Sat.Oct 22, 2022 - Fri.Oct 28, 2022

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Former Uber Health founder launches new startup with a fresh take on egg freezing

MedCity News

Cofertility is a new startup aiming to make egg freezing more accessible by tying it to egg donation. The startup offers women two programs: Keep and Split. With Keep, women can pay to freeze their eggs and store them all for their own later use. The Split program allows women to freeze their eggs for free when they give half to a family who can’t otherwise conceive.

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3D Bioprinted Breast Tumors for Immunotherapy Testing

Medgadget

A team of scientists at Penn State has bioprinted breast tumor mimics with significant complexity, including a form of vascularization and the ability to precisely place cells in certain locations within the construct. The scientists used a technique called aspiration-assisted bioprinting to achieve this. With many anti-cancer therapies failing at the clinical trial stage and the ethical considerations of animal studies, there is a need for better in vitro cancer models that allow for advanced t

Ethics 126
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Cloud robotics labs are accelerating drug discovery and development

Pharmaceutical Technology

Drug discovery and development is an incredibly expensive and time-consuming process, taking between 12 and 18 years, and costing on average between $2 billion and $3 billion. Considering the low chances of success, with only 10% of drug candidates making it into clinical development, pharma companies must prevent the increased erosion of profit margins.

Pharma 124
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The Imperative for KAM in Pharma

PM360

Over the past decade, macro trends in healthcare have pushed life sciences companies to pursue increasingly sophisticated key account management (KAM) strategies and capabilities to provide unique offerings and value. This capability requires an orchestrated, cross-functional go-to-market model designed to address the needs and engagement preferences of a defined segment of large, complex, and strategically important healthcare systems and groups.

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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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5 years after FDA approval, CAR-T treatment looks like the future of medicine

MedCity News

CAR-T has become increasingly recognized as an exciting and potentially paradigm-shifting treatment in the past five years. In fact, more than 10,000 patients have undergone this new treatment for certain types of leukemia, lymphoma. and multiple myeloma.

Medicine 132
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mRNA Therapy Prevents COVID Virus Entering Cells

Medgadget

Scientists at Oregon State University have developed a new treatment for COVID-19. The technology is based on mRNA, which has also been put to good use in COVID-19 vaccines. However, in this instance, the delivered mRNA encodes for human angiotensin-converting enzyme 2 (hACE2), which is the binding site for SARS-CoV-2 on airway cells. The lipid nanoparticle-encapsulated mRNA therapeutic is delivered to cells in the body, and then the cells begin to produce and release a free-floating form of hAC

Patients 113

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A longtime believer in mRNA, Strand Therapeutics’ co-founder is now pushing the tech to the next level

PharmaVoice

The company’s co-founder and head of R&D on how it’s using synthetic mRNA to create “smarter” therapies that could provide cures for cancer and more.

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3 key reasons why Americans are under-utilizing primary care

MedCity News

In order to engage more Americans in primary care, we need to understand the main challenges that surround primary care in the U.S., according to Dr. Stephen Ezeji-Okoye, Crossover Health’s chief medical officer. Some of these include the increasing shortage of primary care physicians and the lack of incentivization to focus on whole-person health and preventive care.

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Wearable EEG Patch Measures Brain Activity

Medgadget

Researchers at Osaka University in Japan engineered a wearable electroencephalography (EEG) device that can measure brain activity, potentially letting clinicians monitor conditions such as depression or dementia. At present, assessing brain activity requires a trip to a facility with bulky and expensive equipment, making long-term monitoring difficult.

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Novartis drops presbyopia drug acquired with Encore Vision

pharmaphorum

Novartis has abandoned development of its drug to treat presbyopia, a common age-related loss of near distance vision, after it failed a phase 2b trial. The eyedrop formulation of UNR844 (lipoic acid/choline ester chloride) was acquired as part of the group’s buyout of privately-held ophthalmology biotech Encore Vision for $375 million upfront in 2017, and was designed to work by restoring the elasticity of the eye’s lens that declines with age.

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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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Woman of the Week: Ironwood Pharmaceuticals’ Diane Stroehmann

PharmaVoice

The VP of regulatory affairs and global patient safety explains why her line of work lets her do “a little of everything,” and the company’s plans to score a new approval for its blockbuster drug.

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How pharma companies can leverage asynchronous telemedicine

MedCity News

Through apps, pharmaceutical companies can actually influence patient adherence and mindset after that patient has been prescribed that company’s medication by their physician.

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Understanding the Future Regulatory Concerns of AI in Pharma to Harness Its Full Power

PM360

Shepherding a new drug to market is a long, expensive, and uncertain process. On average, it requires 10 to 12 years and $2.6 billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. During the last decade, the return on investment in drug development has seen diminishing returns.

Pharma 105
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Astellas to support development of Taysha’s gene therapy programmes

Pharmaceutical Technology

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). There are options in the future to possibly apply the worldwide research and development (R&D), manufacturing and marketing expertise of Astellas in gene therapy to AAV gene therapy development programmes of Taysha for genetic ailments of the central nervous system (CNS).

Biopharma 105
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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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First patient receives new engineered mRNA epigenetic

European Pharmaceutical Review

Biotech firm Omega Therapeutics, Inc. revealed the first patient to be dosed with OTX-2002, the first programmable mRNA therapeutic for c-Myc (MYC) oncogene overexpression, which targets cancer cells while sparing healthy cells. OTX-2002 targets c-Myc (MYC), a key oncogene and master transcription factor that regulates cell proliferation, differentiation and apoptosis and plays a major role in over half of all human cancers.

