November, 2021

New Merck study results raise questions about its COVID-19 pill

Bio Pharma Dive

Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday

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“Game-changing” obesity drug over-promising?

World of DTC Marketing

SUMMARY: Wegovy is selling so well that it’s hard to get at pharmacies. It’s being positioned as an anti-obesity drug, but one study by Novo Nordisk has shown that people who stop taking Wegovy after a few months tend to regain much of their lost weight within a year.

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Equal Parts Caregiver and Advocate: Clinical Trials from the Caregiver’s Point of View

Camargo

“There are only four kinds of people in the world: Those who have been caregivers, those who are currently caregivers, those who will be caregivers, and those who will need caregivers.”. Roslyn Carter.

A Cure for Type 1 Diabetes? For One Man, It Seems to Have Worked.

NY Times

A new treatment using stem cells that produce insulin has surprised experts and given them hope for the 1.5 million Americans living with the disease.

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.

Pangolin trafficking: iceberg tip of Nigeria’s illegal trade revealed

Scienmag

Since the first reported pangolin seizure in Nigeria in 2010, the country has seen an explosion in the black market for the world’s most trafficked mammal – becoming Africa’s hub for the criminal export of pangolin products to East Asia.

Native Advertising is Exploding Across Healthcare, Have you Jumped In?

Pharma Marketing Network

In the last 2 years, and accelerated by Covid, native advertising has exploded across healthcare for DTC and HCP marketing. Native ads have been adopted by all healthcare industries including pharma, device, health systems, retailers, pharmacies, payers, and the gamut of regional service providers.

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The current pricing of cancer treatments is unsustainable

World of DTC Marketing

SUMMARY: The U.S. needs to take substantial steps to address the high costs of cancer drugs. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… … Does the question become how much is a month(s) of other life worth?

In the News: October 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. FDA Guidance Addresses Real-World Evidence Data Standards.

Will the Vaccines Stop Omicron? Scientists Are Racing to Find Out.

NY Times

A “Frankenstein mix” of mutations raises concerns, but the variant may remain vulnerable to current vaccines. If not, revisions will be necessary.

Drinking alcohol to stay healthy? That might not work, says new study

Scienmag

Increased mortality risk among current alcohol abstainers might largely be explained by other factors, including previous alcohol or drug problems, daily smoking, and overall poor health, according to a new study publishing November 2nd in PLOS Medicine by Ulrich John of University Medicine Greifswald, Germany, and colleagues.

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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.

Where Are All the OTC Rapid Antigen Tests for COVID? FDA’s Role in Blocking These Tests from the American Market

FDA Law Blog

By Jeffrey K. Shapiro & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — In England, over?the?counter counter (OTC) rapid antigen tests for COVID are widespread and available at low cost. In America, these tests are scarce and relatively high?priced. priced. Why is that?

FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

Bio Pharma Dive

The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country

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Omnichannel marketing is the answer but what’s the question?

World of DTC Marketing

SUMMARY: Omnichannel marketing employs the simultaneous implementation of channels across personal, non-personal, and media and addresses the integrated needs of multiple stakeholders – consumers/patients, healthcare professionals, and payers. Sounds good but is that the answer?

Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available.

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.

F.D.A. Authorizes Coronavirus Booster Shots for All Adults

NY Times

If the C.D.C. agrees, adults who received a second shot of the Pfizer or Moderna vaccine at least six months ago could be eligible by this weekend.

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How far away is help? Researchers map access to HIV care

Scienmag

In sub-Saharan Africa, 7 million people with HIV live more than 10 minutes from health care services and 1.5

How to Reduce Your Chance of Medication Errors

Triage Cancer

Medication errors, which occur in hospitals, care facilities, and at home, can lead to serious health consequences, including death. Therefore, it’s critical that you learn how to reduce your chance of medication errors. Medication issues in hospitals and healthcare facilities.

Years later, a first-of-its-kind treatment shows the power, and limits, of gene therapy

Bio Pharma Dive

Luxturna, approved four years ago as the first gene therapy for an inherited disease in the U.S., is improving sight and quality of life for several of the patients who received it

Does CVS have a crystal ball into the future?

