PharmaShots

JANUARY 27, 2023

Magenta Therapeutics Pauses the P-I/II Study in AML Patients Date: Jan 27, 2023 | Tags: Magenta Therapeutics, MGTA-117, AML, Clinical Trial, P-I/II Ipsen Receives CHMP Negative Opinion for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva Date: Jan 27, 2023 | Tags: Ipsen, Palovarotene, Fibrodysplasia Ossificans Progressiva, Regulatory, CHMP, (..)

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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. HER3 is expressed in more than 80% of EGFR-mutant NSCLC, and overexpression is associated with poor outcomes, but no HER3-targeted drugs have been approved to date.

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pharmaphorum

DECEMBER 12, 2022

Updated results from the ADVANCE IV study of Vyvgart (efgartigimod alfa) showed that more than half of patients with ITP treated with Argenx’ drug showed an improvement in platelet counts, which are dramatically reduced in the disorder. After 24 weeks, 21.8%

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pharmaphorum

MARCH 23, 2022

Argenx only recently scored FDA approval for its intravenous anti-neonatal FC receptor (FcRn) antibody Vyvgart for generalised myasthenia gravis (gMG), but is already looking to defend its franchise with a new subcutaneous version of the drug. Preliminary results from UCB’s phase 3 RAISE study are expected in the coming weeks.

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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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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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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. Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression.

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pharmaphorum

JANUARY 11, 2022

It is well-established for conventional drugs and medical devices but has only recently started to be used for DTx. The post Blue Note leukaemia DTx gets FDA breakthrough tag appeared first on. Breakthrough designations can speed up the development of new therapies, making them available to patients sooner.

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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. They also employ exceptionally high levels of ‘test and learn’ activities to understand which campaigns work and should be upscaled.

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pharmaphorum

OCTOBER 29, 2021

Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy (sacituzumab govitecan) will be paired with Merck’s PD-1 inhibitor Keytruda (pembrolizumab) in a new phase 3 trial in previously-untreated subjects with locally advanced or metastatic TNBC. While its headline revenue of $7.4

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Chemotherapy FDA 52

pharmaphorum

DECEMBER 23, 2022

There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives. CellCentric, a U.K-based These are particularly important in the progression of certain blood cancers.

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Roots Analysis

JANUARY 28, 2024

Velocity: Big Data needs to be handled promptly as businesses generate data at an unprecedented speed, driven by the growing adoption of Internet of Things (IoT), and technologies, such as RFID tags, sensors, and smart meters are used to deal with the high velocity of data in real-time. It is loosely arranged into categories using meta tags.

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pharmaphorum

DECEMBER 2, 2020

The company’s first product, a palatable anti-parasitic drug, made to taste like toffee, united Pfizer’s skills as a chemist with Erhart’s training as a confectioner. The “first industrial war” involved drug producers as much as weapons manufacturers. It was a success, and set the pattern for the company’s future development.

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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 How to navigate the new climate. At more than $2.1

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The FDA Law Blog

JUNE 27, 2023

Valentine Named Top Lawyer Under 40; Only Food and Drug Lawyer Selected Hyman, Phelps & McNamara, P.C. (HP&M) James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list. HP&M’s James E. Valentine , as a 2023 Rising Star.

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The Checkup by Singlecare

AUGUST 30, 2023

Jublia is a brand-name prescription drug FDA approved to treat fungal toenail infections (onychomycosis). Its active ingredient, efinaconazole, is a new antifungal drug. In clinical trials, the drug cured the fungal infection in more than half the participants. Jublia is only available as a premium-priced brand-name drug.

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Insurance Insurance Coverage FDA 52

Viseven

SEPTEMBER 14, 2023

The procurement cycle presupposes all decisions related to selecting suppliers and monitoring drug delivery and distribution. It typically falls into the following steps: Reviewing drug selections. Determining drug quantities. Receiving and checking drugs. Aligning needs with the budget. Selecting a procurement method.

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Packaging Pharmaceutical Companies Pharmaceutical Companies Pharmacy Procurement 52

pharmaphorum

AUGUST 26, 2022

BioMarin will no doubt have an eye on the earlier experience of bluebird bio, which secured EU approval for rare disease gene therapy Zynteglo (betibeglogene autotemcel) in 2019 for beta thalassaemia with a price tag of around €1.6 The post Roctavian okay sets up another gene therapy test for Europe appeared first on.

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The Checkup by Singlecare

MARCH 15, 2023

As a brand-name drug, Breztri Aerosphere has a premium price. The average out-of-pocket cost for people with either health insurance or Medicare Part D drug coverage varies based on the insurance plan’s formulary, copay cost, and any coverage gaps. The listed SingleCare price references the price of generic drugs if available.

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Insurance Hospitals FDA 52

The Checkup by Singlecare

JUNE 21, 2023

The condition causes higher levels of androgen hormone production, resulting in symptoms such as irregular menstrual cycles, acne, excess hair growth, cysts, skin tags, thinning hair, skin darkening, and infertility. But she says that other GLP-1 RAs have more data to support their use as weight loss drugs. Is Ozempic good for PCOS?

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Pharmaceutical Technology

JANUARY 27, 2023

On January 18, Sanofi launched a new warranty program for its rare blood disorder drug Cablivi (caplacizumab), which tackles value-based agreements in a slightly different way. Cablivi stops platelets from clumping together, which prevents small clots, and can be used along with other drugs that suppress the immune system.

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European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. Transformative treatments have exposed and tested the limitations of our value assessment and reimbursement systems. 1 This is assuming a $1M price tag for all gene therapies.

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The Checkup by Singlecare

JANUARY 19, 2023

It is important to recognize the symptoms of high blood sugar (such as increased thirst and urination), as well as test your blood sugar, and know what to do if your blood sugar is high. Although you can test your blood sugar at home, it is best to see a healthcare professional for a medical diagnosis—and treatment if required.

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Immunization Hospitals Communication 105

pharmaphorum

DECEMBER 7, 2021

The researchers from the Cleveland Clinic discovered the association between Viagra and a lower risk of Alzheimer’s as part of a wide-ranging study that looked at more than 1,600 FDA-approved medicines to try to find drugs that could be re-purposed as dementia therapies.

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The Physician Pharmacist

SEPTEMBER 14, 2023

However, a lot of the time the physicians name tags will just say physician you won't even know if they're an MD or do there's actually been a few times I remember from happiness where the physicians and techs at MD and I looked them up to see where they went to school and they went to an osteopathic medical school.

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