzheimer's disease.
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pharmaphorum
MARCH 14, 2024
Cybin files a $150m placement on the back of new clinical data with its psychedelic drug CYB003 for depression and an FDA breakthrough designation.
pharmaphorum
MAY 23, 2023
Grünenthal’s non-opioid pain drug gets breakthrough tag Phil.Taylor Tue, 05/23/2023 - 08:20 Bookmark this
pharmaphorum
JANUARY 4, 2024
Digital health company Click Therapeutics has won an FDA breakthrough device designation for CT-155, a digital therapeutic (DTx) for the negative symptoms of schizophrenia, like social withdrawal and apathy, that tend not to respond well to antipsychotic drugs.
pharmaphorum
MARCH 8, 2024
In another inflection point for the psychedelic medicines category, Mind Medicine (MindMed) has claimed breakthrough status from the FDA for its LSD-based treatment candidate MM120 as a treatment for anxiety.
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. Preliminary results from that study showed a 53.8%
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.
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.
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. The post FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag appeared first on.
pharmaphorum
NOVEMBER 24, 2021
Digital health company Pear Therapeutics has won FDA breakthrough device status for reSET-A, its development-stage prescription digital therapeutic (DTx) for people with alcohol-use disorder. The post Pear claims breakthrough tag for alcohol use disorder DTx appeared first on. Photo by thom masat on Unsplash.
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. The post Roche nabs breakthrough tag for TIGIT cancer immunotherapy appeared first on.
BioSpace
NOVEMBER 7, 2023
Cell and gene therapy represents the most promising breakthrough in cancer treatment for decades, but it comes with a hefty price tag. Here’s how to drive costs down.
Pharmaceutical Technology
SEPTEMBER 30, 2022
Spark Therapeutics’ Luxturna, indicated for inherited retinal disease (IRD), was the first gene therapy to be approved, in 2017, with a price tag of $850,000 for each eye. Prior to bluebird's approvals, there were only two FDA-approved gene therapies for inherited conditions on the market.
BioSpace
OCTOBER 12, 2020
NASH is a metabolic disease similar to cirrhosis of the liver, but occurs in people who drink little, if any, alcoholic.
Pharmaceutical Technology
MAY 19, 2023
DMTs for MS have a high price tag, particularly in the US. The development and approval of safe and reliable curative therapies would be a major breakthrough in the treatment of MS, with considerable implications for patients’ financial circumstances and health-related quality of life.
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.
Drug Discovery World
JULY 25, 2023
DDW recently hosted Where are the breakthroughs in mRNA drug discovery and development? In this webinar, sponsored by Elegen, attendees learnt about the breakthroughs in mRNA drug discovery and development. We have shown that the excipient does not only work for our SNAP-tag lipid (SNaP) LNP, but also for the commercialised vaccines.
XTalks
APRIL 18, 2024
Roche has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 early Alzheimer’s blood test. 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).
pharmaphorum
AUGUST 25, 2022
Talquetamab has also shown promise in myeloma in the phase 1 MonumenTAL-1 study, which showed a 70% overall response rate (ORR) with the drug, and claimed a breakthrough designation from the FDA in June. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.
Rethinking Clinical Trials
MAY 10, 2023
Denny, MD, MS CEO, All of Us Research Program Slides Keywords Precision Medicine, All of Us Research Program Key Points The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. We are looking forward to supporting more.
XTalks
JANUARY 28, 2022
Immunocore received Breakthrough Device Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators. Kimmtrak has a price tag of $18,760 per vial, which amounts to a weekly dose.
pharmaphorum
AUGUST 21, 2022
Axsome’s drug was given a breakthrough designation from the FDA, reflecting the need for new treatment options in patients at increased risk of self harm or suicide, and was also given a priority review. However, it has a broader label as unlike J&J’s drug it is indicated for use in previously-untreated MDD.
The Pharma Data
MARCH 16, 2022
using SNAP-tag) involves labeling cell proteins with a fluorescent dye, thereby enabling researchers to observe how proteins interact in the living cell and where in the cell they are located. With Spirochrome, he commercialized fluorescent probes for cell biology, while with Covalys, he marketed SNAP-tag and other protein labeling methods.
pharmaphorum
JULY 25, 2022
Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA. Pfizer is hot on J&J’s heels with its BCMA and CD3 bispecific antibody elranatamab, and reported phase 2 data at ASCO this year in a similarly heavily pre-treated patient population.
Delveinsight
FEBRUARY 9, 2021
In the pharmaceutical and healthcare domain, where discoveries take ample time, and success rates are unpredictable, translational research helps in ensuring better and innovative discoveries that act as the fuel for revolutionizing breakthroughs in the domain. The funding will help to create and launch Riverway Discoveries.
Drug Discovery World
JUNE 14, 2023
We have now our lead product in a Phase I/II study, which is a HER-2 directed tag T cell product for patients with HER-2 positive solid tumours. You can even look at it in from a broader perspective of what is the next breakthrough in oncology. I’ve been with a company for more than five years now. AB: There have been many.
pharmaphorum
MAY 10, 2022
The FDA awarded a fast-track designation to lecanemab in December and has also given the drug breakthrough tag as a treatment for early-stage Alzheimer’s, and Biogen and Eisai will be hoping the drug can sidestep the controversy that engulfed Aduhelm from the moment it was approved.
