September, 2021

Pfizer, Merck launch large new trials of oral COVID-19 drugs

Bio Pharma Dive

Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year

Trials 285

What is Biogen and can they repair their reputation?

World of DTC Marketing

SUMMARY: If I were to ask you, “what type of company is Biogen?” ” what would be your response? I tried asking that of several colleagues in the industry, and they couldn’t come up with an answer. Biogen has lost its way and is in desperate need of a corporate rebranding.

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Advancing from Research to Development: What Can Go Wrong?

Camargo

The drug development process is a long journey, beginning with drug discovery, moving through nonclinical and clinical studies, and ultimately culminating in regulatory approval.

Phony Diagnoses Hide High Rates of Drugging at Nursing Homes

NY Times

At least 21 percent of nursing home residents are on antipsychotic drugs, a Times investigation found.

2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

Dr. Daniel Pauly’s extraordinary life and work revealed in new book

Scienmag

Daniel Pauly is the world’s most-cited fisheries scientist, but life for the UBC professor has been far from easy. The biracial son of a French woman and an American GI, he was born in Paris and kidnapped as a child to be a live-in servant for a Swiss family. He escaped to Germany at […].

Automatic Student Loan Forgiveness for People with Disabilities

Triage Cancer

Breaking News: Thanks to a new decision by the U.S. Department of Education , many people with disabilities will receive automatic student loan forgiveness through the Total and Permanent Disability (TPD) Discharge program! What is a Total and Permanent Disability (TPD) Discharge?

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Medicare savings won’t make a dent in healthcare costs

World of DTC Marketing

SUMMARY: Allowing Medicare to negotiate drug prices is popular with voters because the media has been focused on the high price of some drugs, but this measure won’t lead to lower healthcare costs.

In the News: August 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. Some Drugs May Require Reclassification to Devices.

Purdue Pharma Is Dissolved and Sacklers Pay $4.5 Billion to Settle Opioid Claims

NY Times

The ruling in bankruptcy court caps a long legal battle over the fate of a company accused of fueling the opioid epidemic and the family that owns it.

Drugs 96

TDP-43 DNA methylation may contribute to the mystery of age-dependent motor cortex involvement in ALS

Scienmag

Niigata, Japan – Amyotrophic lateral sclerosis (ALS) is an intractable neurological disease. Aging is a risk factor for the accumulation of TDP-43 (transduction responsive region DNA-binding protein of 43kDa) in the motor cortex.

DNA 89

An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

The D.C. District Court Slaps Down on Procedural Grounds FDA’s 20-year Effort to Implement its Memorandum of Understanding to Address Interstate Shipments of Compounded Drug Products

FDA Law Blog

By Karla L. Palmer — The tale of “David versus Goliath” is never a dull skirmish. This time, “David” consists of a cast of seven compounding pharmacies and their amicus curiae supporters.

After talks with FDA, a biotech prepares to submit its closely watched ALS drug

Bio Pharma Dive

Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months

Drugs 283

Of course, ageism exists in pharma

World of DTC Marketing

SUMMARY: Those working in pharma know that ageism exists, especially in the sales force. Pharma has been purging older employees for some time, and when you reach the magic age of 50+, you’re going to be pushed to take “early retirement.”

Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 2

Camargo

As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined.

Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

Joe Rogan, A Podcasting Giant Who Has Been Dismissive of Vaccination, Has Covid

NY Times

“I got fevers, sweats, and I knew what was going on,” he said in a video on Instagram on Wednesday, after returning from a series of shows in Florida.

UCLA bioengineers develop new class of human-powered bioelectronics

Scienmag

A team of bioengineers at the UCLA Samueli School of Engineering has invented a novel soft and flexible self-powered bioelectronic device.

Pharmacy Owner Pleads Guilty to Federal Charges for Illegally Administering COVID-19 Vaccines to Children Under 12

FDA Law Blog

By Kalie E.

