Bio Pharma Dive

DECEMBER 16, 2021

Days after the FDA strengthened safety warnings for the company's shot, a CDC panel recommended Pfizer's and Moderna's vaccines be "preferred" over J&J's.

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Vaccination Vaccine 323

Pharma Mirror

DECEMBER 16, 2021

Impaired driving due to prescription medication is often given less attention than driving under the influence of illegal drugs. Yet, prescription drugs are just as dangerous, if not more dangerous, because many people are either not aware of the drug’s influence on their driving or assume prescribed medication is “safe.” Some medication, however, significantly increases the risk of car crashes.

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Drugs 130

Bio Pharma Dive

DECEMBER 16, 2021

Novartis is using funds gained from the recent sale of its stake in Roche to buy back $15 billion worth of its own shares, while Pfizer is signaling more dealmaking could follow its buyout of Arena.

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Sales 291

NY Times

DECEMBER 16, 2021

The ruling said the company’s owners, members of the Sackler family, could not receive protection from civil lawsuits in return for a $4.5 billion contribution.

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Drugs 145

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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

Clinical Research

Bio Pharma Dive

DECEMBER 16, 2021

The European Medicines Agency is still reviewing Paxlovid but, citing fast increasing cases and deaths from COVID-19, offered flexibility to EU countries which may authorize emergency use.

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Regulation Medicine 257

Pharma Times

DECEMBER 16, 2021

Venetoclax is an oral once-daily treatment, which blocks the action of the B-cell lymphoma-2 protein, the presence of which helps cancer cells survive.

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Protein 118

Drug Patent Watch

DECEMBER 16, 2021

Annual Drug Patent Expirations for XERAVA Xerava is a drug marketed by Tetraphase Pharms and is included in one NDA. There are two patents protecting this drug. This drug has…. The post New patent for Tetraphase Pharms drug XERAVA appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 98

Bio Pharma Dive

DECEMBER 16, 2021

In granting approval, the FDA gave Biogen roughly nine years to run and submit results from an additional study of Aduhelm. Now, the company says it will do so in about half the time.

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Trials Drugs 213

NY Times

DECEMBER 16, 2021

The decision will broaden access to medication abortion, an increasingly common method, but many conservative states are already mobilizing against it.

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Drugs 105

Scienmag

DECEMBER 16, 2021

With over a million known species, insects are by far the most diverse group of organisms on Earth, with conservative estimates indicating there are millions more waiting to be found. But extinction due to human pressures may be outpacing the rate of discovery, with species disappearing before researchers even knew they existed. Credit: Florida Museum […].

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Research Engineer 93

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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

Clinical Trials

XTalks

DECEMBER 16, 2021

Alternative meat brand Jack & Annie’s, which makes plant-based meat products from jackfruit, recently secured $23 million in a Series B funding round. Co-led by Creadev and Desert Bloom and existing investors Beta Angels and InvestEco, the funding round was the largest to date for the brand. So, how did Jack & Annie’s earn millions from investors and what will it do with the funding?

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Branding Production Medicine Marketing 90

Scienmag

DECEMBER 16, 2021

Researchers at UT Southwestern Medical Center studied outcomes for young women at a county hospital and found that while 97% of them accessed prenatal care, those with greater social needs were associated with adverse outcomes both during pregnancy and during the early weeks of their babies’ lives. The differences persisted even after adjusting for age, race, […].

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Research Medicine 93

Pharma Times

DECEMBER 16, 2021

A warning has been issued to UK MPs from the head of NHS England that hospitalisations could exceed numbers recorded in January 2021.

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106

Scienmag

DECEMBER 16, 2021

Researchers at QuTech—a collaboration between the TU Delft and TNO—have reached a milestone in quantum error correction. They have integrated high-fidelity operations on encoded quantum data with a scalable scheme for repeated data stabilization. The researchers report their findings in the December issue of Nature Physics. Credit: DiCarlo Lab and Marieke de Lorijn Researchers at […].

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Research Engineer 92

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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.

Clinical Supply

Drug Channels

DECEMBER 16, 2021

This week, I’m rerunning some popular posts while I prepare for tomorrow's live video webinar: Drug Channels Outlook 2022. Hope you can join me! Click here to see the original post and comments from September 2021. Cardinal Health recently released the annual report for its 2021 fiscal year, which ended on June 30. See the links below. Today, I delve into the financials behind Cardinal’s relationship with its largest customer, CVS Health.

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Drugs Pharmacy 78

Scienmag

DECEMBER 16, 2021

In habituation, an organism gets so used to a ubiquitous sight, smell, sensation or sound that it virtually disappears. Runa Hamid of the CSIR-Centre for Cellular and Molecular Biology in Hyderabad, India, and colleagues have identified a transporter protein in the brain that plays a vital role in habituation, which they report in a new […].

