March, 2023

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‘The Last of Us’ might be fiction, but fungi are a looming threat

PharmaVoice

Fungal infections are a growing challenge for hospitalized patients, and new treatments are badly needed.

Patients 122
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AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump

Fierce Pharma

AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump aliu Wed, 03/22/2023 - 11:17

FDA 333
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How Patients Can Achieve True Adherence – Two Elements For the Path Forward

Impetus Digital

This is a guest article written by Luke Buchanan, CEO of Redi.Health , and does not necessarily reflect the views and values of Impetus Digital. When we think of adherence in the medical world, it’s often simplified to something along the lines of the degree to which a patient correctly follows medical advice. It’s a simple statement with many, many moving parts, especially when we’re talking about patients with multiple chronic conditions.

Patients 114
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Supporting integrity of the scholarly record: Our commitment to curation and selectivity in the Web of Science

Clarivate

We have the important responsibility of providing our customers with trustworthy intelligence to help them transform the world for the better. The need for high-quality data from rigorously selected sources is becoming ever more important as the scholarly record becomes increasingly polluted. A trusted record of research is essential for the global R&D community to effectively use published research outcomes to elevate ideas that will benefit everyday life.

Leads 145
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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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First nasal monoclonal antibody COVID-19 treatment shows potential

European Pharmaceutical Review

A pilot study has demonstrated that a nasal version of the drug Foralumab, an anti-CD3 monoclonal antibody suppressed the inflammatory T cell response and decreased lung inflammation in patients with COVID-19. “This is the first nasal monoclonal antibody—other monoclonal antibody treatments were delivered intravenously and are no longer given as treatment because they are not effective against currently circulating viral variants,” explained Dr Howard Weiner, founder and Director of the Brigham

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How the EU’s New Data Laws Could Affect American Health Tech Companies

MedCity News

In the EU, there is a widespread distrust of American tech companies, according to a recent conference presentation by an international healthcare lawyer. Because of this, the EU has established a number of new laws protecting its citizens’ data privacy and creating frameworks for the secure exchange of information — laws that American health tech companies will have to comply with if they do business in the EU.

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Pfizer, Viatris and more must face 'overarching conspiracy' claims in generic price-fixing suit

Fierce Pharma

Pfizer, Viatris and more must face 'overarching conspiracy' claims in generic price-fixing suit aliu Wed, 03/01/2023 - 10:03

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Scientists Grow Electrodes Inside The Body

Medgadget

Researchers at Linköping University in Sweden have developed a method whereby the body can ‘grow its own’ electrodes. The minimally invasive technique involves injecting a hydrogel that is laden with enzymes into target tissues. The enzymes interact with molecules that are present in the tissue to change the structure of the gel and allow it to become electrically conductive.

Medical 128
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SXSW 2023: Moving from NFTs to LSD

PM360

Technology evolves fast. Nothing illustrates that better than attending SXSW each year and noticing how much has changed in just 12 months. In 2022, SXSW was all NFTs and metaverse activations and events, and in 2023 they weren’t anywhere to be found. But a lot was shared at this year’s SXSW that had staying power. In place of NFTs, psychedelics were given their own conference track this year.

Media 119
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Identifying origin of fungi in cleanrooms

European Pharmaceutical Review

In a recent video , pharmaceutical microbiology expert Tim Sandle highlighted areas of concern and attention relating to mycological contamination control in manufacturing. Pharmaceutical product recalls due to fungal contamination have been increasing. These, together with environmental monitoring trend data, highlight several fungal contamination issues associated with pharmaceutical cleanrooms , cold rooms and other controlled areas.

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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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The Drive to Adopt Digital Therapeutics: Where do we Stand?

MedCity News

As regulatory processes and reimbursements are refined, there needs to be a continued focus on how to maximize the benefits for patients and ensure DTx can play a role in improving outcomes. The key to this is integration into the clinical workflow.

Patients 140
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InvisiShield and Gladstone partner to develop intranasal preventatives

Pharmaceutical Technology

Pre-clinical-stage biotechnology firm InvisiShield Technologies has partnered with Gladstone Institutes to develop intranasal preventatives against airborne viral infections including influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. Under the partnership terms, InvisiShield will offer technical support, as well as funding to develop the intranasal preventatives.

Safety 115
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Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret

Fierce Pharma

Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret kdunleavy Fri, 03/10/2023 - 10:22

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Smartphone Photos to Detect Anemia

Medgadget

Researchers at University College London and at the University of Ghana have developed a smartphone-based system that can detect anemia through simple photos taken using the phone’s camera. The technology is intended for use in low- and middle-income countries where access to routine medical diagnostics may be unreliable. The process involves obtaining images of areas of the body which are least pigmented, including the white of the eye, the lower eyelid, and the lip.

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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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An Inside Look at Pharma Revenue Management

PharmExec

According to the 2023 State of Revenue Report, pharma companies are prioritizing digital transformation while struggling with inflation and supply chain disruptions.

