Bio Pharma Dive

JANUARY 13, 2021

Brain drugs, private equity players and blank-check companies are just some of the things deal experts say they'll be keeping an eye on this year.

Drugs 353

Drugs 353

BioSpace

JANUARY 13, 2021

The COVID-19 pandemic that has upended life across the globe has also ignited a reawakening to the value of vaccines, and Hu believes the momentum will carry forward into the new year.

Vaccination 115

Vaccination Vaccine 115

Bio Pharma Dive

JANUARY 13, 2021

The deal expands an earlier agreement between Regeneron and the U.S., though many of the issues limiting the drug's use haven't been solved.

Antibody 296

Antibody Drugs 296

BioSpace

JANUARY 13, 2021

Adastra Pharmaceuticals’ positive results from a Phase Ib trial of its therapy for recurrent high-grade glioblastomas suggest an effective treatment could be available within the next several years.

Trials 101

Trials 101

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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

Scienmag

JANUARY 13, 2021

International Ukraine Genetic Diversity Project finds a quarter of the genetic variation in Europe, dramatically increasing information on population diversity and medical genetic variation Credit: Oakland University Today, the largest study of genetic diversity in Ukraine was published in the open science journal GigaScience. The project was an international effort, bringing together researchers in Ukraine, […].

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Genome Genomics Genetics Research 98

BioSpace

JANUARY 13, 2021

In many regards, the incoming Biden Administration is expected to be a redux of the Obama Administration, likely with strong support for scientific research and a reinvigoration of the Affordable Care Act. Yet concerns of pricing controls still loom.

Drugs 94

Drugs Research 94

BioSpace

JANUARY 13, 2021

In an interview with BioSpace, Marianne De Backer, Head of Business Development & Licensing in Bayer’s Pharmaceuticals Division, outlined Bayer’s thought process for opening its purse strings and diving into the deep end of the cell and gene therapy space.

Gene Therapy 92

Gene Therapy Gene Licensing Licensing 92

pharmaphorum

JANUARY 13, 2021

Everything, from exercise classes to pub quizzes, went online last year – and medical education was no exception. In their droves, congresses, conferences, and masterclasses went virtual in a bid to ensure healthcare professionals were supported, up to date, and socially distanced. But is this change here to stay? Are the days of queuing for coffee, rushing to symposiums, and the glitzy conference dinner a thing of the past?

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Sales Marketing 82

BioSpace

JANUARY 13, 2021

Flagship Pioneering launched a new company called Inzen Therapeutics, which will discover and develop a new class of medicines based on a new area of biology that will provide new therapeutic approaches to multiple types of diseases.

Medicine 80

Medicine Development 80

pharmaphorum

JANUARY 13, 2021

IO Biotech, an oncology specialist formed and backed by Denmark’s Novo Holdings, has raised €127 million ($155 million) to further develop its cancer vaccine technology that has boosted efficacy of PD-1 immunotherapy in early trials. The Series B fundraiser follows the FDA’s decision to grant Breakthrough Therapy designation last month for a combination of its lead immune-oncology therapies IO102 and IO103, with anti-PD-1 monoclonal antibodies for patients with metastatic melanoma.

Vaccination 80

Vaccination Vaccine Development In-Vivo 80

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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

Outsourcing Pharma

JANUARY 13, 2021

A leader from the anti-counterfeit solutions firm says that while packaging-level efforts may have an effect, on-dose technology is worth a closer look.

Packaging 83

Packaging Packaging Regulation Marketing 83

BioSpace

JANUARY 13, 2021

Sana Biotechnology has filed with the U.S. Securities and Exchange Commission to raise up to $150 million in an initial public offering to help support the company’s cell-based therapy discovery and development operations.

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Development 75

Outsourcing Pharma

JANUARY 13, 2021

Fight the Fakes gathers manufacturers and other stakeholders to brainstorm on ways to combat falsified medicines and safeguard the worldâs medicine supply.

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Manufacturing Medicine Contract Manufacturing 80

BioSpace

JANUARY 13, 2021

Cancer companies Delfi Diagnostics and Elucida Oncology announced Series A raises worth $144 million so far.

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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

Outsourcing Pharma

JANUARY 13, 2021

The pharmaceutical firm reports a counterfeit version of its Symtuza HIV treatment has been found and pulled from shelves at three American pharmacies.

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Pharmacy Drugs Regulation Marketing 76

BioSpace

JANUARY 13, 2021

Major players in the biotech industry are moving full steam ahead in their 2021 operations goals despite the ongoing pandemic, with global pharmaceutical giant Takeda being no exception.

