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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Drugs FDA Approval Marketing Development 246

STAT News

OCTOBER 6, 2022

And this is especially true for us, since we hit the proverbial pause button yesterday to observe ancient rituals. Please feel free to join us. million tag as cost effective for a Bluebird Bio drug called Zynteglo for the blood disorder beta thalassemia, Arbuckle said in an interview. Our choice today is Jack Daniels.

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Gene Therapy Gene Insulin Drugs 98

Pharmaceutical Technology

NOVEMBER 9, 2022

In the EU however, two years later, the European Commission awarded a conditional marketing authorisation for Roctavian. The European Commission withdrew the marketing authorisation of Zynteglo, at the request of bluebird bio, in March 2022. million price tag. million ($1.5 million ($1.8 million at the time).

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Gene Therapy Gene FDA Approval Medicine 278

pharmaphorum

DECEMBER 24, 2021

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. The $56,000-a-year price tag for the drug, which has now been cut in half in the US, also hasn’t helped the drugmakers make a case for Aduhelm with US payers.

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Drugs FDA Approval Trials Marketing 111

Pharmaceutical Technology

MAY 2, 2023

There are more than 20 marketed ICIs with approvals across a very wide spectrum of solid tumour indications. Marketed bispecific antibodies are largely bispecific T-cell engagers (BiTEs), which work by directing T-cells to antigen-expressing tumour cells. Cost-related unmet needs also scored highly.

Genetic Engineering 130

Genetic Engineering Antibody Clinical Trials Clinical Trials 130

Pharmaceutical Technology

FEBRUARY 22, 2023

Amgen could be the winner of a high-stakes patent spat with Sanofi as tensions run high weeks before the March 27 US Supreme Court hearing. Both drugs come with a high price tag. Since April 2020, Sanofi is responsible for Praluent outside of the US, while Regeneron handles its sale in the US.

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Antibody Drugs Sales Protein 262

Intouch Solutions

NOVEMBER 17, 2021

blue links) of the organic results appeared to be pulling from content outside of the HTML title tag at a much higher frequency. Title Tag – This is an HTML element that provides a title for the page. It can be seen by hovering over the browser tab and has often been used to populate the SERP Title. Source: Google.

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Marketing Engineer Branding 52

Rethinking Clinical Trials

OCTOBER 2, 2023

PROTEUS leaders reviewed and categorized the solutions into 4 categories: education and engagement, information technology or technological resources, incentives, mandates, and marketing, and research. Can you elaborate on the incentives and marketing recommendation from the Underserved Advisory Group? We are pursuing funding.

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Clinical Trials Clinical Trials Research Trials 152

XTalks

APRIL 18, 2024

Roche has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 early Alzheimer’s blood test. However, Roche has several CSF tests on the market, which include assays in the company’s Elecsys line that are used in conjunction with PET in the diagnosis and monitoring of the disease.

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Clinical Trials Clinical Trials In-Vitro Protein 52

pharmaphorum

JULY 23, 2019

Customer journeys in pharma are changing, with important implications for the marketing supply chain. How can pharmaceutical marketers capitalise on this trend and free up budget to invest in additional marketing channels? Overview Join our live webinar taking place on Tuesday 23rd July at 16:00 BST / 11:00 EST / 08:00 PST.

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Marketing Production Development Research 52

Drug Discovery World

DECEMBER 20, 2022

The first gene therapy for haemophilia B could soon be available to patients in Europe following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). . The therapy was also recently approved by the FDA for patients in the US. . A one-time treatment with etranacogene dezaparvovec costs US$3.5

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 8, 2024

While direct-to-consumer (DTC) TV advertising remains a mainstay marketing strategy in pharma, ads have mostly been relegated to evening hours during certain programs for older audiences. After all, nearly half of women in the US going through menopause may experience moderate to severe VMS. billion Japanese yen ($8.8

Life Science 105

Life Science Marketing Branding Drugs 105

XTalks

JULY 16, 2021

There are several factors to consider, and understanding them will help us to answer the ultimate question: will plant-based meat ever be cheaper, or at least on par, with real meat? But yet, the price tag is still higher than real meat. A pound of Beyond Meat’s Beef burgers carries a price tag of $6.25, Vox reported.

