Wed.Jan 18, 2023

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AbbVie, Novartis and more win national coverage in China even as Pfizer's Paxlovid gets left out

Fierce Pharma

AbbVie, Novartis and more win national coverage in China even as Pfizer's Paxlovid gets left out. aliu. Wed, 01/18/2023 - 14:00.

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Arrive Health Acquires Medication Adherence Tech from UPMC

MedCity News

Arrive Health (formerly RxRevu) recently acquired a suite of technology developed at UPMC. The technology suite includes an AI-powered chatbot and customer relationship management platform, both designed to support improved medication adherence and prescription capture rates.

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FDA fires back at conservative group's lawsuit over abortion pill approval

Fierce Pharma

FDA fires back at conservative group's lawsuit over abortion pill approval. zbecker. Wed, 01/18/2023 - 11:30.

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As Cell Therapy Gains Ground, Efforts Emerge to Improve CAR T-Manufacturing

MedCity News

Cell therapy offers a treatment option for some advanced blood cancers, but the manufacturing process is lengthy and complex. The biopharmaceutical industry is working on various technologies that could make manufacturing faster and more efficient, or perhaps supplant the current process altogether.

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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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Servier, Taiho score in phase 3 colorectal cancer trial to support Lonsurf combo nod

Fierce Pharma

Servier, Taiho score in phase 3 colorectal cancer trial to support Lonsurf combo nod. kdunleavy. Wed, 01/18/2023 - 15:13.

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Gympass Adds Headspace Health To Wellbeing Platform for Employers

MedCity News

Headspace Health’s mindfulness services will now be offered on Gympass’ platform. The company has a network of more than 50,000 gyms, classes, trainers and wellbeing apps that it offers to more than 10,000 companies.

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Evernorth Discovers 314% Year-over-year Increase in Flu Med Prescriptions

MedCity News

The Evernorth report also found that there is a higher prevalence of flu medication prescriptions among children and people living the South. Employers and payers have a responsibility to encourage people to get vaccinated, said Urvashi Patel, vice president of the Evernorth Research Institute.

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JPM23: Ipsen CEO happy to take on Big Pharma in rare diseases but says gene therapy is rife with risk

Fierce Pharma

JPM23: Ipsen CEO happy to take on Big Pharma in rare diseases but says gene therapy is rife with risk. aliu. Wed, 01/18/2023 - 09:51.

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J&J Stops Work on HIV Vaccine After Failure in Phase 3 Clinical Trial

MedCity News

Johnson & Johnson is stopping clinical development of an experimental HIV vaccine after the four-shot regimen did not beat a placebo in a late-stage study. The clinical trial failure comes follows the 2021 failure of the vaccine candidate in a different study population.

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UK medical cannabis manufacturer granted GMP registration

European Pharmaceutical Review

The first good manufacturing practice (GMP) registration of a UK pharmaceutical facility for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API) has been granted since the legalisation of medical cannabis in 2018. Celadon Pharmaceuticals’ Midlands site is now registered by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for GMP manufacturing.

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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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Report: Small Practices Can’t Afford to Neglect Patient Experience Investments

MedCity News

Small healthcare practices aren’t very eager to spend extra cash right now. However, investments in the patient experience could be worth it to give them the upper hand over competitors, according to a new report.

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Governing Principles for Successful Biotechnology Companies

PharmExec

Pete O'Heeron, founder, chairman, and CEO of FibroBiologics, explains the key principles that biotechnology companies should follow.

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FDA Clears Cytovale’s® IntelliSep® Sepsis Test, First in a New Class of Emergency Department-Focused Diagnostic Tools

Legacy MEDSearch

Cytovale ® , a medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, announced today that its IntelliSep ® test has received U.S. Food and Drug Administration (FDA) 510(k) clearance to aid in the early detection of sepsis for the approximately 30 million adult patients with signs and symptoms of infection who present to US emergency departments (ED) each year.

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After ‘limping along,’ Novavax sees a path forward

PharmaVoice

With a new CEO and a long-term booster strategy, the company believes there’s plenty of room to grow in the COVID-19 vaccine space.

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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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Hydrogel Scaffold Makes a Living Electrode

Medgadget

A team of researchers at the Harvard Wyss Institute have developed a soft, hydrogel scaffold that can function as a living electrode for brain-computer interface applications. The researchers used electrically conductive materials and created a porous and flexible scaffold using a freeze-drying process. They then seeded the scaffold with human neural progenitor cells (NPCs) and cultured the scaffolds for extended periods, prompting the cells to differentiate into a variety of neurons and astrocy

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Pfizer offers 1.2 billion in poorer countries access to full medicine portfolio

European Pharmaceutical Review

Pfizer has announced it is expanding its ‘An Accord for a Healthier World’ initiative, to include its full portfolio of medicines and vaccines for which Pfizer has global rights. The initial not-for-profit offering provided access to all its patented medicines and vaccines available in the US or European Union (EU) to 1.2 billion people in 45 lower-income countries (LICs).

