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

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Pfizer says coronavirus vaccine study still on track for October readout

Bio Pharma Dive

Importantly, the study committee hasn't had reason to pause vaccinations in the trial, something AstraZeneca and the University of Oxford recently reported in tests of their vaccine.

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Oncology DTC: Opportunities

World of DTC Marketing

IN SUMMARY: According to a Takeda Oncology report “for people diagnosed with multiple myeloma, there can be an abundance of information, which can lead to confusion around the next steps in their diagnosis and treatment plan. Particularly, there appears to be a disconnect between what they understand and what they want to know about the treatment journey that lies ahead.

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Royal Society of Chemistry’s journal archives now available to companies for Text and Data Mining

Pharma Mirror

The Royal Society of Chemistry has launched its new Text and Data Mining (TDM) solution, making its full collection of research journals available to companies for AI and machine learning applications. With the volume of published research available growing hourly, access to the RSC’s collection in machine-readable format offers companies the opportunity to extract, pinpoint.

Research 243
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iBio’s FastPharming® Platform Produces Decoy Therapeutic to Bind to SARS-CoV-2

BioSpace

Recently licensed from Planet Biotechnology, the candidate is a recombinant protein made from human angiotensin converting enzyme 2 (ACE2) fused to a human immunoglobulin G Fc fragment.

Licensing 143
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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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AstraZeneca, Oxford vaccine study allowed to restart in UK

Bio Pharma Dive

Six days after a worrisome illness in a U.K. study participant led to a worldwide pause in vaccinations, the country's drugs regulator and an independent committee allowed testing to resume.

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Our healthcare has failed us

World of DTC Marketing

IN SUMMARY: American healthcare is failing. Not only has the FDA become a political pawn but almost half the population is now obese. While there are lots of reasons for this the silence of healthcare providers is a huge reason. The adult obesity rate passed 40 percent nationally for the first time according to the 2017–2018 National Health and Nutrition Examination Survey (NHANES), a 26 percent jump from 2007–2008.

More Trending

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UPMC Researchers Isolate Tiny Antibody That Neutralizes SARS-CoV-2 Virus

BioSpace

The researchers used this antibody, which is 10-times smaller than a full-sized antibody and the smallest isolated biological molecule to date, to develop a potential therapeutic and prophylactic agent against the virus termed “Ab8.

Antibody 129
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Moderna, in bid for transparency, discloses detailed plan of coronavirus vaccine trial

Bio Pharma Dive

The biotech, among the furthest along in coronavirus vaccine development, is the first developer to share the so-called study protocol of its large Phase 3 trial.

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AbbVie doesn’t care about employees

World of DTC Marketing

THE BASICS: A “critical part” of pharmaceutical company AbbVie ‘s success is “face-to-face” interaction, CEO Richard Gonzalez explained in an Aug. 27 email outlining its process for bringing thousands of U.S.-based employees back to work. This is beyond irresponsible. According to CNBC “AbbVie workers say they worry that the company is putting profits ahead of safety and the health of its U.S. employees and their families at risk.

Drugs 192
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Vaccine Makers Keep Safety Details Quiet, Alarming Scientists

NY Times

Researchers say drug companies need to be more open about how vaccine trials are run to reassure Americans who are skittish about getting a coronavirus vaccine.

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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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Pfizer, BioNTech Say COVID-19 Vaccine Might Be Ready by End of October

BioSpace

In a weekend interview on CBS’ “Face the Nation,” Albert Bourla, chief executive officer of Pfizer indicated they may have key data from its Phase III trial of the vaccine to the U.S. Food and Drug Administration by the end of October.

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Lilly offers first evidence that its antibody drug may help treat COVID-19

Bio Pharma Dive

The results, from a mid-stage study of Lilly's drug, suggest treatment helped lower virus levels, but the degree to which patients benefited remains unclear.

Antibody 315
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Online ads: Creative vs. media

World of DTC Marketing

TO THE POINT: When it comes to online advertising the creative is more important than the money you’re spending on media. DTC marketers need to create a “hook point” to lead to action. Consumers today are bombarded with so much information you have to grab their attention quick. In fact, you realistically only have 3-seconds or less.

Packaging 165
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Vaxart's oral COVID-19 tablet vaccine to enter clinical trials

BioPharma Reporter

Vaxart will start a Phase 1 clinical trial for its oral COVID-19 vaccine candidate, having received Investigational New Drug (IND) clearance.

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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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BioNTech Receives €375 Million German Grant to Help Fund COVID-19 Vaccine Effort

BioSpace

Only days after saying it expects to have key data from its Phase III clinical trial of its COVID-19 vaccine in October, Germany’s BioNTech received a grant of up to €375 million from the German Federal Ministry of Education and Research.

