Sat.Nov 28, 2020 - Fri.Dec 04, 2020

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4 storylines at the year's biggest meeting on blood diseases

Bio Pharma Dive

A closely watched gene editing therapy, a slate of new multiple myeloma drugs and much more are set to highlight the American Society of Hematology conference this weekend.

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Is digital the future of medicine?

World of DTC Marketing

SUMMARY: McKinsey estimates that global digital-health revenues—from telemedicine, online pharmacies, wearable devices, and so on—will rise from $350bn last year to $600bn in 2024. I’m not so sure. EHR’s have been a failure. Some 70% of American hospitals still fax and post patient records, and patients don’t have one record to share among all their doctors.

Medicine 201
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A Timeline of COVID-19 Vaccine Development

BioSpace

Vaccine development is an arduous process, taking about 10-15 years on average to accomplish. But with the imminent worries surrounding the COVID-19 pandemic putting unprecedented pressure on our healthcare systems and economies, unprecedented measures needed to be put in place.

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iRhythm digital heart monitoring service backed by NICE

pharmaphorum

A heart monitor developed by iRhythm has become the first product to be endorsed by NICE in a pilot project covering digital health technologies. In new guidance, the health technology assessment (HTA) agency has recommended iRhythm’s Zio XT service for detecting abnormal heart rhythms – provided NHS organisations that deploy it collect evidence of its benefits.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Regeneron, UPenn to use gene therapy tools to deliver a COVID-19 antibody drug

Bio Pharma Dive

Working with University of Pennsylvania researcher Jim Wilson, Regeneron aims to develop a nasal spray version of the coronavirus treatment recently cleared by the Food and Drug Administration.

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Pharma websites need disruption

World of DTC Marketing

Walk into any corporate pharma HQ, and you’re likely to see a mission statement that’s pure b t about how patients come first. We all know that Wall Street and sales come well before patients. Want proof? Just look at any pharma product website that is nothing but a sales brochure in a majority of cases. ROI drives pharma companies. If it doesn’t add value to the bottom line, it’s not worth spending money on.

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A history of Pfizer

pharmaphorum

Few companies embody the term ‘pharma giant’ as much as Pfizer. Here we take a look at the colourful history of one of the biggest drugmakers in the world. Pfizer was founded in 1849 by two recent German immigrants to the USA, Charles Pfizer and Charles Erhart. Both in their mid-twenties, the two men set up what was initially a fine chemicals business in a Brooklyn factory, using a loan from Pfizer’s father as capital.

Sales 128
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Moderna, finishing key study, to ask FDA for emergency approval of coronavirus vaccine

Bio Pharma Dive

New results confirm the shot's strong efficacy against COVID-19, and should raise confidence vaccination can prevent against severe symptoms as well.

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Prescription drug marketing misconceptions

World of DTC Marketing

Another TED talk on the evils of prescription drug marketing was filled with misinformation as usual. Today consumers don’t run to their doctor after seeing a DTC ad, they do their research, and in some cases, the ads actually help them identify potential health problems. It’s been a while since I’ve seen any research on DTC TV ads’ effectiveness, but a couple of years it was estimated that TV ads were 7% effective.

Marketing 181
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Can Janssen Cure Cancer? Its 80+ ASH Presentations Suggest It’s On the Right Track

BioSpace

With 36 Janssen-sponsored studies and another nearly 50, it has supported, the Janssen Pharmaceutical Companies of Johnson & Johnson has a presence in more than 80 of the hematology studies presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, December 5-8.

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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

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Valneva accelerates Lyme disease vaccine R&D project with Pfizer

pharmaphorum

Valneva has said it plans to accelerate research into its Lyme disease vaccine candidate VLA15, bringing forward a trial including children into the first quarter of 2021. Subject to approval from regulators the vaccine specialist said it plans the trial known as VLA15-221 as a randomised, observer-blind phase 2 study including around 600 healthy people aged 5-65 years of age.

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Vaccine production in focus as Moderna, Pfizer await FDA decision

Bio Pharma Dive

Moncef Slaoui, a leader of Operation Warp Speed, said he expects 100 million Americans to be vaccinated by the end of February — an ambitious target even as Moderna and Pfizer ramp up manufacturing.

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DTC Marketers job just got harder

World of DTC Marketing

SUMMARY: Both emergency room visits and doctors’ visits are down by about half because people are putting off treatment for medical emergencies due to fears of contracting COVID-19. How is pharma going to get patients back into to ask their doctor about branded medications? Year-to-date spending on health services is down about 2% from last year.

