June, 2021

Intellia, with first results, delivers a 'landmark' for CRISPR gene editing

Bio Pharma Dive

Results published in The New England Journal of Medicine offer the first clinical evidence that CRISPR gene editing inside the body can be safe and effective, a culmination of years of scientific research

Novo’s obesity drug has serious warnings and barriers to overcome

World of DTC Marketing

SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings.

Insiders

Sign Up for our Newsletter

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

Niche Nonclinical Studies: Uncommon Routes of Administration and Animal Models

Camargo

Camargo Research Group , Camargo’s managed nonclinical solution, has worked on more than 200 nonclinical programs since its inception in 2005, many of which include rare routes of administrations (ROAs) and use of uncommon animal species.

70-year-old coffee-killing fungus brought back to life to fight the disease

Scienmag

Credit: CABI Researchers have re-animated specimens of a fungus that causes coffee wilt to discover how the disease evolved and how its spread can be prevented.

The Rise of Audio Social Networks – Where Pharma Can Make an Impact

Pharma Marketing Network

Anyone with a smart device has been feeling the grueling effects of social isolation and screen fatigue since the start of the COVID-19 outbreak.

Decentralized Clinical Trials: A patient-centric way forward

Clairnes

The post Decentralized Clinical Trials: A patient-centric way forward appeared first on Clinical Trial Recruitment & Management Services.

8 key clinical trials to watch for the rest of 2021

Bio Pharma Dive

The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19, microbiome drugs and gene-targeted cancer therapy

More Trending

Improving the Pediatric Patient Journey with Decentralized Clinical Trials

Camargo

While the COVID-19 pandemic has accelerated innovation in many areas, including clinical trial design, many recent advancements were already in motion before 2020 as sponsors and CROs sought to improve the patient journey and encourage trial participation.

Research lays groundwork for restoring lost oral functions with pacemaker-like devices

Scienmag

Researchers determine suitable amplitude for electrically stimulating nerves in the mouth Credit: Dr. Hangue Park, Texas A&M Engineering Even the mundane act of swallowing requires a well-coordinated dance of more than 30 muscles of the mouth.

4D Pharma expanding clinical data in multiple indications

BioPharma Reporter

Live biotherapeutic product (LBP) developer, 4D Pharma, says it is building a âstrong body of evidenceâ for its portfolio of bacterial strains in relation to cancer, asthma, and neurodegenerative diseases, while the company also calls its recent dual listing a âtransformational milestoneâ.

BioNTech takes its first cancer vaccine into phase 2

Pharma Phorum

It would be easy to forget that back in 2019, BioNTech was an early-stage biotech firmly focused on cancer vaccines, before being catapulted onto the world-stage with its COVID-19 shot.

Former FDA chief Hahn joins venture firm that launched Moderna

Bio Pharma Dive

Hahn's appointment as chief medical officer of Flagship Pioneering is another example of FDA officials joining industry after their government service. Hahn's predecessor, Scott Gottlieb, sits on Pfizer's board of directors

275
275

A sad day for us all as the FDA continues to lose credibility

World of DTC Marketing

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company.

Drugs 177

Patient-Centric Approach and FDA Expertise Lead to Orphan Approval

Camargo

Challenge. An international company developing an orphan drug product needed support navigating the US regulatory process from beginning formulation to NDA approval from a partner with experience in FDA interactions and a deep understanding of the Agency’s evolving thinking. Background.

Discovery of the role of a key gene in the development of ALS

Scienmag

Loss of function of the C9orf72 gene may affect communication between neurons and muscles Credit: Christian Fleury Amyotrophic lateral sclerosis, or ALS, attacks nerve cells known as motor neurons in the brain and spinal cord, gradually leading to paralysis.

Gene 83

Data Supports Use of Anti-Parasitic Drug Ivermectin in COVID-19 Patients, Study Shows

BioSpace

Use of the anti-parasitic drug ivermectin could reduce COVID-19 related deaths, data from a peer-reviewed study shows

Drugs 114

Privacy issues widespread with digital health apps, says BMJ

Pharma Phorum

Developers of mobile health apps are comprehensively failing to safeguard the privacy of users, according to a study by researchers in Australia.

An AstraZeneca, Merck drug slows the return of genetic breast cancer. Will testing speed up?

Bio Pharma Dive

Study results disclosed ahead of ASCO could make Lynparza a standard "adjuvant" treatment for people with an inherited form of breast cancer — as long as they know they have it

Personal responsibility in the obesity epidemic

World of DTC Marketing

SUMMARY: The U.S. is one of the wealthiest countries in the world and accordingly has high obesity rates; one-third of the population has obesity plus another third is overweight. The cost of doing nothing is not an option.

