Mon.Oct 11, 2021

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Sarepta outlines final push for Duchenne gene therapy

Bio Pharma Dive

The biotech still believes a speedy approval filing for the closely watched treatment is possible, but expects to have to wait for the results of the recently launched Phase 3 trial, CEO Doug Ingram said on a conference call.

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DTC is evolving: 10 things you must do

World of DTC Marketing

SUMMARY : DTC marketing is evolving as patients become more thoughtful about choosing treatment options. The model of “heavy TV followed by a website designed to sell people isn’t going to work anymore. I hear more and more from top pharma clients that “our DTC ROI is not where we want it to be.” In a detailed analysis across different health conditions, I’m finding two common causes.

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Adamas, Flexion sell for $825M combined as biotech's dealmaking pace picks up

Bio Pharma Dive

After lagging for months, M&A has accelerated over the past five weeks. But the average size of each transaction remains low compared to past years, as evidenced by the dual Monday buyouts of Adamas and Flexion.

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Samsung Biologics to help Enzolytics advance clinical development of mAbs

BioPharma Reporter

Samsung Biologics and Enzolytics have entered into a strategic CDMO partnership agreement targeting monoclonal antibody production.

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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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Merck, Ridgeback seek US clearance of first oral COVID-19 drug

Bio Pharma Dive

The two partners have officially filed for emergency authorization of their antiviral pill, a milestone in the fight against COVID-19. It's not yet clear whether vaccine recipients will be eligible for treatment, however.

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‘Build back better’ cannot mean longer waiting times for change

pharmaphorum

Global Blood Therapeutics (GBT) UK general manager Nigel Nicholls discusses the impact of COVID-19 for sickle cell patients in the UK. If the COVID-19 pandemic has shown us anything, it has highlighted the extent to which health inequity plagues our society. Although the Government, public and health care system have started to wake up to the insidious nature of systemic racism in the wake of the pandemic, many have been left facing tougher situations than pre-pandemic.

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Hormel Foods Partners with Better Meat Co. To Bring Mycoprotein Products to Market

XTalks

Hormel Foods Corporation’s 199 Ventures which is the company’s venturing company, is entering the plant-based protein sphere by partnering with The Better Meat Co. Together, they will bring new mycoprotein and plant-based protein products to the market. In 2019 Hormel Foods wanted to bring forward a food incubator where the company invests in others that align with Hormel Foods’ growth strategies, which was when 199 Ventures was born.

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Association Between Risk of COVID-19 in Nonimmune Individuals and Immunity in Family Members

JAMA Internal Medicine

This cohort study examines the spread of COVID-19 infection within family members living in the same residence with different levels of immunity.

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Merck Asks F.D.A. for Emergency Approval of Covid Pill

NY Times

The company is seeking authorization for the pill to be given to high-risk people sick with Covid. Tens of millions of Americans could be eligible.

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New Evidence Suggests COVID-19 Vaccines Might Mitigate Long COVID

BioSpace

Evidence is emerging that not only can COVID-19 vaccines help to prevent the condition, but they could serve as a form of “rescue” for those already stricken with it.

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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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Mastering data management can lead to improved outcomes: CitiusTech

Outsourcing Pharma

According to two leaders from the healthcare tech firm, improving the way healthcare data is collected, stored, and used can contribute to improved care.

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Companies Enter Licensing Agreements to Expand Gene Therapy Programs

BioSpace

Takeda entered into a licensing pact with Poseida, Spark entered into a licensing agreement with CombiGene AB, while BridgeBio Pharma announced plans for its second annual R&D Day.

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UK pharmacy M&A transactions up by 26%

Pharma Times

Pharmacies saw increased customer demand during the pandemic, says UHY Hacker Young

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Pfizer-BioNTech Lead Globally with COVID-19 Vaccine

BioSpace

Although there are many effective and safe COVID-19 vaccines around the world, the preferred vaccine is the Pfizer-BioNTech vaccine. For that and more stories, read on.

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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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Medable launches Site Network Council to elevate decentralized trials

Outsourcing Pharma

The patient-centric platform firm is gathering representatives from different corners of the industry to work on solutions to drive progress and innovation.

