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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FDA 117

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.

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FDA 113

pharmaphorum

MAY 23, 2023

Grünenthal’s non-opioid pain drug gets breakthrough tag Phil.Taylor Tue, 05/23/2023 - 08:20 Bookmark this

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Fierce Healthcare

DECEMBER 7, 2021

CMS to roll out 'birthing-friendly' hospital tag on Care Compare site. Tue, 12/07/2021 - 15:43.

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Hospitals 110

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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FDA 103

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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FDA 109

Pharmaceutical Technology

NOVEMBER 9, 2022

million price tag. The post Can gene therapies for haemophilia defend their high price tags? After its approval, bluebird had set Zynteglo’s price at roughly EUR1.6 million ($1.8 million at the time). Since its FDA approval in August 2022, the beta-thalassemia therapy was launched in the US with a $2.8

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FDA 111

Fierce Pharma

APRIL 29, 2024

The price tag includes both the approved cancer drug Qinlock and another Deciphera candidate heading to the FDA’s desk in the coming months.

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pharmaphorum

JANUARY 5, 2022

The post FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag appeared first on. Hutchmed’s drug is also being paired with Tagrisso and AZ’s PD-L1 blocker Imfinzi (durvalumab) in global registrational trials.

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FDA Chemotherapy 109

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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FDA 105

pharmaphorum

OCTOBER 3, 2022

Following news of Relyvrio’s $158,000 annual price tag, both ALS advocates and outside observers have voiced outrage at the cost. The post Amylyx ALS drug draws criticism over $158,000 price tag appeared first on. ALS affects over 30,000 people in the US. It can lead to progressive paralysis and death.

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Insurance FDA 52

Pharmaceutical Technology

FEBRUARY 12, 2024

The humanised monoclonal antibody DISC-3405 is under investigation in a Phase I clinical trial, with data expected this year.

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pharmaphorum

JANUARY 11, 2022

The post Blue Note leukaemia DTx gets FDA breakthrough tag appeared first on. In 2020, it formed an alliance with Memorial Sloan Kettering Cancer Centre in the US to develop an app that can be used by patients who are living in fear of their cancer, for example. Other DTxs are aimed at people being treated for breast and lung cancers.

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FDA Chemotherapy Hospitals 62

pharmaphorum

DECEMBER 23, 2021

The post FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag appeared first on. The Japanese drugmaker was originally developing patritumab as an antibody for NSCLC, but abandoned the drug after it showed little efficacy in mid-stage testing, pivoting to the ADC version.

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FDA Chemotherapy 70

Drug Topics

NOVEMBER 3, 2023

During a session at AMCP Nexus, presenters discussed the delicate balance between cost and innovation as it relates to forthcoming oncology treatments.

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Fierce Pharma

MARCH 20, 2024

After scoring an FDA nod Monday for the first gene therapy to treat the rare genetic disease metachromatic leukodystrophy (MLD) in the U.S., Kyowa Kirin and its subsidiary Orchard Therapeutics have | After scoring an FDA nod Monday for the first gene therapy to treat the rare genetic disease metachromatic leukodystrophy in the U.S.,

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FDA 109

pharmaphorum

APRIL 27, 2022

The post Enhertu gets breakthrough tag in HER2-low breast cancer appeared first on. .” AZ and Daiichi Sankyo have previously been awarded breakthrough designations for Enhertu as a treatment for second- and later-line therapy of HER2-positive breast cancer, as well as HER2-positive non-small cell lung cancer (NSCLC) and gastric cancer.

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Chemotherapy FDA 57

Fierce Healthcare

JUNE 9, 2023

Emerging Alzheimer’s disease medications come with high price tags, but researchers with the University of Chicago calculate that in the long run, it’s much less costly to cover these therapies for | Emerging Alzheimer’s medications come with high price tags, but researchers with the University of Chicago calculate that in the long run, it’s much less (..)

