Thu.Dec 03, 2020

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4 storylines at the year's biggest meeting on blood diseases

Bio Pharma Dive

A closely watched gene editing therapy, a slate of new multiple myeloma drugs and much more are set to highlight the American Society of Hematology conference this weekend.

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Prescription drug marketing misconceptions

World of DTC Marketing

Another TED talk on the evils of prescription drug marketing was filled with misinformation as usual. Today consumers don’t run to their doctor after seeing a DTC ad, they do their research, and in some cases, the ads actually help them identify potential health problems. It’s been a while since I’ve seen any research on DTC TV ads’ effectiveness, but a couple of years it was estimated that TV ads were 7% effective.

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US buys another 650,000 doses of Lilly's COVID-19 drug as outbreak surges

Bio Pharma Dive

The U.S. government has ramped up spending on Lilly's and Regeneron's antibody-based COVID-19 treatments, but each remain in short supply.

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The Keto Diet: A Beginner’s Guide on Making the Switch to Keto

Pharma Mirror

The keto diet, also known as a ketogenic diet, is a type of food-based lifestyle that many people adopt. Essential, it lets you eat foods that are very high in fat and low in carbohydrates. The keto diet lowers insulin levels and increases your body’s ability to burn fat. This diet type is very alluring as it keeps you healthy and feeling full, unlike other diets.

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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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Cell therapy commercialization: How to achieve positive customer experience

Bio Pharma Dive

What are the critical needs your commercial model must address to deliver a best-in-class experience?

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A Timeline of COVID-19 Vaccine Development

BioSpace

Vaccine development is an arduous process, taking about 10-15 years on average to accomplish. But with the imminent worries surrounding the COVID-19 pandemic putting unprecedented pressure on our healthcare systems and economies, unprecedented measures needed to be put in place.

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Why is the FDA Taking So Long to Review a COVID-19 Vaccine?

BioSpace

the robustness and independence of FDA review – even under an EUA – is an important factor in encouraging a skeptical public to accept COVID-19 vaccinations.

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Cyberattacks Discovered on Vaccine Distribution Operations

NY Times

IBM has found that companies and governments have been targeted by unknown attackers, prompting a warning from the Homeland Security Department.

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Janssen acquires rights to novel AMD gene therapy

BioPharma Reporter

Janssen Pharmaceuticals, Inc. has acquired the rights to Hemera Biosciencesâ investigational gene therapy HMR59: which has been designed to help preserve vision in patients with severe age-related macular degeneration (AMD).

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Global Governments Snap Up COVID-19 Vaccines Well Ahead of Approval

BioSpace

Governments across the globe have flexed their financial muscles to secure promises of as many doses of COVID-19 vaccines as possible when they become available.

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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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Merck KGaA signs DNA damage response cancer deal with Artios Pharma

pharmaphorum

Germany’s Merck KGaA has joined with UK-based Artios Pharma in a potential multi-billion dollar deal to investigate novel DNA damage response targets in cancer. The principle of DNA damage response is already being exploited by AstraZeneca and other companies with their poly (ADP-ribose) polymerase (PARP) inhibitor drugs. These target the inherent genetic instability in certain cancer cells, which have switched to a backup mechanism to repair damage to their DNA code.

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3D protein modeling suggests why COVID-19 infects some animals, but not others

Scienmag

New insights into protein structures could help inform drug development and predict future outbreaks Credit: Rodrigues et al. 2020 (CC-BY 2.0) Some animals are more susceptible to Covid-19 infection than others, and new research suggests this may be due to distinctive structural features of a protein found on the surface of animal cells. João Rodrigues […].

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PureTech begins trial of potential ‘Long COVID’ drug as cases mount

pharmaphorum

As the pandemic drags on there are increasing concerns about “Long COVID” – where symptoms persist long after the initial infection has been fought off. PureTech has joined the effort to find ways to treat the scarring and inflammation that are thought to cause the ongoing symptoms such as shortness of breath and fatigue. After promising results in an early stage study, the company has begun a phase 2 trial of its LYT-100 (deupirfenidone) in Long COVID respiratory complications and related seque

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AstraZeneca Most Recent Victim of Hackers Posing as Recruiters

BioSpace

As if attempting to steal hard-won research wasn’t bad enough, hackers are now hitting people where it really hurts – with e-documents containing malicious code embedded in false offers of employment.

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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.

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Licensing deal set to enhance CRISPR/Cas libraries for target discovery and drug development

BioPharma Reporter

ERS Genomics, which was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property co-owned by the one of the joint 2020 Nobel Prize winners for Chemistry, Dr Emmanuelle Charpentier, has granted a non-exclusive license agreement to German startup, Vivlion.

