September, 2020

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

How Are Biopharma Companies Evaluating Partnerships in the Rare Disease Space?


Panel Summary from the World Orphan Drug Congress 2020. Last month, executives from leading international biopharma companies came together at the World Orphan Drug Congress 2020 to discuss how they are evaluating new opportunities in the rare disease space.


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Prescription Digital Therapeutics: When Software Is the Active Ingredient


With smartphones now ubiquitous, interest has increased in digital health solutions such as telemedicine platforms. The post Prescription Digital Therapeutics: When Software Is the Active Ingredient appeared first on Camargo. Blog Combination Products Device

Pfizer pushes deeper into China with stake in cancer biotech

Bio Pharma Dive

The $200 million investment in CStone Pharmaceuticals puts Pfizer in charge of selling a cancer immunotherapy in the world's second largest drug market

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.

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.)

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.

More Trending

In the News: August Regulatory and Development Updates


Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explore how those changes could impact your program. Fitbit developing algorithm COVID-19 early detection.

After a rare win, a biotech details long-awaited results for its ALS drug

Bio Pharma Dive

Data published Wednesday describe what one study investigator deems a milestone in the fight against ALS, a deadly and progressive neurological disorder

Drugs 277

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.

National parks preserve more than species


Study of Costa Rican rainforest shows national parks are more resilient than expected Credit: Jeff Fitlow/Rice University HOUSTON – (Sept.

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.”

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.

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

How biotech and pharma companies pay their CEOs, and their workers

Bio Pharma Dive

The median CEO of 231 drug companies analyzed by BioPharma Dive earned 50% more last year than in 2017, a leap that far outpaced the more modest pay gains among employees

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 based employees back to work.

Drugs 165

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


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 […]. Medicine & Health Biology Cell Biology Circadian Rhythm Diet/Body Weight Genes Genetics Medicine/Health Metabolism/Metabolic Diseases Physiology

Gene 81

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

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.


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

Drugs 274

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.

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.

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

Provide shady spots to protect butterflies from climate change, say scientists


Credit: Andrew Bladon Researchers have discovered significant variations in the ability of different UK butterfly species to maintain a suitable body temperature. Species that rely most on finding a suitably shady location to keep cool are at the greatest risk of population decline.

Could a COVID-19 breath test help UK out of lockdown?

Pharma Phorum

A potential COVID-19 breath test has been unveiled in the UK, as the country desperately searches for alternatives to crippling lockdown measures to prevent the disease from spreading.

Biogen's all-important Alzheimer's drug enters the review gauntlet

Bio Pharma Dive

On Nov. 6, aducanumab will go before a panel of experts who will review it and make recommendations to the FDA. Meanwhile, the drug has also caught the attention of a powerful cost watchdog group

Drugs 272

Launching a new drug: How much to spend on DTC?

World of DTC Marketing

HERE”S THE DEAL: Determining how much to spend for the launch of a new drug is a challenge we all face and you have to be ready to shift funds from channels that are failing to provide the lift in brand awareness to channels that hit the bullseye on your objectives.

Sales 153

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

Bradykinin Hypothesis of COVID-19 Offers Hope for Already-Approved Drugs


A group of researchers at Oak Ridge National Lab used the Summit supercomputer, the second-fastest in the world, to analyze data on more than 40,000 genes from 17,000 genetic samples related to COVID-19

Gene 113

New study reveals why flu can be devastating for pregnant women


Pre-clinical study suggests virus does not stay in the lungs but spreads throughout the mother’s body Credit: RMIT University New research helps explain why flu can lead to life-threatening complications during pregnancy, suggesting the virus does not stay in the lungs but spreads throughout the mother’s body.

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.

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

Ageism within pharma

World of DTC Marketing

WHAT”S HAPPENING? As more and more pharma companies merge and the industry consolidates good jobs are going to shrink, Unfortunately, what I’m hearing and seeing is that the industry is passing on older candidates with experience in favor of younger candidates who may be perceived as more technology literate. Kathy was someone who impressed me from the first time I met her. Her knowledge of all aspects of pharma marketing was like an encyclopedia.

HR 127

Epilepsy gene therapy candidate moves closer to clinical study phase

BioPharma Reporter

Gene therapy developer, CombiGene, and CDMO, Cobra Biologics, have signed off on a deal to secure Good Manufacturing Practice (GMP) production of two essential plasmids needed for the manufacture of CombiGene's gene therapy, CG01. Upstream Processing

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


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

Trials 112

The brain can induce diabetes remission in rodents, but how?