Sat.Jan 23, 2021 - Fri.Jan 29, 2021

article thumbnail

Merck stops coronavirus vaccine development in surprise setback

Bio Pharma Dive

The drugmaker, one of the largest vaccine developers globally, won't move forward with either of two candidates it's been testing after disappointing data in early trials.

article thumbnail

10 Essential pharma content strategy must-haves

World of DTC Marketing

SUMMARY: Pharma has not embraced a content strategy when the number of online health seekers is climbing. A content management strategy can lead to a better brand-patient relationship and turn customers into brand ambassadors. I’m not a huge believer in content strategy for CPGs. I feel that there is so much content already out there that people don’t have the time to read it all.

Branding 202
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA Designations for Rare Disease Products, Part 1

Camargo

Comparing Orphan Drug, Rare Pediatric Disease, and Humanitarian Use Device Designations. The US FDA offers sponsors a variety of special designation programs to incentivize them to develop and deliver therapies to treat unmet patient needs, such as Fast Track Designation (FTD), Breakthrough Therapy Designation , and Qualified Infectious Disease Product Designation.

article thumbnail

Over-the-Counter Nasal Spray Could Be Effective Against COVID-19

BioSpace

An in vitro study conducted by scientists from Northwestern University and Utah State University concluded that components found within the Xlear nasal spray, particularly grapefruit seed extract and xylitol, were successful in statistically reducing the amount of SARS-CoV-2 in a patient.

In-Vitro 145
article thumbnail

The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

article thumbnail

Sanofi, in unusual move, to help Pfizer, BioNTech make coronavirus vaccine doses

Bio Pharma Dive

The French drugmaker, having hit delays with its own coronavirus shot, agreed to manufacture over 100 million doses of Pfizer and BioNTech's vaccine for supply in Europe.

article thumbnail

The complicated ROI measurement for pharma

World of DTC Marketing

SUMMARY: The LinkedIn team had a unique take on measuring ROI. “77% of marketers measure ROI within the first month of their campaign, knowingly trying to “prove ROI in a shorter amount of time than their typical sales cycle., while only 4% of marketers even measure ROI over a six-month period or longer.” So how should DTC marketers really measure ROI?

Marketing 187

More Trending

article thumbnail

Colorado RFP on Drug Importation Accounts for Canada’s Order Protecting Against Shortages

Pharmacy Checkers

This week, the Colorado Department of Health Care Policy and Financing issued a request for proposals, called an Invitation to Negotiate, to operate a state wholesale drug importation program as permitted under federal law and the administrative final rule issued by HHS last year, referred to as the Section 804 rule. Colorado’s proposal request is chock full of details, with many regulatory and legal issues addressed, quite ably predicting pushback from drug companies who virulently oppose impo

Drugs 125
article thumbnail

Safety finding weighs on Pfizer's inflammation drug, and could spell trouble for others

Bio Pharma Dive

A large safety study found that patients given Pfizer's Xeljanz had health issues like major heart complications and cancer at a higher rate than those who got a different kind of anti-inflammation drug.

Drugs 343
article thumbnail

Is pharma digital ready?

World of DTC Marketing

SUMMARY: Digital is a way of thinking; it’s not a tactic. To many going digital can mean a ton of opportunities but if you move too quickly you can lose sight of the end goal. Is your organization digital ready? It’s a question that I ask all of my clients at a time when more people are going online for health information. But let’s start at the beginning… 1ne: What’s the purpose of your product website?

Branding 180
article thumbnail

What we’re expecting in 2021, and beyond…

pharmaphorum

From telehealth to digital trials, customer engagement to healthcare data, Healthware Group outlines the key trends that are expected to shake up digital health this year. Well, it goes without saying, COVID-19 has resulted in a rapid adoption of digital technologies across all industries, most notably in healthcare. There are several important aspects to these shifts for pharma, biotech and medical device companies, so what can we expect to see over the next 12 months and beyond?

article thumbnail

Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

article thumbnail

Biden Pledges to Speed Flow of Vaccines to the States

NY Times

President Biden said the amount of coronavirus vaccines reaching the states would rise next week and a deal was near to provide enough shots to vaccinate nearly all Americans by the end of summer.

article thumbnail

Vaccine makers prepare response as coronavirus mutations raise alarms

Bio Pharma Dive

So far, both Pfizer's and Moderna's vaccines appear to work against more transmissible variants, but preparation is underway for the day they don't.

article thumbnail

Selling digital to skeptics within pharma

World of DTC Marketing

SUMMARY: The future of healthcare involves digital transformation but moving too fast in a matrix management environment can cause problems and set digital back months. Most of us know the importance of digital when to comes to healthcare. The pandemic has accelerated digital transformation, but organizations need to be careful about moving too fast without getting company influencers’ buy-in.

Marketing 154
article thumbnail

Bad news for Pfizer as blockbuster Xeljanz flunks safety study

pharmaphorum

JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. Now, a study designed to prove its safety has achieved the opposite. The post-marketing safety study showed that Xeljanz (tofacitinib) – used to treat rheumatoid arthritis (RA) – was associated with a higher rate of heart attacks and cancer than a TNF inhibitor in patients aged over 50 with underlying cardiovascular risk factors.

