Fierce Pharma

SEPTEMBER 12, 2023

The CDC wants to reset expectations for flu vaccines to correct falling uptake. | The CDC wants to reset expectations for flu vaccines to correct falling uptake. After tracking declines in vaccine use in pregnant people and children, the health body has initiated its “Wild to Mild” campaign to raise awareness of the benefits of vaccination and encourage more people to get their shots.

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MedCity News

SEPTEMBER 12, 2023

U.K. doctor David Watkins has been a public critic of Babylon Health for years, during which has received anonymous emails from Babylon employees saying that the company’s AI is a sham. After Babylon collapsed, a former employee also publicly declared that the AI engine was faulty. As a longtime skeptic of Babylon’s claims surrounding its technology, Watkins said that Ali Parsa, the company’s CEO, belongs behind bars.

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Engineering Doctors Healthcare Healthcare 142

Fierce Pharma

SEPTEMBER 12, 2023

Xspray Pharma, before receiving an FDA slapdown in July, had expected to launch its competitor to Bristol Myers Squibb’s leukemia blockbuster Sprycel within the second half of 2023. | Xspray and BMS have settled patent litigation around their potential rivals Dasynoc and Sprycel, Xspray said Tuesday. The deal clears “all pending claims” and tees up a potential Dasynoc launch on Sept. 1, 2024, or potentially earlier under certain circumstances.

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FDA Pharma 264

European Pharmaceutical Review

SEPTEMBER 12, 2023

As part of The Future of Pharma/Biopharma Analysis 2023 , which took place on 28-29 June 2023, European Pharmaceutical Review ( EPR ) gathered an expert panel to discuss developing a modern contamination control strategy. The participants were: Dr Tim Sandle, Head of GxP Compliance at Bio Products Laboratory Limited (BPL) as moderator; Dr Edward Tidswell, Executive Director within the Microbiological Quality and Sterility Assurance organisation of Merck & Co; Frederic Ayers, Research Scienti

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Consulting Biopharma Manufacturing Pharmaceutical 125

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Fierce Pharma

SEPTEMBER 12, 2023

Eight companies are finding themselves in hot water for allegedly churning out illicit eye drugs, the FDA said Tuesday. | The companies included in the warning letter sweep are: Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance.

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FDA 229

MedCity News

SEPTEMBER 12, 2023

Talkiatry, Array Behavioral Care, Iris Telehealth and Quartet Health sent a letter to the DEA asking for a special registration process that would allow for the prescribing of certain controlled medications via telemedicine.

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Specialization Medical 121

Copyright Clearance Center

SEPTEMBER 12, 2023

September 12, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, today announced Gold Open Access (OA) publisher Frontiers has adopted the industry-leading Ringgold Identify Database as its Persistent Identifier (PID) solution to help power its OA models by normalizing and disambiguating organization data.

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Leads Management Marketing 114

Fierce Pharma

SEPTEMBER 12, 2023

As Jazz Pharmaceuticals turns the page from its long-time growth driver Xyrem and leans on a trio of newer medicines for growth, its executive roster is undergoing some changes. | As Jazz turns the page from its long-time growth driver Xyrem and leans on a trio of newer medicines for growth, its executive roster is undergoing some changes.

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Medicine Pharmaceutical 152

MedCity News

SEPTEMBER 12, 2023

As health systems shore up their defenses against cybercriminals, they should openly communicate with their third-party vendors about data security risks and work together to actively manage those risks. That was some of the advice given by Aaron Miri, Baptist Health’s chief digital and information officer, during a Tuesday webinar.

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Management Healthcare Healthcare 113

Medgadget

SEPTEMBER 12, 2023

Researchers at the University of Washington School of Medicine have developed a method to create stem cell-derived organoids that can produce tooth enamel proteins. The breakthrough could pave the way for lab grown enamel that can be used in dental repairs and may even allow for living fillings or completely new living teeth that can be implanted into a patient’s jaw.

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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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MedCity News

SEPTEMBER 12, 2023

This on-demand webinar explores the impact of poor data quality and methods to improve patient data quality. It highlights technology that can improve workflows to help reduce workforce burnout.

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Healthcare Healthcare Patients Medical 110

European Pharmaceutical Review

SEPTEMBER 12, 2023

The next generation of therapeutics has arrived: from simple design and development to theoretically unlimited targets, messenger RNA ( mRNA )‑based therapeutics offer a multitude of benefits. However, creating these innovative treatments harbours challenges. This article explores common developmental and design issues and how to mitigate difficulties before they occur.

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Pharmaceutical 101

MedCity News

SEPTEMBER 12, 2023

If we want to support people with obesity, the weight loss debate must stop conflating obesity prevention with obesity treatment. Instead, we should focus on the tools that best solve the needs of people where they are – just as we would for cancer or diabetes – by making the most effective treatments possible available.

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Biopharma 109

European Pharmaceutical Review

SEPTEMBER 12, 2023

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months. Data predicted that in 2030, more than half of US Food and Drug Administration (FDA)-approved drugs will involve AI in their development and/or manufacturing.

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Food and Drug Administration Manufacturing FDA Pharmaceutical 98

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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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MedCity News

SEPTEMBER 12, 2023

Avalon BioVentures unveiled new portfolio company Arialys Therapeutics. The startup’s lead program, an antibody from Astellas Pharma, is a potential treatment for anti-NMDA receptor encephalitis (ANRE), a rare autoimmune inflammatory disorder.

