Mon.Jan 18, 2021

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Pharma’s move to digital Part 1 HCP Marketing

World of DTC Marketing

OPENING: Pharma companies are starting to embrace digital marketing forced, in large part, by changes brought on by the pandemic. There is, however, a difference between an evolutionary move to digital and a revolutionary move to digital. Digital marketing is becoming a valuable tool. But the reality is, health care relies on significant in-person engagements, and digital is only one part of the equation.

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Nanoparticles: The Next Generation of Vaccine Technology

BioSpace

One approach that is being developed by researchers at Stanford University leveraged nanoparticles. Preclinical research was recently published on it in the journal ACS Central Science.

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Allergic reactions prompt Moderna COVID vaccine pause in California

pharmaphorum

Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one immunisation clinic. According to state epidemiologist Dr Erica Pan, there were a higher-than-expected number of suspected allergic reactions at a community clinic being used to administer the shot, with some people needing medical attention in a 24-hour period.

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FDA Grants Rare Pediatric Disease, Orphan Drug Designation to Taysha’s Rare Epilepsy Candidate

BioSpace

The U.S. FDA has granted rare pediatric disease and orphan drug designations for Taysha Gene Therapies’ AAV9-based gene treatment candidate currently in development for epilepsy caused by SLC13A5 deficiency.

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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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AZ/Daiichi Sankyo’s Enhertu gets second US cancer indication

pharmaphorum

AstraZeneca and Daiichi Sankyo’s Enhertu cancer drug has picked up a second indication, in patients who have stomach cancer and haven’t responded to Roche’s Herceptin (trastuzumab). This latest indication adds to Enhertu first approval at the end of 2019 for advanced HER2-positive breast cancer after two or more HER2-targeted regimens. Around one in five gastric cancers are HER2-positive, opening up a new market niche for AstraZeneca and Daiichi Sankyo, who have been working on Enhertu (trastuzu

Sales 111
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Using Cutting Edge Tech, Georgetown Team Proves Pancreatic Cancer Target

BioSpace

Pancreatic cancer is one of the deadliest forms of cancer. The five-year survival rate is a paltry 5-10%. The tumors are basically invisible to the immune system and rarely respond to chemotherapy or immunotherapy.

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Thermo Fisher Buys Mesa Biotech for a Total Deal of $550 Million

BioSpace

Thermo Fisher Scientific, based in Waltham, Massachusetts, is acquiring Mesa Biotech for about $450 million in cash. There is also an additional $100 million in cash after certain milestones are hit.

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J&J’s Darzalex Faspro is first US therapy for rare blood disorder

pharmaphorum

Johnson & Johnson’s Darzalex Faspro has become the first product approved by the FDA to treat light chain (AL) amyloidosis, a rare and often fatal blood cell disorder. The new indication is the second for Darzalex Faspro, a subcutaneous version of blockbuster intravenous therapy Darzalex (daratumumab) which is used to treat multiple myeloma on its own and as part of multiple combination therapies.

Drugs 98
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Xalkori bags FDA green light for rare paediatric non-Hodgkin lymphoma

Pharma Times

Therapy approved for the treatment of paediatric patients with anaplastic large cell lymphoma

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Inexpensive battery charges rapidly for electric vehicles, reduces range anxiety

Scienmag

Credit: Chao-Yang Wang’s lab, Penn State Range anxiety, the fear of running out of power before being able to recharge an electric vehicle, may be a thing of the past, according to a team of Penn State engineers who are looking at lithium iron phosphate batteries that have a range of 250 miles with the […].

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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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Decentralized trials, remote monitoring continue surging: KCR

Outsourcing Pharma

A representative from the global CRO outlines how forces like COVID-19, decentralized studies, globalization and others are driving change in the industry.

Trials 104
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Lasers & molecular tethers create perfectly patterned platforms for tissue engineering

Scienmag

Credit: Batalov et al., PNAS, 2021 Imagine going to a surgeon to have a diseased or injured organ switched out for a fully functional, laboratory-grown replacement. This remains science fiction and not reality because researchers today struggle to organize cells into the complex 3D arrangements that our bodies can master on their own. There are […].

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COVID-19 a ‘catalyst’ for innovation in 2020: Oracle

Outsourcing Pharma

A leader from Oracle Health Sciences examines the dynamic, challenging year and highlights creativity and ingenuity displayed by research professionals.

Research 104
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Synthesis of potent antibiotic follows unusual chemical pathway

Scienmag

Credit: Booker Lab, Penn State UNIVERSITY PARK, Pa. — Images of a protein involved in creating a potent antibiotic reveal the unusual first steps of the antibiotic’s synthesis. The improved understanding of the chemistry behind this process, detailed in a new study led by Penn State chemists, could allow researchers to adapt this and similar compounds […].