Marketing 155
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Auris Medical Stock Soars With Promising COVID-19 Nasal Spray Results

BioSpace

Auris Medical rose by as much as 480% yesterday after it announced lab test results, which appeared to show that its nasal spray could potentially protect users against COVID-19.

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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.

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Healthware Group buys Finnish digital agency Make Helsinki

pharmaphorum

Healthcare agency, consultancy and digital health group Healthware Group has acquired Finland-based digital service development and creative agency Make Helsinki. The acquisition builds on prior collaborations between the two organisations, including in best-in-class full-service agency offerings, digital transformation, technology/enterprise solutions and corporate venturing.

Trials 121
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UK drug regulator is first to clear Pfizer, BioNTech's coronavirus vaccine

Bio Pharma Dive

The approval is a notable milestone in the historic pursuit of a protective shot for COVID-19. The two drugmakers plan to ship the first doses within days.

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Colchicine added to UK’s COVID-19 ‘RECOVERY’ trial

Pharma Times

Commonly used anti-inflammatory drug added to list of potential treatments

Trials 166
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UK Approves Pfizer-BioNTech COVID-19 Vaccine, Plans to Begin Dosing Next Week

BioSpace

The United Kingdom’s Medicines & Healthcare Products Regulatory Agency granted temporary authorization for emergency use to Pfizer and BioNTech for their COVID-19 mRNA vaccine, BNT162b2.

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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.

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Pfizer cut vaccine production targets because of raw material shortage – reports

pharmaphorum

Pfizer slashed its production targets for its COVID-19 vaccine because of a lack of raw materials for its supply chain, according to press reports. The big pharma has said in recent weeks that it expects to produce 50 million doses of the vaccine it developed with the German BioNTech, down from an earlier target of 100 million doses. That’s enough to inoculate 25 million people as the dosing schedule involves two shots three weeks apart.

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FAA says first flight shipping coronavirus vaccine takes off

Bio Pharma Dive

With two experimental shots now undergoing FDA review, airports and shipping companies are readying for the mass shipment of vaccine doses.

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London A.I. Lab Claims Breakthrough That Could Accelerate Drug Discovery

NY Times

Researchers at DeepMind say they have solved “the protein folding problem,” a task that has bedeviled scientists for more than 50 years.

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Defying Skeptics, Pfizer and Moderna Gun for Global COVID-19 Vaccine Approval

BioSpace

As the year winds down, the top companies in the COVID-19 vaccine race are nearing the finish line in the United States and other countries around the world.

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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.

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Healthcare that no longer leaves out the patient

pharmaphorum

For so long the US healthcare system was built around the provider, with appointments and services set by the provider (along with insurance reimbursement systems). This structure relies on in-person visits of patients to operate and become profitable. But when the industry suddenly shifted due to COVID-19, so too did the power dynamics of the patient-provider relationship.

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J&J pushes further into eye gene therapy

Bio Pharma Dive

The pharma licensed a treatment for a severe type of age-related vision loss, building on past deals that gave it a foothold in gene therapy.

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Cyberattacks Discovered on Vaccine Distribution Operations

NY Times

IBM has found that companies and governments have been targeted by unknown attackers, prompting a warning from the Homeland Security Department.

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AstraZeneca Looks to Clear Confusion Over Vaccine Results with Additional Studies

BioSpace

Another clinical study could confirm the 90% efficacy data that stemmed from accidental use of a half-dose in an arm of its Phase III trial.

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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.

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‘Knowledge is power’ for rare diseases and NAbs

pharmaphorum

Cure Rare Disease’s Rich Horgan discusses the importance of preclinical NAbs screening and helping rare disease patients better understand their eligibility for gene therapies. Neutralising antibodies (NAbs) present a unique challenge to researchers looking to treat patients with AAV treatment. As AAV is a virus derived from the common cold, the immune system can easily have levels of pre-existing NAbs that will recognise and neutralise AAV, rendering it ineffective.

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A closer look at the behind-the-scenes companies moving coronavirus vaccines around the world

Bio Pharma Dive

Freight forwarders, the linchpins of the supply chain, face the daunting task of ensuring hundreds of millions of doses make the journey from factory to clinic.

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Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine

NY Times

The first shots could be given as early as Dec. 21, if authorization is granted.

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Potential for an Alzheimer’s Treatment Appears to Be Closer Than Ever

BioSpace

Over a decade of research and billions of dollars have been poured into the Alzheimer’s industry. Experts are hopeful we could finally be headed towards a light at the end of the long dark tunnel.

Research 116
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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.