Wed.Mar 22, 2023

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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

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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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Sanofi and Regeneron's Dupixent scores trial win in tough-to-treat COPD

Fierce Pharma

Sanofi and Regeneron's Dupixent scores trial win in tough-to-treat COPD kdunleavy Thu, 03/23/2023 - 01:37

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Is There a Mental Health Disconnect Between Employers and Employees? Experts Weigh In

MedCity News

Research shows that about 73% of benefits leaders believe their companies have increased mental health support, but about 40% of employees either don’t believe or are unsure if their company promotes a healthy workplace. When it comes to if there’s a disconnect between employers and employees in mental health, the issue often lies in communication, said Adam Stavisky, senior vice president of US benefits at Walmart.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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After appeals loss, Johnson & Johnson will take Texas two-step case to the US Supreme Court

Fierce Pharma

After appeals loss, Johnson & Johnson will take Texas two-step case to the US Supreme Court kdunleavy Wed, 03/22/2023 - 14:39

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42 Hospitals Sue HHS for ‘Tens of Millions’ of Dollars in Delayed Medicare DSH Payments

MedCity News

Forty-two safety net hospitals recently sued HHS, alleging that the Medicare program “unlawfully withheld and unreasonably denied” DSH payments for decades. The plaintiff hospitals said that HHS’ failure to recalculate DSH payments have cost them “tens of millions of dollars in funds that should have been paid to them many years ago.

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More Trending

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Viral roots: A look at how modern outbreaks began

PharmaVoice

As experts wrestle with COVID-19’s lab leak versus animal market debate, here’s what experts say are the suspected origins for some of the worst viral outbreaks in the last century.

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In a surprise approval, FDA green-lights Incyte's PD-1 inhibitor to treat rare cancer type

Fierce Pharma

In a surprise approval, FDA green-lights Incyte's PD-1 inhibitor to treat rare cancer type zbecker Wed, 03/22/2023 - 17:30

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AppliedVR Earns First Unique CMS Code Ever Granted to a Digital Therapeutic

MedCity News

CMS recently established a unique code for AppliedVR’s flagship product, marking the first time a digital therapeutic or immersive therapeutic has ever been placed in an existing benefit category. The eight-week program is a physician-prescribed solution that allows patients to manage their chronic lower back pain without opioids from the comfort of their own home.

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Moderna CEO Bancel holds the line on COVID shot pricing at Senate hearing

Fierce Pharma

Moderna CEO Bancel holds the line on COVID shot pricing at Senate hearing fkansteiner Wed, 03/22/2023 - 15:49

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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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Maven Clinic Expands Presence in UK With Acquisition of Naytal

MedCity News

Through Maven’s acquisition, Naytal’s over 50 providers will join Maven’s platform, more than doubling the company’s number of providers in the U.K. Maven will also be able to sign on additional U.K.-based clients.

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FDA expands use of Regeneron's HoFH drug Evkeeza to kids 5 and up

Fierce Pharma

FDA expands use of Regeneron's HoFH drug Evkeeza to kids 5 and up kdunleavy Wed, 03/22/2023 - 10:03

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StartUp Health Gains a New Investor and Adds a University [Sponsored]

MedCity News

StartUp Health’s presence at ViVE will highlight the launch of its Health Transformer University and the addition of Helmsley Charitable Trust as an investor. Its pavilion will showcase 16 health tech companies and include panel discussions on remote patient monitoring, automation and more.

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Novartis, after prior deal with NHS England, scraps large-scale Leqvio trial

Fierce Pharma

Novartis, after prior deal with NHS England, scraps large-scale Leqvio trial zbecker Wed, 03/22/2023 - 11:10

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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NASH Drug Biotech 89bio Nails Phase 2 Goals; Next Up Is a Pivotal Clinical Trial

MedCity News

89bio reported its NASH drug candidate met the main endpoints of a mid-stage clinical trial. In addition to demonstrating efficacy and safety according to measures the FDA says are needed to support a regulatory submission, 89bio says the results also show its drug could offer a dosing edge over potential rivals.

