Sat.Mar 19, 2022 - Fri.Mar 25, 2022

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As biotech retreats, gene therapy companies retrench and redraw plans

Bio Pharma Dive

At least nine biotechs working in cell or gene therapy have announced layoffs, cost cuts or restructured their research since December — restructurings that have coincided with a stock market downturn.

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Passing the trash

World of DTC Marketing

I’ve seen some new energy and thinking taking root in some big pharma companies. Still, I’m also seeing some recycled executives show up at other companies when they should have been removed permanently from the industry. John worked for a division of a major pharma company in Cambridge. He came from the salesforce, and his mentality was simple; marketing supports sales.

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UK’s first digital health training programme for all NHS frontline staff

Pharma Times

The platform to build a digital-ready frontline workforce will be available to all NHS and social care staff

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The Digital Health Start-up Journey: Series A to scale-up

pharmaphorum

Although resources exist for digital health entrepreneurs looking to raise their first key investment round, industry advice on next steps is harder to find. The growth of a start-up after obtaining Series A funding is a transformational phase when scaling up the company becomes critical. The CEO can experience pressure to deliver on the revenue growth goals, whilst still developing their product, growing the team, and implementing core processes for the company.

Nurses 145
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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GSK partners with LifeMine as startups advance plans to make drugs from fungi

Bio Pharma Dive

The deal, announced alongside a $175 million round, makes biotech entrepreneur Greg Verdine's startup the most well-funded among an emerging group of companies searching for drugs in fungal DNA.

DNA 325
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Healthcare’s greater good?

World of DTC Marketing

The promise of one-stop, total healthcare was supposed to be led by retailers like Wal*Mart and CVS, but they’re finding out it costs a lot of money to equip and market these facilities. Patients still want convenience in their healthcare, but it may take decades to materialize. One of the biggest complaints about healthcare is that it’s too fragmented.

Pharmacy 212

More Trending

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Virtual and augmented reality: Bringing the future to pharma manufacturing

pharmaphorum

Virtual and augmented reality tools have reached a level of maturity to be utilised across various industries. In this article, Ben Hargreaves asks whether there is particular potential for the technologies to revolutionise staff training and reduce costs in pharma manufacturing. Virtual reality (VR) and augmented reality (AR) have spent a lot of time in the headlines recently.

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Argenx boosted by positive trial results for new shot

Bio Pharma Dive

An easier-to-take version of Vyvgart could help Argenx expand the drug's use in autoimmune disease, potentially adding to the biotech's appeal as an acquisition target.

Trials 297
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Telehealth: Supply exceeds demand

World of DTC Marketing

An increasing number of headlines amplifying many incomplete data around telehealth have led industry stakeholders to extrapolate discrete data points about telehealth to the entire U.S. population. Using an economic framework to analyze national telehealth data. Only 25.6% of Americans utilized telehealth during the two years of the pandemic. Said another way, investments in the telehealth market have been made on the thesis that telehealth is preferred among most Americans.

Marketing 206
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Poolbeg signs AI deal to advance human challenge data

Pharma Times

Collaboration will focus on AI analysis of flu progression, immune responses and the development of new vaccines

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

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Join the annual conference 2022

Deltaclinical

Don’t miss us at the Annual Conference by Healixia on March 24th! A great opportunity to network with likeminded in the field of patient centric solutions for healthcare. ???? ???? Our managing director Geert Briers will be hosting a break-out session about Home Therapy. ???? Afterward Geert will be able to answer any additional questions regarding his vast experience in the field of clinical home studies.

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Pfizer claims study success for drug key to Arena buyout

Bio Pharma Dive

Etrasimod, the basis of the $7 billion acquisition and a potential rival to Bristol Myers Squibb's Zeposia, has cleared the first of two trials in ulcerative colitis.

Drugs 294
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Do patients care about accelerated approval drugs?

World of DTC Marketing

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. Do patients care? No. Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA.

Drugs 200
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SmiLe Inject invests 2 MSEK in eHealth company developing a voice robot for the elderly

Pharma Mirror

SmiLe Incubator’s angel investment company, SmiLe Inject Capital, invests 2 MSEK in Call Knut, an incubator company that is developing a voice robot- based service using AI and ordinary phone calls as a complement in communicating with and caring for elderly people living on their own. The investment will be used to complete the development of the product and enable a commercial launch during the year.

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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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Join the annual conference 2022

Deltaclinical

Don’t miss us at the Annual Conference by Healixia on March 24th! A great opportunity to network with likeminded in the field of patient centric solutions for healthcare. ?. ? Our managing director Geert Briers will be hosting a break-out session about Home Therapy. ? Afterward Geert will be able to answer any additional questions regarding his vast experience in the field of clinical home studies.

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Al Sandrock takes on CEO role at gene therapy developer

Bio Pharma Dive

The well-known researcher and Biogen alumnus has agreed to take the top spot at Voyager Therapeutics, which, last spring, underwent a "strategic shift" that saw its then-CEO and research head depart.

