XTalks

FEBRUARY 11, 2022

On February 3, NBCUniversal announced that it was officially sold out of commercial time, with 30-second ad slots commanding a price tag of as much as $7 million in some cases. . Super Bowl commercials have become a cultural phenomenon of their own alongside the game itself, as many viewers only watch the game to see the commercials.

Containment 97

Containment Production Branding Marketing 97

Rethinking Clinical Trials

OCTOBER 26, 2023

point of care diagnostic tests, provide broad access to curative Hepatitis C medications with a national subscription model, with Medicare co-pay assistance and commercial insurance coverage. The initiative would bring to the U.S.

Clinical Research 141

Clinical Research Clinical Trials Clinical Trials Research 141

pharmaphorum

JANUARY 9, 2023

Zolgensma meanwhile is now approved in 45 countries, with over 2,500 patients treated globally across clinical trials, managed access programs, and in the commercial setting. ” Zolgensma is one of the most expensive therapies available, with a price tag of around $2.1

Gene Therapy 115

Gene Therapy Genetics Gene Clinical Trials 115

The Pharma Data

AUGUST 18, 2020

The $475 million price tag on the deal will be made by BMS in near-term upfront payments, and Dragonfly will have access to further milestone payments contingent on regulatory and commercial successes of drugs under the partnership, as well as up to 24% royalties on net sales worldwide. .

Protein 52

Protein Sales Drugs 52

The Pharma Data

DECEMBER 3, 2020

Utilizing Clover’s proprietary Trimer-Tag © technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag © Technology. Trimer-Tag © is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. About Dynavax.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

XTalks

JANUARY 28, 2022

Kimmtrak has a price tag of $18,760 per vial, which amounts to a weekly dose. Immunocore’s commercial chief Ralph Torbay said the company has created a Kimmtrak Connect program to help patients access the therapy irrespective of their financial situation. The median treatment time is about 23 weeks (or 5.3

FDA Approval 98

FDA Approval Development Licensing Licensing 98

Drug Discovery World

JANUARY 30, 2024

 Even as more therapies become commercially available, costs remain high and insurer knowledge needs to keep pace. Other Challenges: Limited insurance coverage: Many insurance companies are hesitant to cover CGTs due to their high price tags and limited long-term data.

Gene Therapy 71

Gene Therapy Manufacturing Gene Clinical Trials 71

The Pharma Data

JANUARY 31, 2021

Utilizing Clover’s proprietary Trimer-Tag© technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate. About Trimer-Tag© Technology. Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. . EMERYVILLE, Calif.

Vaccination 52

Vaccination Vaccine Trials Protein 52

XTalks

NOVEMBER 24, 2022

CSL Behring is set to market the drug after having secured global commercialization rights from uniQure for $450 million in 2020. The company also said the price does not reflect anticipated discounts that it will offer for the therapy, including value-based agreements with commercial payers.

Gene Therapy 52

Gene Therapy Gene FDA Approval Genetics 52

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 57

Gene Therapy Gene Marketing Trials 57

XTalks

SEPTEMBER 27, 2022

The record-breaking price tag of Skysona is not surprising for one-time gene therapies like it. Case in point, bluebird had to pull both Zynteglo and Skysona and cease commercial activities in Europe after it failed to reach reimbursement agreements with local governments. Related: Bluebird’s $2.8M

FDA Approval 52

FDA Approval Gene Therapy Drugs Gene 52

Rethinking Clinical Trials

DECEMBER 6, 2022

For the step-down RCT, patient recruitment started in August 2019 with 587 patients consenting and 552 included in the primary analysis. It was a labor of love; the site payment was low; we asked friends to be sites in the trial. Sites have a lot of trials that are competing. One pays more than another. pctGR, @Collaboratory1.

Trials 130

Trials Clinical Trials Clinical Trials Compliance 130

Intouch Solutions

APRIL 11, 2024

Commercial : Improved experience and communication between patients and doctors. Transforming Commercial and Medical Functions with Precision Engagement AI is reshaping the pharmaceutical industry, from drug discovery to customer engagement. Clinical : Optimized efficiency, inventory management, and service quality of clinical trials.

