August, 2021

Pfizer taps McKinsey executive to lead dealmaking efforts

Bio Pharma Dive

Aamir Malik, a managing partner at the consulting firm, will replace longtime Pfizer executive John Young as chief business innovation officer next week

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HCP’s use of social media: the good and the not so good

World of DTC Marketing

SUMMARY: A survey of more than 4,000 physicians showed that virtually every physician uses social media for personal reasons, while two-thirds use it for professional reasons.

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Developmental and Reproductive Toxicology (DART) Studies: What Are They, and How Do They Fit into Your Program?

Camargo

Development and Reproductive Toxicology studies, or DART studies, are required for most non-oncology programs between IND and NDA filings.

F.D.A. Aims for Full Approval of Pfizer Covid Vaccine on Monday

NY Times

Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates. Vaccination and Immunization Coronavirus (2019-nCoV) Drugs (Pharmaceuticals

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.

Is Facebook Ghosting Pharma?

FDA Law Blog

By Dara Katcher Levy & Kalie E. Richardson — In what appears to be an “about face” in terms of Facebook’s historical wooing of big pharma (are we the only ones that immediately thought, “ More Cowbell ” when seeing that headline?

Von Hippel-Lindau Market Space Expected to Expand at a CAGR 8.3% by 2030 Owing to Increasing Prevalence and Emerging Therapies

Delveinsight

Rare diseases, collectively, can not be considered rare at all. According to the National Institute of Health, approximately 30 million Americans that makeup 10% of the total American population, are affected by one of the 7,000 known rare diseases.

More Trending

Change of leadership is needed badly at the FDA and CDC

World of DTC Marketing

SUMMARY: It’s almost impossible for the average person to get accurate and reliable information from the media. Even vaccine booster shots are being debated by HCPs and Pfizer. We need to follow the science. Physiican trust in the FDA is decling as well.

In the News: July 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: Repurposed Transplant Drug Approved Based Only on Real-World Evidence.

Ivermectin Should Not Be Used to Treat Covid, F.D.A. Says

NY Times

“You are not a horse,” the Food and Drug Administration said. Stop it.”. Coronavirus (2019-nCoV) Drugs (Pharmaceuticals) Vaccination and Immunization Mississippi Food and Drug Administration ivermectin

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SAVE THE DATE: PMN Fall 2021 Summit: Pharma-Marketing Innovations & Trends of 2021 – Sep. 16th

Pharma Marketing Network

SAVE THE DATE – PMN Fall 2021 Summit: Pharma-Marketing Innovations & Trends of 2021 | SEP. 16th, 12:00PM – 1:30PM EST. SAVE YOUR SEAT TODAY. Telehealth: Is It Here to Stay?

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.

Fecal Incontinence Therapeutics Market Surges with Innovative Therapies in the Pipeline

Delveinsight

Fecal Incontinence (FI) is a condition in which individuals lose the control of bowel movements leading to unexpected, involuntary leakage of stools. Also known as Bowel Incontinence, it is a result of constipation, diarrhea, and nerve damage due to aging.

Pfizer stocks cancer drug pipeline with $2.3B deal for Trillium

Bio Pharma Dive

The acquisition reflects growing industry interest in the cancer-linked protein targeted by Trillium's drugs, most notably shown by Gilead's acquisition of Forty Seven last year

DTC Study: Marketers misaligned with online health seeker needs

World of DTC Marketing

SUMMARY: People are going online more and more to sarch for health information after seeing a DTC pharma TV spot. Pharma websites are not consdiered a top resource for infromation on new products. Cost is not that big of an issue for people who have health insurance.

Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 1

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.

F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month

NY Times

The Food and Drug Administration’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops.

The Code is Cracked: Interchangeable Biologics are Here

FDA Law Blog

By Sara W. Koblitz — About two weeks ago, FDA made an exciting announcement (and it remains exciting even if we’re late posting about it): FDA approved the first interchangeable biosimilar.

Shape Therapeutics-Roche’s Deal; AllStripes Raises $50M; Datavant-Real Chemistry’s Partnership; BlueWillow’s Nasal Vaccine

Delveinsight

Shape Therapeutics inks gene therapy deal with Roche worth up to USD 3 Billion. Seattle biotech firm Shape Therapeutics has signed a deal potentially exceeding USD 3 billion with pharma giant Roche to bolster the development of gene therapies for Alzheimer’s and Parkinson’s disease.