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Pharma’s ambition in connected health not yet matched by execution

pharmaphorum

Four out of five biopharma companies think that the market opportunity for connected health products exceeds their traditional drug business, but adoption remains low, with only 20% of use cases at present going beyond proof of concept. That’s one of the conclusions of a new study by Capgemini, which suggests that the number of approved connected health offerings – digital health products and services including wearables, digital therapeutics and software-as-a-medical-device (SaMD) – will

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metaMe Health partners with Indegene to launch Regulora(R), an FDA-cleared Prescription Digital Therapeutic for adults with Irritable Bowel Syndrome

Pharma Mirror

PRINCETON, N.J. and CHICAGO. Indegene, a technology-led global healthcare solutions provider, and metaMe Health, Inc. (metaMe), a Prescription Digital Therapeutics (PDT) company and developer of Regulora®, today announced a partnership to bring Regulora to market for the treatment of abdominal pain due to Irritable Bowel Syndrome (IBS). IBS is a chronic condition that affects 10-15% of adults in the United States.

Marketing 130
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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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Join the annual conference 2022

Deltaclinical

Don’t miss us at the Annual Conference by Healixia on March 24th! A great opportunity to network with likeminded in the field of patient centric solutions for healthcare. Our managing director Geert Briers will be hosting a break-out session about Home Therapy. Afterward Geert will be able to answer any additional questions regarding his vast experience in the field of clinical home studies.

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Novartis wins FDA OK for radiopharmaceutical drug, cashing in on Endocyte deal

Bio Pharma Dive

The approval of Pluvicto for prostate cancer is a notable step forward for the field of radiopharmaceutical therapy and validates the Swiss drugmaker's $2.1 billion buyout of Endocyte in 2018.

Drugs 279
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Google seeks FDA nod for passive AFib detection with Fitbit

pharmaphorum

Tech giant Google has filed for FDA approval to use its Fitbit wearable to help detect atrial fibrillation (AFib), a common heart abnormality that raises the risk of heart attack, stroke and sudden death. Fitbit is already approved by the FDA to provide electrocardiogram (ECG) monitoring of heart rhythms, and in 2020 its Sense Smartwatch was cleared by the regulator to use the ECG functionality to detect AFib – although that requires active input from the user.

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DrugPatentWatch Week in Review

Drug Patent Watch

FEATURED ARTICLE Branded Generics Promise Profits for Drugmakers, Peace of Mind for Patients Developing nations offer welcoming and growing markets as Abbott focuses exclusively on reformulating and marketing off-patent medications…. The post DrugPatentWatch Week in Review appeared first on DrugPatentWatch - Make Better Decisions.

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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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Misleading Food Labeling a Cause for Concern Among Consumers and Food Manufacturers

XTalks

“Cholesterol-free,” “low-fat,” “super light,” “sugar-free” or “anti-ageing” are all examples of believable claims on food labels. However, only two of these claims are legally permitted in the European Union. Since consumers are more health-conscious than ever, some food manufacturers are pulling out all the stops to convince people to purchase highly processed and unhealthy products with misleading food labeling. .

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FDA rebuffs MEI, Kyowa Kirin as another cancer drug class draws scrutiny

Bio Pharma Dive

The companies said the FDA is now requiring results from a randomized study in the latest sign the agency is raising the bar for accelerated approval of so-called PI3K inhibitors.

Drugs 264
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Jazz Pharmaceuticals reveals new manufacturing facility for cannabis-based medicines

Pharma Times

The site in Kent will support the manufacture of regulatory approved cannabis-based medicines while also leveraging environmental practices

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The efficacy of Mental Health Apps

pharmaphorum

In January, PLOS Digital Health published a study which claimed that there’s “sparse” data to support the efficacy of most mental health apps. In their meta-analysis of published studies, the authors found universal deficiencies and concluded that there’s no convincing evidence that app-based interventions deliver meaningful outcomes. Without digging further, one might think the current case for digital therapeutics is weak.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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2 Strategies to Grow Your Excipient Business by Tracking Drug Patents

Drug Patent Watch

Drugs contain ingredients with therapeutic activity, so-called “active ingredients” as well as inactive ingredients. These inactive ingredients, called excipients, are included in oral products for various reasons, such as to…. The post 2 Strategies to Grow Your Excipient Business by Tracking Drug Patents appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 115
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FDA approves new epilepsy drug, handing Marinus a long-awaited victory

Bio Pharma Dive

Nearly 20 years since its founding, Marinus Pharmaceuticals will make the leap to a commercial-stage biotechnology company with Friday's approval of Ztalmy.

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Stalicla completes phase 1b trials into precision medicine for autism spectrum disorder

Pharma Times

STP1 has demonstrated good safety and tolerability profiles, while also showing positive results for neurological function

Medicine 114
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Moderna’s Australian mRNA manufacturing facility set to become operational in 2024

BioPharma Reporter

Moderna has finalized a strategic partnership with the Australian government to build an mRNA manufacturing facility in Melbourne: which is expected to produce up to 100 million mRNA respiratory vaccine doses annually.

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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.