Thu.Mar 11, 2021

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FDA sets meeting to review 6 speedy cancer drug approvals as evaluation widens

Bio Pharma Dive

At a public hearing in April, the agency will ask a panel of experts whether three immunotherapies should remain on the market for certain cancer types, the latest step in an industrywide review.

Drugs 319
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Telehealth concerns rise

World of DTC Marketing

SUMMARY: Once again, the “hype” may be bigger than the reality around telehealth. First, people aren’t always completely honest with their doctors. A recent study published in the journal JAMA Network Open found that 60 to 80 percent of patients have been less than fully forthright with their doctors at some point which can be worse with telehealth.

Doctors 180
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How Rocket Pharma quietly became one of gene therapy's high flyers

Bio Pharma Dive

An unconventional strategy is behind the rise of Rocket, a New Jersey biotech whose executives boldly talk of turning into the "Genentech of gene therapy.

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EU regulators probe safety of AstraZeneca vaccine batch after blood clot reports

pharmaphorum

European safety regulators have launched an investigation into the safety of a batch of the Oxford University/AstraZeneca COVID-19 vaccine, as countries including Denmark suspended its use as a precaution following reports of blood clots. Initial findings showed no issue with the shots suspended by Austrian authorities after a person was diagnosed with severe blood clotting and died 10 days after vaccination.

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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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Vir breaks through with study success for COVID-19 antibody

Bio Pharma Dive

A data monitoring board said a study testing Vir's drug should be stopped early because of an overwhelming benefit from treatment.

Antibody 268
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AI drug discovery firm Valence joins Parkinson’s disease push

pharmaphorum

Canada’s Valence Discovery has joined a University of Montreal-led project to try to find new drugs to treat the involuntary movement complications that can accompany treatments for Parkinson’s disease. . The go-to treatment for the five million people worldwide with Parkinson’s is levodopa, which replaces the activity of the dopamine neurotransmitter dopamine that gets depleted by the degeneration of nerve cells in the brain in the disease.

Drugs 126

More Trending

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Pharma poised to cash in on ‘long COVID’ symptoms

pharmaphorum

While there’s hope that vaccination campaigns may bring the pandemic under control, “long COVID” side effects may continue to affect patients for some time. According to analysts from Jefferies, several pharma companies could stand to benefit with products that could help with issues such as mental health, lung scarring, kidney disease and heart failure.

Sales 105
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Monoclonal antibodies: GSK and Vir to seek US approval for their COVID-19 candidate, EMA starts rolling review of Lilly's medicines

BioPharma Reporter

GSK and its partner, Vir Biotechnology, report that their jointly developed monoclonal antibody, VIR-7831, reduces hospitalization and risk of death in early treatment of adults with COVID-19.

Antibody 105
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AI, big data and deep real-world evidence – the challenges and opportunities

pharmaphorum

Real-world evidence (RWE) is emerging as an important area of research to reveal, in real time, new insights and innovations and is accelerating the development of new and innovative therapies and treatments to improve patient outcomes. An important source of RWE has, until recently, been locked in the electronic health record (EHR). Now, artificial intelligence (AI) techniques such as natural language processing (NLP) and machine learning are helping clinicians unlock the data from this valuabl

Big Data 110
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100-day vaccine development and an ‘all-in-one’ coronaviruses vaccine: CEPI’s $3.5bn ambition

BioPharma Reporter

The Coalition for Epidemic Preparedness Innovations (CEPI) has set out a $3.5bn plan to âdramatically reduce or even eliminate the future risk of pandemicsâ. Its ambitions are for an âall-in-oneâ vaccine against SARS, MERS-CoV and SARS-CoV-2 coronaviruses; as well as reducing vaccine development into a 100 day timeframe.

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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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FDA fast tracks type 1 diabetes cell therapy from Vertex

pharmaphorum

Vertex Pharma has made its name with treatment for cystic fibrosis, but has big plans in cell and genetic therapies – and has just chalked up fast-track status from the FDA for a cell-based therapy for diabetes. . VX-880 (formerly known as STx-02) derives from Vertex’ near $1 billion acquisition of Semma in 2019, and has started enrolling patients in a phase 1/2 study in the US.

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Paleontology: Microscope helps with dinosaur puzzle

Scienmag

Comparison of fossil bone tissue allows more reliable assignment to individuals Credit: (c) Sauriermuseum Aathal Fossil sites sometimes resemble a living room table on which half a dozen different jigsaw puzzles have been dumped: It is often difficult to say which bone belongs to which animal. Together with colleagues from Switzerland, researchers from the University […].

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Preclinical Data Boosts Case for Cell Source’s CD8+ Veto Cells in BMT

BioSpace

Recently published data from a mouse model of sickle cell disease (SCD) is bolstering the case for the safety of Cell Source’s CD8+ veto cells, currently in Phase I/II testing to improve peripheral blood stem cell transplantation in patients with hematological malignancies.

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How does a crustacean become a crab?

