Tue.Apr 20, 2021

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The next 2 months in biotech and pharma will be busy. Here's what to watch.

Bio Pharma Dive

New developments could come soon for two coronavirus vaccines while, a bit further off, the fate of Biogen's Alzheimer's drug hangs in the balance. Important data are expected, too, for Vertex and Sarepta.

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Pharma Tuesday Stuff

World of DTC Marketing

QUICK READ: Here are some recent stories that you should all be aware of. Last month I hit 80,000 readers when accounting for email, social media, and direct traffic. I love the industry, and although I want to see some changes, I know there are many good people trying every day to make it happen. After a year of pandemic-delayed medical tr eatments, doctors are seeing more cases of advanced illnesses.

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Bluebird to withdraw gene therapy from Germany after dispute over price

Bio Pharma Dive

The biotech will cut staff, primarily in Europe, after negotiations with German health authorities resulted in a price lower than Bluebird had sought.

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NICE says yes to Novartis’ multiple sclerosis therapy Kesimpta

pharmaphorum

Novartis has secured backing from NICE for its relapsing multiple sclerosis (RMS) therapy Kesimpta in the UK, just two weeks after the drug was approved by the national drugs regulator. . The cost-effectiveness agency has said that anti-CD20 antibody Kesimpta (ofatumumab) can be prescribed via the NHS in England and Wales as a treatment for adults with RMS with active disease, as either a first-line therapy or after alternative drugs have been tried.

Sales 111
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Europe's drug regulator links J&J's vaccine to rare clots as US pause continues

Bio Pharma Dive

The EMA reiterated the vaccine's benefits outweigh its risks but recommended a warning be added to highlight the rare, but serious side effect. Regulators in the U.S. are expected to soon make a similar decision.

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Study explores synthetic cannabinoid for cancer-related anorexia

Outsourcing Pharma

Artelo Biosciences is investigating the viability of its novel cannabinoid product as a solution to treat cancer-related anorexia in oncology patients.

More Trending

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Celebrating Medical Laboratory Professionals Week 2021

XTalks

This week marks Medical Laboratory Professionals Week (MLPW), or Lab Week, which is taking place April 18–April 24 this year. The annual event celebrates the work of professionals in the medical laboratory industry, which include medical technicians, medical technologists, lab assistants, pathologists, biologists, geneticists and a host of other specialists.

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Healthware Group Acquires UK-Based SWM

pharmaphorum

SWM and Healthware Join Forces to Help Physicians Connect to Science & Learning. Salerno, Italy / London, UK | 20 April 2021 – Healthware Group , an integrated global digital health organization with a focus on strategic consulting, marketing communications, and healthcare innovation has announced its acquisition of London-based SWM (Streaming Well Motion) , a creative motion lab and consultancy focused on virtual hybrid experiences, content development, and medical education.

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Astronauts’ mental health risks tested in the Antarctic

Scienmag

No bounce back for declines in positive emotion Credit: University of Houston Astronauts who spend extended time in space face stressors such as isolation, confinement, lack of privacy, altered light-dark cycles, monotony and separation from family. Interestingly, so do people who work at international research stations in Antarctica, where the extreme environment is characterized by […].

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Beam’s New CRISPR Base Editing Tool Targets Sickle Cell Mutation

BioSpace

Beam Therapeutics has recently unveiled a new CRISPR base editing tool to target sickle cell mutations, a promising approach that holds substantial clinical value for patients with these blood disorders.

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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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Can extreme melt destabilize ice sheets?

Scienmag

Credit: Farrin Abbott Nearly a decade ago, global news outlets reported vast ice melt in the Arctic as sapphire lakes glimmered across the previously frozen Greenland Ice Sheet, one of the most important contributors to sea-level rise. Now researchers have revealed the long-term impact of that extreme melt. Using a new approach to ice-penetrating radar […].

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Immunomics firm reels in $14m to advance drug discovery

Outsourcing Pharma

ImmunoScape plans to use the investor funds to grow its Asia presence, expand into the US, and to further develop its Deep Immunomics platform technology.

Drugs 97
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OU Doctoral student’s research on fruit fly behavior earns award at international conference

Scienmag

Credit: Preston Larson Mehrnaz Afkhami, a doctoral biology student at the University of Oklahoma, was awarded the graduate student poster award at this year’s 62nd Annual Drosophila Research Conference. She was selected for this honor among hundreds of posters, beating out the two runners-up from Cornell University and Johns Hopkins University.

Doctors 97
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Enhertu accepted via cancer drugs fund for HER2-positive breast cancer

Pharma Times

Decision is based on results from the Phase II DESTINY-Breast01 trial

Drugs 129
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Surpassing the lower limit on computing energy consumption

Scienmag

Topological materials beat Boltzmann’s tyranny Credit: Errol Hunt (FLEET) New FLEET research confirms the potential for topological materials to substantially reduce the energy consumed by computing. The collaboration of FLEET researchers from University of Wollongong, Monash University and UNSW have shown in a theoretical study that using topological insulators rather than conventional semiconductors to make […].

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Let’s Get to Know Paula Ragan, CEO and President of X4 Pharmaceuticals

BioSpace

BioSpace spoke with Paula Ragan, CEO and President of X4 Pharmaceuticals, a company focused on restoring healthy immune system function in people with rare diseases.

