Sat.Feb 20, 2021 - Fri.Feb 26, 2021

article thumbnail

FDA review supports safety, efficacy of J&J coronavirus vaccine

Bio Pharma Dive

Agency scientists noted the shot's strong protection against severe COVID-19, even for the virus variant first detected in South Africa and known to weaken vaccine potency.

article thumbnail

The health care industry should also invest more preventative health

World of DTC Marketing

SUMMARY: In a recent study by The Harris Poll on behalf of TIME, the overwhelming majority of Americans (78%) admitted to delaying routine medical services and health care appointments due to the coronavirus pandemic. The health care industry should invest more in patient outreach, communication and education. Via The NY Times “the coronavirus pandemic has yet to end, but we are already beginning to feel the aftershocks.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Top 5 Common Misconceptions About Meeting with the FDA

Camargo

Preparing to meet with the FDA can be challenging and stressful for sponsors, especially when they do not know what to expect. Many have misunderstandings about how meetings should be conducted and what constitutes success. Others find themselves needing to dispel incorrect preconceptions about this interactive process for board members or investors.

article thumbnail

Pfizer/BioNTech to trial COVID-19 vaccine in pregnant women and children

BioPharma Reporter

Pfizer and BioNTech have dosed the first participants in a Phase 2/3 study for their COVID-19 vaccine in pregnant women; and plan to trial the vaccine in children later this year.

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

Moderna, Pfizer ready multi-pronged plans for coronavirus variants

Bio Pharma Dive

Moderna has delivered a modified version of its vaccine to NIH scientists, while Pfizer has begun testing of an additional booster shot in a clinical trial, both precautionary steps against emerging strains.

article thumbnail

Jazz Pharma uses flying pig for huge grey area DTC

World of DTC Marketing

SUMMARY: One of the biggest complaints people have about their health is the lack of sleep caused by many factors, from diet and weight to chronic stress. DTC for a product that can keep people awake for nine hours is a message for potential abuse. Did I mention that they are using a flying pig in their DTC? One of the most common complaints people have is “lack of energy” Consumers have turned to energy drinks which was valued at $53.01 billion in 2018, and is expected to grow at a

Doctors 181

More Trending

article thumbnail

Climate impacts drive east-west divide in forest seed production

Scienmag

Western forests may be less able to regenerate following large-scale diebacks Credit: USGS DURHAM, N.C. — Younger, smaller trees that comprise much of North America’s eastern forests have increased their seed production under climate change, but older, larger trees that dominate forests in much of the West have been less responsive, a new Duke University-led […].

article thumbnail

FDA lays out shortened path for testing vaccines against new coronavirus variants

Bio Pharma Dive

Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance.

article thumbnail

Drug side effects should be easier to understand

World of DTC Marketing

SUMMARY: Per the Times, “what if consumers could calculate the benefits and risks of taking a prescription drug as easily as they can gauge the carbohydrates and calories in an Oreo cookie?” Drug facts boxes are needed, but the FDA disagrees. According to the AMA one of the key reasons for non-adherence is that patients may be frightened of potential side effects.

Drugs 173
article thumbnail

Common but not normal: It’s time to talk about maternal mental health

pharmaphorum

As part of our Patients Insights series, the founder and CEO of Motherhood Understood shares her experience of postpartum depression, talks about the power of peer support, and explains what the wider healthcare community could do to play their part. Within days of giving birth to her first child, Jen Schwartz’s fairy tale view of motherhood lay in tatters at the foot of the bed she found it impossible to leave.

Doctors 122
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

'Vaccines are working': UK unveils real-world data from vaccination campaign

BioPharma Reporter

Real-world data from England shows that the Pfizer/BioNTech vaccine offers 'clear protection from first dose' and may help interrupt transmission; while Scottish data shows the first doses of vaccines led to a substantial fall in hospital admissions.

article thumbnail

Top Moderna executive to leave company later this year

Bio Pharma Dive

Tal Zaks, the biotech's chief medical officer for the past six years, will depart in September after playing a high-profile role in the company's coronavirus vaccine development.

article thumbnail

15 Clinical Research Job Roles & Responsibilities (2021)

Clinical Trial Podcast

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”. That’s when this post comes handy. Clinical Research is sometimes also referred to as Medical Affairs or Clinical Affairs.

article thumbnail

Why we need research into the mental health impact of a rare disease diagnosis

pharmaphorum

Rare diseases impact between 3.5%-5.9% of the world’s population. For Rare Disease Day, RBW Consulting’s Emma Thorp discusses why the consultancy is taking revenue earned from its rare disease clients and using it to fund research into the mental health impact of a rare disease diagnosis. Rare diseases are often chronic and life-threatening, and with a large percentage of cases presenting in young children, a diagnosis has a profound and unique impact on everyone affected.

