Rethinking Clinical Trials

FEBRUARY 28, 2024

The global decentralized clinical trial market is expected to grow at a compound annual growth rate of 30.1% Was there complete ascertainment of primary and secondary efficacy data? Was there complete ascertainment of primary and secondary safety data? from 2021 to 2026. Were there any major GCP-related issues?

Clinical Trials 146

Clinical Trials Clinical Trials Trials Clinical Research 146

Pharmaceutical Technology

NOVEMBER 9, 2022

On November 7, the company announced that the FDA has scheduled a pre-licensure inspection of BioMarin’s manufacturing facility, and required the company to submit three-year Phase III Roctavian data in the approval application. million price tag. The post Can gene therapies for haemophilia defend their high price tags?

Gene Therapy 278

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.

Drugs 111

Drugs FDA Approval Trials Marketing 111

World of DTC Marketing

SEPTEMBER 24, 2021

Then, against the advisory panel’s advice, Aduhelm was approved, but insiders within the industry criticized both the FDA and Biogen weren’t sold on the drug or its price tag. 2wo: The new CEO needs to withdraw Aduhelm from the market until such a time that they have independent data that confirms efficacy.

Drugs 222

Drugs Pharma Companies Doctors Doctor 222

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

JULY 14, 2022

The commercial investment required to research and develop an innovative drug, prove its safety and efficacy, and bring it to market is staggering. Go-to-market strategies. The challenge of providing adequate access to the peripheral EU markets is quite evident. Efforts have been made to change this.

Drugs 147

Drugs Medicine Marketing Development 147

Rethinking Clinical Trials

OCTOBER 2, 2023

The PROTEUS Consortium’s objective is to ensure that patients, clinicians, and other decision-makers have high-quality PRO data from clinical trials and clinical practice to make the best decisions they can about treatment options. Can you elaborate on the incentives and marketing recommendation from the Underserved Advisory Group?

Clinical Trials 159

Clinical Trials Clinical Trials Research Trials 159

pharmaphorum

OCTOBER 18, 2022

Medtech giant Beckton Dickinson (BD) has signed a deal with France’s Biocorp to use the latter’s near-field communication (NFC) tags in injectable devices. The Injay tag can confirm a complete injection and transfer that information via an NFC reader to a smartphone or tablet for review by a healthcare professional.

Drug Delivery 52

Drug Delivery Manufacturing Drugs Marketing 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.

Marketing 52

Marketing Production Development Research 52

Pharmaceutical Technology

JUNE 29, 2022

In a series of data-driven deep dives, we will examine how the development of orphan drug therapies has evolved over the years, and use the FDA’s orphan drug program as a barometer of these advances. However, extended market exclusivity is often associated with high drug pricing and limited patient access.

Drugs 246

Drugs FDA Approval Marketing Development 246

Roots Analysis

JANUARY 28, 2024

Big Data in healthcare refers to the vast amount of data that is continuously expanding and cannot be efficiently stored or processed using traditional tools. Within the healthcare sector, structured data includes demographic details, vital indicators (like, height, weight, blood pressure, blood glucose).

Big Data 40

Big Data Medicine Marketing Clinical Trials 40

pharmaphorum

JANUARY 24, 2022

A private equity group has agreed to take over most of IBM Watson Health, seven years after the business was launched with a pledge to revolutionise healthcare data analysis. For its part, IBM has said that the Watson for Oncology product has been improving year-on-year as the AI crunches more and more data.

Radiology 111

Radiology Marketing Genome Genomics 111

Rethinking Clinical Trials

JULY 6, 2023

This guidance and others in development in other markets act as an important countermeasure to ensuring sustained adoption and implementation of DCTs. Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

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.

Regulation 97

Regulation Marketing Sales Branding 97

Intouch Solutions

APRIL 11, 2024

Pharmacovigilance : Early identification of adverse drug reactions, higher data integrity and faster response times. Precision engagement is a data-driven approach developed for marketing and sales needs. Precision engagement is a data-driven approach developed for marketing and sales needs.

Compliance 52

Compliance Marketing Drugs Pharma Companies 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. Bayer is preparing to file for FDA approval based on strong Phase III data it shared last month. In its first year on the market, Veozah earned 1.3

Life Science 105

Life Science Marketing Branding Drugs 105

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 130

Branding Marketing Pharma Companies Life Science 130

Roots Analysis

MARCH 1, 2024

Examples of such technologies include DNA Taggants (a unique DNA tag used in the product / packaging that can be scanned using a designated instrument / equipment), invisible printing technologies, digital watermark technologies and hidden markers / print technologies.

Packaging 52

Packaging Packaging Production Manufacturing 52

XTalks

JULY 12, 2021

The FDA based the decision on the fact that there is “no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”. The backtracking from the FDA is unusual as the revision was not prompted by new data or information.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

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

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.

