Sat.Dec 05, 2020 - Fri.Dec 11, 2020

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A CRISPR gene editing treatment continues to show promise for two blood diseases

Bio Pharma Dive

Results from 10 patients with beta thalassemia or sickle cell disease show CRISPR Therapeutics and Vertex's pioneering treatment to be effective, building on earlier study data.

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A new normal for digital health?

World of DTC Marketing

SUMMARY : According to Harvard Business Review, “digital health solutions and technology will play a crucial role in the difficult work of optimizing processes and systems for greater efficiency, financial viability, and enhanced outcomes. While this is true digital health won’t go anywhere unless there is a renewed effort on the user experience.

Doctors 245
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SARS-CoV-2, the COVID-19 Virus, is Mutating, But So Far, Slowly

BioSpace

Viruses mutate, and SARS-CoV-2, the virus that causes COVID-19, is not different. Luckily, it appears to mutate relatively slowly. Meanwhile, researchers are beginning to get a grip on the virus’s evolution.

Research 145
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Pfizer's Covid Vaccine and Allergies: How Concerned Should You Be?

NY Times

British health officials recommended that people with severe allergy reactions not be given the vaccine. Such reactions to vaccines are rare, even in people who have allergies to food or bee stings.

Allergies 140
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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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Researchers of the Year: The RECOVERY team

Bio Pharma Dive

The U.K.'s RECOVERY trial proved a cheap steroid could keep COVID-19 patients from dying, and showed two other widely considered drugs didn't work — crucial findings in a sprawling and sometimes messy global hunt for coronavirus treatments.

Research 334
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Consumers fall into three COVID-19 vaccine adoption segments

World of DTC Marketing

(Mckinsey) Much of the prevailing market research on COVID-19 vaccination frames sentiment as “likely,” “unlikely,” or “neutral.” McKinsey’s research is designed to uncover a more granular continuum of sentiments and to account for the fact that many consumers may take a “wait and see” approach to their decision about vaccination. Their research has found that consumers’ attitudes towards receiving a COVID-19 vaccine fall into three primary segments.

More Trending

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What HCPs think about COVID-19’s impact on cancer

pharmaphorum

COVID-19’s knock-on effect on cancer patients is of concern by HCPs, with delayed or decreased diagnosis seen as a key worry. CREATION.co’s Lara Meyer explores why HCPs need more support. The COVID-19 pandemic has been mainstream headline news throughout 2020 and continues to have a profound impact on all our lives. A key concern that has emerged from the crisis is how COVID-19 will affect other areas of healthcare, particularly cancer diagnosis and treatment.

Nurses 124
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FDA advisers meet to review Pfizer, BioNTech's coronavirus vaccine

Bio Pharma Dive

A panel of vaccine and infectious disease experts will publicly vet the drugmakers' study results on Thursday. Follow the discussion along with BioPharma Dive reporters here.

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It’s time to bring emarketing expertise in house

World of DTC Marketing

SUMMARY: Pharma has been relying on digital agencies for too long but agencies can’t begin to understand your audience like brand team members. Having a brand digital marketer constantly communicating with digital agencies is a waste of time and money. Pharma brands have come to rely too heavily on digital marketing agencies for a range of services, from paid media to actual website development.

Branding 154
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Sinopharm’s COVID-19 Vaccine Shows 86% Efficacy, UAE Health Agency Says

BioSpace

The COVID-19 vaccine under development by China’s Sinopharm is showing efficacy of 86%, health authorities from the United Arab Emirates reported this morning.

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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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Novartis signs ophthalmology AI deal with RetinAI Medical

pharmaphorum

Novartis has signed a multi-year agreement with RetinAI Medical, which will see the companies work together to use artificial intelligence (AI) tools to support ophthalmology and digital health projects. Both companies have already worked on pilot projects in this area. The first project under a new master agreement will involve a multi-centre international clinical study involving patients with neovascular age-related macular degeneration (nAMD).

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J&J study shows multiple myeloma cell therapy to be strongly effective

Bio Pharma Dive

The company plans to submit an approval application to the FDA in the next few weeks, chasing a rival Bristol Myers therapy that's now under review.

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What next for AstraZeneca's 'intriguing' half-dose COVID-19 vaccine?

BioPharma Reporter

AstraZeneca and the University of Oxford's COVID-19 vaccine candidate threw up a surprise last month when a lower initial dose of the two-dose vaccine showed higher efficacy. More detailed results from this interim analysis, now peer-reviewed and published in The Lancet this week, shed some light on this 'intriguing' efficacy.