XTalks
FEBRUARY 27, 2024
The accelerated approval of Amtagvi is the first step in realizing Iovance’s ambition to usher in the next generation of cell therapy by bringing this breakthrough to patients with advanced solid tumors,” said Frederick Vogt, PhD, JD, interim CEO and president of Iovance in a news release announcing the approval.
pharmaphorum
JANUARY 21, 2022
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.”. In recent years, revolutionary medicines have come with price tags to match, but this is simply a symptom of our current model.
Drug Discovery World
JANUARY 30, 2024
She said: “The emerging therapies of recent years, and the near future, have been long sought-after as breakthrough treatments for otherwise incurable diseases, which benefit millions globally yet are only attainable by a handful, in part because the onus of the dollar ultimately lands on the shoulders of the patient.
XTalks
SEPTEMBER 27, 2022
The record-breaking price tag of Skysona is not surprising for one-time gene therapies like it. The price tag reflects “the clinical benefit [it] provides as an urgently needed treatment option to slow the progression of neurologic dysfunction in children impacted by progressive, irreversible and fatal rare disease,” Obenshain added.
XTalks
AUGUST 23, 2021
And, in fact, Grill maintains that there is still a place for placebo-controlled trials in the post-aducanumab approval Alzheimer’s space, namely in breakthrough trials and in those that recruit patients who fail to respond to the approved therapy or decide not to take it for safety reasons.
XTalks
FEBRUARY 27, 2024
Despite high price tags of a couple of million dollars, gene therapy makers say they are working to ensure patients are able to access the treatments through patient assistance programs developed in conjunction with the support of governments. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.
XTalks
AUGUST 17, 2020
This is where the core insights for Cue came in, in terms of the breakthrough on which the company’s platform is built, explains Dr. Suri. Nature by Design. The beauty with Neo-STAT is that you can make the entire [HLA-based] scaffold along with the IL-2 elements for cancer immunotherapy without a peptide.
Drug Discovery World
FEBRUARY 21, 2023
Breakthroughs in synthetic biology Pillai explains that in recent years, there have been significant improvements to the gene editing space within the synthetic biology sector. How can you track and tag information so that when someone looks at it a week later or three years later, the data still makes sense?”
Intouch Solutions
JULY 27, 2021
The majority of new products coming to market are specialty drugs targeting rare diseases and new breakthrough approaches to cancer treatment – but innovation comes with large price tags. Drug pricing is not going to disappear from legislators’ desks, and even big-business-friendly politicians have pharma in their sights.
Drug Discovery World
FEBRUARY 9, 2023
One thing is for certain, as an industry we have always overcome new challenges that potentially stand in the way of finding breakthroughs. It also carries a much higher price tag for failure. How and where we apply that advantage is crucial to finding new breakthroughs. We have the tools at our disposal to meet this challenge.
XTalks
JANUARY 19, 2024
Omer Nawaz, PhD, Molecular Imaging Director of an emerging biotech, and Michael Lamba, PhD, DABR, Academic Medical Physicist, explored recent breakthroughs in radiotherapy. Anderson, PharmD, PhD, Radiation Clinical Pharmacologist, A. There is also potential for using several radiotherapies in combination therapies.
Drug Discovery World
OCTOBER 21, 2022
A major breakthrough in the technology was the development of biologically active fluorescent reagents that could be detected by the instruments. The main principle involves a well-defined light source such as that produced by lasers that excites fluorescent tags bound to the cells or particles present in a sample.
The Pharma Data
MAY 15, 2021
Whenever our team comes upon a new natural breakthrough from miltary and defense experts, you’ll be the first to know about it. Web Beacons are tags that can monitor the behavior of a user visiting the Website or sending an e-mail. We’ll tell you what to do, how to do it and for how long so you can reap the full reward.
The Pharma Data
MAY 5, 2021
AbbVie’s Humira regains top pharma TV spender spot, while sibling brands Rinvoq and Skyrizi tag along ( Fierce ). AI, digital health feature in latest batch of FDA breakthrough device designations ( MedTech Dive ). Pfizer ups COVID-19 vaccine revenue estimates ( BioPharma Reporter ).
The Pharma Data
MAY 4, 2021
Each of these accomplishments further demonstrates our commitment to Pfizer’s purpose: Breakthroughs that change patients’ lives.”. Frank D’Amelio, Chief Financial Officer and Executive Vice President, Global Supply, stated: “I am very happy with the performance of all of our therapeutic areas this quarter. Amy Rose 212.733.7410.
Pharma Marketing Network
JUNE 8, 2020
I mean, you know, there has obviously been a lot of breakthrough biologics and different therapeutics like around cancers and things like that, that have high price tags because maybe they don’t have as big a market as you know, something’s wrong, you know blood pressure medication. Don (PMN): The specialty pharmacy.
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