Compliance 52

Compliance Marketing Drugs Pharma Companies 52

pharmaphorum

NOVEMBER 24, 2021

The DTx – also known as Pear-009 – is still in the proof-of-concept trial stage, but draws on the same cognitive behavioural therapy (CBT) deployed in Pear’s commercial-stage products reSET and reSET-O for people living with substance and opioid use disorders. Photo by thom masat on Unsplash.

Production 57

Production Development Trials 57

Pharmacy Checkers

FEBRUARY 21, 2020

While that ban was put in place to stop companies from reimporting and selling American-made drugs in the commercial market, it can stop patients from reimporting a drug they bought in a foreign country for their own use. They did not have to include the phrase “commercial use.” Emphasis added. exported here and sold in U.S.

Drugs 61

Drugs FDA Approval Manufacturing Pharmacy 61

pharmaphorum

AUGUST 18, 2022

The US approval comes three years after Zynteglo (betibeglogene autotemcel) was approved for the same indication in Europe, and subsequently withdrawn after bluebird concluded that it wasn’t possible to build a commercially viable business for the gene therapy as the pricing and reimbursement environment there was too “hostile.”

Gene Therapy 52

Gene Therapy FDA Approval Gene Clinical Trials 52

Camargo

AUGUST 22, 2021

As of 24 months (for NDAs, ANDAs, and BLAs) or 36 months (for commercial INDs) after the publication of these guidance documents, the FDA may issue a refuse to file (RTF) letter for NDAs and BLAs, or a refuse to receive (RTR) letter for ANDAs for non-conforming submissions. Validation Code. Criteria Being Verified. Code 1734.

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Containment Bioavailability Cosmetics Packaging 190

The Pharma Data

MARCH 16, 2022

using SNAP-tag) involves labeling cell proteins with a fluorescent dye, thereby enabling researchers to observe how proteins interact in the living cell and where in the cell they are located. With Spirochrome, he commercialized fluorescent probes for cell biology, while with Covalys, he marketed SNAP-tag and other protein labeling methods.

Protein 52

Protein Scientist Gene Development 52

pharmaphorum

DECEMBER 23, 2022

price tag of $475,000 when it was first launched in 2017 – and it becomes apparent that these may not be desirable treatment options for every patient and in every setting. Add to this the considerable cost of these medications – the first approved CAR-T, Novartis’ Kymriah (tisagenlecleucel), had a U.S.

Development 52

Development Drugs Clinical Development Antibody 52

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.

FDA Approval 40

FDA Approval Trials Clinical Trials Clinical Trials 40

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. Besides, Clover is set to advance multiple new pipeline products in 2021 and expand its in-house R&D and cGMP commercial biomanufacturing capabilities.

In-Vitro 52

In-Vitro Vaccination Vaccine Licensing 52

pharmaphorum

FEBRUARY 22, 2021

They note however that so far there have been no reported cases of secondary cancers to date with Kymriah, which has been available commercially for around three years. Bluebird has said it hopes to have some data within the next few weeks that should explore the possibility of a causal link. million in Europe.

Gene Therapy 52

Gene Therapy Gene Gene Sequencing Gene Expression 52

The Pharma Data

OCTOBER 29, 2021

Merck has tagged to withdraw its Premerger Notification and Report Form, which was originally filed on October 14, 2021, to give the Federal Trade Commission (the “ FTC”) with fresh time for review, and expects to refile similar form on or about November 1, 2021. c/ o Voluntary Commercial Conduct,P.O.

Containment 52

Containment Regulation Vaccination Vaccine 52

XTalks

FEBRUARY 27, 2024

Addressing the high price tag, Iovance’s commercial chief Jim Ziegler said, “Payers have expressed their appreciation for the value proposition for Amtagvi.” Vogt said Iovance set Amtagvi’s price based on its value as the first drug approved in the post-PD-1 melanoma setting, and the company’s analysis of relevant benchmarks.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

Pharmaceutical Technology

JUNE 21, 2023

The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective. UniQure announced that it had received $100m from this first commercial sale milestone, on top of a $450m upfront payment.

