Sat.Dec 12, 2020 - Fri.Dec 18, 2020

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AstraZeneca to buy Alexion for $39B

Bio Pharma Dive

The deal launches AstraZeneca, a company that has been growing mostly because of newer drugs for cancer and diabetes, into the market for rare disease treatments.

Marketing 362
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Telehealth will be worth about $25 billion in 2021

World of DTC Marketing

SUMMARY: Deloitte predicts that the percentage of virtual video visits to doctors will rise to 5% globally in 2021, up from an estimated 1% in 2019. While 5% may not sound like much, consider that 8.5 billion doctor’s visits, worth a total of approximately US$500 billion. The most time-consuming task is to make an appointment with your doctor just to ask for a new Rx or an Rx renewal.

Doctors 309
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Best Features of Mobile Workstations in Pharmaceutical Production

Pharma Mirror

The future of pharmaceutical manufacturing is mobile. Advances in cloud computing and the onset of Industry 4.0 has led to the proliferation of mobile IT solutions for manufacturing, including pharmaceuticals. Particularly, mobile workstations and tablets are becoming staples of the pharmaceutical manufacturing workflow due to their cost-effectiveness, particularly in demanding environments like cleanrooms, where even modular fixed human-machine interfaces (HMIs) can be exorbitantly priced and c

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You Have a Product – Now What? Key Considerations for an Effective Commercial Strategy

Camargo

Whether a sponsor develops a new product or plans to license an exciting new asset developed somewhere else, commercial success or failure will depend on its understanding of the market and ability to develop an effective commercial strategy. The product may be based on an elegant and compelling scientific premise, but if it does not provide a set of benefits that could change current behaviors, or if it is not accessible to patients, it might be best to consider alternatives.

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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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Novartis acquires a small biotech and its trio of brain drugs

Bio Pharma Dive

More active in neuroscience than most pharmaceutical firms, Novartis would gain three experimental drugs for depression, schizophrenia and movement disorders through the deal.

Drugs 322
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American healthcare is unsustainable

World of DTC Marketing

SUMMARY: (Axios) The U.S. spent $3.8 trillion on health care last year, accounting for about 18% of the entire American economy, according to new federal data. The U.S. has by far the most expensive health care system in the world, and every year it eats up a little more — from the federal government, states, employers, and individuals. This is unsustainable.

Medicine 181

More Trending

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Brain Fog Explained as Study Shows SARS-CoV-2 Crosses Blood-Brain Barrier

BioSpace

A study in Nature Neuroscience shows SARS-CoV-2, the virus responsible for COVID-19, is capable of crossing the blood-brain barrier, likely contributing to symptoms of brain fog and other cognitive effects reported by people infected with the virus.

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FDA scientists back safety, efficacy of Moderna's coronavirus vaccine

Bio Pharma Dive

A review by agency staff affirmed the strongly positive results Moderna reported from a large Phase 3 study, clearing the way for a possible emergency authorization in the coming days.

Scientist 321
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Virtual ad boards

World of DTC Marketing

Pharma has adapted virtual ad boards which is essential for impact marketing. I’ve noticed, however, that some best practices for ad boards seem to be slipping. Here is a checklist. 1ne: “Let’s have an ad board.” The first question you need to ask is whether you really need an ad board. Ad boards should not be used to tell something you already know. 2wo : What’s our objective?

Marketing 180
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Moderna Vaccine Is Highly Protective and Prevents Severe Covid, Data Show

NY Times

The positive review likely ensures that the F.D.A. will grant emergency authorization for a second coronavirus vaccine this week for millions of Americans.

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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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Experts Say Benefits of COVID-19 Vaccines Outweigh Risks of Reported Temporary Side Effects

BioSpace

After four people in the Pfizer-BioNTech's and three people in Moderna’s COVID-19 vaccine trials developed temporary facial weakness or paralysis, some people became concerned that it could happen to them. But experts suggest that the condition, known as Bell’s palsy, is fairly prevalent in the p.

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FDA advisers meet to review Moderna's coronavirus vaccine

Bio Pharma Dive

Support from the advisory committee Thursday would likely result in an emergency authorization for the shot within days. Track the meeting's progress with BioPharma Dive's reporters here.

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Common sense approach to the pharma industry

World of DTC Marketing

SUMMARY: The “goodwill” that many believe was gained from the development of a Covid-19 may be more of a wish than a reality. Pharma companies are still too focused on profits while people continue to rely on prescription drugs to compensate for unhealthy lifestyles. The headline and byline in a Times editorial said it all “Don’t Fall for Big Pharma’s Savior Act, Heroic work went into the development of the coronavirus vaccines.