Pharma 105
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New NHS cell and gene therapy centre opens

European Pharmaceutical Review

Today marks the opening the NHS Blood and Transplant (NHSBT)’s new Clinical Biotechnology Centre (CBC) in Bristol. The state-of-the-art facility was part-funded by a £9.43 million Government grant and is designed to expand the UK’s ability to manufacture new gene and cell therapies. The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international market.” “The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international

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How Remote Patient Monitoring Can Help Advance Health Equity

MedCity News

The recent growth in RPM has demonstrated its importance and potential to reduce or eliminate barriers and improve access to care for patients. By leveraging RPM and other digital health solutions as an important part of a multi-prong approach to care delivery, a future where all patients have equal access to high-quality healthcare becomes a closer reality.

Patients 135
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Brazil’s ANVISA approves Takeda’s dengue vaccine candidate Qdenga

Pharmaceutical Technology

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these.

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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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As deadly pathogen spreads, GSK throws a lifeline to Scynexis with $90M deal to market antifungal

Fierce Pharma

As deadly pathogen spreads, GSK throws a lifeline to Scynexis with $90M deal to market antifungal aliu Thu, 03/30/2023 - 10:39

Marketing 290
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Nanoparticles Get Lymphatic Vessels Pumping

Medgadget

Researchers at the Georgia Institute of Technology have developed a nanotechnological solution for lymphedema, a failure of the lymphatic system that results in uncomfortable and irreversible fluid retention. Previous research efforts have focused on trying to grow new lymphatic vessels, but these researchers have taken a different approach, and instead engineered a drug delivery technology that can directly target sluggish lymphatic vessels and kickstart their pumping action.

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Congress Probes PBM Link to Higher Drug Prices

PharmExec

Latest investigation signals more scrutiny of pharmacy benefit managers and their role in treatment cost and coverage.

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Pfizer to acquire Seagen for $43 billion

European Pharmaceutical Review

Pfizer has announced it will acquire Seagen Inc. for a total enterprise value of $43 billion. “Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining Seagen’s antibody -drug conjugate (ADC) technology… with Pfizer’s capabilities and expertise,” shared Dr Albert Bourla, Pfizer Chairman and Chief Executive Officer.

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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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Should Employers and Insurers Cover Psychedelic-Assisted Therapy?

MedCity News

Despite ketamine-assisted therapy being approved for treating several mental health conditions, it’s generally not covered by insurance or employers. Though that likely won’t always be the case, as psychedelics gather more research and employers notice the benefits for their workplaces.

Insurance 134
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Hipra’s Covid-19 booster gets EMA nod and enters an uncertain landscape

Pharmaceutical Technology

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.

Medicine 110
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Eli Lilly slashes insulin prices by 70%, caps out-of-pocket costs in major access overhaul

Fierce Pharma

Eli Lilly slashes insulin prices by 70%, caps out-of-pocket costs in major access overhaul fkansteiner Wed, 03/01/2023 - 08:40

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SCOTUS to decide ‘fundamental change’ in biologics patents with fate of Amgen v. Sanofi

PharmaVoice

The Supreme Court will now decide whether Amgen can protect Repatha as a whole class of drugs or whether Sanofi’s rival product Praluent can retain a place in the market.

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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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Cancer Patient-Support Program Uptake is Low: Here’s How to Change That

PM360

Cancer-support programs provide vital assistance to patients and their caregivers as they face one of the toughest times of their lives. Yet while patients are interested in these programs, new survey data suggests they aren’t taking advantage of them. Results from 825 patients diagnosed with or treated for cancer who were surveyed on Phreesia’s PatientInsights platform as they checked in for their doctors’ appointments revealed that few cancer patients are accessing the support resources availa

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Rapid microbiology testing market growth expected 2022 to 2027

European Pharmaceutical Review

A report has predicted the rapid microbiology testing market size is estimated to grow at a compound annual growth rate (CAGR) of 9.31 percent between 2022 and 2027. According to the data, the market is forecasted to increase by $2,487.91 million. The research includes historic market data from 2017 to 2021, using 2022 as the base year. It covers various testing methods such as growth-based, nucleic-acid-based and viability-based.

Marketing 106
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Too Many Dashboards, Not Enough Insight: How Companies Can Build Remote Patient Monitoring Tech

MedCity News

To build remote patient monitoring technology for ready adoption, repetitive data streams must be avoided. To be successful in clinical adoption, we offer technology companies the following three recommendations.

Patients 132
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BioNTech targets infectious diseases for vaccine development

Pharmaceutical Technology

Following on from its Covid-19 vaccine programmes, BioNTech has set its sights on a range of infectious diseases for vaccine development. In its FY 2022 report, BioNTech has identified herpes simplex virus (HSV), malaria, and shingles as disease targets. The company saw major successes with its Covid-19 vaccine, developed in collaboration with Pfizer.

Sales 110
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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.