Fierce Pharma

AUGUST 4, 2023

In a bid to thwart shortages of critical hospital drugs, Pfizer is relegating certain products made in Rocky Mount, North Carolina, to its emergency ordering list. | In a bid to thwart shortages of critical drugs, Pfizer is relegating certain products made in Rocky Mount, North Carolina, to its emergency ordering list. The move comes after a tornado hit the company's injectables facility late last month, creating questions about potential supply disruptions.

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MedCity News

AUGUST 4, 2023

Sage Therapeutics’ Zurzuvae is the biotech’s second FDA approved product for postpartum depression, following the 2019 nod for IV-infused Zulresso. But in a blow to the multi-billion dollar partnership between Sage and Biogen, Zurzuvae did not win an additional approval in major depressive disorder.

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FDA Biopharma Pharma 95

Fierce Pharma

AUGUST 4, 2023

And the hits just keep on coming for Galapagos. | Based on the results of a phase 3 study, Galapagos has decided not to submit a Marketing Authorization Application in Europe for Jyseleca (filgotinib) in Crohn’s disease. The company also will not proceed with its application for filgotinib in ulcerative colitis in Switzerland. Galapagos revealed the moves in reporting its first-half earnings.

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Sales Marketing 194

Medgadget

AUGUST 4, 2023

LUMINELLE , a medtech company based in North Carolina, has developed a suite of endoscopic tools that allow clinicians to perform visually guided gynecological procedures right from their office. At present, the majority of uterine biopsies taken to investigate the cause of abnormal uterine bleeding are taken blind, with no visual guidance at all. This leads to suboptimal outcomes, and the frequent need to repeat the biopsy procedure because the first attempt did not yield an adequate sample.

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Physicians Leads Medical Training 93

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Fierce Pharma

AUGUST 4, 2023

In January, when Amgen launched the first biosimilar to compete with AbbVie’s Humira in the U.S., the company looked forward to six months of exclusivity in competing one-on-one against the immunol | When Amgen launched the first biosimilar to compete with AbbVie’s Humira in the U.S., the company looked forward to six months of exclusivity in competing one-on-one against the immunology powerhouse.

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Sales 187

MedCity News

AUGUST 4, 2023

Celebrating teamwork is essential for acknowledging its profound impact on healthcare excellence. It is a powerful catalyst that fosters patient-centered care, optimizes resource utilization, nurtures professional growth, and strengthens the healthcare system.

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Healthcare Healthcare Patients 89

MedCity News

AUGUST 4, 2023

Geisinger is launching a pilot program in partnership with virtual heart failure monitoring startup Bodyport. About 200 of the health system’s heart failure patients will be using Bodyport’s cardiac scale at home — the scale uses sensors to measure a person’s metrics of heart function and body fluid status after they stand on it for about 20 seconds.

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Patients 87

Fierce Pharma

AUGUST 4, 2023

For years, Gilead has been on a mission to become a power player in oncology. | The company is sticking to its ambitions of pulling a third of its revenue from its oncology portfolio by 2030. This year, the company expects $3 billion to come from its cancer trio of Trodelvy, Tecartus and Yescarta.

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MedCity News

AUGUST 4, 2023

Hims & Hers can now provide treatment to men for cardiovascular issues, the company recently announced. This treatment combines sexual health and heart health together in a single pill.

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Pharmaceutical Technology

AUGUST 4, 2023

Amid one of the worst dengue fever outbreaks in decades, Bangladesh has recorded the highest number of hospitalised cases of the disease in a day.

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Marketing 98

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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

AUGUST 4, 2023

Engaging with patients in the early stages of their bariatric journey allows providers to ultimately understand and support their patient’s unique motivational, emotional, and intellectual drivers. Providers can use these drivers to help empower positive health outcomes.

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Patients 85

European Pharmaceutical Review

AUGUST 4, 2023

A £33 million grant from the UK Government ’s Life Sciences Innovation Manufacturing Fund ( LSIMF ) is set to enhance manufacturing of sustainable inhalers. The joint government-industry investment will aid capability and capacity for the drug delivery device contract development and manufacturing organisation (CDMO) Kindeva Drug Delivery to manufacture next generation green pressurised metered-dose inhalers (pMDIs).

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Government Manufacturing Pharmaceutical Medicine 83

Pharmaceutical Technology

AUGUST 4, 2023

The US FDA has granted approval for an expanded indication of Merck’s Ebola vaccine, Ervebo, for usage in the paediatric population.