Research 117
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

70% Drop in COVID-19 Cases in UK Analyses After Just One Pfizer Shot

BioSpace

Public Health England (PHE) published real-world analyses of people in the UK who had received the first shot of the Pfizer-BioNTech COVID-19 vaccine.

article thumbnail

Regeneron wins FDA OK in lung cancer for immunotherapy rival to Merck's Keytruda

Bio Pharma Dive

The approval of Libtayo in first-line lung cancer will pit Regeneron's drug, developed in partnership with Sanofi, against Merck's top-selling immunotherapy Keytruda.

article thumbnail

Need Health Insurance? Marketplaces are Open Now!

Triage Cancer

Health Insurance Marketplaces are now open for a Special Enrollment Period (SEP). In the 36 states with Marketplaces on www.HealthCare.gov, individuals have the opportunity to buy a new health insurance policy or change policies until May 15, 2021. While this SEP was created in response to the pandemic, you do not have to have been impacted by COVID-19 to benefit.

98
article thumbnail

Healthcare’s digital transformation began within weeks of pandemic – report

pharmaphorum

Healthcare organisations that have been traditionally slow to adopt new technology produced a response to the pandemic that was almost in line with less regulated industries, according to a new report. Findings of research from the cloud communications platform Twilio based on 2,500 enterprise decision makers, including 117 healthcare organisations, showed it took 36 days on average to accelerate a digital transformation strategy.

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

FDA Approves Third Sarepta Treatment For Duchenne Muscular Dystrophy

BioSpace

The U.S. FDA approved Sarepta Therapeutics’ Amondys 45 (casimersen) for patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation amenable to exon 45 skipping.

article thumbnail

After FDA feedback, a biotech's ALS therapy faces murky path forward

Bio Pharma Dive

Brainstorm Cell Therapeutics said that, following a review of Phase 3 data, the agency felt the results were not enough to support an approval application.

305
305
article thumbnail

Clinical Research Jobs: How to Choose the Right Career Path

XTalks

Clinical research is part of a growing industry that provides individuals with rewarding career options and a ladder to climb. Working in the clinical trials industry allows clinical researchers to work with patients and bring new drugs to market. There are many professions under the clinical research umbrella. To become a professional in this field, one must begin by achieving a bachelor’s degree in a science-related field.

article thumbnail

Altimmune begins trial of nasal vaccine for COVID-19

pharmaphorum

Pfizer/BioNTech’s mRNA vaccine against COVID is a technical marvel – but the ultra-cool temperatures required for storage and stability has been tricky to handle. Maryland, US-based company Altimmune is among the biotechs and research labs trying to find more convenient alternatives and believes a nasal vaccine spray that is stable at room temperature could be the answer.

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

FDA Plans Ahead for COVID-19 Mutations with Booster Shot Guidance

BioSpace

The U.S. FDA issued new guidance for vaccine makers as it is preparing for the possibility of needing to approve COVID-19 booster shots against variants of the SARS-CoV-2 virus.

article thumbnail

Sarepta wins FDA approval of another drug for rare muscular dystrophy

Bio Pharma Dive

Amondys 45 is now cleared for the estimated 8% of Duchenne patients eligible for treatment. Like other Sarepta drugs, it comes with a high price tag and its clinical benefits haven't been confirmed.

article thumbnail

The Coronavirus Is Plotting a Comeback. Here’s Our Chance to Stop It for Good.

NY Times

Many scientists are expecting another rise in infections. But this time the surge will be blunted by vaccines and, hopefully, widespread caution. By summer, Americans may be looking at a return to normal life.

article thumbnail

Sanofi’s immunotherapy Libtayo gets FDA not in first line lung cancer

pharmaphorum

Sanofi’s cancer immunotherapy Libtayo (cemiplimab) has a third US indication after the FDA approved it for certain untreated lung cancer patients. The approval in first-line lung cancer, in non-small cell lung cancer patients whose tumours have high PD-L1 expression brings the drug into competition with Merck & Co’s Keytruda (pembrolizumab), which has become the go-to therapy in this disease.

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

How the Recession Has Boosted Plant-Based Eating

XTalks

Long before the COVID-19 pandemic, many have made the case for going vegetarian , not only to reduce animal suffering, benefit the environment or lead a healthier life, but also for the economic value. With millions of Americans temporarily laid off or unemployed, many are turning to a “rice and beans” diet during this recession. Prior to the most recent economic downturn, misconceptions have existed that plant-based or vegetarian diets are too expensive for the average American, specifically fo

Sales 94
article thumbnail

Icon to buy contract researcher PRA Health for $12B

Bio Pharma Dive

The cash-and-stock deal gives PRA shareholders roughly one-third ownership of the new company, which will be one of the larger providers of contract research support.

Research 289
article thumbnail

PharmaTimes are excited to announce the launch of CROY 2021

Pharma Times

The prestigious Clinical Researcher of the Year – The Americas has now opened its doors for entry, continuing the successes of the 10th anniversary last year.

article thumbnail

Building a better future for people with rare diseases in all four UK nations

pharmaphorum

How has rare disease care changed over the last few years? And what might we expect from the next five? We attended the Rare Disease Day Virtual Parliamentary Event to find out. The rare disease community has a golden opportunity to transform the way care is delivered across all four UK nations – that’s according to speakers at a parliamentary reception held to mark 2021’s Rare Disease Day.

Genome 111
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.