AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump
Fierce Pharma
MARCH 22, 2023
AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump aliu Wed, 03/22/2023 - 11:17
Wed.Mar 22, 2023
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Identifying origin of fungi in cleanrooms
European Pharmaceutical Review
MARCH 22, 2023
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
MARCH 22, 2023
Sanofi and Regeneron's Dupixent scores trial win in tough-to-treat COPD kdunleavy Thu, 03/23/2023 - 01:37
Is There a Mental Health Disconnect Between Employers and Employees? Experts Weigh In
MedCity News
MARCH 22, 2023
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.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
After appeals loss, Johnson & Johnson will take Texas two-step case to the US Supreme Court
Fierce Pharma
MARCH 22, 2023
After appeals loss, Johnson & Johnson will take Texas two-step case to the US Supreme Court kdunleavy Wed, 03/22/2023 - 14:39
42 Hospitals Sue HHS for ‘Tens of Millions’ of Dollars in Delayed Medicare DSH Payments
MedCity News
MARCH 22, 2023
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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AppliedVR Earns First Unique CMS Code Ever Granted to a Digital Therapeutic
MedCity News
MARCH 22, 2023
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.
In a surprise approval, FDA green-lights Incyte's PD-1 inhibitor to treat rare cancer type
Fierce Pharma
MARCH 22, 2023
In a surprise approval, FDA green-lights Incyte's PD-1 inhibitor to treat rare cancer type zbecker Wed, 03/22/2023 - 17:30
Maven Clinic Expands Presence in UK With Acquisition of Naytal
MedCity News
MARCH 22, 2023
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.
Moderna CEO Bancel holds the line on COVID shot pricing at Senate hearing
Fierce Pharma
MARCH 22, 2023
Moderna CEO Bancel holds the line on COVID shot pricing at Senate hearing fkansteiner Wed, 03/22/2023 - 15:49
How Machine Learning Drives Clinical Trial Efficiency
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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.
NASH Drug Biotech 89bio Nails Phase 2 Goals; Next Up Is a Pivotal Clinical Trial
MedCity News
MARCH 22, 2023
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.
FDA expands use of Regeneron's HoFH drug Evkeeza to kids 5 and up
Fierce Pharma
MARCH 22, 2023
FDA expands use of Regeneron's HoFH drug Evkeeza to kids 5 and up kdunleavy Wed, 03/22/2023 - 10:03
StartUp Health Gains a New Investor and Adds a University [Sponsored]
MedCity News
MARCH 22, 2023
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.
Novartis, after prior deal with NHS England, scraps large-scale Leqvio trial
Fierce Pharma
MARCH 22, 2023
Novartis, after prior deal with NHS England, scraps large-scale Leqvio trial zbecker Wed, 03/22/2023 - 11:10
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
FDA Approves Incyte Drug for Rare Skin Cancer Merkel Cell Carcinoma
MedCity News
MARCH 22, 2023
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.
Viral roots: A look at how modern outbreaks began
PharmaVoice
MARCH 22, 2023
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.
CPHI Pharma Awards marks 20th anniversary
European Pharmaceutical Review
MARCH 22, 2023
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
Imaging Technique Reveals Contraction Patterns During Labor
Medgadget
MARCH 22, 2023
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.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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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.
Collaboration to produce 3D screen printed pharmaceuticals
European Pharmaceutical Review
MARCH 22, 2023
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.
Why Advances in Imaging Will Revolutionize the Way We Detect and Treat Disease
MedCity News
MARCH 22, 2023
Recently, scientists shared new findings that may indicate the inner core of the earth has […]
ABPI responds to rebooted MHRA clinical trials framework
PharmaTimes
MARCH 22, 2023
Measures include a requirement to publicly register studies and share results among research participants
Some Additional Wrinkles to US Copyright Terms
Copyright Clearance Center
MARCH 22, 2023
The post Some Additional Wrinkles to US Copyright Terms appeared first on Copyright Clearance Center.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
Evgen reveals results from pivotal phase 1b trial
PharmaTimes
MARCH 22, 2023
Study involves SFX-01 candidate and emerging preliminary pharmacokinetic data from study
Scott Burrows, Workplace Safety Speaker
Scott Burrows
MARCH 22, 2023
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).
FDA Issues Warning Letter on Nyquil
Pharma Leaders
MARCH 22, 2023
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.
Scorpius BioManufacturing Announces New Microbial Capacity and New Interim President
PharmaTech
MARCH 22, 2023
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.
Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics
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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
Scott Burrows, Workplace Safety Speaker
Scott Burrows
MARCH 22, 2023
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.
Invitae and Deerfield Management Team Up on Novel Therapeutics for Rare Diseases
PharmaTech
MARCH 22, 2023
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.
5 Ways to Gamify Verbalization Workshops
CLD, Inc.
MARCH 22, 2023
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.
FDA Expands Indications for Use of FibroScan® for Comprehensive Liver Management
Legacy MEDSearch
MARCH 22, 2023
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.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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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.
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