Pfizer taps McKinsey executive to lead dealmaking efforts
Bio Pharma Dive
AUGUST 26, 2021
Aamir Malik, a managing partner at the consulting firm, will replace longtime Pfizer executive John Young as chief business innovation officer next week.
August, 2021
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HCP’s use of social media: the good and the not so good
World of DTC Marketing
AUGUST 9, 2021
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. 86% of diagnostic device companies, 65% of pharma marketers, and over half of biotechs use social as a critical part of their marketing mix to reach HCPs. Doximity was flagged for having anti-vaccine information.
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In the News: July 2021 Regulatory and Development Updates
Camargo
AUGUST 5, 2021
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. In July, Astellas Pharma US received FDA approval for the use of Prograf (tacrolimus) capsules, injection, and oral suspension for the prevention of lung transplant rejection.
UK trial to assess Sativex for the treatment of ‘aggressive’ brain tumours
Pharma Times
AUGUST 4, 2021
Sativex is a complex botanical formulation that contains the principal cannabinoids THC and CBD
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
F.D.A. Aims for Full Approval of Pfizer Covid Vaccine on Monday
NY Times
AUGUST 20, 2021
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.
Moderna to Launch Clinical Trials for mRNA-Based HIV Vaccine
BioSpace
AUGUST 16, 2021
Moderna is expected to launch a human clinical trial as early as this week for an mRNA-based vaccine against HIV and indicated that it is looking for 56 people ages 18 to 50 who are HIV-negative.
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DTC Study: Marketers misaligned with online health seeker needs
World of DTC Marketing
AUGUST 4, 2021
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. It’s more about weighing the benefit against the potential side effects. TV spots are the number one way people learn about new pharma products.
Regulatory Strategy Considerations for Working with the FDA vs the EMA, Part 1
Camargo
AUGUST 11, 2021
As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during the development process.
Novartis’ Kymriah fails to hit primary survival endpoint in late-stage trial
Pharma Times
AUGUST 24, 2021
Phase III study was investigating treatment for B-cell non-Hodgkin lymphoma
Around 250 digital health apps are launching every day, says IQVIA
pharmaphorum
AUGUST 6, 2021
There was a dramatic increase in the launch of health-related mobile applications last year, taking the total number on offer in app stories to 350,000 – and while average quality is currently “middling” it is on the rise, according to a report from IQVIA. The pandemic contributed to another 90,000 apps being introduced in 2020 – an average of 250 per day – and this coupled with rising number and functionality of wearable devices “provides evidence of digital health’s acc
Artificial intelligence stands to ‘revolutionize’ research: Bioclinica
Outsourcing Pharma
AUGUST 5, 2021
A leader from the clinical research tech specialist explains how the use of AI is increasing in the field and outlines the many ways it could SOMETHING.
Biotech M&A tracker: After hitting new heights, deals have slowed down. Here are the latest.
Bio Pharma Dive
AUGUST 10, 2021
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.
Health literacy is a huge problem
World of DTC Marketing
AUGUST 6, 2021
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. Only 23% of people get enough exercise and only one in ten eats enough fruit and vegetables, says the CDC.
The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?
Camargo
AUGUST 22, 2021
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. This validation check determines if the submission is uploaded into the FDA’s system, or if it is technically rejected.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month
NY Times
AUGUST 3, 2021
The Food and Drug Administration’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops.
SMA Awareness Month: How pharma and digital solutions can improve patient care
pharmaphorum
AUGUST 4, 2021
Spinal Muscular Atrophy (SMA) is a rare disease affecting the motor nerve cells in the spinal cord. It’s a debilitating condition that affects 1 per 8,000 to 10,000 people worldwide , impacting their ability to walk, eat, and breathe. SMA Type 1 represents an estimated 50% of all cases, for which life expectancy is less than 18 months without treatment. .
Although Rare, New Data Suggests Higher Rate of Myocarditis with Moderna Shot
BioSpace
AUGUST 19, 2021
As governments and now even businesses push citizens to get vaccinated against COVID-19, anti-vaxxers are loading up more ammo for their argument with this week's report.
Pfizer stocks cancer drug pipeline with $2.3B deal for Trillium
Bio Pharma Dive
AUGUST 23, 2021
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.
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Small versus big digital agencies for pharma
World of DTC Marketing
AUGUST 17, 2021
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. She had received a proposal from her digital agency to build their product website and a proposal for paid media.
Existing drug could offer hope as new therapy for ALL in children
Pharma Times
AUGUST 26, 2021
Early stage research found 5-azacytidine may be used to treat 'devastating' disease
Ivermectin Should Not Be Used to Treat Covid, F.D.A. Says
NY Times
AUGUST 21, 2021
“You are not a horse,” the Food and Drug Administration said. “Stop it.”.
Older people ‘more likely to engage with digital physiotherapy care’
pharmaphorum
AUGUST 25, 2021
Researchers in the US have found that older people are far more likely to engage with digital physiotherapy programmes digitally than those in younger age groups. Gen Xers, working-age baby boomers and retirees – collectively the over-41 age bracket – were more likely to start a musculoskeletal (MSK) programme delivered via digital channels than Gen Zers and millennials, according to Hinge Health, whose back and joint pain programme was used in the study.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
New COVID-19 Variant C.1.2 Sparking International Concern
BioSpace
AUGUST 29, 2021
A new variant, C.1.2. is causing public health experts worldwide to keep an eye out for its presence as it seems to be more infectious and even more resistant to vaccines than other variants.
How Bayer lured a biotech away from an IPO and into a buyout
Bio Pharma Dive
AUGUST 4, 2021
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.
The Constitution and vaccinations
World of DTC Marketing
AUGUST 26, 2021
SUMMARY : Via Marci Hamilton is a professor at the University of Pennsylvania “the Constitution is not a suicide pact guaranteeing a right to harm others. The government has latitude to protect citizens from deadly conditions, especially when the science supporting vaccination is so clear” Prof Hamilton goes on to say, “One frequently heard pushback against vaccine mandates is that there is a “constitutional right” to choose whether to be vaccinated or not for adult
Virtual reality technology transforming COVID-19 drug discovery
Outsourcing Pharma
AUGUST 9, 2021
Nanomeâs virtual reality tech is being put to use by Oak Ridge National Laboratory and top pharma firms to study COVID-19 and explore drug candidates.
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
AZ’s Saphnelo scores US approval for systemic lupus erythematosus
Pharma Times
AUGUST 2, 2021
Saphnelo is the first type I interferon receptor agonist to receive regulatory approval
Funding round swells digital health firm Whoop’s value to $3.6bn
pharmaphorum
AUGUST 31, 2021
Fitness wearable company Whoop has raised another $200 million in funding that will help fund its expansion into international markets – and take on deep-pocketed rivals like Amazon, Apple and Google. The sixth-round financing was led by SoftBank’s Vision Fund 2, taking the total raised by the company to date to around $400 million, and catapults Whoop’s valuation to a massive $3.6 billion.
Could DNA-based COVID-19 vaccine offer variant-busting booster shot?
BioPharma Reporter
AUGUST 2, 2021
With Scancell taking its DNA-based COVID-19 vaccine tech into clinical trials this year, it is already focusing its attention on the techâs potential to be used as a needle-free booster shot to address Variants of Concern.
Moderna founder's next big play in RNA raises $440 million
Bio Pharma Dive
AUGUST 30, 2021
Just a few months out of stealth mode, Laronde and its "endless RNA" technology have caught the attention of well-known investors like Fidelity, T. Rowe Price Associates and Invus.
An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
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