Trials 52

Trials Sales Marketing FDA Approval 52

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. Novo’s Ozempic shortage may also challenge Lilly’s “ability to meet expanding demand [for Trulicity] in most international markets,” Ashkenazi explained. In the third quarter of 2022, Mounjaro scored $187.3

Sales 98

Sales FDA Approval Production Insulin 98

XTalks

DECEMBER 13, 2023

Morgan analysts were also hopeful about bluebird’s clearer commercialization plan for Lyfgenia and market readiness from Zynteglo. However, a William Blair team pointed to Vertex’s general “extensive commercial experience” as a threat to bluebird being able to compete in the commercial market.

Gene Therapy 98

Gene Therapy FDA Approval Gene In-Vivo 98

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. Twenty years ago, the cost of implementing RFID tags and the ecosystem (software) was much more expensive than today.

Production 264

Production Pharma Production Pharma Companies Drugs 264

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

World of DTC Marketing

JUNE 23, 2021

In my career in healthcare marketing, I have done my best to understand the “science” behind certain health conditions along with how some medications can help. Not to mention the $56,000 annual price tag. When I didn’t understand something, I went to the medical people on the team to gain insights.

Drugs 218

Drugs FDA Approval Doctors Doctor 218

pharmaphorum

NOVEMBER 27, 2022

Empowering labs with automated equipment that produces rich, traceable, and actionable data insights means pharmaceutical companies can ensure drug production runs smoothly – even under stress. This means batch sizes can be tailored to daily demands rather than market forecasts. Better communication with traceable data.

Production 105

Production Manufacturing Drugs Marketing 105

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

Gene Therapy 71

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. Leschly will also take the role of executive chair at bluebird, according to a company statement.

Gene Therapy 66

Gene Therapy Gene Genetic Disease Manufacturing 66

Intouch Solutions

AUGUST 25, 2021

Updates to the Apple Mail app will allow users to change their privacy settings and allow Apple to hide their data in emails. While this is a big step in the ongoing movement toward protecting consumer privacy, there is increased attention to its impact on email marketing.

Marketing 52

Marketing Regulation Engineer Branding 52

pharmaphorum

NOVEMBER 24, 2022

Johnson & Johnson’s Spravato therapy for treatment-resistant depression (TRD) hasn’t made the impact the company hoped for in the market, and it is looking to new clinical results to accelerate its take-up.

Trials 52

Trials Sales Drugs Marketing 52

pharmaphorum

DECEMBER 23, 2022

Here, Richard Staines reports on phase I/II data unveiled at the American Society of Hematology conference that supports further clinical development of inobrodib in multiple myeloma and other blood cancers. Oral therapy data presented at ASH. CellCentric, a U.K-based

Development 52

Development Drugs Clinical Development Antibody 52

pharmaphorum

JUNE 8, 2021

Instead, the FDA granted Aduhelm a conditional approval, allowing it to be prescribed and used while Biogen conducts a post-marketing, phase 4 confirmatory study – which could take years to complete. If benefit is not verified, we can act to remove the drug from the market. — Brad Loncar (@bradloncar) June 7, 2021.

Drugs 98

Drugs Marketing FDA Approval Trials 98

XTalks

MAY 2, 2024

During a midday session, Anal Dave from Dessert Holdings and David Hatch, Vice President of Digital Solutions Marketing at Neogen , showcased their digital transformation strategies in environmental testing, enhancing detection and compliance. We’re incorporating AI into everything that we do.

Compliance 110

Compliance Regulation Production Containment 110

Delveinsight

JULY 22, 2020

The Internet of Things is the interconnection of available medical devices, software applications and other resources to collect and exchange data to provide a reliable, efficient, and smart healthcare service to the patients. Sensors/Devices are the primary data collection point in IoT. New Insight/Data For Research.

Doctors 59

Doctors Doctor Marketing Production 59

pharmaphorum

MAY 17, 2021

C5 inhibitor Soliris – which has a list price in the US of more than $500,000 per year – has been a standard therapy for the rare disorder since 2007, and was joined on the market by longer-acting follow-up Ultomiris in 2018 which launched with a price tag of around $450,000 per year. billion and $1.1

Drugs 52

Drugs FDA Approval Marketing Clinical Trials 52

Drug Discovery World

JANUARY 10, 2023

Scientists purchase antibodies with the expectation that they will recognise their intended targets and produce reliable data, but the presence of improperly validated antibodies on the market can make this process both time-consuming and expensive. Pillar 5: Protein OE/Epitope Tags. Pillar 4: Biological Characteristics.

Antibody 52

Antibody Protein Reagent Scientist 52