Fourth trial volunteer dies in Astellas gene therapy study

Bio Pharma Dive

The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used

The hypocrisy of big pharma

World of DTC Marketing

SUMMARY: Pfizer will earn over 26 billion dollars from their COVID vaccine, while Moderna and J&J also look to their vaccines for more profit dollars. The suggestion by Pfizer’s CEO that drug pricing negotiations with the government would slow innovation is PR doubletalk.

World Pharmacists Day 2021 Celebration

Pharma Mirror

25th September is celebrated as world pharmacists day, and it brings a new theme every year. The main motive behind this celebration is to give an excellent message to improve people’s health worldwide. And also, create an acceptance and encourage the role of a pharmacist in health.

83

Pfizer Vaccine Protection Wanes, C.D.C. Study Shows

NY Times

The study found that the shots’ effectiveness in preventing hospitalization fell to 77 percent from 91 percent four months after full vaccination. Vaccination and Immunization Drugs (Pharmaceuticals) Research BioNTech SE Centers for Disease Control and Prevention Pfizer Inc

Infants exposed to domestic violence have poorer cognitive development

Scienmag

COLUMBIA, Mo. While assessing a pregnant woman with premature labor in 1983, Linda Bullock noticed bruises on the woman. When she asked what happened, the woman told Bullock a refrigerator had fallen on her while cleaning the kitchen. Credit: MU COLUMBIA, Mo.

Best Places to Visit in Florida

Riverside Clinical Research

Florida is one of our nation’s, if not the world’s, most popular vacation destinations…and for very good reason. Although it is extremely hard to narrow down, here is a small sampling of the best places to visit if you happen to be in Florida.

After long wait, Editas reveals first data for CRISPR gene editing treatment

Bio Pharma Dive

Early study results offer some hopeful signs of efficacy, but the small number of patients treated and short follow-up limit firmer conclusions

PhRMA buys politicians and patients lose

World of DTC Marketing

SUMMARY: Three House Democrats on a key committee voted against the measure to lower drug prices as PhRMA ramped up its lobbying dollars to buy politicians.

How pharmacists can partner with health coaches

Pharma Mirror

What is a health coach? A health coach is someone with expertise in wellness who assists people achieve good health by being a mentor and educator on lifestyle and nutritional changes.

83

Study of Covid Booster Shot Benefits Fans Debate Over Extra Doses

NY Times

Independent experts, including government scientists, were skeptical of the research from Israel, which included limited data over a short period.

The first corona lockdown was a ‘live experiment,’ revealing big behavioral gender differences

Scienmag

[Vienna, September 28, 2021] In a crisis, women make significantly longer phone calls and adhere more closely to governmental measures than men; men are less likely to have their mobility restricted and return to normal more quickly than women.

FDA Approves First Human Trial for Potential CRISPR-Led HIV Cure

BioSpace

?The FDA's IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy

CDC panel clears way for Pfizer booster shots, but divided on broader use

Bio Pharma Dive

Agency advisers supported giving a third Pfizer vaccine dose to older adults and those with medical conditions. But in a break with the FDA, they voted against recommending it for younger people in high-risk jobs

The drug industry can’t fight change

World of DTC Marketing

SUMMARY: John F. Kennedy said, “Change is the law of life, and those who look only to the past and present are certain to miss the future”. Change is coming for one simple reason; our country can’t sustain the current costs of healthcare.

Pharmacists must be mobilised to mitigate health impacts of air pollution

Pharma Mirror

The Hague, Pharmacists must be allowed to do more to manage respiratory conditions in communities if the urgent need to address the harmful effects of air pollution on health is to be met, the International Pharmaceutical Federation (FIP) said today.

82

Cancer Without Chemotherapy: ‘A Totally Different World’

NY Times

A growing number of cancer patients, especially those with breast and lung cancers, are being spared the dreaded treatment in favor of other options. Chemotherapy Breast Cancer Lung Cancer Genetics and Heredity Drugs (Pharmaceuticals) Women and Girls Tumors Immunotherapy Longevity

How land birds cross the open ocean

Scienmag

Researchers at the Max Planck Institute of Animal Behavior and University of Konstanz in Germany have identified how large land birds fly nonstop for hundreds of kilometers over the open ocean—without taking a break for food or rest.