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Machine-learning, robotics and biology to deliver drug discovery of tomorrow

pharmaphorum

Biology 2.0: Combining machine-learning, robotics and biology to deliver drug discovery of tomorrow. Intelligent OMICS, Arctoris and Medicines Discovery Catapult test in silico pipeline for identifying new molecules for cancer treatment. Medicines discovery innovators, Intelligent OMICS, supported by Arctoris and Medicines Discovery Catapult, are applying artificial intelligence to find new disease ‘drivers’ and candidate drugs for lung cancer.

Drugs 128
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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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Eureka’s InvisiMask™ Anti-SARS-CoV-2 Nasal Spray Protects for 10 Hours in Preclinical Results

BioSpace

Eureka Therapeutics' InvisiMask™ Human Antibody Nasal Spray can provide 10 hours of protection from SARS-CoV-2 virus in animal models, according to preclinical results released today. Now it’s heading to clinical trials.

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With trial plans, Novo wagers its diabetes drug can help treat Alzheimer's

Bio Pharma Dive

Similar diabetes drugs from Novo have shown signs of promise in treating dementia. The Danish biotech is now putting that hypothesis to the test.

Drugs 332
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New Zealand secures COVID-19 vaccines from Novavax and AstraZeneca

BioPharma Reporter

New Zealand now has enough COVID-19 vaccines for everyone in the country, says the government, as it announces two new supply agreements with Novavax and AstraZeneca today.

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Green light for UK trial of nasal coronavirus vaccine

Pharma Times

The trial is expected to begin next month, with first data anticipated in the second quarter of 2020

Trials 165
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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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FDA Approves First Non-Prescription, OTC Test for At-Home COVID-19 Detection

BioSpace

The U.S. Food and Drug Administration has authorized the first non-prescription, over-the-counter, at-home antigen test that can be used to identify infection with SARS-CoV-2, the virus responsible for COVID-19, in people two years of age or older.

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Moderna's first FDA clearance brings the US a second coronavirus vaccine

Bio Pharma Dive

The FDA's emergency authorization of the biotech’s shot bolsters an immunization campaign in the U.S. that’s just beginning.

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US starts COVID-19 vaccinations

BioPharma Reporter

The US has started COVID-19 vaccinations this morning: after the Pfizer/BioNTech vaccine was granted Emergency Use Authorization (EUA) by the FDA on Friday.

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With First Dibs on Vaccines, Rich Countries Have ‘Cleared the Shelves’

NY Times

The U.S., Britain, Canada and others are hedging their bets, reserving doses that far outnumber their populations, as many poorer nations struggle to secure enough.

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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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ABPI chief exec on the UK industry’s learnings from COVID-19

pharmaphorum

The ABPI’s chief executive Dr Richard Torbett shares his views on how the industry has adapted to COVID-19 and explains why the post-pandemic future is looking bright for the UK industry. January 2020 would have been an interesting time for anyone to start a new job, but for Richard Torbett, who moved into the chief executive position at the ABPI after five years at the Association, it meant taking the helm of an organisation that quickly found itself on the frontline of global efforts to fight

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Hospitals start coronavirus vaccinations in sweeping, nationwide effort

Bio Pharma Dive

A New York nurse was among the first to get the shot after FDA authorization late Friday. Many other health systems are either preparing to receive supplies or are already beginning immunizations.

Nurses 294
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Valneva’s inactivated COVID-19 vaccine candidate enters Phase 1/2 clinical trial

BioPharma Reporter

Valneva has started a Phase 1/2 trial of its COVID-19 vaccine: eying up potential regulatory approval in the fourth quarter of 2021. It champions a âtried and testedâ approach with its inactivated candidate.

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Five Companies Earn Validation as FDA Recognizes New Breakthrough Therapies

BioSpace

Novartis' Iptacopan isn’t the only drug to receive Breakthrough Therapy designation this week. Several other experimental treatments were also awarded the designation.

Drugs 122
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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.

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Los países prósperos aseguraron sus vacunas, pero ‘han vaciado los estantes’ para el resto

NY Times

Estados Unidos, el Reino Unido, Canadá y otros países hicieron pedidos de vacunas que superan con creces a sus poblaciones, mientras muchas naciones pobres luchan por asegurarse las dosis que necesitan.

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Lilly pays $880M for Prevail, pushing further into genetic medicine

Bio Pharma Dive

The acquisition marks a significant bet by Lilly on gene therapy's potential to address tough-to-treat neurological disorders like Parkinson's disease.

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EU for AZ' COPD maintenance therapy

Pharma Times

The triple combination therapy Trixeo Aerosphere cut the rate of moderate or severe exacerbations compared with dual-combination therapies in clinical trials

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Pharma still reluctant to back gamification for health; interview

pharmaphorum

The pharma industry has been making great strides forward in digital health, but one element of that – gamification – hasn’t yet made much headway in the sector. Armed with new data from a randomised clinical trial, one company is hoping to change that mindset. The company is FriendsLearn – based in India and with an R&D office in San Francisco – which recently reported results from a trial showing that its fooya!

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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.