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tag fda 
Pharmaceutical Technology
FEBRUARY 29, 2024
LUT014 is being investigated in an ongoing Phase II trial as a first-line treatment for EGFR inhibitor-induced acneiform rash, for which there is no approved drug.
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Fierce Pharma
NOVEMBER 23, 2022
price tag, CSL and uniQure's hemophilia B gene therapy crosses FDA finish line. Sporting a $3.5M Wed, 11/23/2022 - 10:10.
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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 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.
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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.
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Pharmaceutical Technology
OCTOBER 17, 2023
The Netherlands-based company’s treatment has been awarded the designation by the US FDA following a successful Phase I trial.
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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%
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Pharmaceutical Technology
JUNE 23, 2023
Sarepta will now need to complete a confirmatory trial to prove the therapy improves physical function and mobility.
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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. Last year, Biofourmis said its heart failure tool BiovitalsHF was the first DTx to be awarded breakthrough status by the FDA.
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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. The post FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag appeared first on.
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pharmaphorum
JUNE 8, 2021
The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. The post FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag appeared first on.
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BioTech 365
JULY 20, 2021
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Ardelyx stock craters as FDA slaps biotech with dreaded ‘deficiencies’ tag on kidney drug.Ardelyx stock craters as FDA slaps biotech with dreaded ‘deficiencies’ tag on kidney drug … Continue reading →
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BioSpace
NOVEMBER 21, 2023
Will the FDA follow suit? What can patients expect the price tag to be? CRISPR gene-editing has had its first ever approval in the UK.
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Pharmaceutical Technology
SEPTEMBER 30, 2022
After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September. They usually face resistance from insurers and may struggle to gain coverage at launch.
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Fierce Pharma
NOVEMBER 7, 2023
Two long-awaited treatments for sickle cell disease (SCD) are on the docket for FDA decisions next month. Two long-awaited treatments for sickle cell disease (SCD) are on the docket for FDA decisions next month. Vertex and CRISPR Therapeutics are up first with a Dec. |
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World of DTC Marketing
JUNE 1, 2021
SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Knopman, a Mayo Clinic neurologist who treats Alzheimer’s patients and is a member of the FDA advisory committee. If the drug is approved you can bet that it’s going to carry a huge price tag. Washington Post.
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Rethinking Clinical Trials
FEBRUARY 7, 2024
Winckler, RPh, Esq Chief Executive Officer Reagan-Udall Foundation for the FDA Slides Keywords U.S. Food and Drug Administration, FDA, Misinformation, Communication, Health Information Key Points U.S. The FDA can leverage more communications channels, messengers, and mediums to reach the public.
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STAT News
JANUARY 10, 2023
Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems.
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pharmaphorum
DECEMBER 24, 2021
Biogen and Eisai head towards the end of the year with some much-needed good news in their Alzheimer’s programmes, as the FDA awards a fast-track designation to lecanemab, their follow-up to recently approved Aduhelm. The post Biogen, Eisai Alzheimer’s drug lecanemab fast tracked by FDA appeared first on.
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Rethinking Clinical Trials
JUNE 29, 2022
Food and Drug Administration (FDA). Big data; Real-word evidence; Real-world data; 21st Century Cures Act; FDA Draft Guidance. With the 21st Century Cures Act of 2016, the FDA established a program to evaluate the potential use of real-world evidence to support new indications for drugs and satisfy post-approval study requirements.
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Pharmaceutical Technology
NOVEMBER 9, 2022
On November 7, the company announced that the FDA has scheduled a pre-licensure inspection of BioMarin’s manufacturing facility, and required the company to submit three-year Phase III Roctavian data in the approval application. Since its FDA approval in August 2022, the beta-thalassemia therapy was launched in the US with a $2.8
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Rethinking Clinical Trials
JULY 6, 2023
The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials. Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance.
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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. Casgevy’s approval by the FDA is momentous: it is the first CRISPR-based gene-editing therapy to be approved in the US. Both therapies will be available in early 2024.
