Thu.Aug 20, 2020

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Novartis set to take on Roche as FDA clears first at-home, injectable MS drug

Bio Pharma Dive

Kesimpta, a new multiple sclerosis drug from Novartis, works the same way as Roche's blockbuster Ocrevus, but patients can take it without leaving home.

Drugs 300
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The erosion of trust in health information?

World of DTC Marketing

QUICK READ: The belief that the development of a vaccine for coronavirus is being dangerously rushed, in part to improve Donald Trump’s prospects ahead of the presidential election in November are very real. In addition, Avaaz discovered that”global health misinformation spreading networks” had generated roughly 3.8 billion views for their content on Facebook.

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BioMarin's gene therapy rejection didn't shock everyone

Bio Pharma Dive

The FDA's decision not to approve Roctavian raises the question of why BioMarin was able to submit the hemophilia A therapy in the first place.

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First trial participant gets GSK's 5-in-1 meningitis jab

Pharma Times

The Phase III study is evaluating the safety, tolerability and immunogenicity of GSK’s MenABCWY vaccine candidate compared to Bexsero and Menveo

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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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Coronavirus vaccine Pfizer, BioNTech chose for late-stage testing appears safer than first

Bio Pharma Dive

The companies' second experimental shot caused less fever, without compromising potency, when compared to an earlier version, according to preliminary data.

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FDA Greenlights Novartis’ Kesimpta for Multiple Sclerosis

BioSpace

The U.S. Food and Drug Administration (FDA) approved Novartis’ Kesimpta (ofatumumab) for relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

More Trending

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Russia Plans 40,000 Patient Study for Approved Coronavirus Vaccine

BioSpace

Following approval of its coronavirus vaccine, the first in the world, Russia plans to initiate a new study involving 40,000 people as the country looks to boost production and distribute the drug to patients in that country, as well as to patients in countries it has struck deals with.

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The cost of medication: A critical provider/patient dialogue

Bio Pharma Dive

Read a discussion with a Pharmacist and M.D.

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Why the next blockbuster in mental health might be a video game

pharmaphorum

David Keene looks at the difficulties faced in treating mental health patients and how digital technologies are changing the game. In 1919 a young Dwight Eisenhower participated in a cross-country road trip to deliver tanks from Fort Meade in Maryland to San Francisco. Most of the roads on the journey were muddy, rut filled trails, and after 62 days at an average speed of 5 miles per hour, the convoy finally arrived.

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Boehringer Ingelheim to Pay $379,000 to Settle Wage Discrimination Charges

BioSpace

Boehringer Ingelheim’s Animal Health USA division will reimburse $379,089 in back pay and interest to 75 female employees to resolve alleged wage discrimination at its St. Joseph, Missouri, facility.

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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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How Fitbit Wearables Could Detect COVID-19 Symptoms

XTalks

As part of efforts to find solutions for the current coronavirus pandemic, Fitbit has released data from a collaborative study it has undertaken with researchers at Stanford University and The Scripps Research Institute on the use of wearable health trackers for the detection of COVID-19. The wearable device giant partnered with Scripps Research and Stanford Medicine to study the role of wearables to detect, track and contain infectious diseases like COVID-19 before the onset of symptoms.

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A new iron based superelastic alloy capable of withstanding extreme temperatures

Scienmag

Credit: Tohoku University Researchers from Tohoku University’s Graduate School of Engineering have discovered a novel iron-based superelastic alloy (SEA) capable of withstanding extreme temperatures -both high and low. SEAs are found in a wide variety of commercial applications because of their superelasticity, allowing them to regain their original shape.

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Sanofi Pays $3.68 Billion for Principia Biopharma and its MS Pipeline

XTalks

Looking to bolster its autoimmune portfolio, Sanofi has announced it will be acquiring San Francisco-based Principia Biopharma in a deal valued at $3.68 billion. This all-cash deal will see Sanofi paying $100 per share with unanimous approval from both Boards of Directors. The main attraction for Sanofi was Principia’s portfolio of Bruton tyrosine kinase (BTK) inhibitors, one of which is being developed to treat multiple sclerosis (MS).

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Research team develops the first physics-based method for predicting large solar flares

Scienmag

Credit: Institute for Space-Earth Environmental Research, Nagoya University Solar flares emit sudden, strong bursts of electromagnetic radiation from the Sun’s surface and its atmosphere, and eject plasma and energetic particles into inter-planetary space. Since large solar flares can cause severe space weather disturbances affecting Earth, to mitigate their impact their occurrence needs to be predicted. […].

