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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Development Production Drugs 64

pharmaphorum

DECEMBER 23, 2021

The designation – which is awarded to therapies that could represent a significant improvement over standard of care in either efficacy, safety, or both – has been awarded on the strength of phase 1 results in patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer (NSCLC).

Drugs 72

Drugs Antibody Clinical Trials Clinical Trials 72

pharmaphorum

APRIL 27, 2022

The coveted status has been awarded to the HER2-targeting antibody-drug conjugate (ADC) on the back of the DESTINY-Breast04 trial results, unveiled in February, which involved patients with HER2-low, unresectable and/or metastatic breast cancer previously treated with one to two prior lines of chemotherapy.

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Sales Drugs Antibody Licensing 59

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.

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Antibody Drugs Protein Gene 111

Drug Discovery World

JANUARY 30, 2024

Natalia Elizalde, Chief Business Development Officer, VIVEbiotech, says that Dr Naldini’s award represents the significant benefits and demonstrated safety of the therapies developed using lentiviral vectors that are being used for more and more clinical trials and more prevalent diseases.

Gene Therapy 71

Gene Therapy Manufacturing Gene Clinical Trials 71

Rethinking Clinical Trials

MAY 10, 2023

We are a platform, so we do not have awards open that support science. Tags #pctGR, @Collaboratory1 The post Grand Rounds May 5, 2023: All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine (Joshua C. New researchers get $300 of free credits which will handle a lot of EHR access.

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Medicine Research Clinical Trials Clinical Trials 130

Pharmaceutical Technology

JUNE 29, 2022

For example, while orphan drug designations have more than doubled in the last decade compared to the previous one, only 16% of therapies with orphan tags have managed to gain FDA approval in some indications.

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Drugs FDA Approval Marketing Development 246

pharmaphorum

JANUARY 18, 2022

The hope is that they will harness and re-programme natural cellular mechanisms to selectively remove the disease driving proteins from human tissues, working by boosting interactions – gluing – between therapeutically relevant proteins and the machinery used by cells to naturally tag and destroy proteins.

Dermatology 52

Dermatology Protein Pharma Companies Research 52

XTalks

DECEMBER 13, 2023

The landmark approvals were awarded to bluebird bio’s Lyfgenia (lovo-cel) and Vertex Pharmaceuticals and CRISPR Therapeutics’ jointly developed Casgevy (exa-cel). 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.

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Gene Therapy FDA Approval Gene In-Vivo 98

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.

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FDA Approval Trials Clinical Trials Clinical Trials 40

The Pharma Data

NOVEMBER 9, 2020

Global icons such as multi-award winning chart-topping artist Rita Ora, soul-singing legend Heather Small (singer of 2000’s hit Proud) and Formula One hero Romain Grosjean are just some of the big name supporters of the. WeAreFamily #COVID19 #HealthforAll and tag @WHO, @The_WorldWeWant and @thewhof. Upload your video to [link].

Nurses 40

Nurses Doctors Doctor Scientist 40

FDA Law Blog

JUNE 27, 2023

The honor was bestowed on only 183 attorneys, which is awarded to “top attorneys under 40 whose legal accomplishments belie their age.” Karst Awarded WWL: Life Sciences 2023 Global Elite Thought Leader HP&M Director Kurt R. (HP&M) is pleased to announce that Law360 has recognized one of our firm’s Directors, James E.

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Life Science FDA Approval Drugs Development 81

XTalks

NOVEMBER 30, 2022

The approval was awarded to CSL Behring’s Hemgenix, a single-dose gene therapy that delivers a working copy of the gene that codes for the Factor IX protein that is deficient, or made in insufficient amounts, in patients with Hemophilia B. The therapy is now officially the world’s most expensive drug at $3.5 million per dose.

Gene Therapy 52

Gene Therapy Life Science Gene FDA Approval 52

XTalks

AUGUST 19, 2022

Bluebird bio’s gene therapy Zynteglo (betibeglogene autotemcel, beti-cel) has been awarded a much anticipated approval from the US Food and Drug Administration (FDA) for the treatment of adult and pediatric patients with beta thalassemia who need regular blood transfusions. Zynteglo’s hefty price tag of $2.8

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Gene Therapy FDA Approval Gene Clinical Trials 95

XTalks

FEBRUARY 27, 2024

Both therapies were awarded their approvals on the same day in December 2023. 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.

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Research Drugs Gene Therapy Clinical Trials 59

XTalks

DECEMBER 21, 2022

And almost every time a new gene therapy approval was awarded, it would more often than not break the previous ‘world’s most expensive drug’ record. Clinical trials in these indications are among some of the most complex and expensive to conduct, which is another factor contributing to the high price tags of gene therapies.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

XTalks

FEBRUARY 11, 2021

The trio of Watson, Crick and Wilkins went on to be awarded the Nobel Prize in Physiology or Medicine in 1962 “for their discoveries concerning the molecular structure of nucleic acids and its significance for information transfer in living material.”. This was the first time two women had won a Nobel Prize in science together.

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Genetics DNA Genome Genomics 119