Trials 135
article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

article thumbnail

UPDATE: Bomb Threat Forces Evacuation of AstraZeneca COVID-19 Vaccine Manufacturing Plant

BioSpace

Police have sealed off the area, according to the report. Few details were available, but eye witnesses said a robot was investigating a suspicious package found at the plant.

Packaging 129
article thumbnail

J&J says study data on coronavirus vaccine due 'early next week'

Bio Pharma Dive

Results from the large Phase 3 trial are highly anticipated. If proven effective, J&J's shot could provide much-needed reinforcements to a constrained immunization effort.

article thumbnail

AstraZeneca and University of Oxford dismiss German media claims about vaccine efficacy in elderly

BioPharma Reporter

AstraZeneca along with its scientific partners at the University of Oxford have rejected German media reports that their vaccine against COVID-19 had low efficacy in people aged over 65.

article thumbnail

Clinical research in 2021: A new era of collaboration and innovation

pharmaphorum

The clinical research community has been disrupted in a number of ways due to COVID-19 and sparked a spirit of collaboration and innovation. Worldwide Clinical Trial’s Aman Khera gives five predictions of how clinical research could change in 2021. The pandemic has propelled the life science industry toward higher expectations for faster, more responsive and more inclusive drug development.

article thumbnail

What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

article thumbnail

Vertex Moves Full Steam Ahead on Type 1 Diabetes Drug Trial With FDA’s OK

BioSpace

The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application that will allow Boston-based Vertex Pharmaceuticals to proceed with a clinical trial of its investigational stem cell-derived, fully differentiated pancreatic islet cell treatment for type 1 diabetes (.

article thumbnail

Can new Regeneron, Lilly data move the needle for COVID-19 antibody drugs?

Bio Pharma Dive

The results show that drugs from both companies can help prevent or treat COVID-19 when given at the right time. But that won't mean much if barriers to use remain high.

Antibody 334
article thumbnail

PharmaTimes confirms INTCR 2021 virtual finals days

Pharma Times

The 2021 International Clinical Researcher of the Year competition will continue the successes of last year and be conducted virtually.

article thumbnail

RedX Pharma CEO focuses on pipeline that found Lilly’s rising star

pharmaphorum

Back in 2017, the UK biotech RedX Pharma had to sell its prized asset after administrators stepped in to stave off a debt crisis, with Loxo Oncology snapping up the BTK inhibitor for $40 million. That drug, now known as LOXO-305 was one of the stars of the American Society of Haematology (ASH) conference in December, finding its way into Eli Lilly’s pipeline after the big pharma’s $8 billion takeover of Loxo.

Sales 119
article thumbnail

The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

article thumbnail

UK doctors ask for ‘urgent review’ of COVID-19 vaccine second dose delay

BioPharma Reporter

The British Medical Association (BMA), the trade union and professional body for doctors in the UK, is calling for the delay between Pfizer/BioNTech COVID-19 vaccine doses to be reduced from 12 weeks to six weeks.

Doctors 111
article thumbnail

FDA approves first-of-its-kind lupus drug

Bio Pharma Dive

Lupkynis, the first oral drug approved for lupus nephritis, comes with a high list price. Its developer, Aurinia Pharmaceuticals, expects average net revenue of roughly $65,000 per patient per year.

article thumbnail

eCOA tech helps trials tackle COVID-19 obstacles: IQVIA

Outsourcing Pharma

Two leaders from the clinical technology solutions company discuss how digital tools like eCOAs have been invaluable in facing pandemic-related challenges.

Trials 122
article thumbnail

Novartis hails digital strategy as profits hold up during pandemic

pharmaphorum

Novartis has said that its investment in digital technology has helped it to ride out the worst of the pandemic, although sales of some of its newly-launched products have been affected by a fall in prescriptions and hospital visits. The big Swiss pharma still managed to grow sales in Q4 compared with the same period last year, with sales increasing a reported 3% to $12.8 billion and profits growing 2% to just over $3 billion.

Doctors 111
article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

article thumbnail

J.P. Morgan: Will Biotech’s Virtual 2021 Launch Become the New Reality?

BioSpace

At the annual J.P. Morgan conference, the biotech industry launched its encore to a wildly successful 2020 – virtually. And, as is becoming the common scenario, attendees found both pros and cons to our new (temporary?) reality.

113
113
article thumbnail

Gene therapy for hemophilia: So close, yet so far away

Bio Pharma Dive

Significant setbacks for pace-setting programs from BioMarin and UniQure have renewed questions about gene therapy’s promise, and its safety.

article thumbnail

Researchers identify existing drug’s potential for triple negative breast cancer

Pharma Times

Study suggests that palbociclib could be used to treat around a fifth of people with TNBC

Research 151
article thumbnail

The US biosimilar market: Predictions for 2021

pharmaphorum

It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. As we’ve seen over those five years, biosimilars are critical in continuing to provide doctors and patients choice in their care plans as well as continuing to decrease overall healthcare costs.

Marketing 119
article thumbnail

Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.