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pharmaphorum

MARCH 20, 2024

Orchard Therapeutics has revealed the US price of Lenmeldy, its gene therapy for rare disease MLD, placing a $4.25m price tag on the one-shot treatment

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pharmaphorum

NOVEMBER 24, 2021

The post Pear claims breakthrough tag for alcohol use disorder DTx appeared first on. The company – which is in the process of going public via a merger with special purpose acquisition company (SPAC) Thimble Point – has predicted it will make around $4 million from its DTx portfolio in full-year 2021. Photo by thom masat on Unsplash.

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FDA 57

Fierce Pharma

SEPTEMBER 22, 2023

Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break.

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pharmaphorum

JUNE 8, 2021

The post FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag appeared first on. GlobalData does see the approval of Aduhelm encouraging more research on combination therapies, for example with anti-tau drugs.

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STAT

MARCH 26, 2024

A price tag was not included in documents filed with the state, and Optum officials did not immediately respond to comment. On Tuesday, a subsidiary of Optum, Collaborative Care Holdings, LLC, filed notice with the state’s Health Policy Commission over the sale. Continue to STAT+ to read the full story…

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Hospitals Documentation Insurance 145

Med Ed 101

MAY 23, 2018

The F-Tags have been given a little facelift and renumbering. I’m a consultant pharmacist, so I’m going to focus on the changes in Pharmacy Services F-Tags. The pharmacy services F-Tags run between F755-F761. There are now seven possible pharmacy services F-Tags. I’ll […].

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pharmaphorum

OCTOBER 29, 2021

The post Gilead tags Merck for first-line triple negative breast cancer trial appeared first on. Analysts welcomed the performance but also noted it points to underlying weakness at the company. While its headline revenue of $7.4 billion was a healthy 13% rise, taking Veklury out of the equation would have resulted in a 3% decline.

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Chemotherapy FDA 52

Pharmaceutical Technology

OCTOBER 9, 2023

The FDA decision follows a similar designation for the vaccine UV1 against malignant melanoma in December 2021.

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Vaccines FDA 52

Med Ed 101

JUNE 4, 2017

The CMS F-tag, F-329 Unnecessary Medications tag is by far (in combination with F-428) the most common survey deficiency that a consultant pharmacist can help a facility avoid. The F-tags have been changed, get the update at LTCPHARMD.com – my […].

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Nursing Homes 40

Pharmaceutical Technology

JANUARY 31, 2024

The FDA has granted an orphan drug designation to Revolo’s ‘1104, with plans for a Phase IIb study later this year.

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FDA 52

Pharmacy Times

DECEMBER 12, 2022

Following the approval of cabotegravir in 2021, governments and donor agencies in low- and middle-income countries are contemplating replacing oral pre-exposure prophylaxis or augmenting the approach with long-acting treatment.

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Fierce Pharma

JULY 14, 2023

The potentially curative promise of gene therapies often carries a steep price tag. | The potentially curative promise of gene therapies often carries a steep price tag. But for a pair of personalized medicine prospects in sickle cell disease (SCD), the cost could be worth it, at least as far as ICER is concerned.

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Pharmaceutical Technology

APRIL 25, 2024

A Senate Committee is investigating the “outrageously high” US price tags of the blockbuster diabetes and obesity drugs.

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Pharmacy Times

APRIL 17, 2023

Although payers have become somewhat accustomed to the high cost of specialty drugs, the price tags for gene therapies are causing “sticker shock.”

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Pharmaceutical Technology

FEBRUARY 22, 2024

Harmony is advancing pitolisant into a Phase III clinical trial that is expected to start in Q1 2024.

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STAT

APRIL 12, 2024

Often, these treatments — which target small patient populations of 200,000 or less people — carry high price tags, which the pharmaceutical industry argues simply reflects large investments for testing and development. Continue to STAT+ to read the full story…

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Pharmaceutical Commerce

MARCH 6, 2024

Navigating the complex landscape of healthcare coverage can be an intimidating task, especially for patients with rare diseases for which treatments often come with a high price tag.

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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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FDA 52

Pharmaceutical Technology

NOVEMBER 20, 2023

NeoImmuneTech is developing NT-17, an IL-7 treatment, to promote rapid T-cell recovery in patients with acute radiation syndrome.

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