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

Gene Therapy 59

Gene Therapy Gene Marketing Trials 59

pharmaphorum

JANUARY 11, 2022

It has since been joined by other products in the software as a medical device (SaaMD) category, including Pear Therapeutics’ alcohol-use disorder candidate Pear-009 and another Blue Note DTx, codenamed BNT001, which is also being tested for anxiety and depression in cancer patients.

Development 64

Development Production Drugs 64

pharmaphorum

AUGUST 21, 2022

There’s no word yet on its pricing, but for comparison Spravato was launched with an annual price tag of around $32,400, which the Institute for Clinical and Economic Review (ICER) concluded was around 25% to 52% too high to be cost effective. Following after is AXS-12 (reboxetine) for narcolepsy, which could be filed in 2023.

Drugs 96

Drugs FDA Approval Production Marketing 96

pharmaphorum

OCTOBER 21, 2021

Vounatsos also insisted that Aduhelm’s price tag has not been a factor discouraging treatment with the drug. Biogen stumped up $1.525 billion upfront for rights to the drug and another Sage candidate for neurological diseases last year, when the expectation was that Aduhelm was unlikely to get FDA approval.

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Sales Doctors Doctor Gene Therapy 118

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

pharmaphorum

NOVEMBER 19, 2020

Because Roche has never applied for Avastin to be used in wet AMD, clinics in the US have had to choose between the peace of mind offered by the regulatory process and Lucentis’ higher price tag, or the unapproved off-label formulation of Avastin at a lower price.

FDA Approval 64

FDA Approval Marketing Drugs Clinical Development 64

The Pharma Data

MARCH 23, 2022

Back in 2018, researchers tested a broad-spectrum antiviral candidate called remdesivir/VEKLURY, which acts as a nucleotide decoy to get incorporated into the viral RNA genome and stop viral polymerase. In fact, antiviral therapies designed to treat viruses such as hepatitis C (Sofosbuvir/SOVALDI) work by blocking viral polymerase.

Protein 52

Protein Genome Genomics Research 52

pharmaphorum

MARCH 23, 2022

Vyvgart (efgartigimod alfa) became the first drug in the FcRn class to be approved by the FDA last December, and despite a $225,000 annual price tag is predicted to make relatively modest sales in its IV version, which will compete with other IV gMG drugs like AstraZeneca/Alexion’s C5 inhibitor Soliris (eculizumab).

Antibody 52

Antibody Sales FDA Approval Trials 52

XTalks

FEBRUARY 8, 2024

Along with the hefty price tag for screen time that may not be perceived to be a worthwhile investment, and despite favoring advertising at other major events like the Grammys, pharma tends to stay somewhat clear of all the Super Bowl hoopla. Bayer is preparing to file for FDA approval based on strong Phase III data it shared last month.

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Life Science Marketing Branding Drugs 105

Rethinking Clinical Trials

SEPTEMBER 22, 2022

You can always use the system to identify potential candidates and then guide them to the local cardiology, kidney department. -These one-time interventions, like vaccines, contact people, deliver intervention, what about chronic care that is needed for a trial where more monitoring is needed? Learn more. Read about DANFLU-1.

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Trials Cardiology Vaccination Vaccine 130

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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pharmaphorum

JANUARY 5, 2021

Another rival – Astellas – fell out of the running last year when it abandoned its phase 1 candidate ASP8374, acquired as part of its $405 million Potenza takeover in 2018. The post Roche nabs breakthrough tag for TIGIT cancer immunotherapy appeared first on.

Immune Response 52

Immune Response FDA Approval Drugs Sales 52

Drug Discovery World

JANUARY 10, 2023

Pillar 5: Protein OE/Epitope Tags. We generate numerous candidates for you to test in your assays and workflows ensuring the antibodies are effective in whatever application they’re being used. This pillar requires that antibody-independent and antibody-dependent assays produce results that are correlative.

Antibody 52

Antibody Protein Reagent Scientist 52

pharmaphorum

AUGUST 18, 2022

million price tag attached to the therapy when it was first made available in Europe, and is also well above the proposed $2.1 Zynteglo is a customised, one-time treatment created using a patient’s own bone marrow stem cells hat are genetically modified to produce functional beta-globin, which is mutated in the disease.

Gene Therapy 52

Gene Therapy FDA Approval Gene Clinical Trials 52

Drug Discovery World

MAY 22, 2023

But are these price tags a barrier to access? For instance, apprenticeships are on the rise as technical areas such as bioprocessing become more reliant on unconventional candidates, including training of personnel without a biologics or life science background. million per dose.

Gene Therapy 52

Gene Therapy Gene Drugs Contamination 52

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.

Big Data 40

Big Data Medicine Marketing Clinical Trials 40

XTalks

DECEMBER 21, 2022

Bluebird is also now back on track in evaluating its candidate gene therapy for sickle cell disease (SCD) after the FDA lifted a clinical hold on studies of the drug this month. 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.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

Delveinsight

FEBRUARY 23, 2021

The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform. Moreover, Clover plans to initiate a global phase II/III efficacy trial for SCB-2019 (S-Trimer), its COVID-19 vaccine candidate, in the first half of 2021.

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In-Vitro Vaccination Vaccine Licensing 52

Delveinsight

DECEMBER 3, 2020

It has been speculated that modifications to the epigenome drive cell ageing, especially a process known as DNA methylation, by which methyl groups are tagged onto DNA. Merck chooses TriNKET cancer immunotherapy program. Merck has snapped up Dragonfly’s TriNKET cancer immunotherapy program.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

The Pharma Data

NOVEMBER 15, 2020

16, 2020 /PRNewswire/ — Cytiva , a global life sciences leader, is supporting Clover Biopharmaceuticals , a global clinical-stage biotechnology company, to help accelerate the development and manufacturing of a protein-based S-Trimer subunit vaccine candidate. . SHANGHAI , Nov.

Vaccination 52

Vaccination Vaccine Manufacturing Life Science 52

Drug Discovery World

NOVEMBER 13, 2023

Stefan Ewert, PhD, Associate Director, Biologics Center, Novartis Institutes for Biomedical Research, on: ‘Computational counterselection identifies nonspecific therapeutic biologic candidates’. Hiroki Shirai, PhD, Coordinator, RIKEN Center for Computational Science, on: ‘Applying deep learning anomaly detection to antibody structures’.

Protein 59

Protein Antibody Engineer Scientist 59

Drug Discovery World

NOVEMBER 9, 2023

Fabian Richter, PhD, Immatics Biotechnologies, on: ‘TCER development: safety aspects from discovery to lead candidate’. The presentations include: Angela Boroughs, PhD, Associate Director, Immunology, ArsenalBio, on: ‘High-throughput screening to enable the selection of a multi-feature, logic-gated CAR T cell candidate’.

Engineer 52

Engineer Antibody Protein In-Vivo 52

The Pharma Data

MAY 4, 2021

It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration. PF-06482077 (20-Valent Pneumococcal Conjugate Vaccine Candidate).

Vaccination 40

Vaccination Vaccine Production Sales 40