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Helpful, engineered ‘living’ machines in the future?

Scienmag

New soft, responsive metamaterial holds potential for wide variety of societal benefits Credit: ELIZABETH FLORES-GOMEZ MURRAY/ PENN STATE Engineered, autonomous machines combined with artificial intelligence have long been a staple of science fiction, and often in the role of villain like the Cylons in the “Battlestar Galactica” reboot, creatures composed of biological and engineered materials. […].

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Nearly $1.3 Billion in OWS Funds Went to ApjJect Systems for Syringes Yet to Be Authorized

BioSpace

ApiJect’s syringe is designed to be prefilled with a dose of a vaccine before it is shipped out to be used by doctors, pharmacists, hospitals, and many of the vaccination centers set up across the country. NBC noted that the prefilled technology had not been approved in the U.S.

Doctors 86
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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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Gold digger: Neural networks at the nexus of data science and electron microscopy

Scienmag

Researchers at the Max Planck Florida Institute for Neuroscience used machine learning to develop a new, fully automated way to search and identify gold particles markers in electron micrographs with near human-level accuracy Credit: Max Planck Florida Institute for Neuroscience From sample preparation to image acquisition, electron microscopy (EM) requires precise and time-consuming steps to […].

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IPO Flurry Continues: Talaris, Gyroscope, Sagimet All Plan to Go Public

BioSpace

Six months after bagging $115 million in a Series B financing round, Talaris Therapeutics is aiming to raise another $100 million through in initial public offering. It’s one of three companies joining in the flurry of IPOs this week.

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Food allergies, changes to infant gut bacteria linked to method of childbirth, ethnicity

Scienmag

Babies born by caesarean section to mothers of Asian descent are eight times more likely to develop peanut allergy by age three, study shows Credit: Faculty of Medicine & Dentistry, University of Alberta Researchers have found a causal link between caesarean section birth, low intestinal microbiota and peanut sensitivity in infants, and they report the […].

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What comes next: digital transformation in B2B life sciences sales

pharmaphorum

As the contours of a post-pandemic world begin to take shape, those working B2B sales in the life sciences acknowledge that the industry must adapt to some permanent shifts. Mert Yentur looks at what is next for the industry. Even prior to COVID-19, sales teams reckoned with traditional online-only CRM systems that didn’t align well with the needs of health care providers’ customers.

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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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Fearsome tyrannosaurs were social animals, study suggests

Scienmag

The report, based on research at a unique fossil site in Utah, provides new evidence that tyrannosaurs were social carnivores and not solitary hunters as popularly envisioned. Credit: U.S. Bureau of Land Management FAYETTEVILLE, Ark. – The fearsome tyrannosaur dinosaurs that ruled the northern hemisphere during the Late Cretaceous period (66-100 million years ago) may […].

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Money on the Move: April 14-20

BioSpace

Investment funds continue springing up into life sciences companies across the globe. Here’s where the money’s being planted this week.

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Predicting the onset of diseases

Scienmag

Scientists have created a statistical model that helps them predict when diseases like high blood pressure, heart diseases and type 2 diabetes will occur. Credit: IST Austria A myriad of genetic factors can influence the onset of diseases like high blood pressure, heart diseases, and type 2 diabetes. If we were to know how the […].

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NICE’s five-year strategy sets a ‘positive vision for the future’

Pharma Times

Pharma and diagnostic sectors respond to organisation’s latest guideline recommendations

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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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City, University of London joins forces with Engineers Without Borders UK

Scienmag

The strategic university partnership is aimed at embedding global and social responsibility into education and student experience. Credit: EWB UK City, University of London has joined forces with Engineers Without Borders UK. It represents the first-ever strategic university partnership initiative undertaken by the engineering charity and is aimed at embedding global responsibility into education and […].

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Healthware acquires UK creative motion lab and consultancy SWM

pharmaphorum

Healthware Group has expanded its long-standing collaboration with UK-based SWM by acquiring the creative motion lab and consultancy. Founded in London last year by Francis Mahmud Namouk and Genevieve Robson, SWM (Streaming Well Motion) is an evolution of Streaming Well , the health-focused video agency the duo set up in 2009. SWM managing director Namouk said: “Joining the Healthware Group allows us to solidify our years-long working relationship and leverage the Group’s outstanding network and

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Drug development platform could provide flexible, rapid and targeted antimicrobials

Scienmag

Credit: College of Engineering & Applied Science, University of Colorado Boulder When disease outbreaks happen, response time in developing and distributing treatments is crucial to saving lives. Unfortunately, developing custom drugs as countermeasures is often a slow and difficult process. But researchers at the University of Colorado Boulder have created a platform that can develop […].

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From biosimilars to process intensification: 5 key trends in the biopharma space today

BioPharma Reporter

Efficiency in the biopharmaceutical space has never been more top-of-mind. The COVID-19 pandemic brought an unprecedented urgency to R&D and the key players delivered: Several groups produced a vaccine in record time. To maintain and improve on this level of efficiency, biopharma companies must reevaluate their infrastructure to make sure itâs optimized for long-term success.

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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.