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GSK Consumer Health Business Has a Slew of Potential Suitors

BioSpace

GSK shares are climbing in premarket trading on rumors that the company’s consumer health business it intends to spin off into a separate company next year is attracting interest from venture capitalists.

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Medtech firm Entia raises $12m for ‘virtual oncology solution’

Pharma Times

Virtual monitoring service enable patients to perform their own at-home blood tests

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For Kezar Life Sciences’ John Fowler, Variety Truly is the Spice of Life

BioSpace

Variety, passion and the ability to make tangible improvements in people’s lives have propelled John Fowler, co-founder and CEO of Kezar Life Sciences, throughout his career.

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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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NICE backs Rinvoq for moderate active RA

Pharma Times

Decision expands access to oral therapy to around 27,000 people in England

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vTv Drug Candidate Lowers Blood Sugar Without Increasing DKA Risk

BioSpace

The positive results from a mechanistic study of TTP399 in type 1 diabetes patients suggest that the drug can lower blood glucose without increasing the risk of DKA.

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COVID-19 vaccine trial participants to be offered additional doses

Pharma Times

‘Top-up’ doses of approved vaccines to be offered to ensure clinical trialists can travel abroad

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Arcus is Uncloaking Cancer with Well-Informed Optimism

BioSpace

This year – 2021 – will be a transformational year, Rosen predicted, citing three important milestones.

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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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Exploring How COVID-19 Has Accelerated Digital in Healthcare: A Re-cap of the PMN Innovation Summit

Pharma Marketing Network

Quickly adapting to a new reality due to the COVID-19 pandemic was a theme throughout this year’s Pharma Marketing Network Innovation Summit 2021, linking all three panels: “ Telehealth: Past. Present. Future ,” “Marketing Agility: The Path to Digital Engagement and Innovation, ” and “Digital Health: Where Is It Headed?” While the global outbreak of COVID-19 was the catalyst that pushed Pharma to innovate, think differently, and do things faster, we still aren’t moving fast enough in some areas.

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Dana-Farber Adjusts Policy In Light of Conflict of Interest Accusations

BioSpace

?This followed a report that found that some trustees had, perhaps, taken advantage of this close connection with startups and research programs for their financial gain.

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New study sheds light on molecular motion

Scienmag

New research has shown how a synthetic self-made fibres can guide molecular movement that can be fuelled by light over long distances, a discovery that could pave the way for new ways to use light as a source of sustainable energy. Credit: University of Nottingham New research has shown how a synthetic self-made fibres can […].

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Late in the Game, CureVac Lays Down COVID Vaccine for a Better Hand

BioSpace

Teamed up with pharma giant GlaxoSmithKline, CureVac is now focusing on a more promising target – second-generation mRNA vaccines.

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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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Exploring How COVID-19 Has Accelerated Digital in Healthcare: A Re-cap of the PMN Innovation Summit

Pharma Marketing Network

Quickly adapting to a new reality due to the COVID-19 pandemic was a theme throughout this year’s Pharma Marketing Network Innovation Summit 2021, linking all three panels: “ Telehealth: Past. Present. Future ,” “Marketing Agility: The Path to Digital Engagement and Innovation, ” and “Digital Health: Where Is It Headed?” While the global outbreak of COVID-19 was the catalyst that pushed Pharma to innovate, think differently, and do things faster, we still aren’t moving fast enough in some areas.

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Another Top J&J Exec Will Make His Exit at End of Year

BioSpace

Two months after J&J CEO Alex Gorsky announced plans to step down, Chief Scientific Officer Paul Stoffels will retire from the life sciences giant at the end of the year.

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Gerresheimer AG: Gerresheimer on growth course

BioTech 365

DGAP-News: Gerresheimer AG / Key word(s): Quarter Results/9 Month figures 12.10.2021 / 07:00 The issuer is solely responsible for the content of this announcement. Core business revenue shows third-quarter organic growth of 9.

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NIH Believes Common Diuretic Drug Could Lower Risk of Alzheimer's

BioSpace

?The NIH revealed that bumetanide, a drug typically used as a diuretic, may be a potential treatment for those genetically at risk for Alzheimer's.

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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.