Fierce Pharma

SEPTEMBER 19, 2023

Novo Nordisk’s shares continued to trend downward Tuesday after reports surfaced that the FDA had recently flagged manufacturing shortfalls at the Danish drugmaker’s Clayton, North Carolina product | After inspecting Novo’s Clayton, North Carolina, facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality control lapses, according to a Form 483 seen by Fierce Pharma.

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MedCity News

SEPTEMBER 19, 2023

For the gridlock in mental healthcare to be resolved, 100% of mental healthcare providers must practice measurement-based care, utilizing validated rating scales to monitor and measure longitudinal outcomes for every patient. And payers then must offer reimbursement that appropriately rewards providers for delivering high-quality, effective care, and incentivize proactive mental health management.

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Fierce Pharma

SEPTEMBER 19, 2023

Novartis has ended its major cancer immunotherapy collaboration with BeiGene more than two years after touting the benefits of having a PD-1 inhibitor. | Novartis has ended its major cancer immunotherapy collaboration with BeiGene more than two years after touting the benefits of having a PD-1 inhibitor.

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MedCity News

SEPTEMBER 19, 2023

The Federal Trade Commission doesn’t get notified about every deal, which can lead to a slow consolidation of the market, said Lina Khan, chair of the FTC. She made these comments on Monday during the Oliver Wyman Health Innovation Summit 2023 held in Chicago.

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Fierce Pharma

SEPTEMBER 19, 2023

Gaining FDA approval last month for its geographic atro | Astellas reported results of a phase 3 trial that assessed Izervay’s effectiveness and safety over a 24-month period. While the company said that the study met its primary objective of reducing the rate of geographic atrophy growth compared to a sham therapy, it offered little else about the results.

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MedCity News

SEPTEMBER 19, 2023

Roberta Schwartz, Houston Methodist’s chief innovation officer, has had years of experience overseeing technology adoption at her organization. At a conference, she shared some pieces of wisdom that give us a window into her technology investment strategy. For example, she highlighted how important it is for digital health tools to have strong EHR integrations, and she encouraged hospital leaders to not be afraid of starting various technology initiatives in unrelated areas.

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PharmaVoice

SEPTEMBER 19, 2023

This year’s honorees are influential and devoted leaders lifting the pillars of the industry to new heights.

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Fierce Pharma

SEPTEMBER 19, 2023

Artificial intelligence (AI) has enormous potential in healthcare, but all too often, it gets misunderstood. Especially with the proliferation of AI in other industries and chatGPT. | With the right infrastructure, intelligent tools stand to not only process data but also improve clinical decision-making—helping find more patients for biopharma companies, and faster, too.

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MedCity News

SEPTEMBER 19, 2023

Magnet Biomedicine builds on decades of molecular glue research from its scientific co-founder, Harvard University Professor Stuart Schreiber. The startup is developing drugs that take these glues beyond the biotech industry’s current focus on targeted protein degradation.

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Fierce Pharma

SEPTEMBER 19, 2023

Auden Mckenzie and Actavis UK—now known as Accord-UK—will remain on the hook to pay hefty fines for their roles in introducing costly price hikes on hydrocortisone tablets. | In a judgment, the U.K.’s Competition Appeal Tribunal upheld previous findings by the country’s Competition and Markets Authority that multiple drugmakers had charged “excessive and unfair prices” for generic hydrocortisone tablets over the course of 10 years.

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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 19, 2023

BeiGene welcomes the return of the immunotherapy’s rights as an opportunity to make it the backbone of its solid tumors strategy. But Novartis cedes an opportunity to gain a competitor to established cancer immunotherapies from Merck and Bristol Myers Squibb.

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Fierce Pharma

SEPTEMBER 19, 2023

The biosimilar fracas targeting AbbVie’s megablockbuster Humira is taking shape. But to Biocon Biologics CEO Shreehas Tambe, the battle doesn’t solely revolve around market share. | The biosimilar fracas targeting AbbVie’s megablockbuster Humira is taking shape. But to Biocon Biologics CEO Shreehas Tambe, the battle doesn’t solely revolve around market share.