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Why early participant engagement is now a top priority in genetic disease research

pharmaphorum

In 2016, scientists behind a study called the Resilience Project analysed genetic data from 589,000+ people and found 13 adults who carried genetic variants that should have resulted in serious – even deadly – childhood disease, but who were apparently healthy. The DNA of these so-called ‘genetic superheroes’ may contain clues about how to treat severe disease.

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Scottish Medicines Consortium recommends Merck’s Tepmetko

PharmaTimes

Therapy is the first oral MET inhibitor treatment option for certain advanced NSCLC adult patients

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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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Has the Glass Ceiling Finally Been Broken at the Big Four Consulting Firms?

PharmExec

Author Deepa Purushothaman discusses the progress of women and women of color in corporate America.

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NHS Confederation very concerned by latest industrial action

PharmaTimes

Unrelenting pressure caused by strikes, flu and COVID-19 may be keeping NHS in vicious cycle

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NewAmsterdam’s CETP renaissance gathers pace

pharmaphorum

NewAmsterdam Pharma’s bold play to resurrect an all-but defunct cholesterol-lowering drug class has been rewarded with a positive phase 2 trial of its oral CETP inhibitor obicetrapib. The ROSE2 study found that obicetrapib was able to reduce LDL cholesterol (LDL-c) levels when added to high-intensity statin therapy, raising the prospect that it could help patients struggling to manage their cholesterol levels with current drug therapy.

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New Research from Clarify Health Institute Validates Orthopedic Surgeons with Higher Surgical Volume Deliver Better Care Outcomes at Lower Costs

Clarify Health

SAN FRANCISCO, January 18, 2023–-Clarify Health Institute (CHI), the research arm of Clarify Health, has published new research highlighting the relationship between the number of orthopedic surgeries a doctor has performed and patient outcomes. More than 15 million Americans undergo elective surgery each year, at an estimated cost of $147.2 billion.

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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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Bayer snaps up digital imaging partner Blackford

pharmaphorum

German pharma group Bayer has made another play in the digital medical imaging category, buying Blackford Analysis and its artificial intelligence-based platform for radiological assessments. The takeover comes a few months after Bayer stepped up the digital capabilities of its radiology business with the launch of AI-powered software for X-ray, MRI, and CT imaging under the Calantic Digital Solutions umbrella brand.

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The Role of Patient Experience in Healthcare Loyalty

LEVO Health

The healthcare industry has long focused on the quality of medical treatment as the primary factor in patient satisfaction. However, a recent report released by Accenture found patient experience factors such as convenience, communication, and respect to be just as important to patients when choosing a healthcare provider. Failure to meet patient experience expectations is a major contributing factor to why some patients are willing to switch providers.

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AffaMed signs deal for Lilly’s Galcanezumab in Mainland China

Pharmaceutical Technology

AffaMed Therapeutics has signed an agreement with Eli Lilly and Company (Eli Lilly) to secure exclusive commercialisation rights for the latter’s Galcanezumab. In June last year, Eli Lilly submitted a new drug application to the National Medical Products Administration (NMPA) of China for Galcanezumab to prevent episodic migraine in adult patients. Under the latest agreement, AffaMed Therapeutics will get exclusive rights for importing, marketing, promoting, distributing, and detailing Galcanezu

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Bob Harrell

Pharma Marketing Network

Bob is a life sciences and technology marketing leader with more than 25 years of experience working directly for pharmaceutical manufacturers (Merck, AstraZeneca, and Shire) and for technology companies that serve the industry (Appature, IQVIA, and Sparta). Bob has deep experience in digital marketing, serving as an account leader for one of the industry’s first digital agencies and building Shire’s first digital marketing function into an industry leader.

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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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China’s NMPA approves Henlius’ monoclonal antibody to treat ES-SCLC

Pharmaceutical Technology

The National Medical Products Administration (NMPA) of China has approved Shanghai Henlius Biotech ’s monoclonal antibody Hansizhuang (serplulimab injection) along with carboplatin and etoposide to treat extensive stage small cell lung cancer (ES-SCLC). Hansizhuang is the company’s first self-developed anti-PD-1 monoclonal antibody (mAb). It is claimed to be the first anti-PD-1 mAb approved as the first-line treatment for SCLC worldwide.

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With filing due soon, Moderna stakes a claim to the RSV vaccine market

pharmaphorum

Look out, Pfizer and GSK. Moderna is looking to make a swift dash to the finish line with its respiratory syncytial virus (RSV) vaccine candidate, based on the same mRNA technology as its COVID-19 shots, with a filing in with the FDA in the first half of this year. The submission for the vaccine, codenamed mRNA-1345 , will be made on the strength of just-released phase 3 data that showed it had 83.7% efficacy in preventing RSV lower respiratory tract disease (RSV-LRTD) in older adults aged 60 an

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Artificial Intelligence Tool Reflects Risk of Cognitive Decline, Alzheimer Disease Based on Brain Age

Pharmacy Times

The model can predict the chronological ages of cognitively normal participants with an average absolute error of 2.3 years, which is about 1 year more accurate than an existing model.

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Cambrex Acquires Snapdragon Chemistry

PharmaTech

Snapdragon Chemistry concentrates in API batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges.

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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.