5 questions ahead of next week's FDA meeting on coronavirus vaccines

Bio Pharma Dive

Normally staid affairs, next Thursday's advisory committee meeting could be historic and set expectations for how the FDA will approach any future vaccine approval

Pharma still doesn’t understand transparency

World of DTC Marketing

As development towards a COVID-19 vaccine continue so do the number of people who have said they won’t get vaccinated. The only way to get people on board with a vaccination is complete transparency about the product yet both J&J and Pfizer remain silent.

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Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020


Sponsors and regulators use surrogate endpoints to predict the long-term benefits of drug products that. The post Accelerated Authorizations Using Surrogate Endpoints: Takeaways from DIA 2020 appeared first on Camargo. Blog Clinical Studies, Phases I-IV

Clinical Course and Molecular Viral Shedding Among Patients With SARS-CoV-2 Infection

JAMA Internal Medicine

This cohort study quantitatively describes molecular viral shedding in asymptomatic and symptomatic patients with SARS-CoV-2 infection


CBD helps reduce lung damage from COVID by increasing levels of protective peptide


Johns Hopkins Scientists Discover Possible Key to Controlling COVID-19 Immune Response


They believe that by inhibiting factor D, it would reduce the inflammatory reactions that make COVID-19 so deadly

More Trending

Benefits of Getting Counseling

Triage Cancer

Like many people, I thought fighting cancer was a physical battle and that recovering from surgery was the victory. Looking back now, seven years later, I see that the battle had two fronts: the physical and the emotional. I neglected the latter.

Quantitative Biomarkers in Clinical Research Imaging Trials


Quantitative imaging techniques are defined by the Radiologic Society of North America’s Quantitative Imaging Biomarkers Alliance (RSNA QIBA) as ”… the extraction of quantifiable features from medical images for the assessment of normal, or the severity, degree of change, or status of a disease, injury, or chronic condition relative to normal.”

5 Ways That Digital Signage Improves a Doctor’s Office

Pharma Mirror

When you many patients think of a doctor’s office, hospital, or healthcare facility, they picture a stuffy, cold, and outdated facility that increases your anxiety. Offices with old decor prevent patients from visiting the doctor regularly and feeling relaxed.

Modeling Coronavirus – Cytokine Storm

Pharma R&D Today

Figure 1. Classification of COVID-19 Disease States. Adapted from Sidiqi, H.K. and M.R. Mehra, COVID-19 Illness in Native and Immunosuppressed States: A Clinical-Therapeutic Staging Proposal. J Heart Lung Transplant, 2020. [1]. This piece was co-authored by Prof.

With Eli Lilly data, another drug emerges to stop breast cancers from returning

Bio Pharma Dive

The highly anticipated results could signal a change in how some patients with the most common form of breast cancer are treated — and drive up the costs of care

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COVID-19 and obesity is a lethal mix

World of DTC Marketing

QUICK READ : Obesity is associated with a higher risk of developing severe symptoms and complications of coronavirus disease, independent of other illnesses, such as cardiovascular disease. So why haven’t we acted?

Single-Arm Trials Using Real-World Evidence for Rare Disease Product Development


As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider.

Efficacy and Safety of Hydroxychloroquine vs Placebo for Pre-exposure SARS-CoV-2 Prophylaxis Among Health Care Workers

JAMA Internal Medicine

This randomized clinical trial evaluates the efficacy of hydroxychloroquine to prevent transmission of SARS-CoV-2 in health care workers with exposure to patients with COVID-19 at 2 hospitals in Philadelphia, Pennsylvania

Deep learning helps explore the structural and strategic bases of autism?


Credit: KAIST and IEEE Spectrum (Image usage restrictions: News organizations may use or redistribute this image, with proper attribution, as part of news coverage of this paper only.)

12 facts you must know – FLU SEASON 2020/2021


With just one month to go, flu season 2020/2021 is just around the corner. It is expected to be that demand for flu vaccination service will be high this year. NHS England has an ambitious target for the uptake in eligible patients groups of at least 75%.

A Dose of Optimism, as the Pandemic Rages On

NY Times

The months ahead will be difficult. But the medical cavalry is coming, and the rest of us know what we need to do


The Supreme Court & Potential Implications for our Health Care System

Triage Cancer

The passing of Justice Ruth Bader Ginsburg has left a vacancy on the Supreme Court of the United States.

Giving the forgotten generation of cancer patients a voice

Pharma Phorum

Young people with cancer need a “seat at the table”, but instead they are often side-lined and voiceless. That’s according to advocate Megan-Claire Chase, who has been blogging about her experiences since she was diagnosed with invasive lobular breast cancer in her early 30s.

The Themes of The World Pharmacists Day 2010-2020

Pharma Mirror

Pharmacists are healthcare professionals who have enough knowledge about the effective uses of medications. World Pharmacist Day is celebrated on 25th September every year since 2010 on the day FIP (International Pharmaceutical Federation) started their journey.


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. Bio Developments

Moderna says its coronavirus vaccine sparks immune response in older people

Bio Pharma Dive

An initial look at the vaccine's effects on the elderly shows those in their 70s had similar responses to those under 55, Moderna told a government panel

The sweeping biotech business model

World of DTC Marketing

R&D has been replaced with acquisitions. The latest is J&J’s deal to buy out Momenta for $6.5 billion. This week alone Sanofi, BMS, and other big pharma companies have spent billions on the purchase of smaller, promising companies who have drugs that could lead to happy investors.

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In the News: September Regulatory and Development Updates


Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Establishes Digital Health Center of Excellence.

Community Outbreak Investigation of SARS-CoV-2 Transmission Among Bus Riders in Eastern China

JAMA Internal Medicine

This cohort study examines the potential for airborne spread of COVID-19 through investigation of an outbreak among bus riders in Eastern China


Rethinking the link between cannabinoids and learning


Credit: Illustration by Rita Félix, PhD. Cannabinoids have a strong influence on how our brains work and how we behave. Many people are only aware of the recreational aspect of cannabinoids.

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


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

Project Management & Planning for Successful Clinical Trials

Forte Research Systems®

Follow these project management and planning basics while conducting clinical research at your site. Efficient Clinical Trials Site Management

Ensuring process consistency and cost effectiveness with AIM 3000

Syntegon Technology Pharma Blog

Liquid Dosage Pharma AIM Ampoules Inspection


Life science leaders sign new ‘Biotech Social Pact’ for Europe

Pharma Phorum

The signatories of a new Biotech Social Pact with Europe and patients explain why healthcare calls for a new social contract, not a pharmaceutical strategy.

F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say

NY Times

Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about where a key statistic came from

Potential HIV cure Phase I trial gets FDA green light

Outsourcing Pharma

American Gene Technologies has received the agencyâs approval to launch the first human trial for its lead HIV program, starting in Baltimore and DC. Clinical Development

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A cure for hemophilia is closer than ever. For many patients, it could be just out of reach.

Bio Pharma Dive

Approval of BioMarin's Roctavian, should it come as expected this week, would deliver on decades of unfulfilled hopes for a gene therapy fix to one of the earliest identified inherited diseases

Pharma is hiring

World of DTC Marketing

IN BRIEF: Pharma companies have been posting jobs on LinkedIn almost every day. While most offices remain closed pharma is preparing for the launch of new products and has to have the infrastructure to ensure a successful launch.