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Merck pays Seattle Genetics $1.7B as antibody cancer drugs continue comeback

Bio Pharma Dive

Merck's deal for Seattle Genetics' antibody-drug conjugate comes as Gilead agreed to acquire rival developer Immunomedics in the biotech industry's largest buyout of 2020.

Genetics 294
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Lilly’s antibody therapy cuts hospitalisation rates in COVID-19

pharmaphorum

Eli Lilly has followed up supportive data from its Olumiant in COVID-19 with results of a study showing its antibody treatment could help prevent hospitalisation from the disease. An interim analysis of the BLAZE-1 clinical trial showed a reduced rate of hospitalisation in patients treated with Lilly’s LY-CoV555, an antibody that neutralises the SARS-CoV-2 coronavirus, in a phase 2 trial.

Antibody 128
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BioNTech acquires German manufacturing site to boost COVID-19 vaccine production

BioPharma Reporter

BioNTech will acquire Novartisâ GMP certified manufacturing facility in Marburg, Germany: with the site set to become one of the largest mRNA manufacturing plants in Europe.

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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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Stem Cells May Help COVID-19 and ARDS Patients Breathe Easier

BioSpace

One company working towards an ARDS treatment is Athersys, a biotech company focusing on regenerative medicine therapies for diseases with significant unmet need.

Medicine 137
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Seattle Genetics stays step ahead of rivals with bladder cancer data

Bio Pharma Dive

Data confirming the company's drug Padcev can extend the lives of bladder cancer patients should strengthen its position with regulators, although Immunomedics is close behind with a competing treatment.

Genetics 289
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A history of AstraZeneca

pharmaphorum

AstraZeneca is a company with a turbulent history but, for now, a promising future. We take a look at the company’s story, from its creation as a merger of two equals, to its recent major restructuring and its drives in cutting-edge oncology and COVID-19. In 1998, Europe’s corporate landscape was riding a “merger wave” – intensive competitive pressure meant that opportunities arose for companies to merge with their competitors in order to rationalise both businesses.

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Germany grants BioNTech, CureVac $745m to advance Covid-19 vaccine work

BioPharma Reporter

To accelerate Covid-19 vaccine development, as well as upscale domestic manufacturing capabilities, the German government has announced a â750m (US$890m) fund to support the vaccine programs of three German developers, BioNTech, CureVac and IDT Biologika.

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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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Finch Closes $90 Million Series D to Advance C. Difficile Infection Product

BioSpace

The company plans to use the funds to advance its lead candidate CP101 for recurrent C. difficile infection through the final stages of clinical development and regulatory submission.

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Moderna and Pfizer, having shown speed with coronavirus vaccines, see opportunity in seasonal flu

Bio Pharma Dive

Both companies believe the messenger RNA technology they're using in their coronavirus vaccines could be applied to create a better flu shot.

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Education as the solution to the rare disease ‘diagnostic odyssey’

pharmaphorum

It took more than a year for Don Legere to receive a diagnosis of scleroderma, a rare disease that causes the skin and connective tissues to thicken and harden, robbing people of their jobs and passions. It means that in his role as president of the New England chapter of the Scleroderma Foundation, he is determined to make sure others do not suffer the same fate.

Doctors 116
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Shine bright in 2020!

Pharma Times

The deadline for entering the 2020 PharmaTimes Communications Awards, Sales Awards and Marketer of the Year competitions has been extended to Friday October 2 after a last-minute spike in enquiries

Sales 101
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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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Unity Bio Cuts 30% of Staff, Restructures to Focus on Ophthalmology and Neurology

BioSpace

UNITY Biotechnology launched a restructuring program to focus on cellular senescence in ophthalmology and neurology. As part of the plan, it is decreasing its workforce by about 30% to optimize capital.

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Lilly says its arthritis drug helps speed COVID-19 recovery

Bio Pharma Dive

The benefit of adding Lilly's Olumiant to Gilead's antiviral Veklury appeared modest, reducing time to recovery by one day in a study of hospitalized patients.

Drugs 292
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Trial backs Lilly’s Olumiant plus remdesivir as combo COVID-19 therapy

pharmaphorum

Adding Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) and Gilead Sciences’ remdesivir reduces recovery time in COVID-19 patients compared to remdesivir alone, says a new trial. The ACTT-2 trial, funded by the US government and run by the National Institute for Allergy and Infectious Diseases (NIAID), involved COVID-19 patients who had been hospitalised because of severe symptoms.

Trials 111
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Time-restricted feeding improves health without altering the body’s core clock

Scienmag

When it comes to metabolic health, it’s not just what you eat, it’s when you eat it. Studies have shown that one effective means of losing weight and tackling obesity is to reduce the number of hours in the day that you eat. Time-restricted feeding – otherwise known as intermittent fasting – has also been […].

Gene 111
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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.