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Clarivate

SEPTEMBER 19, 2023

The Citation Laureates 2023 list has been announced, recognizing a select group of influential, highly cited researchers whose contributions are on par with Nobel Prize recipients. We explore their profound impact on our world and their enduring commitment to the pursuit of knowledge, inspiring the next generation of researchers. We at the Institute for Scientific Information (ISI) at Clarivate have announced 23 new Citation Laureates , a designation that recognizes researchers of Nobel class b

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Fierce Pharma

SEPTEMBER 19, 2023

Two large Indian suppliers of generic medicines in the U.S. and beyond are at the center of the industry's M&A rumor mill this week. | Torrent is looking for financial help to potentially make a bid for its larger rival Cipla, according to Reuters.

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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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Medgadget

SEPTEMBER 19, 2023

Researchers at Nanyang Technological University in Singapore have developed a tiny, flexible battery that is intended for use in smart contact lenses. The device is as thin as the human cornea and can be charged by a saline solution, which is particularly useful in the eye, as it is full of salty tears. When the battery-equipped smart lens is not in use, such as at night, then it can be stored in a saline solution, helping to further recharge the battery.

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Fierce Pharma

SEPTEMBER 19, 2023

Revance has rolled out a new strategy for Daxxify, revealing a drop in price that the company says will allow it to challenge AbbVie powerhouse Botox.

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Medgadget

SEPTEMBER 19, 2023

Researchers at ETH Zurich have developed an insulin delivery system that relies on music as a trigger. The unusual technology is based on calcium ion channels that typically reside in the cell membrane. Such channels are sensitive to mechanical deformation and these researchers discovered that sound waves will activate the channels. When insulin-producing cells are genetically modified to express this channel, they will experience an influx in calcium ions when music is played close by, promptin

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MedCity News

SEPTEMBER 19, 2023

Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.

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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.

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Medgadget

SEPTEMBER 19, 2023

Researchers at the University of Colorado Anschutz Medical Campus have developed a technique that may spot the very early signs of Alzheimer’s disease, years before symptoms arise. The method may alert patients and clinicians to an increased risk of the disease, potentially allowing them to take steps to slow the disease progression. The method involves using a simple EEG headband while sleeping.

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MedCity News

SEPTEMBER 19, 2023

The revenue cycle management business is using AI tools to automate cumbersome tasks to help hospitals operate more efficiently. It’s beginning to attract the attention of major healthcare organizations.

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PharmaTech

SEPTEMBER 19, 2023

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

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Pharmaceutical Technology

SEPTEMBER 19, 2023

The company will suspend the development of three assets, considering strategic alternatives for two clinical programmes.

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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.

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European Pharmaceutical Review

SEPTEMBER 19, 2023

Kite’s Yescarta ® (axicabtagene ciloleucel) facilitated a high response rate in transplant ineligible relapsed/refractory (R/R) large B-cell lymphoma (LBCL), Phase II study results show. Patients with R/R LBCL who had received one prior line of therapy and were deemed ineligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) were evaluated in the trial.

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Pharmaceutical Technology

SEPTEMBER 19, 2023

Pelican Technology has combined business with Primordial Genetics under a deal to create a private biotechnology company Primrose Bio.

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PharmaTimes

SEPTEMBER 19, 2023

The platform identifies antigens to fight against bacterial infectious disease - News - PharmaTimes

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Evolve Your Success

SEPTEMBER 19, 2023

Your success in sales isn’t determined by what you sell, but how you connect. In this episode, we have Sales Coach and Founder of MMS Consulting Katie Mullen to reveal the secrets to becoming a better sales professional. Katie walks us through her journey, from her early days in the industry to becoming a sought-after sales trainer. As the episode progresses, Katie dissects the different categories of medical sales and explains the lifestyle implications of each.

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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

PharmaTimes

SEPTEMBER 19, 2023

BeiGene will utilise Nona’s Harbour Mice platform as part of the agreement - News - PharmaTimes

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PharmaTech

SEPTEMBER 19, 2023

The finalists for this year’s CPHI Barcelona Pharma Awards span 12 categories with awards ranging from accelerating innovations through to improved sustainability and best start-up initiative.

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PM360

SEPTEMBER 19, 2023

Digital Health Networks has announced the winners of the first annual Cinehealth International Health and Wellness Film and Video Festival. At an awards ceremony in Philadelphia, PA, winners took the stage on the evening of Tuesday, September 12 th during Digital Pharma East to be honored for their work in film, video, and podcasting. The festival is an international film festival focusing exclusively on health and wellness.

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Pharmacy Times

SEPTEMBER 19, 2023

Moving cannabis to Schedule 3 will make it easier to research, resulting in the development and creation of new cannabinoid-based pharmaceuticals, with notable potential in oncology.

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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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