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XTalks
AUGUST 31, 2022
In this episode, Ayesha discussed the FDA approval of Axsome Therapeutics’ rapid-acting oral treatment Auvelity for the treatment of major depressive disorder (MDD). Ayesha shared news about another significant FDA approval for a gene therapy to treat transfusion-dependent beta thalassemia. Bluebird’s $2.8M
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World of DTC Marketing
JUNE 23, 2021
One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. Biogen’s Aduhelm won FDA approval after discovering that some patients on higher dosages had displayed improvement of.39 Not to mention the $56,000 annual price tag.
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Rethinking Clinical Trials
SEPTEMBER 13, 2023
For the RSI trial the FDA regulations had not been updated yet. We discussed doing RSI under waiver, we asked FDA a question and FDA said it could only be conducted under EFIC. -If If most intubations in the U.S. For the novice operator, VL cut rate of failure on the first attempt from 50% to 20% (3 to 4 patients).
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XTalks
JUNE 28, 2023
Gene therapies for Duchenne muscular dystrophy (DMD) have been an area of intense research and Sarepta’s Elevidys is now the first one to be approved by the US Food and Drug Administration (FDA). The FDA approval came after several delays and a narrow advisory committee vote of eight to six in favor of the gene therapy’s risk-benefit profile.
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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. After an unstable period, they lost their CEO and some very good people who decided to abandon ship.
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pharmaphorum
OCTOBER 3, 2022
Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry. ALS affects over 30,000 people in the US.
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pharmaphorum
AUGUST 21, 2022
Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. The post Axsome bounces back as FDA clears depression drug appeared first on. Following after is AXS-12 (reboxetine) for narcolepsy, which could be filed in 2023.
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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. There are currently no FDA-authorized blood tests for detecting Alzheimer’s disease. However, the guidance doesn’t say whether it could serve as a study’s primary endpoint on its own.
Pharmaceutical Technology
JUNE 29, 2022
The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.
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Rethinking Clinical Trials
JULY 27, 2022
ACTIV-6 is testing medication doses approved by the FDA for other purposes, i.e., repurposed drugs. Participants test positive for COVID-19 with a FDA-authorized test, register from home, are randomized remotely, receive study medication through the central pharmacy, and follow instruction until their clinical symptoms improve.
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The Pharma Data
MAY 7, 2021
Johnson & Johnson COVID-19 Vaccinations Resume Following CDC and FDA Decision. Remarketing tags may not be associated with personally identifiable information or placed on pages related to sensitive categories. See more information and instructions on how to setup the tag on: [link] >. Skip to content. Learn More.
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Pharmaceutical Technology
FEBRUARY 10, 2023
On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 This is not the first treatment to come with a high price tag.
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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. A marketing application for teclistamab is also under review at the FDA, with a decision expected later this month or in early September.
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XTalks
NOVEMBER 3, 2022
Demand for Lilly’s GIP/GLP-1 receptor agonist Mounjaro is also rising because of high patient demand since the drug’s May 13 FDA approval and expanding insurance coverage. Related: Mounjaro (tirzepatide), Eli Lilly’s Highly Awaited Type 2 Diabetes Injection Gets FDA Nod. billion in sales in the third quarter of the year.
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XTalks
JULY 12, 2021
The US Food and Drug Administration’s (FDA) recent approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) was met with a lot of backlash, prompting the health agency to narrow its recommendation of the drug for mild forms of the disease. This would be a huge burden on Medicare, while private insurers would be shying away from it.
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pharmaphorum
JUNE 12, 2022
bluebird bio started last week on tenterhooks, as FDA advisors cast their eyes over data for two gene therapy candidates that are key to its future as a commercially viable concern. Beti-cel has already been approved for marketing in Europe as Zynteglo, with a price tag of around $1.8
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World of DTC Marketing
SEPTEMBER 7, 2022
In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. Wall Street wants growth, as do investors, but that may be impossible for pharmaceutical companies. Biogen’s failure should be a warning to other pharma companies. ” Why are the costs so high?
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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. 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.
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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.
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pharmaphorum
NOVEMBER 19, 2020
Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival.
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Rethinking Clinical Trials
MAY 25, 2023
The study required an FDA exemption because Aspirin is not approved for this indication. Tags #pctGR, @Collaboratory1 The post Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD) appeared first on Rethinking Clinical Trials.
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