September, 2021

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

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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.

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 […].

Lessons in Supply Chain Digitization from PepsiCo and Conagra

Speaker: Craig Weiss, ConAgra Brands; Mari Roberts PepsiCo; and Matt Elenjickal, FourKites

Supply chain digitalization is key to success as market volatility, widespread disruption & stiff competition for consumer dollars puts pressure on every aspect of the supply chain. Register to hear how 2 global brands are accelerating digital transformation and increasing efficiency & automation throughout their operations.

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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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.

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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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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3 Ways End-to-End Visibility Helps Minimize the Risks of Ocean Freight

Download this playbook to learn how end-to-end visibility helps to mitigate risk associated with the ocean freight market.

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.

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.”

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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.

4 Silver Linings of the Chaotic Ocean Freight Market

Speaker: Peter Tirschwell, Chris Stauber, Sarah Barnes Humphrey, and Audrey Ross

Join this webinar exploring the silver linings that have emerged from the chaotic ocean freight market. The discussion will highlight solutions that prioritize digitization and build a more efficient international supply chain. Jan 25 at 10am CT.

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.

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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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

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

The Smart Data Revolution: How AB InBev Drives Efficiency with Visibility Data

Speaker: AB InBev and FourKites

Register for our upcoming webinar to learn how leveraging the right data to make quick, well-informed decisions is the key to success in supply chain & logistics. Join FourKites and AB InBev to learn what’s possible with a data-driven supply chain strategy & real-time transportation visibility.

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.

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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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Brands can boost their own reputations and sales by praising rivals

Scienmag

Whether they’re beefing on billboards or sparring on social media, big brands are known for taking jabs at their competitors (see the famous “Get a Mac” ads or “the chicken sandwich wars”).

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.

Modernizing Pharmaceutical Supply Chains

Speaker: Nimesh Patel, Gregory Demitrack, and Sarah Barnes Humphrey

Register for our upcoming webinar to better understand the state of the pharmaceutical supply chain. FourKites partnered with Accenture to survey supply chain executives working in pharmaceuticals, biotech, cell and gene therapy, medtech, and other related industries.

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

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.

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Telling it how it is: The need for plain language summaries in medical journals

BioPharma Reporter

Open Pharma wants to see articles in peer-reviewed medical journals provide plain language summaries: those written in everyday language that is easy to understand by anyone from patients to policymakers. It's now set out its recommendations on how to write a good plain language summary.

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Minimizing Retail Supply Chain Disruptions in 2021 and Beyond

Speaker: Izaac Moran, Customer Success Manager, FourKites; Glenn Koepke, SVP of Customer Success, FourKites; and featuring interviews with supply chain experts from Dollar Tree and Best Buy

Register for our upcoming webinar to see how savvy retailers including Dollar Tree and Best Buy are leveraging real-time visibility across their end-to-end supply chains in creative ways to drive agility and thrive in today’s unpredictable environment.

A 3D printed vaccine patch offers vaccination without a shot

Scienmag

CHAPEL HILL, N.C. Scientists at Stanford University and the University of North Carolina at Chapel Hill have created a 3D-printed vaccine patch that provides greater protection than a typical vaccine shot. Credit: University of North Carolina at Chapel Hill CHAPEL HILL, N.C.

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.

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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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

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.