Fri.Jul 29, 2022

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With new $670M healthcare fund, General Catalyst seeks more health system partners

MedCity News

General Catalyst recently launched a $670 million healthcare investment fund. The fund, called Health Assurance Fund II, seeks to carry on the mission of the venture capital firm’s first healthcare-focused fund, but with a new focus on health system partnerships.

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Pfizer reports 53% operational growth in Q2 2022 revenues

Pharmaceutical Technology

Pfizer has reported a 53% operational growth in revenues to $27.7bn in the second quarter (Q2) of 2022 compared to $18.9bn in the same quarter last year. The rise in revenues was chiefly driven by robust contributions from Covid-19 therapies Paxlovid and Comirnaty. On an operational basis, the revenues rose by $128m or 1%, excluding Paxlovid and Comirnaty’s contributions.

Sales 105
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Widespread health inequities persist despite employer-sponsored insurance, report finds

MedCity News

Even with employer-sponsored insurance, many still have issues with chronic conditions, maternal health, behavioral health, substance use and healthcare access. When comparing by race, disparities become more apparent.

Insurance 119
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FDA accepts to review ImmunityBio’s BLA for bladder cancer treatment

Pharmaceutical Technology

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease. A decision from the regulatory agency on approval for the treatment is anticipated on 23 May next year.

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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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U.S. government places $1.74B order for Moderna’s new Covid-19 vaccine boosters

MedCity News

The U.S. government has signed a supply agreement securing 66 million doses of Moderna’s Covid-19 vaccine booster shots, which are designed to address the omicron subvariants driving new cases of infection. The agreement follows a similar supply agreement reached with Pfizer and BioNTech.

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Can a nasal spray tackle agitation in autism?

Pharmaceutical Technology

The rate at which children are being identified with autism spectrum disorder (ASD) has tripled in the past two decades. While the prevalence was 1 in 150 children in 2000, it reached the rate of 1 in 44 in 2018, in the US, according to the Centers for Disease Control and Prevention. Some people with ASD can experience acute agitation and crisis behaviours.

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Schizophrenia trials continue to test drug candidates as Covid-19 pandemic continues

Pharmaceutical Technology

Schizophrenia Awareness Day, marked on 25 July, is a national observance that aims to raise awareness about this mental illness. Schizophrenia is a chronic brain disorder that affects a person’s ability to function, such as thinking and feeling. According to GlobalData’s Epidemiology and Market Size database, epidemiologists estimate there are more than 21 million prevalent cases within the tracked 16 countries.

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5 actionable steps health care professionals can take right now to remove barriers, improve patient care

MedCity News

Removing barriers to care won’t be easy, and it won’t happen overnight, but by having a consumer-driven health mindset, we can make health care more equitable.

Patients 102
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CAMP4’s funding influx paves the way for tapping regulatory RNA to treat urea cycle disorders

Pharmaceutical Technology

Last week, CAMP4 Therapeutics announced the close of a $100 million Series B round , which will be used to advance their regulatory RNA (regRNA)-focused programs. Their use of regRNA technology provides a unique approach to treating rare conditions like urea cycle disorders. CAMP4’s CSO David Bumcrot PhD tells Pharmaceutical Technology that the company plans to see clinical trials go forward for their urea cycle disorder programs late next year.

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Biohybrid microrobots could be effective cancer drug delivery systems

European Pharmaceutical Review

Researchers have constructed biohybrid microrobots, by equipping Escherichia coli bacteria with artificial components, that could one day offer a highly targeted and effective cancer treatment option. The team of scientists from the Physical Intelligence Department at the Max Planck Institute for Intelligent Systems combined robotics with E. coli bacteria to construct their innovative drug delivery system.

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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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Magnetic Activation of Specific Brain Circuits

Medgadget

Scientists at Rice University developed a system to wirelessly and rapidly activate specific brain circuits using magnetic fields. The technology has been developed in fruit flies, a common experimental animal, but the researchers hope that it could help in understanding the brain and to develop new treatments for neurological disorders in humans. The technology involves genetically modified fruit flies that express heat sensitive ion channels in specific brain circuits.

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Regulators commit to collaborating on RWE integration

European Pharmaceutical Review

Both the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have endorsed a statement calling for international collaboration on integrating real-world evidence (RWE) into regulatory decision-making. The statement, published by the International Coalition of Medicines Regulatory Authorities (ICMRA), describes how collaboration between regulators and researchers that formed a critical aspect of the world’s COVID-19 response could be leveraged to enhance medicines regulatio

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Assessing Heart Function and Fluid Status with Cardiac Scales: Interview with John Lipman, CEO, and Corey Centen, Founder, Bodyport

Medgadget

Bodyport , a medtech company based in San Francisco, developed the Bodyport Cardiac Scale, a set of weighing scales that can non-invasively assess fluid status and heart function. The scales can detect these signals through the feet when a patient steps onto the device. The technology is intended to be convenient and requires only 20 seconds each morning, and should easily lend itself to integration into a daily routine. .

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Properly Accommodating the Patient Journey

Pharmaceutical Commerce

OptimizeRx’s Steve Silvestro on how the healthcare sector is performing when it comes to patient care, and how the use of technology can positively impact that process.

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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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The power of reflection

pharmaphorum

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional, and global life science communications to offer some little tips for enjoying a big business career. This post recommends setting aside regular time for reflection to critically think through major opportunities, projects and issues in order to make well-considered, high-quality decisions.