In the News: May 2021 Regulatory and Development Updates

Camargo

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. Approval of the Month: Non-Opioid for Post-Surgical Pain Gets FDA Nod.

NTU launches two new programs to develop human resource talent with Institute for Human Resource Professionals

Scienmag

Credit: NTU Singapore Nanyang Technological University, Singapore (NTU Singapore) is collaborating with the Institute for Human Resource Professionals (IHRP) to launch two new MiniMasters™ programmes to develop talent in human resources (HR).

HR 83

Innate Pharma’s ANKET NK Engager Platform Eradicates Tumors Safely and Efficiently

BioSpace

Innate Pharma has an alternative to T cell-based immunotherapy that has the potential to quickly and safely eradicate solid and metastatic tumors in the body

113
113

Reflections of a Cancer Diagnosis in a New Book of Poetry: Mid-Bloom

Triage Cancer

by Katie Budris. Cancer has long impacted the women in my family, starting with my grandmother, then my mother, and now me. When I was 10, my grandmother moved in with us along with a live-in nurse to help my mother care for her until cancer and old age took her life.

In historic move, FDA approves a closely watched and controversial Alzheimer's drug

Bio Pharma Dive

With the decision, the agency cleared the way for what many predict will become a lucrative and highly sought-after option — though fierce debate continues over whether the medicine, Biogen's aducanumab, actually benefits patients' daily lives

Are Biogen employees drinking the Kool-Aid?

World of DTC Marketing

SUMMARY: The debate around Biogen’s Alzheimer’s drug continues to rage. The clinical evidence supporting the approval of the drug is at best “weak.” ” How could the FDA approve a drug with such poor clinical data?

Drugs 167

Digital fabric could be used to measure health data

Pharma Phorum

Researchers in the US have developed a wearable fabric that can sense, store and analyse data that could be used to measure physiological functions or detect illness.

Newly discovered proteins protect against progression of diabetic kidney disease

Scienmag

Credit: Copyright Joslin Diabetes Center Elevated levels of three specific circulating proteins are associated with protection against kidney failure in diabetes, according to research from the Joslin Diabetes Center that will be published 30th June in Science Translational Medicine.

Aduhelm Approval Draws Mixed Reaction, Sparks New Controversy Over Pricing

BioSpace

Not everyone is so confident that Aduhelm will transform the Alzheimer’s drug development landscape

Drugs 111

Are eCOA Screenshots Required When Submitting for Ethical Review?

ERT

The purpose of Ethical Committee (EC) review as part of the clinical trial process is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

Bristol Myers partners with Eisai in $650M deal for targeted cancer antibody

Bio Pharma Dive

The U.S. drugmaker is the latest to invest large sums of money in antibody-drug conjugates, following recent deals by Gilead, Merck and AstraZeneca

Um, about that diabetes drug that helped patients lose weight

World of DTC Marketing

SUMMARY: According to the NEJM “in participants with overweight or obesity, 2.4

Drugs 167

Novo Nordisk crowns cell therapy pipeline with $598m Heartseed deal

Pharma Phorum

Novo Nordisk is paying $55 million upfront to secure rights to a cell therapy for heart failure developed by Japanese startup Heartseed.

Pumped to assist the heart with an artificial aorta

Scienmag

Credit: © 2021 EPFL / Yoan Civet. In January of this year, EPFL engineers announced in Advanced Science their concept of a novel cardiac assist device that is devoid of rigid metallic components.

Inside ReCode’s New-in-Class Approach to Treating Cystic Fibrosis

BioSpace

The data showed that both experimental therapies restored function in the cystic fibrosis transmembrane conductance regulator gene

Gene 108

NHS England announces extra funding for young people’s mental health services

Pharma Times

An extra £40m will go toward enhancing mental health services for children and young people

105
105

Gilead matches Bristol Myers in showing benefit to earlier CAR-T treatment

Bio Pharma Dive

A study of Gilead's Yescarta found the cell therapy dramatically outperformed chemotherapy and stem cell transplant in treating lymphoma, a result that could support much broader use of the drug

Drugs 255

The Future of Health Care

World of DTC Marketing

IN SHORT : Out-of-control health care spending exact an enormous and growing toll on Americans. The scale of the broken US health care system reveals itself in tragic ways. Fraud accounts for about $300 billion of annual US health care spending.