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Protein 92

pharmaphorum

DECEMBER 16, 2021

UK digital health company Brainomix has raised £16 million ($21.5 million) that will be used to extend the use of its artificial intelligence-based medical imaging software for stroke to new therapeutic areas. The Oxford University spinout – which has said that AI and machine learning is set to become the “driving force” behind imaging diagnostics – has its eye on diagnosing of lung fibrosis and cancer as it looks to expand its focus.

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Clinical Trials Clinical Trials Pharma Companies Trials 75

Scienmag

DECEMBER 16, 2021

The percentage of infants fully breastfed at 1,3, and 6 months significantly decreased during the COVID-19 pandemic among participants of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in Southern California. The percentage of infants who received any breastfeeding also decreased during these time periods, as reported in a study published in […].

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Medicine 91

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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.

Clinical Trials

Outsourcing Pharma

DECEMBER 16, 2021

Professionals from various corners of the life-sciences field share views on significant challenges of 2021, bright spots, and what to look for in 2022.

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Life Science Regulation Marketing 80

Scienmag

DECEMBER 16, 2021

Often autistic adults can have several co-occurring physical and mental health conditions and, like in non-autistic adults, these may differ by racial and/or ethnic group. Researchers from Drexel University’s A.J. Drexel Autism Institute recently published research showing autistic adults on Medicaid have increased odds of some health, nutrition and psychiatric conditions, compared to the general […].

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Research 90

Outsourcing Pharma

DECEMBER 16, 2021

A leader from the information technology specialist explains how evolved thinking and digital transformation are leading to benefits across the industry.

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Manufacturing Contract Manufacturing 68

Scienmag

DECEMBER 16, 2021

“Our simulations based on surveys and many other data reveal that mobility transition will be possible when attractive alternatives to the private car are provided and stricter regulations for motorized individual transport will be adopted,” says Dr. Martin Kagerbauer from KIT’s Institute for Transport Studies (IfV). “Our study provides major indications as to which elements […].

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Regulation 89

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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.

Clinical Supply

Outsourcing Pharma

DECEMBER 16, 2021

While the pandemic saw many trials to shift to decentralized midstream, an expert from the trial tech firm suggests a ground-up design approach is preferable.

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Trials Clinical Development Development 64

Scienmag

DECEMBER 16, 2021

Researchers recently made a major discovery ­­– 14 new species of shrews, which is the largest number of new mammals described in a scientific paper since 1931. After a decade-long journey taking inventory of Indonesian shrews living on the island of Sulawesi, a group of scientists led by Louisiana State University mammologist Jake Esselstyn has […].

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Scientist Research 88

BioPharma Reporter

DECEMBER 16, 2021

Australia company, Inventia Life Science, which is focused on advanced 3D cell cultures for research and clinical purposes, has just closed a US$25M Series B funding round, led by Blackbird Ventures.

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Life Science Development Research Regulation 59

Scienmag

DECEMBER 16, 2021

MADISON — Small, unique antibody-like proteins known as VNARs — derived from the immune systems of sharks — can prevent the virus that causes COVID-19, its variants, and related coronaviruses from infecting human cells, according to a new study published Dec. 16. Credit: Bryce Richter / University of Wisconsin–Madison MADISON — Small, unique antibody-like proteins […].

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Protein Antibody Medicine 87

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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.

Clinical Trials

NY Times

DECEMBER 16, 2021

On Thursday morning, prosecutors are expected to begin their closing arguments as they try to prove that Ms. Holmes, 37, is guilty of 11 counts of wire fraud and conspiracy to commit wire fraud.

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Trials Drugs 54

Scienmag

DECEMBER 16, 2021

The unique beat of each person’s timed ticker has been pronounced just as identifiable as a fingerprint by some biotech companies. And while each heart may beat to a different rhythm, this rhythm should remain steady — patterned and predictable. The consistent pulsing and pumping of the heart provides oxygen-rich blood to the entire body […].

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Engineer 87

Outsourcing Pharma

DECEMBER 16, 2021

A leader from the R&D tech provider discusses the obstacles faced by drug development professionals in recent months, and ways they rose to the occasion.

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Development Drugs Research 59

Scienmag

DECEMBER 16, 2021

EMBARGOED UNTIL 2 P.M. ET (11 a.m. PT) ON THURSDAY, DECEMBER 16, 2021 Credit: Junqiao Wu, Lawrence Berkeley National Laboratory EMBARGOED UNTIL 2 P.M. ET (11 a.m. PT) ON THURSDAY, DECEMBER 16, 2021 Scientists have developed an all-season smart-roof coating that keeps homes warm during the winter and cool during the summer – without consuming […].

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Scientist Development 87

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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.

Clinical Trials