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Medtronic serves up platform for stroke-care startups

MedCity News

The innovation platform promises to match entrepreneurs with the resources they need to advance treatments for stroke care but also to help the device maker process all the new ideas it sees.

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Krystal Biotech’s B-VEC Topical Gene Therapy Shows Promise in Treating Rare Skin Disease

PM360

Krystal Biotech, Inc. , a clinical-stage biopharmaceutical company focused on gene therapies for dermatological diseases, recently announced positive results from a Phase 3 clinical trial on its investigational compound Beremagene Geperpavec (B-VEC), a topical gene therapy designed to treat the debilitating skin condition dystrophic epidermolysis bullosa (DEB).

Safety 104
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Pfizer and Flynn appeal £70m epilepsy drug fines in UK

pharmaphorum

Drugmakers Pfizer and Flynn Pharma have formally launched an appeal against a £70 million ($84 million) fine levied by the UK Competition and Markets Authority (CMA) for overcharging the NHS for a widely-used epilepsy drug. The two drugmakers were fined in July, after the CMA upheld a preliminary judgment that Pfizer and Flynn had abused a dominant position in phenytoin sodium capsules, causing NHS spending on the drug to swell from around £2 million a year in 2012 to £50 million the following y

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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BioMed X and Sanofi partner to leverage AI for drug development

Pharmaceutical Technology

BioMed X has entered a research partnership with Sanofi to leverage artificial intelligence (AI) for drug development. Under the joint research project, a new research team will be set up at the BioMed X Institute in Heidelberg, Germany. This team will focus on creating a versatile computational platform that can precisely forecast the first-in-class drug candidates’ efficacy in virtual patient groups.

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The future of wearable health tech

MedCity News

Consumer-led healthcare will change patient care pathways, driving the industry to grow and collaborate in new ways, both with patients around their own health and with partners and innovators.

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Top Tips for Optimizing Your Brand’s Performance with Real-World Demand Assessments

PM360

Understanding the journeys of healthcare professionals and patients when prescribing and receiving treatments has never been more important. As the industry struggles to maintain the same levels of productivity in R&D as in previous years, a greater emphasis than ever is being placed on providing an accurate estimation of demand and prescription trends.

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EndoStim Receives FDA Breakthrough Device Designation for the EndoStim System for the Treatment of Drug Refractory GERD

Legacy MEDSearch

EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. FDA Breakthrough Device Designation is intended to provide patients and health care providers with timely access to medical devices for more effective treatment or diagnosis of life-t

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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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CCC Wins Several Top Workplaces Cultural Excellence Awards

Copyright Clearance Center

October 26, 20 22 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, has earned several 2022 Top Workplaces Culture Excellence Awards for Employee Appreciation, Employee Well-Being, Professional Development, and being Women-Led. Earlier this year, CCC won national recognition for Compensation & Benefits, Leadership, and Work-Life Flexibility.

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Hazel Health raises $51.5M to scale school-based telehealth

MedCity News

Hazel Health, a company that provides school-based telehealth, has closed a $51.5 million Series C1 funding round. The company also announced it has deployed its services in more than 3,000 schools across 14 states.

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Galen Growth and FINN Partners Will Release the First “Global State of Digital Health Report” this November at HLTH

PM360

Galen Growth , a leading digital health, data-driven market intelligence company, and FINN Partners , a global integrated marketing services agency, announced a joint effort to mine data and produce the first “Global State of Digital Health Report.” The first report drawing input from some 200M data points and more than 12,000 digital health ventures across the globe, will be released at the November HLTH Conference in Vegas, NV.

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$3 trillion growth reported for biotech sector

European Pharmaceutical Review

The Biotechnology Innovation Organization (BIO) and the Council of State Bioscience Associations (CSBA) has released new data on the US bioscience industry, indicating it was valued at $2.9 trillion dollars in 2021. The report also found that in 2021, the US industry employed 2.1 million people in over 127,000 businesses. The report , developed in partnership by TEConomy Partners and BIO, is the tenth in a biennial series that assesses the state of the US bioscience industry and its innovation s

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Weak data for Fasenra undermine AZ’s ambitions for the drug

pharmaphorum

AstraZeneca’s IL-5 inhibitor Fasenra is already making blockbuster sales from its use in eosinophilic asthma, but the drugmaker’s efforts to expand its label keep running into difficulties. Earlier this year, the FDA rejected AZ’s application for Fasenra (benralizumab) as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) with a request for more data.

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House report finds PBMs and insurers aren’t covering birth control like ACA requires

MedCity News

The investigation also found that companies denied exceptions requests on average four or more times out of ten, raising barriers to accessing birth control, according to a news release on Tuesday.

Insurance 113
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Flexible Catheter for Brain Access Bioinspired by Wasps

Medgadget

Researchers at Imperial College London in the UK have developed a flexible catheter system that is designed to enable access and treatment of the deep areas of the brain. At present, catheters intended for such applications can suffer from rigidity, making it difficult to access the brain safely and effectively. This latest technology includes a robotic arm that steers the catheter through the brain.

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ADC developers opt to outsource

European Pharmaceutical Review

Some 70-80% of antibody drug conjugate (ADC) developers outsource their operations to contract development and manufacturing organisations (CDMOs) to yield cost savings opportunities, according to a recent market report. Manufacturing agreements emerged as the most popular type of partnership model for ADC developers, adopted by 18 percent of stakeholders, followed by product development agreements (16 percent) and research agreements (15 percent), the market research found. .

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.