PharmaShots

FEBRUARY 10, 2023

LEO Pharma Reports P-III Trial (DELTA 2) Results of Delgocitinib for Chronic Hand Eczema Date: Feb 10, 2023 | Tags: LEO Pharma, Delgocitinib, Chronic Hand Eczema, Clinical Trial, P-III, DELTA 2 Trial GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Regular Approval for Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer (..)

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FDA 40

PharmaShots

MAY 19, 2023

Alimera Acquires Rights from EyePoint Pharmaceuticals to Commercialise Yutiq in the US Date: May 19, 2023 | Tags: Alimera, EyePoint Pharmaceuticals, Yutiq, Iluvien, chronic non-infectious uveitis, US, Pharma Sobi Reports EMA’s Validation of MAA for Efanesoctocog Alfa to Treat Haemophilia A Date: May 19, 2023 | Tags: Sobi, Efanesoctocog Alfa, (..)

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Medical Schools FDA Immunization Vaccines 40

PharmaShots

FEBRUARY 24, 2023

Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive Positive Solid Tumors Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive

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FDA Vaccines 40

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.

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FDA 109

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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Pharmaceutical Companies Pharmaceutical Companies FDA 98

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. Drugs given the designation are hastened through the development process by the FDA, which can grant them a faster six-month review.

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Chemotherapy FDA 57

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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Pharmaceutical Technology

JANUARY 17, 2023

On January 12, Versanis Bio announced that enrollment had begun for its Phase IIb trial, BELIEVE (NCT05616013), which aims to study bimagrumab’s (BYM-338) efficacy and safety in the US, among other locations. In addition to facilitating loss of fat, the Phase II trial also showed that a lean mass gain of 4.5% was observed in the study.

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Hospitals 52

pharmaphorum

AUGUST 21, 2022

In this product, bupropion is designed to increase levels of dextromethorphan in the blood and extend its half-life. 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.

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European Pharmaceutical Review

AUGUST 24, 2022

ANTIBODY-DRUG conjugates (ADCs) are therapeutic molecules designed as highly targeted medicines with the promise of changing the way we treat cancer and other diseases. In total, there are 14 approved ADCs on the global market, all for oncology indications, and over 140 ADCs currently in clinical development.

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Compounding Pharmaceutical Companies Pharmaceutical Companies 85

pharmaphorum

JULY 25, 2022

It showed an overall response rate with Tecvayli of 63%, including 39% complete responses which is a remarkable result given that the patient recruited into the trial were very ill and heavily pre-treated. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

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FDA 52

pharmaphorum

MAY 10, 2022

As with Aduhelm (aducanumab), lecanemab is being filed via the accelerated approval pathway, with the companies seeking a green light on the strength of the results of a phase 2b trial ahead of the readout of the confirmatory Clarity AD trial, due in the autumn.

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FDA 40

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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PharmaShots

MARCH 9, 2023

Designation: Chief Medical Officer (CMO) and Head of Worldwide Medical and Safety at Pfizer Previous company: Stanford University (12 yrs. An elected member of Association of American Physicians (AAP) and the American Society for Clinical Investigation (ASCI), she also serves fellow of the American Gastroenterological Association.

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Pharmaceutical Technology

APRIL 5, 2023

But access to these treatments continues to remain limited due to high price tags and variable availability across regions. And my estimate is that between 25,000 and 30,000 patients have been treated with those therapies globally, which does not include patients treated in clinical trials.

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FDA Immunization 59

pharmaphorum

AUGUST 10, 2020

While this is not cheap by anybody’s reckoning, Roche hopes that the less intimidating price tag, plus the patient-friendly oral administration method will give it a competitive edge. Evrysdi is designed to treat SMA by increasing production of the survival of the motor neuron (SMN) protein.

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FDA Specialty Pharmacies 57

European Pharmaceutical Review

JULY 11, 2022

Funding of up to $30 million will support vaccine design, its development through Phase I trials and regulatory activities. . is designed to focus the immune response on parts of RBD shared by all viruses in the Severe Acute Respiratory Syndrome (SARS)-like Betacoronavirus family. 2 is the virus that causes COVID-19.).

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Vaccines Immunization 94

pharmaphorum

DECEMBER 2, 2020

The FDA had already granted fast-track designation to the combination therapy, allowing extra help during the development process on the basis of earlier clinical data. The trial continued enrolment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil.

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FDA Chemotherapy 52

Viseven

FEBRUARY 6, 2023

Instead, they should consider the website or application as a personal business card with a mindful message and accurate design. In addition, AI-driven software attracts pharma companies that study its potential in new drug discovery, patient diagnostics automation, and clinical trials which is great for recruitment campaigns.

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Communication 75

The Checkup by Singlecare

MARCH 7, 2024

Ozempic cost Unfortunately, like many new drugs, Ozempic comes with a hefty price tag. For example, an Ozempic pen designed to deliver 0.25 The human clinical trials were for Ozempic, and the doses are studied with that particular drug and brand,” Dr. Makhija explains, as the generic version is not FDA approved.

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Health and Personal Care Stores Insurance Packaging Insurance Coverage 52

Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. Bariatric surgeries show 30% weight loss in the first year and 25% weight loss in the long term,” says Papamargaritis, while that the clinical data for Mounjaro shows that the drug leads to a 16–22.5%

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Insurance Labelling Communication FDA 105

Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. Bariatric surgeries show 30% weight loss in the first year and 25% weight loss in the long term,” says Papamargaritis, while that the clinical data for Mounjaro shows that the drug leads to a 16–22.5%

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Insurance Labelling Communication FDA 98