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FDA 98

Medgadget

AUGUST 4, 2023

Researchers at Chalmers University of Technology in Sweden have developed a new technique that could allow above-elbow amputees to better use robotic prostheses, including making individual finger movements. Unlike below-elbow amputees, these patients have a more limited number of remnant muscles with which to produce fine control of multiple bionic structures, such as bionic fingers.

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Electronics Distribution Patients Medicine 83

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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

Distribution

European Pharmaceutical Review

AUGUST 4, 2023

According to data and analytics company GlobalData , Boehringer Ingelheim’s Cyltezo has demonstrated the intersection of price and regulation in the biosimilars market. “Of all the adalimumab biosimilars, Cyltezo is of note due to the company taking the extra and uncommon step of showing interchangeability to Humira,” highlighted Adeleke Badejo, Senior Analyst of Immunology at GlobalData.

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Marketing Food and Drug Administration Food Medicine 81

Medgadget

AUGUST 4, 2023

Researchers at Duke University have developed a gravity-powered microfluidic device that is intended for use as a diagnostic technology in low-resource areas. Microfluidics have enormous potential for point-of-care diagnostics, but the inclusion of tiny pumps and other sophisticated electronic components dramatically increases the complexity and cost of such devices.

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Specialization Electronics Medicine 76

Copyright Clearance Center

AUGUST 4, 2023

The post Court Limits Arkansas “Harmful” Book Law appeared first on Copyright Clearance Center.

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PharmaVoice

AUGUST 4, 2023

From Congress to the FTC to state legislatures, regulators are cracking the whip against PBMs.

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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

PharmaTimes

AUGUST 4, 2023

Research is evaluating the company’s novel investigational FKRP gene replacement therapy - News - PharmaTimes

Patients 80

Patients 80

Spotio

AUGUST 4, 2023

Looking for a creative way to motivate your sales team and improve performance? Just jump on the sales leaderboard bandwagon, which has been picking up a lot of steam lately. Sales leaderboards will help you keep your reps accountable, boost their productivity levels, and most importantly, help them close more deals than they ever have before. In this comprehensive article, we’ll teach you everything you need to know about sales leaderboards, from what they are to which apps you should use

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Sales CRM Sales tools Competition 52

PharmaTimes

AUGUST 4, 2023

Therapy is a treatment option for adults with severe and moderately severe haemophilia B - News - PharmaTimes

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Contrarian Sales Techniques

AUGUST 4, 2023

In the self-development world, you may have stumbled upon the concept of affirmations, but what about " afformations "? In this intriguing exploration, we will dive into the depths of afformations, how they work, and why they may be a key tool in your personal and professional growth journey. What Are Afformations? History of Afformations Afformations are a unique twist on the familiar concept of affirmations.

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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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PharmaTech

AUGUST 4, 2023

Under a manufacturing agreement, Northway Biotech will develop a manufacturing process for iTolerance’s fusion protein in development for regenerative therapy.

Manufacturing 52

Manufacturing 52

Pharmaceutical Technology

AUGUST 4, 2023

Gilead Sciences has posted net income of $1.03bn in Q2 of 2023 compared with $1.13bn in the same quarter of the previous year, a dip of 8.45%.

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Pharmaceutical Commerce

AUGUST 4, 2023

Companies' emphasis on delivering pharmaceuticals is evolving into a collaboration focused on healthcare outcomes.

Healthcare 52

Healthcare Healthcare Pharmaceutical 52

Pharmaceutical Technology

AUGUST 4, 2023

BlueRock Therapeutics signed an agreement with bit.bio to discover and manufacture iPSC-derived regulatory T cells (Tregs) based therapies.

Manufacturing 52

Manufacturing 52

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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 Commerce

AUGUST 4, 2023

The key questions and considerations for drug manufacturers pursuing an effective alternative distribution model.

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Distribution Pharma Manufacturing 52

Pharmaceutical Technology

AUGUST 4, 2023

Cellectis provided updates for the three CAR-T cell therapies trials, with the three trials recruiting across various cancer indications.

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Recruitment 52

Pharmacy Times

AUGUST 4, 2023

Compared to the BNT162b2 vaccine, the mRNA-1273 vaccine was associated with a lower risk of adverse events, which investigators speculate was due to interrelated safety and efficacy.

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Safety 49

Pharmaceutical Technology

AUGUST 4, 2023

Hipra’s Bimervax targets the alpha and beta viral variants, but the EMA recently said it seeks vaccines designed against XBB 1.5 Omicron.

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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.

Management