Scienmag

Researchers find five independent carcinizations in both true and false crabs and at least seven instances of decarcinization Credit: Courtesy of Joanna M. Wolfe. Crabs are living the meme life on social media lately. The memes joke that everything will eventually look like a crab. But it’s actually based in some truth. The crab shape […].

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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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Four Biotechs Bringing Home the Bacon for Cancer Therapies, Vaccines and MRSA

BioSpace

Investment dollars continue to flood the life sciences industry as new technologies and groundbreaking approaches tear down the dams that have previously hindered advancement.

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New insight into how cancer spreads

Scienmag

Heide Ford, Ph.D., associate director of basic research at the CU Cancer Center, published a study in Oncogene investigating how cancer metastasizes Credit: University of Colorado Cancer Center Breast cancer is harmful enough on its own, but when cancer cells start to metastasize — or spread into the body from their original location — the […].

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Pharma, comms and patient group leaders join judging panel for Patient Partnership Index 2021

Pharma Times

Senior leaders from UK and European pharma have come together to judge the Patient Partnership Index 2021

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HAWC Gamma Ray Observatory discovers origin of highest-energy cosmic rays in the galaxy

Scienmag

Photon origins tracked to Cygnus OB2 star-forming region Credit: TeV: Binita Hona (HAWC Collaboration), IR: Hora et. al, Spitzer’s Growing Legacy, ASP Conference Series, 2010, P. Ogle, ed. LOS ALAMOS, N.M., March 11, 2021–A long-time question in astrophysics appears to finally be answered, thanks to a collection of large, high-tech water tanks on a mountainside […].

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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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COVID-19 Vaccine News: Novavax Effective Against Variants; Sanofi/Translate Begin Early Trials

BioSpace

While existing vaccines are being rolled out worldwide, Novavax’s is demonstrating effectiveness in late-stage trials and the partnership of Sanofi and Translate Bio is beginning early-stage trials for their mRNA vaccine.

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New study finds shared origins for individual chronic diseases in multimorbidity

Scienmag

Credit: Dr Maik Pietzner at the MRC Epidemiology Unit A new study published today in Nature Medicine has identified key risk factors that increase the likelihood of individuals developing not only one but multiple non-communicable diseases, which include cardiovascular disease, cancer, chronic respiratory disease and diabetes. The analysis of over 11,000 people found that rather […].

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EMA Launches Safety Review After Gene Therapy Trial Patient Develops Blood Cancer

BioSpace

The European Medicines Agency has launched a safety review of bluebird bio’s thalassaemia drug Zynteglo, a conditionally licensed gene therapy in Europe.

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NIH awards grants to support bacteriophage therapy research

Scienmag

“Phage” therapies offer potential strategy to combat antibacterial resistance Credit: NIAID The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded $2.5 million in grants to 12 institutes around the world to support research on bacteriophage therapy. These awards represent NIAID’s first series of grants focused exclusively […].

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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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GSK to leverage the Cell and Gene Therapy Catapult’s facility in Stevenage

Pharma Times

British drugmaker to expand its clinical manufacturing capacity for cell and gene therapy

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Whooping cranes steer clear of wind turbines when selecting stopover sites

Scienmag

Proliferation of wind-energy infrastructure across the Great Plains has created obstacles along key migration routes; future developers could place infrastructure outside of migration corridors to avert negative impacts Credit: Travis Wooten/USGS As gatherings to observe whooping cranes join the ranks of online-only events this year, a new study offers insight into how the endangered bird […].

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Endemic COVID-19 Needs Novel, Prognostic Tests to Predict Severity and Progression

BioSpace

Some diagnostic developers are looking ahead to the time when COVID-19 is endemic throughout the population and most people are vaccinated. From a public health perspective, COVID-19 will be treated like the seasonal flu.

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DNA production specialist Touchlight raises £42m

Pharma Times

Proceeds will be used to ‘more than triple’ UK biotech's manufacturing capabilities

DNA 109
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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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Firefly tourism takes flight, sparking wonder and concern

Scienmag

First comprehensive review on the growing global phenomenon of firefly tourism Credit: Spencer Black Firefly beetles rank among the world’s most charismatic creatures, with luminous courtship displays that have now turned them into a popular attraction for wildlife tourists. In the first comprehensive review of firefly tourism, published in the journal Conservation Science and Practice, […].

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Research Roundup: AI Helps ID Alzheimer’s Treatments and More

BioSpace

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.

Research 103
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Lehigh U. researchers: ‘One step closer to unlocking mysteries of the bio/nano interface’

Scienmag

Proteins choreograph the infinitesimal dance of living cells and functional biomaterials Credit: Lehigh University | Thamma, Kowal, Falk, Jain An interdisciplinary research team at Lehigh University has unraveled how functional biomaterials rely upon an interfacial protein layer to transmit signals to living cells concerning their adhesion, proliferation and overall development.

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Some Countries Pause Dosing of AstraZeneca Vaccine Due to Clotting Concerns

BioSpace

This morning, the World Health Organization issued a statement that there is no reason to stop using the vaccine because, as of this time, “no causal link has been established.

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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.