World of DTC Marketing

SUMMARY: CVS announced its plans to begin closing its doors –about 900 locations across the country. They know the future isn’t about selling 20 kinds of shampoos and vitamins.

Respiratory Syncytial Virus (RSV) and Its Potential Risks in Infants, Toddlers and the Elderly

Riverside Clinical Research

While most of us were masked up and social distancing, human respiratory syncytial virus, also known as RSV infection, took somewhat of a hiatus; but now that we are coming into more contact with others, and social distancing as well as masking up are becoming less prevalent, respiratory syncytial virus is raging full steam ahead.

Pfizer Will Allow Its Covid Pill to Be Made and Sold Cheaply in Poor Countries

NY Times

The company announced a deal that could help significantly expand access to the Covid-19 treatment, but the agreement excludes a number of countries hit hard by the pandemic.

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Advanced breast cancer patients denied opportunities to join clinical trials

Scienmag

Clinicians and the wider research community involved in treating advanced breast cancer (ABC) need to do more to help and encourage patients to join clinical trials, according to a patient advocate who is leading a study that shows only 14% of ABC patients in the UK have been recruited to a trial.

Proactively Caring for Aging Parents

Triage Cancer

Proactively caring for aging parents can present many unique challenges, both logistically and emotionally. This can become even more complex when a parent is diagnosed with cancer or if you are dealing with your own diagnosis while caring for aging parents.

J&J, world's largest drugmaker, plans to split in two

Bio Pharma Dive

The industry giant and mainstay of corporate America will separate its consumer health business from its drug and medical device units, which will retain the J&J brand

It’s getting harder to launch a new drug to physicians

World of DTC Marketing

SUMMARY: Physicians are tired and overwhelmed with medical information on new drugs. They don’t have the time to sit in the office and search for more information, and they feel that pharma is giving them “too much” information. An exciting development presented itself.

EU nears decision on Novavax COVID-19 vaccine

BioPharma Reporter

The European Medicines Agency (EMA) could issue an opinion on Novavaxâ Conditional Marketing Authorization for its COVID-19 vaccine âwithin weeksâ. Markets & Regulations

U.S. to Buy Enough of Pfizer’s Covid Antiviral Pills for 10 Million People

NY Times

The antiviral drugs have helped inspire hope among senior administration officials that the United States will be able to curb the devastating toll from the Delta variant.

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Researchers discover the first instance of living organisms producing elemental carbon

Scienmag

Carbon is the building block of all known life on our planet. The carbon cycle regulates the release and absorption of carbon from a number of natural sources — including the ocean, soil, geochemical processes, and human emissions — to maintain a delicate balance of this crucial element in our world.

FDA clears GE Healthcare AI algorithm for patient intubation

Pharma Phorum

An artificial intelligence algorithm developed by GE Healthcare that helps with the placement of endotracheal tubes (ETTs) has been approved by the FDA.

FDA panel, after debate, narrowly backs Merck COVID pill

Bio Pharma Dive

While agency advisers raised concerns over molnupiravir's modest benefits and potential risks, a majority felt the antiviral drug is a needed option for COVID-19 patients at high risk of severe disease

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Insulin costs ignore the root cause of diabetes

World of DTC Marketing

OPENING: As the NY Times recently reported , obesity is the leading cause of mortality in the United States. Obesity costs the nation $1.72 trillion every year.

Association of Self-reported COVID-19 Infection and SARS-CoV-2 Serology Results With Persistent Physical Symptoms

JAMA Internal Medicine

This cross-sectional study of individuals from the French CONSTANCES cohort assesses whether the belief in having been infected with SARS-CoV-2, having serological test–confirmed COVID-19 infection, or both are associated with persistent physical symptoms often attributed to long COVID in the general adult population.

House Passes $1 Trillion Infrastructure Bill, Putting Social Policy Bill on Hold

NY Times

Progressives who had threatened to sink the measure agreed to support it after extracting a promise from moderates that they would ultimately back the social safety net and climate bill.

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Why drinking water needs monitoring for HIV drugs

Scienmag

Years ago, there was a time that kids from a rural village in South Africa still wanted to swim in the rivers nearby. But when they got out of the water, those with sensitive skins would have the worst rash ever, says Prof Philiswa Nomngongo.

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