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Research 69

Pharma Times

JANUARY 13, 2021

First patient in global trial dosed in the UK

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Trials 123

pharmaphorum

JANUARY 13, 2021

Hackers posted stolen confidential information about Pfizer/BioNTech’s COVID-19 vaccine online, the European Medicines Agency has said in an update. The EMA last month revealed that documents relating to the Pfizer/BioNTech vaccine were stolen in a cyber-attack on its records. Since then the agency has been investigating the incident involving the theft of documents that formed part of BioNTech’s filing for the BNT-162b vaccine.

Regulation 67

Regulation Vaccination Vaccine Medicine 67

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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

Scienmag

JANUARY 13, 2021

Credit: KIRSTY CHALLEN, B.SC., MBCHB, MRES, PH.D., LANCASHIRE TEACHING HOSPITALS, UNITED KINGDOM. DES PLAINES, IL — Among children who were not in an independently verified incident, evaluation for child abuse should be done by specialty consultation in children aged less than three-years old presenting with rib fractures and children aged less than 18-months presenting with […].

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Clinical Trials Clinical Trials Trials Medicine 66

Outsourcing Pharma

JANUARY 13, 2021

Authorities discovered the fake Pfizer erectile-dysfunction tablets in one of three cargo containers full of fraudulent goods, recently arrived from China.

Containment 67

Containment Regulation Marketing 67

Scienmag

JANUARY 13, 2021

Dark Energy Survey releases catalog of 700 million objects Elliptical galaxies are generally characterized by their relatively smooth appearance when compared with spiral galaxies (one of which is to the left) which have more flocculent structure interwoven with dust… view more The Dark Energy Survey has released a massive, public collection of astronomical data and […].

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BioSpace

JANUARY 13, 2021

Biopharma and life sciences companies from across the globe provide updates on their pipelines and businesses.

Licensing 81

Licensing Licensing Life Science 81

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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

Scienmag

JANUARY 13, 2021

Researchers at the University of Tsukuba in Japan have discovered a group of neurons in the mouse brainstem that suppress unwanted movement during rapid eye movement sleep Credit: University of Tsukuba Tsukuba, Japan — We laugh when we see Homer Simpson falling asleep while driving, while in church, and while even operating the nuclear reactor. […].

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Research 65

BioSpace

JANUARY 13, 2021

Here’s a look at some of the stories that emerged from the conference on Wednesday.

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90

Scienmag

JANUARY 13, 2021

Credit: © Bat Conservation International A group of scientists led by the American Museum of Natural History and Bat Conservation International have discovered a new species of a striking orange and black bat in a mountain range in West Africa. The species, which the researchers expect is likely critically endangered, underscores the importance of sub-Saharan […].

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Scientist Research 61

Pharma Times

JANUARY 13, 2021

Investigational antibody targets a modified form of beta amyloid called N3pG

Antibody 90

Antibody Trials 90

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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

Scienmag

JANUARY 13, 2021

Nearly 200 researchers pitched in to gather, process, and stitch together images for half of the sky to prepare for the start of the Dark Energy Spectroscopic Instrument’s observations Credit: DESI Legacy Imaging Surveys Before DESI, the Dark Energy Spectroscopic Instrument, can begin its 5-year mission from an Arizona mountaintop to produce the largest 3D […].

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Research Engineer 61

Clinical Trial Gurus

JANUARY 13, 2021

Large CROs tend to take larger contracts which makes it more difficult for anyone to open a new CRO and get ahead. One solution to this problem is to focus on opening a site and then work on establishing the new site as a leader in a specific area while networking with other sites. Establishing a strong network of sites can be more profitable in the long run because it allows you to interact with more sponsors and potentially offer services to them.

Clinical Research 59

Clinical Research Research 59

Scienmag

JANUARY 13, 2021

Credit: (U.S. Navy photo by John F. Williams) ARLINGTON, Va.–The Department of Defense (DoD) recently awarded $50 million in grants to 150 university scientists–54 of whom are sponsored by the Office of Naval Research (ONR)–via the Defense University Research Instrumentation Program (DURIP). Through DURIP, the DoD supports the purchase of state-of-the-art equipment and instrumentation to […].

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Research Scientist Engineer Development 60

pharmaphorum

JANUARY 13, 2021

Trial sites have adapted swiftly to the restrictions of COVID-19, and patients have seen many knock-on benefits as a result. The next step is ensuring the industry does not regress to old ways of working once the pandemic is over, say Karen McIntyre and Allyson Small. COVID-19 has changed everything for clinical trials – but in most cases these are changes that were well overdue.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Regulation 59

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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