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Protein Production Manufacturing Branding 105

Roots Analysis

MARCH 1, 2024

Such disadvantages of overt security technologies can be overcome using certain covert security features. Track & Trace technologies constitute a separate segment in the anti-counterfeiting technologies market. Some of the countries include the US, the EU, China, India, Japan, Korea, Brazil, Turkey and Argentina.

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Packaging Packaging Production Manufacturing 52

XTalks

DECEMBER 13, 2023

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. Casgevy is also the first ever CRISPR/Cas9-based therapy approved in the US. Vertex-CRISPR’s Casgevy has a US list price of $2.2 Both therapies will be available in early 2024.

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Gene Therapy FDA Approval Gene In-Vivo 98

XTalks

NOVEMBER 3, 2022

In its first quarter on the market since its approval, sales totalled $97 million between July and September in the US. We have seen unprecedented demand for Mounjaro’s Type 2 diabetes launch in the US,” said Anat Ashkenazi, Lilly’s chief financial officer, on a call with analysts on Tuesday.

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Sales FDA Approval Production Insulin 98

XTalks

AUGUST 25, 2021

In-store food sampling is a key marketing tactic that virtually disappeared during the height of the COVID-19 pandemic. Pre-pandemic, Daniel Maloney could be found working sample booths at food markets around New York City, telling consumers about the brand’s rich history and commitment to ethical farming.

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Branding Marketing Nurses Production 98

pharmaphorum

JUNE 12, 2022

The FDA still has to deliver its own verdict on the applications, and doesn’t always follow its advisors’ lead, but with two unanimous decisions bluebird looks set up for its first approvals in the US. Beti-cel has already been approved for marketing in Europe as Zynteglo, with a price tag of around $1.8

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Gene Therapy Gene Marketing Trials 59

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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FDA Approval Marketing Drugs Clinical Development 64

pharmaphorum

SEPTEMBER 15, 2020

As pharmaceutical marketers prepare their brands for the future, there are a number of important ways they can learn from digitally-native brands. This is reinforced by web-focused marketing strategies that give them a highly-targeted approach when it comes to marketing execution.”. Be more agile .

Branding 110

Branding Marketing Pharma Companies Life Science 110

pharmaphorum

JANUARY 9, 2023

Along with Zolgensma – which made its debut in 2019 – Biogen has had approval to market its antisense-based therapy Spinraza (nusinersen) since 2016, while Roche got a green light for its orally-administered therapy Evrysdi (risdiplam) in 2020. ” Zolgensma is one of the most expensive therapies available, with a price tag of around $2.1

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Gene Therapy Genetics Gene Clinical Trials 118

XTalks

JULY 12, 2021

The US Food and Drug Administration’s (FDA) recent approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) was met with a lot of backlash, prompting the health agency to narrow its recommendation of the drug for mild forms of the disease. This would be a huge burden on Medicare, while private insurers would be shying away from it.

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Drugs Clinical Trials Clinical Trials Trials 98

pharmaphorum

AUGUST 17, 2020

N o one industry is ever quite like another, but there are some valuable lessons for pharma marketing from examining how the financial sector uses technology, builds brands on social channels and approaches digital content. Personalising marketing content. Engagement channels. Joanna Carlish.

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Regulation Marketing Sales Branding 84

pharmaphorum

AUGUST 21, 2022

Auvelity isn’t the first NMDA-targeting antidepressant to reach the market. The biotech hasn’t revealed much information about the reasons for the delay in getting approval, but said in an SEC filing in June this year that it had agreed to “post-marketing commitments” proposed by the FDA, without going into details.