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Pharma Leads Biopharma 107

PM360

SEPTEMBER 12, 2023

Fishawack Health (FH) announced it is expanding its executive leadership team with the addition of Amar Urhekar as its new Chief Operating Officer (COO), a pioneer in bringing together interdisciplinary teams to solve client challenges and accelerate growth. Urhekar will play a key role on the company’s Executive Committee as he unites 1,600 employees as one team under a single vision, breaking down barriers to faster-connect patients to life-enhancing therapies.

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MedCity News

SEPTEMBER 12, 2023

Through a new partnership with Walgreens, Pearl Health will work with primary care providers by offering its technology and data insights to help them better their care and transition to value-based payment models. Walgreens is then providing prescription fulfillment, medication adherence, immunization and diagnostic testing services.

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Prescription Medical 102

European Pharmaceutical Review

SEPTEMBER 12, 2023

A T-cell epitope cancer vaccine significantly improved overall survival in non-small cell lung cancer (NSCLC) compared to chemotherapy, Phase III data published in Annals of Oncology has shown. The immunotherapy activating tumour specific T-cells, off-the-shelf, neoepitope-based vaccine Tedopi ® was evaluated in HLA-A2 positive patients with advanced or metastatic NSCLC in monotherapy in third line NSCLC with secondary resistance to immune checkpoint inhibitors, in the Phase III clinical trial A

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Safety Patients Pharmaceutical 98

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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.

Safety

MedCity News

SEPTEMBER 12, 2023

This new report sheds light on how the benefit consultants’ role has changed and details their perspective on the shifting employer healthcare landscape.

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Consulting Healthcare Healthcare 108

Pharmaceutical Technology

SEPTEMBER 12, 2023

The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.

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FDA 111

European Pharmaceutical Review

SEPTEMBER 12, 2023

CAR T-cell therapy is a form of immunotherapy that uses specially altered T cells to fight cancer. A sample of T cells is collected from the blood of a cancer patient, genetically engineered to produce chimeric antigen receptors (CARs) on their surface, and then expanded and reinfused into the patient. These new receptors enable the cells to latch onto a specific antigen on the patient’s tumour cells and kill them.

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Specialization Engineering Patients Pharmaceutical 95

Medgadget

SEPTEMBER 12, 2023

Researchers at Stanford University have developed a new type of cancer therapy. The technology targets mucins, sugar-coated proteins that help cancer cells to metastasize and avoid the immune system. In particular, mucins enable cancer cells to survive free-floating as they travel through the blood during metastasis and can also trick immune cells into assuming that the cancer cell is not a threat.

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Patients Medicine 91

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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.

Specialization

European Pharmaceutical Review

SEPTEMBER 12, 2023

A new state-of-the-art manufacturing facility for microbiome ecosystem therapies has now completed construction. MaaT Pharma, a company focusing on treatments for oncology, and French contract development and manufacturing organisation (CDMO) Skyepharma formed a partnership in February 2022 to build the largest current good manufacturing practice (cGMP) facility, to date, for full ecosystem microbiome therapies in Europe.

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Manufacturing Pharma Pharmaceutical Leads 92

Medgadget

SEPTEMBER 12, 2023

Researchers at the University of Edinburgh have developed a new method to create multilayered tubes from cells. The technique could be very useful for recreating multilayered tubular constructs that are found in the body, such as the intestines and blood vessels. Accurately modeling such complex structures in the lab could open new doors in terms of medical research and may even pave the way for bioengineered intestinal or vascular constructs that are suitable for implantation in human patients.

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Engineering Distribution Medical Medicine 82

Pharmaceutical Technology

SEPTEMBER 12, 2023

BioLineRx has received the US Food and Drug Administration approval for Aphexda plus filgrastim to mobilise haematopoietic stem cells.

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Food and Drug Administration Food FDA 96

European Pharmaceutical Review

SEPTEMBER 12, 2023

In this exclusive interview, industry experts Laure Pomares Voisin, Quality Director, Catalent Biologics and Tony Cundell Principal Consultant, Microbiological Consulting, share critical insights into the rapidly evolving landscape of pharmaceutical environmental monitoring and microbiology. They discuss the current challenges in rapid detection, adherence to newly revised EU Good Manufacturing Practice (GMP)Annex 1 guidelines, and the importance of robust personnel training.

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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

Leads

Pharmaceutical Technology

SEPTEMBER 12, 2023

CancerVAX plans to adapt its universal cancer vaccine platform to develop a universal CAR-T cell platform.

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PharmaTimes

SEPTEMBER 12, 2023

The research will aim to reveal the mechanism of action of a drug target candidate - News - PharmaTimes

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Pharma 104

PharmaVoice

SEPTEMBER 12, 2023

A new poll shows that Americans generally support several key IRA provisions, including Medicare price negotiations.

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Healthcare Healthcare 98

Contrarian Sales Techniques

SEPTEMBER 12, 2023

A Universal Sentiment Ever found yourself excitedly making a purchase and then, moments later, felt like you were duped by a sales pitch? You're not alone. It's a curious quirk of human nature — we all love the thrill of acquiring something new, but there's an innate aversion to feeling like we've been 'sold to'. Over the years, I've pondered this dichotomy, and it's clear that the secret to great selling lies in understanding this sentiment.

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Sales pitches Sales Product Knowledge Sales Strategy 64

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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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