Gene Therapy 246

Gene Therapy Gene Protein Sales 246

pharmaphorum

MAY 24, 2021

Robb DeFilippis, managing director, life sciences, for end-to-end global creative production and sourcing partner Tag in the Americas agrees. Amid these adjustments, it will be vital to ensure that marketing, commercial and regulatory teams all work closely together.

Marketing 83

Marketing Branding Sales Life Science 83

XTalks

MARCH 22, 2023

Our webinars have become a key vendor-selection tool for decision-makers across the drug development pipeline — from discovery to commercialization — which is why all ten of the top ten contract research organizations (CROs) have worked with Xtalks.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

The Pharma Data

NOVEMBER 15, 2020

Clover aims to double its commercial manufacturing capacity in preparation for global Phase 2/3 trials. In addition, this will meet Clover’s Phase 2/3 clinical production plan and commercial readiness once its vaccine candidate is approved. SHANGHAI , Nov.

Vaccination 52

Vaccination Vaccine Manufacturing Life Science 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. Specific areas of support proffered by the platform span of preclinical through to commercial, strategy implementation and project management.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

Delveinsight

JULY 22, 2020

Now the user can easily access the information through various user interfaces for their personal, commercial or industrial decision making as required. The hospital inventory is equipped with tagged sensors. Upon analysis, valuable information or insights is delivered to the end-user. What are the benefits of using IoT devices?

Doctors 59

Doctors Doctor Marketing Production 59

XTalks

JANUARY 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

DNA 66

DNA Radiology FDA Approval Development 66

Roots Analysis

AUGUST 28, 2022

Furthermore, several live cell imaging and non-destructive fluorescence histological methods measure limited number of biomarkers at a time and the tags introduced may interfere with the natural function of genes and proteins. Several deals are Inked between 90+ industry and non-industry stakeholders in this domain.

Genome 52

Genome Genomics RNA Genome Project 52

pharmaphorum

JUNE 15, 2021

The adoption of New Science – a unique combination of the best in science and health technology that address significant unmet patient needs – is delivering more precise and effective treatments, but often at a higher price tag, according to new research.

Clinical Trials 89

Clinical Trials Clinical Trials Development Marketing 89

pharmaphorum

FEBRUARY 26, 2021

J&J pioneered the first commercial first aid kits, which were initially designed to help railroad workers, but soon became the standard practise in treating injuries”. For all the latest pharma news on Johnson & Johnson, follow pharmaphorum’s J&J and Janssen tags.

Sales 119

Sales Production Pharma Companies Marketing 119

Drug Discovery World

NOVEMBER 13, 2023

Bárbara Schlicht, Head of Product Management, Commercial Operations, Samplix, on: ‘Droplet based flowcytometry for function-based screening of single immune cells in Xdrop DE50 droplets’. Opher Gileadi, PhD, Head, Protein Science SGC, Karolinska Institute, on: ‘Targeting every human protein: Challenges and prospects’.

Protein 59

Protein Antibody Engineer Scientist 59

Drug Discovery World

OCTOBER 21, 2022

The main principle involves a well-defined light source such as that produced by lasers that excites fluorescent tags bound to the cells or particles present in a sample. For instance, commercially available compensation beads would typically give a positive signal that is higher than what’s observed in standard biological samples.

Reagent 52

Reagent Antibody Drugs Protein 52

The Pharma Data

MAY 15, 2021

Web Beacons are tags that can monitor the behavior of a user visiting the Website or sending an e-mail. The Company uses personally identifiable information to undertake such activities as: Like many companies, the Company uses “cookie” and/or “web beacon” technologies on the Website. Registration and Password.

Production 52

Production Containment Medicine Vaccination 52