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RT-PCR’s Days Are Numbered as Faster, Better, & Cheaper COVID-19 Assays Emerge

BioSpace

Nucleic-acid-based assays are the gold standard for detecting the presence of the SARS-CoV-2 virus, but they eventually will be replaced with simpler and more advanced techniques, such as CRISPR-Cas, LAMP, and other faster and less-expensive methods.

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DSRU plans ‘post-authorisation’ study of COVID-19 vaccines in the UK

Pharma Times

Drug Safety Research Unit set to conduct active surveillance study on COVID-19 vaccines

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BioCryst Announces FDA Approval of ORLADEYO, First Therapy to Prevent HAE Attacks in Adults

BioSpace

BioCryst Pharmaceuticals, Inc. announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved ORLADEYO (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and young patients 12 years and older.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Tree lifespan decline in forests could neutralize part of rise in net carbon uptake

Scienmag

Study by Brazilian researchers reported in Nature Communications shows that trees are growing faster in forests worldwide, including the Amazon, but their lives are getting shorter Credit: Roel Brienen/University of Leeds Accelerating tree growth in recent years has been accompanied by a reduction in tree lifespan, which could eventually neutralize part of the increase in […].

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Better Together – Merck KGaA Announces Collaboration with Artios

BioSpace

Merck KGaA and Artios Pharma Limited announced today that they have entered a strategic collaboration agreement to discover and develop multiple precision oncology drugs over the course of the next three years.

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AbbVie partners with Frontier Medicines on protein degrader development

Pharma Times

Partnership will seek to develop small molecules for oncology/immunology targets

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Are pharma’s TV ad strategies out of date?

pharmaphorum

TV viewing habits are changing dramatically, and these trends have only been accelerated by COVID-19 – but Intouch’s Justin Chase says that pharma is still stuck in a traditional advertising mindset. Drawing on research from a recent whitepaper, he tells us how the industry can optimize its TV advertising for an age of hyper-targeted media and modern marketing methodology.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Robot fleet dives for climate answers in ‘marine snow’

Scienmag

Australian research voyage to investigate how life in the Southern Ocean captures and stores carbon from the atmosphere Credit: CSIRO A fleet of new-generation, deep-diving ocean robots will be deployed in the Southern Ocean, in a major study of how marine life acts as a handbrake on global warming. The automated probes will be looking […].

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WTF (What the Finance) is a State Mandated Retirement Plan?

Triage Cancer

Think all workers can participate in a retirement plan? Think again! According to a 2019 study by the Pension Rights Center* out of 139 million full and part-time workers, only 56% are participating in a work sponsored retirement plan. Only 12% of employers with less than 100 employees even offer a 401(k) plan**. As usual, the people left out of the retirement planning picture are disproportionately women, minorities, and workers in lower paying service jobs.

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Artificial intelligence collaboration seeking to hasten COVID-19 insights

Scienmag

Credit: Chris Adam/Purdue University WEST LAFAYETTE, Ind. – During the COVID-19 pandemic, health care professionals and researchers have been confined mostly to using local and national datasets to study the impact of comorbidities, pre-existing medication use, demographics and various interventions on disease course. Now, Purdue University is joining with other organizations for an initiative to […].

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A New Way to Ease the Worry That You May Be Pregnant

NY Times

Marketed as “missed-period pills,” abortion drugs administered as early as 28 days after a woman’s last period can offer comfort in uncertainty to those who want it.

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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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Peanut treatment lowers risk of severe allergic reactions in preschoolers

Scienmag

Credit: Credit: Vladislav Nikonov/Unsplash It’s a peanut-filled world–or at least it can feel that way for kids with peanut allergies. But a new study by researchers at the University of British Columbia and BC Children’s Hospital gives hope to parents and kids who face real danger from exposure to peanuts. “There’s a common misperception about […].

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Bayer establishes new cell and gene therapy platform

Pharma Times

Platform will enable Bayer to pursue external collaborations and bolster internal capabilities

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Leaf microbiomes are a neighborhood affair in northern forests

Scienmag

A study published in Ecological Monographs shows that sugar maple microbiomes change from north to south along the transition from coniferous to deciduous forest Credit: Geneviève Lajoie. Forest leaves are teeming with bacterial life – but despite the vast extent of bacteria-covered foliage across the world, this habitat, known as the phyllosphere, remains full of […].

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Four Biotechs Roar with Strong IPOs, Other Life Sciences Companies Raise Additional Funds

BioSpace

Like the Grinch’s heart at Christmas, the Nasdaq Exchange grew a little bigger this week with multiple life science companies raising hundreds of millions of dollars in initial public offerings.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.