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StartUPDATES: New developments from healthcare startups

MedCity News

Check out new developments from BioMEMS Diagnostics, Neuroflow, Druglike, Health Note, and Rhinostics.

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Ionis antithrombotic with reduced bleed risk clears phase 2b study

pharmaphorum

Patients with end-stage renal disease (ESRD) who are on dialysis often need to be treated with anticoagulants to prevent blood clots, but as a result, can experience bleeding side effects. Now, Ionis and Bayer think they have a new drug that could sidestep that risk. In a phase 2b RE-THINC trial, their experimental antisense-based Factor XI inhibitor fesomersen was able to achieve a “substantial and statistically significant” reduction in levels of the clotting factor, indicating it

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How resilient is the global biopharma industry?

Pharmaceutical Technology

As the full consequences of the COVID-19 virus started to emerge, and many industries found themselves having to either suspend operations or move to remote working, the biopharma sector found itself on the front line facing unprecedented challenges. The need for the sector to rapidly research, develop and test new vaccines had always been of critical importance, but in the context of a global pandemic and national lockdowns, it became even more so, with each part of the supply chain required to

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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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Biometrics and AI technologies in Cancer Treatment

PharmExec

The use of biometric data and novel digital biomarkers in the administration of CAT-T therapy can both improve the safety profile and reduce patient burden of cancer treatment. Jaydev Thakkar, Chief Operating Officer at Biofourmis, will share how this data paired with clinical-grade algorithms can predict the onset of adverse events to allow for proactive intervention and improved patient outcomes.

Safety 59
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Study: Antibody Levels Decrease Within 3 Months After COVID-19 Booster

Pharmacy Times

The immune responses to the Omicron variant waned substantially with neutralizing antibody levels decreasing 2.4- to 5.3-fold by 3 months after the booster dose.

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AstraZeneca raises 2022 guidance, names Demaré as non-exec chair

pharmaphorum

AstraZeneca chief executive Pascal Soriot said this morning that strong revenue increases in 2022 – fuelled by its COVID-19 antibody Evusheld and oncology drugs – have allowed the company to boost its investment in R&D. The drugmaker reported (PDF) revenues up a third to $10.8 billion in the second quarter, allowing it to raise its sales forecast for the full year to growth of at least 20%, against earlier estimates in the high teens.

Sales 52
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An Evolved Ecommerce Payment Strategy Builds Customer Trust – Is Your Brand Keeping Up?

Salesforce

When the ecommerce payment process takes too long or gets too confusing, customers abandon their carts and go elsewhere to shop. While we used to never buy vegetables without seeing them, or shoes without trying them on, brands have amped up their website experience in response to the increased demand on digital. Shoppers are voting with their dollars, and they are resoundingly happy with the conveniences of online commerce.

Media 52
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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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Episode 007: Managing Organizations with Lisa Earnhardt, Executive Vice President at Abbott

Med Device Careers

In this episode, we speak with Lisa Earnhardt, Executive Vice President at Abbott. In our conversation, we discuss how her engineering background informs her commercial and managerial experience, scaling an organization from Series A to IPO, and “expanding the reach of the practical.”. Lisa received a degree from Stanford in Industrial Engineering, and an MBA from Kellogg, and has spent over 25 years working for companies such as Guidant, Intersect ENT, and Abbott.

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Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing. Despite the advanced stage of Covid-19 vaccination programmes in richer countries, which would suggest an approaching drop-off in contract manufacturing demand, there is s

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Senior Star OUTiCO Recruiter promoted to Pharma Resourcing Lead

Star OUTiCO

We sat down with Sarah to congratulate her on her promotion to Pharma Resourcing Lead, and discuss working with clients as their business strategies shift to reflect recent NHS restructures. Hi Sarah, great news on the promotion! What role have you moved on from at Star OUTiCO, and what will you be doing now? I began my career within Star Medical ten years ago on the Pharma side of the Recruitment business and love the fast-paced challenges that it comes with!

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Novartis and UC Berkeley partner to discover new treatments

Pharmaceutical Technology

Novartis has expanded its research-based partnership with the University of California, Berkeley, US, to discover new therapeutic modalities and address ‘undruggable’ disease targets. Based on the successes over the last five years, the alliance will develop new technologies to discover next-generation therapies. The merged team of researchers is analysing various disease targets in cancer, as well as other ailments that have escaped conventional small-molecule compounds and drug discovery app

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Tallac announces first patient treated with TAC-001

PharmaTimes

The phase 1/2 study is for patients with advanced or metastatic solid tumours

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Study: Fourth Dose of COVID-19 Vaccine Provides Protection Against Omicron Variant

Pharmacy Times

A majority of long-term care patients who received a fourth vaccination against COVID-19 were found to have increased protection against the omicron variant.

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Tealium launches industry-first Customer Data Platform for Pharma

PharmExec

Tealium for Pharma utilizes deep integration technology and partnerships to deliver an enhanced customer journey in one of healthcare's most vital sectors.

Pharma 56
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COVID-19 Linked with Disruptions to Medication for Opioid Use Disorder

Pharmacy Times

The pandemic saw reductions in the supply of methadone but no disruption to the supply of more easily accessible buprenorphine, though disparities in supply were observed across states.

Medical 59
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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.