September, 2021

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

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.

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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.

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 […].

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.

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Incyte Names New Member to Its Board of Directors

BioTech 365

Incyte Names New Member to Its Board of Directors Incyte Names New Member to Its Board of Directors WILMINGTON, Del.–(BUSINESS –(BUSINESS WIRE)–$INCY–Incyte (Nasdaq:INCY) announces the appointment of Otis Brawley, M.D.,

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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 282

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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.

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.

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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.

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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?

FDA halts tests of BioMarin drug amid heightened focus on gene therapy safety

Bio Pharma Dive

On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice

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.”

Sales 210

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.

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.

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.

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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.

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

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.

Drugs 203

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

Scientists use nuclear physics to probe Floridan Aquifer threatened by climate change

Scienmag

As rising sea levels threaten coastal areas, scientists are using an emerging nuclear dating technique to track the ins and outs of water flow Credit: (Image by Argonne National Laboratory.)

Codivir Shows Promising Effect Against COVID-19

Pharma Mirror

TEL AVIV, ISRAEL / DE BILT, NETHERLANDS – Codivir, a short synthetic 16 amino-acid peptide, derived from the HIV-1 integrase, was originally discovered at the Hebrew University in Israel.

Amazon names 10 finalists in its first digital health accelerator

Pharma Phorum

Amazon’s push into healthcare takes many forms, and one is decidedly biotech-like – running an accelerator to identify and support startups with promising technology platforms.

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.

Pharma in the Courts: Takeda, AbbVie, RedHill, Pfizer and Gilead

BioSpace

Aside from the fraud trial of Theranos founder Elizabeth Holmes, other court-related cases are taking place, including between Takeda and AbbVie over cancer drug, Lupron

Trials 108

PSMA PET imaging more accurate than CT in detecting hepatocellular carcinoma

Scienmag

Reston, VA (September 30, 2021)—PSMA (prostate-specific membrane antigen) PET/CT is more accurate than conventional CT in the detection of hepatocellular carcinoma metastases, according to research published in the September issue of The Journal of Nuclear Medicine.

Remote Patient Monitoring Industry

Pharma Mirror

Increasing burden of chronic diseases and rising awareness about necessity of early warning signs are fuelling the demand of remote patient monitors With the COVID-19 pandemic, health systems or hospitals rapidly adopted remote patient monitoring technology to maintain social distancing and thereby control viral spread.

AI could be used to guide drug therapy for heart failure

Pharma Phorum

UK researchers have used artificial intelligence (AI) to develop a way to identify patients with heart failure who would benefit from treatment with beta blockers, by interrogating data from nine landmark clinical trials.

At FDA meeting, gene therapy experts wrestle with field's blindspots

Bio Pharma Dive

A panel convened by the regulator suggested ways to make gene therapy research safer, but struggled to propose broader recommendations for the field

DTC messages need to evolve

World of DTC Marketing

SUMMARY: With patients staying away from their doctors because of COVID, DTC messages need to add incentives and better messaging to get people to take action rather than wait. No one message will do this, however. Messages need to evolve in these special times.

Growing Glioblastomas in a Laboratory: 3D Bioprinting a Better Brain Model

BioSpace

This newfound ability to take tumor cells directly from a patient and incorporate them into a more clinically accurate glioblastoma model could lead to greater patient personalization in cancer therapeutics

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Early accumulation of tau in the brain predicts memory decline in Alzheimer’s disease

Scienmag

Researchers at Karolinska Institutet in Sweden have compared how well different Alzheimer’s biomarkers predict the progression of the disease and its effect on the memory.

New report sheds light on medicine shortages in Northern Ireland following Brexit

Pharma Times

Informa Pharma Intelligence (IPI) has found that some drug firms may withdraw up to 90% of their products from Northern Ireland, once the Brexit grace period has passed

How blockchain can revolutionise medical records and save lives

Pharma Phorum

Balancing medical privacy with ease of access for healthcare professionals is a challenge, but technology could provide the solution, says Aleph Zero Foundation’s Matthew Niemerg.

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Acceleron provides biggest biopharma deal this year, with $11.5B sale to Merck

Bio Pharma Dive

The acquisition is notable for Merck, which is under pressure to diversify its business beyond the cancer drug Keytruda and has typically favored smaller buyouts

Sales 266

Mandating vaccinations is the right decision

World of DTC Marketing

SUMMARY: Marci Hamilton, a professor at the University of Pennsylvania Constitution, said, “The Constitution is not a suicide pact guaranteeing a right to harm others.