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Drugs FDA Approval Production Marketing 94

pharmaphorum

APRIL 14, 2022

US cost-effectiveness watchdog ICER has handed bluebird bio some good news ahead of its FDA advisory committee meeting for rare blood disorder gene therapy beti-cel in June, by endorsing its proposed $2.1 million price tag.

Gene Therapy 64

Gene Therapy Gene Marketing Clinical Trials 64

pharmaphorum

JUNE 2, 2022

In 1983, the US Congress passed the Orphan Drug Act to encourage more pharmaceutical companies to engage in R&D to develop treatments for rare diseases through the offering of financial incentives. This is why the action by the US in 1983 and subsequently the European Commission Regulation No. The price is right. Raising questions.

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Drugs Sales Marketing Development 52

XTalks

OCTOBER 28, 2021

A recent lifecycle assessment Perfect Day’s protein production found that “if US consumers switched entirely to Perfect Day whey protein, this would save up to 246 million tons of CO2e emissions, which is the equivalent of up to 28 million homes’ energy use for one year.”. percent from 2019 to 2025.

Protein 98

Protein Packaging Packaging DNA 98

Intouch Solutions

APRIL 11, 2024

Precision engagement is a data-driven approach developed for marketing and sales needs. It uses customer insights to deliver personalized experiences. Contact us to learn more. So, what is precision engagement? Curious about how AI-powered precision engagement can transform the commercial and medical functions of your company?

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Compliance Marketing Drugs Pharma Companies 52

pharmaphorum

JUNE 8, 2021

That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s since 2003, which it says has “no evidentiary basis.” — Dr. Patrizia Cavazzoni (@FDACDERDirector) June 7, 2021.

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Drugs Marketing FDA Approval Trials 98

Drug Discovery World

JANUARY 30, 2024

To achieve this, we need greater collaboration between academia, therapy developers and manufacturing equipment developers.” Stella Vnook , CEO, Likarda , notes that a s more regenerative therapy options come to the market, patients will demand access to the treatments, often using the court system. She

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Gene Therapy Manufacturing Gene Clinical Trials 71

pharmaphorum

JANUARY 11, 2021

US biotech bluebird bio has announced plans to split into two this year, with a separate oncology business spinning off as the company prepares to bring its products to market. million price tag. Zynteglo is already in beta-thalassemia in Europe, where the company will seek to expand access despite its hefty $1.8

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Gene Therapy Gene Genetic Disease Manufacturing 60

pharmaphorum

JULY 25, 2022

J&J filed for approval of the bispecific in the US in December based on the results of the phase 1b MajesTEC-1 study in myeloma patients who had been treated with a median of five lines of prior therapy. Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

Antibody 52

Antibody Medicine Drugs Trials 52

pharmaphorum

DECEMBER 17, 2021

Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

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Trials Sales Marketing FDA Approval 52

Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. As computing has developed in the past decade, so has the potential to store and use information in the cloud.

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Production Pharma Production Pharma Companies Drugs 264

XTalks

JUNE 9, 2021

This Monday, the US Food and Drug Administration (FDA) granted accelerated approval to the drug for the treatment of the disease. million Alzheimer’s patients in the US, some market goers are apprehensive about the implications this could have for the industry. Aducanumab Controversy and Price Tag.

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Drugs Clinical Trials Clinical Trials Trials 98

Drug Discovery World

MAY 22, 2023

Large pharma involvement in advanced therapies has seen ebbs and flows, with AstraZeneca taking a larger stake in the market and Takeda developing its automation and digital capabilities, but also with GSK letting go of its CGT projects, along with most of the staff involved in its R&D. But are these price tags a barrier to access?

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Gene Therapy Gene Drugs Contamination 52

Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. It will be six years since the US FDA approval of Kymriah in August this year.

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Gene Therapy Gene Engineer Production 147