Protein 94
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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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Ex-Merck & Co scientist accused of stealing trade secrets could face jail

pharmaphorum

A former Merck & Co scientist could face up to 10 years in prison after he was accused of stealing trade secrets relating to drugs including the cancer immunotherapy Keytruda by US authorities. In a document outlining the charges against Shafat Quadri, of North Potomac, Maryland the US Department of Justice (DoJ) referred only to “one of the largest pharmaceutical companies in the world” based in New Jersey.

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New method to assist fast-tracking of vaccines for pre-clinical tests

Scienmag

Novel tuberculosis vaccine demonstrated strong immune response in mice Credit: University of Sydney Scientists in Australia have developed a method for the rapid synthesis of safe vaccines, an approach that can be used to test vaccine strategies against novel pandemic pathogens such as SARS-CoV-2, the virus that causes COVID-19. Led by Professor Richard Payne at […].

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$80 Million-Plus Venture Rounds for Gene Editing, Fusion Protein Companies

BioSpace

Sizable venture rounds from cardiac gene-editing company Verve Therapeutics and the retooled fusion protein maker Vera Therapeutics will push their lead therapies into and through the clinic over the next two years.

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A ‘super-puff’ planet like no other

Scienmag

Credit: ESA/Hubble, NASA, M. Kornmesser. The core mass of the giant exoplanet WASP-107b is much lower than what was thought necessary to build up the immense gas envelope surrounding giant planets like Jupiter and Saturn, astronomers at Université de Montréal have found. This intriguing discovery by Ph.D. student Caroline Piaulet of UdeM’s Institute for Research […].

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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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ViiV Healthcare continues HIV care partnership with Chelsea and Westminster Hospital

Pharma Times

Partnership aims to transform HIV patient care with digital services

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How cells move and don’t get stuck

Scienmag

Credit: Rädler Lab, Ludwig Maximilians Universität München Cell velocity, or how fast a cell moves, is known to depend on how sticky the surface is beneath it, but the precise mechanisms of this relationship have remained elusive for decades. Now, researchers from the Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC) and […].

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The elective care conundrum – can digital innovation help?

pharmaphorum

Karina Malhotra from Acumentice explores how digital tech and data could help address the NHS elective care backlog in 2021 and beyond. The repercussions of the COVID-19 pandemic are going to take a considerable time to repair and nowhere is this more pertinent than in NHS elective care. The impact on elective care has been considerable. Reports have shown that the number of people waiting more than a year for an operation has reached its highest level since 2008.

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2021 Biopharma Update on the Novel Coronavirus: January 19

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 19, 2021.

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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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Smart vaccine scheme quick to curb rabies threat in African cities

Scienmag

Credit: Mission Rabies More people could be protected from life-threatening rabies thanks to an agile approach to dog vaccination using smart phone technology to spot areas of low vaccination coverage in real time. Vets used a smart phone app to help them halve the time it takes to complete dog vaccination programmes in the Malawian […].

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Race to Vaccinate Increases as COVID-19 Virus Mutates Again

BioSpace

New variants of COVID-19 are popping up all across the globe, including here in the United States.

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Successive governments’ approach to obesity policies has destined them to fail

Scienmag

Government obesity policies in England have largely failed due to problems with implementation, lack of learning from past experience, and a reliance on trying to persuade individuals to change their behaviour rather than tackling unhealthy environments. Successive governments’ approach to obesity policies has destined them to fail, say researchers.

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Top 10 Biopharma Giants to Work for in Biotech Bay

BioSpace

Here is a list of 10 of the top biopharmaceutical giants that have research sites in Biotech Bay.

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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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Stop global roll out of 5G networks until safety is confirmed, urges expert

Scienmag

Transmitter density means greater population exposure to high levels of radio frequency electromagnetic fields We should err on the side of caution and stop the global roll out of 5G (fifth generation) telecoms networks until we are certain this technology is completely safe, urges an expert in an opinion piece published online in the Journal […].

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Lilly’s Loxo Oncology Stakes Up to $1 Billion in Merus’ T-Cell Antibody Cancer Candidates

BioSpace

Indianapolis-based Eli Lilly is betting big on clinical-stage oncology company Merus, agreeing to pay up to $1.6 billion to the Netherlands-based biotech for a research and development collaboration focused on up to three early experimental cancer drugs.

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Low-carbon policies can be ‘balanced’ to benefit small firms and average households

Scienmag

Some of the low-carbon policy options currently used by governments may be detrimental to the households and small businesses less able to manage added short-term costs from energy price hikes, according to a new study. However, it also suggests that this menu of decarbonising policies, from quotas to feed-in tariffs, can be designed and balanced […].

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‘It Was a Fraud,’ Cuomo Says of Vaccine Rollout

NY Times

Gov. Andrew M. Cuomo of New York said on Monday that he had asked the pharmaceutical giant Pfizer to directly sell doses to the state, so that it does not have to depend solely on the federal government to distribute doses.

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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.