How Bayer lured a biotech away from an IPO and into a buyout

Bio Pharma Dive

Vividion Therapeutics was headed toward an IPO earlier this year, but a company executive said Bayer’s $1.5B offer ended up being a more attractive option

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Corporate politics and eMarketing: Mismatched

World of DTC Marketing

SUMMARY: The biggest barrier to great healthcare marketing is corporate politics. As more companies merge or are bought out big bureaucratic processes run counter to what online marketing is all about.

The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?

Camargo

When a submission is sent through the FDA’s Electronic Submissions Gateway (ESG), it goes through an automated check of many validation rules, as specified in the Electronic Common Technical Document (eCTD) submission standards guidance.

Ivermectin Demand Surges Though It Doesn’t Work for Covid-19

NY Times

Prescriptions for ivermectin have jumped to more than 88,000 per week, some pharmacists are reporting shortages and people are overdosing on forms of the drug meant for horses.

Facebook “Pokes” Pharma Companies, Telehealth, and Online Pharmacies

FDA Law Blog

By Jeffrey N. Wasserstein & Dara Katcher Levy — We are old enough to remember the “poke” function on Facebook, and too old to remember what purpose it served.

Top 7 Pharma Industry Leaders in 2020 By the Numbers

Delveinsight

Pharmaceutical companies play a vital part in our lives and in helping us to live healthier lives.

Biotech M&A tracker: After hitting new heights, deals have slowed down. Here are the latest.

Bio Pharma Dive

Deals were few and far between last quarter. But the recent history of biopharma M&A suggests they'll return. Keep track of them as as they happen with BioPharma Dive's new database

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Health literacy is a huge problem

World of DTC Marketing

SUMMARY: The states struggling the most with covid-19 infections also have the least healthy populations. About two out of five American adults are obese, according to the CDC. Mostly because they don’t understand how what they eat effects their health.

How to address patient privacy and data-security concerns in clinical trials

Clairnes

The post How to address patient privacy and data-security concerns in clinical trials appeared first on Clinical Trial Recruitment & Management Services.

Covid Vaccines Produced in Africa Are Being Exported to Europe

NY Times

Johnson & Johnson is sending shots from South Africa to other parts of the world. African countries are waiting for most of the doses they’ve ordered.

FIFA Cases Hold Lessons for FDA-Regulated Companies – Organizations can be Victims of Their Own Employees’ Criminal Conduct

FDA Law Blog

By JP Ellison — It is a well-accepted fact that even well run ethical and compliant organizations can have serious problems. The Sentencing Guidelines, the DOJ Manual, and the HHHS OIG–among others–all recognize that reality.

FDA approval to Keytruda and Lenvima; FibroGen’s Roxadustat; Pfizer’s TICOVAC; Ipsen’s Palovarotene; Jazz Pharma’s Xywav; Seagen-RemeGen’s Cancer Medicine

Delveinsight

FDA’s Green Flag to Keytruda and Lenvima combination by Merck and Eisai for Advanced renal cell carcinoma (RCC). The FDA approved the combination of Keytruda and Lenvima produced by Merck and Eisai, as a first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

US to offer coronavirus boosters to all Americans in aggressive plan to counter delta's spread

Bio Pharma Dive

The Biden administration's call comes ahead of FDA authorization for additional doses in people who aren't immunocompromised, although agency head Janet Woodcock joined other officials in supporting the plan

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Small versus big digital agencies for pharma

World of DTC Marketing

SUMMARY: You should never choose an agency based on size. It should be because they are a good fit with your brand team and can take your digital marketing to the next level while ensuring that everything they do is best in class. Debra called me up in a bit of a panic.

Increase in extreme precipitation in the northeast caused by Atlantic variability and climate change

Scienmag

Results explain the increase in heavy rain and snow events across the northeast Credit: Figure by Huanping Huang. Recent record-breaking rainfall across the northeastern United States is part of a larger trend.

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The Cocaine Was Laced With Fentanyl. Now 6 Are Dead From Overdoses.

NY Times

The deaths over three days in Suffolk County reflect a dangerous shift in the street-drug marketplace, according to police and prosecutors.

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Superfoods, Super You!

Riverside Clinical Research

A healthy diet can reduce the risk of heart disease, high blood pressure, diabetes and cancer. It can also help you feel and look your best. In order to maintain a healthy diet, we need to consume (in moderation) foods with a wide array of necessary nutrients.