August, 2021

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Top FDA vaccine officials to leave agency as decision on COVID-19 boosters looms

Bio Pharma Dive

Marion Gruber and Phil Krause, two veteran vaccine reviewers, are unexpectedly leaving the agency at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter.

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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. 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.

Nurses 294
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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.

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Moderna to Launch Clinical Trials for mRNA-Based HIV Vaccine

BioSpace

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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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Around 250 digital health apps are launching every day, says IQVIA

pharmaphorum

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

Medicine 145
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Could DNA-based COVID-19 vaccine offer variant-busting booster shot?

BioPharma Reporter

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.

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More Trending

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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. 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.

Marketing 279
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Artificial intelligence stands to ‘revolutionize’ research: Bioclinica

Outsourcing Pharma

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.

Research 145
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New COVID-19 Variant C.1.2 Sparking International Concern

BioSpace

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.

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SMA Awareness Month: How pharma and digital solutions can improve patient care

pharmaphorum

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. .

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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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.

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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.

Drugs 360
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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. Only 23% of people get enough exercise and only one in ten eats enough fruit and vegetables, says the CDC.

Drugs 270
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Find Talent in the Pharmaceutical Industry: A Step-By-Step Guide to Xtalks Job Search

XTalks

The search to find talent in the life sciences isn’t always an easy pursuit. It requires ongoing strategies for attracting, retaining and developing the right candidates. Talent acquisition and employment practices are constantly changing in the pharma industry. This is why employers must stay up to date with the latest hiring trends. Popular online job platforms (such as Indeed, ZipRecruiter and other broader job posting websites) are optimized for unemployed job seekers.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Although Rare, New Data Suggests Higher Rate of Myocarditis with Moderna Shot

BioSpace

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.

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Older people ‘more likely to engage with digital physiotherapy care’

pharmaphorum

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.

Research 144
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Virtual reality technology transforming COVID-19 drug discovery

Outsourcing Pharma

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.

Drugs 138
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Moderna founder's next big play in RNA raises $440 million

Bio Pharma Dive

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.

RNA 350
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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.

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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. She had received a proposal from her digital agency to build their product website and a proposal for paid media.

Branding 249
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How the UAE is Growing Climate-Proof Food in the Desert

XTalks

Desert farming has existed for thousands of years , but one center in Dubai has created desert farming equipped to handle rising temperatures and extreme weather events. While these climate change-induced factors tend to make farming difficult and disrupt food distribution, Dubai’s International Center of Biosaline Agriculture (ICBA) is creating solutions to boost local food production in the driest and hottest conditions.

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Canada Gaining in the Global War for Biotech Talent

BioSpace

Toronto saw the biggest growth in technology jobs of any North American city between 2015 and 2020, while Vancouver, British Columbia also made the top five.

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Beckley Psytech raises $80m for psychedelic meds development

pharmaphorum

UK psychedelic medicine specialist Beckley Psytech has raised an impressive £58 million (around $80 million) in an oversubscribed second-round financing that will help fund clinical development of its psilocybin-based therapies. The Oxford-based company had originally hoped to raise $50 million from the series B, and the scale of the financing is further evidence that repurposing psychedelic compounds as potential therapies for neuro-psychiatric disorders is a hot topic in biopharma.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

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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.

Drugs 122
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HHS watchdog to review FDA accelerated approval process after Aduhelm controversy

Bio Pharma Dive

Acting FDA head Janet Woodcock asked for an investigation of the agency's decision to approve Biogen's Alzheimer's drug, but the inspector general's planned review appears to be more broadly aimed.

Drugs 348
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Pharmaceutical industry must fix broken supply chain: Phlow

Outsourcing Pharma

A leader from the company says to ensure medicines keep reaching the patients that need them, the industry must revamp outdated technologies and techniques.

Medicine 131
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UK trial to assess Sativex for the treatment of ‘aggressive’ brain tumours

Pharma Times

Sativex is a complex botanical formulation that contains the principal cannabinoids THC and CBD

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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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A Pivotal Moment for CRISPR in the Gene Editing Journey

BioSpace

With this milestone, the field is now wide open for the next in vivo CRISPR success, and Editas is hoping that it will be in the ocular disease space.

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Gene therapy specialist bluebird exits “untenable” European market

pharmaphorum

Europe market has proved so hostile to gene therapies when it comes to pricing and reimbursement for gene therapies that bluebird bio has decided to quit the market altogether, according to Andrew Obenshain, president of its severe genetic diseases unit. On the firm’s second-quarter results call, Obenshain said the biotech will start “an orderly wind-down” of its activities in Europe and seek “strategic alternatives” to make its therapies available to patients there

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Mattel Introduces 6 Women in Science Barbie Dolls to Inspire Next Generation Girls

XTalks

British vaccine developer, Sarah Gilbert, has been honored with a Barbie doll. This one-of-a-kind doll looks just like her with long auburn hair, oversized black glasses and wears a pantsuit. Gilbert is a professor at Oxford University who helped lead the development of the Oxford/AstraZeneca COVID-19 vaccine. She now shares the honor of having her own Barbie doll with celebrities such as Marilyn Monroe, Eleanor Roosevelt and Beyoncé.

Scientist 116
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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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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.