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AstraZeneca Hopes COVID-19 Vaccine Will Take Off in Combination with Sputnik V

BioSpace

AstraZeneca, which is jointly developing a COVID-19 vaccine with the University of Oxford, plans to begin clinical trials testing its vaccine in combination with Russia’s Sputnik V vaccine by the end of the year.

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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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AstraZeneca Missteps Undermined U.S. Faith in Coronavirus Vaccine

NY Times

The Oxford-AstraZeneca effort held great promise to help arrest the pandemic. But a series of miscues caused it to fall behind in the U.S.

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Viatris to lay off staff, shutter plants in major restructuring

Bio Pharma Dive

The company created by a merger of Mylan and Pfizer's Upjohn unit is dramatically cutting costs, shedding jobs and closing or divesting up to 15 plants worldwide.

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FDA: No issues around safety and efficacy of Pfizer/BioNTech vaccine candidate

BioPharma Reporter

The US Food and Drug Administration (FDA) said there are âno specific safety concerns that would preclude issuance of an EUAâ for the investigational COVID-19 vaccine (BNT162b2) from US pharma giant, Pfizer, and its German partner BioNTech.

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Gilead’s CAR T therapy Yescarta shows potential in new indication

Pharma Times

ZUMA-12 phase II study is evaluating therapy as a first-line treatment for high-risk large B-cell lymphoma

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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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Obstructive sleep apnoea puts a strain on the heart, too

Scienmag

Credit: UEF / Raija Törrönen Longer nocturnal respiratory events in patients with obstructive sleep apnoea (OSA) cause higher immediate heart rate variability, and greater changes in beat-to-beat intervals are associated with reduced daytime alertness, according to new research from the University of Eastern Finland. Obstructive sleep apnoea affects approximately 1 billion people worldwide.

Research 113
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In milestone, FDA clears coronavirus vaccine from Pfizer, BioNTech for emergency use

Bio Pharma Dive

Vaccinations are expected to begin within days of the historic decision, which follows early approvals in the U.K., Canada and Mexico.

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Cyberattack targets EMA, hacks COVID-19 vaccine data

pharmaphorum

The European Medicines Agency (EMA) says it suffered a cyberattack, with documents relating to a Pfizer and BioNTech’s COVID-19 vaccine accessed. In a terse statement, the EU regulator confirmed its security had been breached and said it had launched an investigation with law enforcement, but would not be providing any additional information while that probe was underway.

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Winners shine bright at PharmaTimes Awards

Pharma Times

Meet the winners of the 2020 PharmaTimes Marketer of the Year, Communications Awards and Sales Awards

Sales 143
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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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Biogen Corporate Event Was COVID Superspreader, Up to 300,000 Related Infections, Study Says

BioSpace

A Biogen corporate conference held in February at the Boston Marriott Long Wharf Hotel was initially traced to about 100 cases of COVID-19 that spread across the country. That number has grown exponentially.

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Sanofi, GSK coronavirus vaccine delayed after early study results disappoint

Bio Pharma Dive

The experimental shot produced a weak immune response in adults over 49, leading the partner drugmakers to change plans and push back their development timelines.

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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

pharmaphorum

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The gist of a briefing document published from FDA reviewers ahead of an expert advisory board meeting is that the vaccine is good to go.

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Novartis signs AI ophthalmology pact with RetinAI

Pharma Times

Agreement will utilise RetinAI's IT solutions and artificial intelligence tools to support projects in ophthalmology

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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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Miniature guttural toads on Mauritius and Réunion stun researchers

Scienmag

Dwarfism occurring in less than a hundred years Credit: James Baxter-Gilbert Researchers from the DSI/NRF Center for Invasion Biology at Stellenbosch University in South Africa have found that, scarcely a hundred years after Guttural Toads were introduced to the islands of Mauritius and Réunion, their overall body size has been reduced by up to a […].

Research 107
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In multiple myeloma, cell therapies lead but antibody drugs could follow fast

Bio Pharma Dive

Two cell therapies might soon be approved for the blood cancer. But a growing group of antibody drugs, several of which were showcased at ASH, aren't far behind.

Antibody 294
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Does a lack of diversity in clinical trials reflect a lack of diversity among researchers?

pharmaphorum

Embedding diversity into clinical research does not start and end at trial recruitment – the community needs processes and institutions that reflect society and provide representation. Greater representation among study designers, research teams, and funding committees would lead to greater diversity among research participants and help to tackle health inequalities.

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MHRA issues allergy warning for Pfizer/BioNTech COVID-19 jab

Pharma Times

Updated guidance warns people with a history of allergic reactions not to receive the shot

Allergies 143
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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.