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CPHI Pharma Awards marks 20th anniversary

European Pharmaceutical Review

The 20 th anniversary edition of the CPHI Pharma Awards is open for entries. Three new categories have been created to reflect the surge of innovation sweeping the industry, from new methodologies to sustainability and philanthropic initiatives. The CPHI Pharma Awards 2023 will celebrate global leaders from across 12 categories, including returning categories spanning development and manufacturing of devices and drugs, alongside packaging , supply chain, sustainability, regulatory compliance, an

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FDA Approves Incyte Drug for Rare Skin Cancer Merkel Cell Carcinoma

MedCity News

Regulatory approval of Incyte’s cancer immunotherapy, Zynyz, comes two years after the FDA rejected an application seeking approval in a rare type of anal cancer. The decision makes the new Incyte drug the third approved treatment for metastatic Merkel cell carcinoma.

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Collaboration to produce 3D screen printed pharmaceuticals

European Pharmaceutical Review

Hovione, a contract development and manufacturing organisation (CDMO) and Laxxon Medical, a pharma-tech company will collaborate to advance 3D screen printing technologies for the pharmaceutical industry. Under the agreement, Hovione will establish Laxxon’s 3D screen printing technology at Hovione’s current good manufacturing practice (cGMP) production sites first in Portugal and later in the US.

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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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Imaging Technique Reveals Contraction Patterns During Labor

Medgadget

Researchers at the Eunice Kennedy Shriver National Institute of Child Health and Human Development have developed a new imaging technique called electromyometrial imaging (EMMI) which clinicians can use to create 3D maps of uterine contraction patterns during labor. The non-invasive imaging method utilizes rapid MRI scanning with an electromyogram obtained through sensors placed on the skin of the belly.

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Some Additional Wrinkles to US Copyright Terms

Copyright Clearance Center

The post Some Additional Wrinkles to US Copyright Terms appeared first on Copyright Clearance Center.

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ABPI responds to rebooted MHRA clinical trials framework

PharmaTimes

Measures include a requirement to publicly register studies and share results among research participants

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Why Advances in Imaging Will Revolutionize the Way We Detect and Treat Disease

MedCity News

Recently, scientists shared new findings that may indicate the inner core of the earth has […]

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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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Evgen reveals results from pivotal phase 1b trial

PharmaTimes

Study involves SFX-01 candidate and emerging preliminary pharmacokinetic data from study

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Scott Burrows, Workplace Safety Speaker 

Scott Burrows

Caring About Safety Has Never Been More Important How safe do you feel on your job? As a workforce safety speaker who once suffered a tragic workplace related accident, I ask you to think carefully before answering. The data for 2022 were not encouraging in terms of improvement. U.S. Workforces are still experiencing more than 2.8 nonfatal accidents each year (with nearly 5,000 fatal accidents).

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FDA Issues Warning Letter on Nyquil

Pharma Leaders

The FDA has accused Procter & Gamble (P&G) of submitting one ingredient list for Nyquil to the agency and using a different one for the over-the-counter product’s physical labeling. In a March 14 warning letter to the company, the agency threatened that a failure to adequately address the matter “may result in legal action,” including the possibility of seizure and injunction.

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Scorpius BioManufacturing Announces New Microbial Capacity and New Interim President

PharmaTech

In addition to a new interim president, the company is opening new microbial capacity at its San Antonio facility and has plans to construct a commercial-scale facility in Manhattan, Kan.

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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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Scott Burrows, Workplace Safety Speaker 

Scott Burrows

Caring About Safety Has Never Been More Important How safe do you feel on your job? As a workforce safety speaker who once suffered a tragic workplace related accident, I ask you to think carefully before answering. The data for 2022 were not encouraging in terms of improvement. U.S.

Safety 52
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Invitae and Deerfield Management Team Up on Novel Therapeutics for Rare Diseases

PharmaTech

Under a new partnership, Invitae and Deerfield Management will harness genetic and clinical testing data from patients to discover potential novel therapeutics for treating rare diseases.

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5 Ways to Gamify Verbalization Workshops

CLD, Inc.

Verbalization activities are a vital part of sales workshops, and for a good reason. Reps communicate with customers daily, whether delivering engaging openers, asking insightful probing questions, sharing marketing resources and approved messaging or compliantly addressing concerns and questions.

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FDA Expands Indications for Use of FibroScan® for Comprehensive Liver Management

Legacy MEDSearch

The U.S. Food and Drug Administration (FDA) has cleared expanded Indications for Use for screening with FibroScan® , the non-invasive liver management technology by Echosens. The update furthers FibroScan® accessibility to more people, enabling physicians to identify those at risk of suffering adverse liver outcomes and connecting them with preventative care and treatment options.

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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.