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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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Research Roundup: Lasting Immunity to COVID-19 and More

BioSpace

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

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Vaccine that harnesses antifungal immunity protects mice from staph infection

Scienmag

Credit: NIAID Immunization of mice with a new vaccine consisting of fungal particles loaded with Staphylococcus aureus (S. aureus) proteins protects mice against S. aureus infection, according to a study published August 20 2020 in the open-access journal PLOS Pathogens by David Underhill of Cedars-Sinai Medical Center, and colleagues. S. aureus is one of the […].

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Biopharma Update on the Novel Coronavirus: August 21

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 21, 2020.

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Doctor invents hybrid mask allowing ENT doctors to see more patients

Scienmag

VA seeking companies to license, manufacture Credit: Dr. Scott Fuller/VA SACRAMENTO, Calif. – An ear, nose, and throat doctor has invented a simple mask design that significantly improves safety during aerosol-generating procedures of the head and neck. The novel coronavirus plummeted the number of patients Dr. Scott Fuller was seeing per day to one, or […].

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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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Pfizer and BioNTech Release Additional Early-Stage Data on COVID-19 Vaccine

BioSpace

Today’s data describes key safety and immunogenicity data from the U.S. Phase I study for BNT162b.

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PharmacyChecker Helps Americans Save 99% on Medications… Domestically

Pharmacy Checkers

I just love this! A new post on the Ask PharmacyChecker resource section is called “ How to Get a 99% Off Your Prescription (without ordering from Canada).” Taking a break from the politics and policy I find myself writing about on these blog pages, I want to brag about PharmacyChecker’s domestic savings. More than ever, if an American compares drug prices on PharmacyChecker.com, they will learn that most generic drugs are far cheaper domestically than in Canada – or, in some cases, even India.

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US expand use of Janssen's Darzalex

Pharma Times

The approval broadens the drug's label to include fifth treatment option in the relapsed/refractory multiple myeloma setting

Drugs 108
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New approach uses wild genes to improve biological nitrogen fixation in soybeans

Scienmag

Credit: Thi Nguyet Minh Dao and Svetlana Y. Folimonova. One of the top four crops grown worldwide, soybean has been an integral part of Chinese agriculture for a long time, having been domesticated more than 6000 years ago. During the domestication process, certain traits are selected that make plants easier to cultivate and cook and […].

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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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Analyst tips first wave of COVID-19 vaccines to generate $20b

BioPharma Reporter

Bernstein's Ronny Gal tips leading vaccine developers to rack up sales of $20 million from COVID-19 shots in the first immunization wave.

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Are Patients Still Seeking Clinical Trials During Covid-19?

Find Me Cure

At the beginning of the global lockdown, our team at FindMeCure had some assumptions, concerns and predictions about the impact of Covid-19 on clinical trials and more specifically – the patients seeking treatments. We anticipated a lot of worried patients in various risk groups anxious to make hospital visits a regular part of their treatment.

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Survey reveals Britains welcome shift to virtual healthcare

Pharma Times

Findings also show increased trust in pharma and healthcare

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Roche, Regeneron ally to triple supply of COVID-19 antibody cocktail

BioPharma Reporter

Roche agrees to distribute Regeneronâs COVID-19 antibody combination outside the US, more than tripling manufacturing capacity.

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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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Creative agency woolley pau regains independence after buyout

pharmaphorum

Healthcare marketing agency woolley pau has gone back to its independent roots following a management buyout by three of its senior team. Ed Shorthose, managing director, said the move “felt right on every level”. Shorthose, Christian Dawson and Dean Woolley bought out the agency, which was had previously been acquired by healthcare communications company gyro in 2007 and then in 2016 by digital marketing company Dentsu Aegis Network.

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Inato: insightful data can boost clinical trial diversity

Outsourcing Pharma

A leader from the clinical research technology firm talks about the importance of a diverse patient population and ways to hit the target.

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Auxolytic’s Nutrient-Based Shut-Off Switch Boosts Cell Therapy Safety Without Transgenes

BioSpace

The process, auxotrophy, uses the engineered inability of an organism to synthesize a compound required for its survival to allow physicians to turn off a gene therapy if serious side effects develop.

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Researchers create nanoclusters that mimic biomolecules

Scienmag

ITHACA, N.Y. – Biological systems come in all shapes, sizes and structures. Some of these structures, such as those found in DNA, RNA and proteins, are formed through complex molecular interactions that are not easily duplicated by inorganic materials. A research team led by Richard Robinson, associate professor of materials science and engineering, discovered a […].

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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.