Thu.Jul 27, 2023

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Eli Lilly's tirzepatide aces 2 more late-stage obesity trials as FDA decision nears

Fierce Pharma

Eli Lilly continues to bolster the case for its dual GIP/GLP-1 agonist tirzepatide as a powerful weight loss agent. | Also known as Mounjaro in its approved type 2 diabetes indication, tirzepatide helped patients across two trials—Surmount-3 and Surmount-4—lose up to 26.6% of their body weight, Lilly said Thursday.

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5 Strategies to Strengthen Relationships with HCPs

Pharma Marketing Network

Developing strong and meaningful relationships with Healthcare Professionals (HCPs) is vital for healthcare organizations, pharmaceutical companies, and medical device manufacturers alike. These partnerships not only improve patient outcomes but also foster mutual trust and collaboration. In this blog, we will explore five effective strategies to enhance your relationship-building efforts with HCPs and ultimately achieve better healthcare outcomes.

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Roche's star eye drug Vabysmo crosses blockbuster threshold as rival stalls at FDA

Fierce Pharma

To Roche’s pharma chief Teresa Graham, no word better describes the company’s eye drug Vabysmo right now than “momentum.” | To Roche’s pharma chief Teresa Graham, no word better describes the company’s eye drug Vabysmo right now than “momentum.” Approved by the FDA in January 2022, Vabysmo already crossed the one-billion-dollar sales mark in the first half of 2023.

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The Urgent Care Crisis of Low Reimbursement: A Looming Threat to Accessible Healthcare

MedCity News

I invite insurance companies to engage in meaningful dialogue with urgent care providers to understand the challenges they face and explore fair reimbursement models that reflect the value they bring to patients.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Fierce Pharma Asia—Daiichi's leukemia nod; Astellas' protein degrader pact; Takeda's neuroscience setback

Fierce Pharma

Daiichi Sankyo's FLT3 inhibitor overcame FDA rejection to win an approval. Astellas signed another protein degrader deal, this time with PeptiDream. | Daiichi Sankyo's FLT3 inhibitor has overcome an FDA rejection to win an approval. Astellas signed another protein degrader deal. Takeda's enzyme replacement therapy flunked a mid-stage trial in a rare neurological disorder.

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RapidAI Rakes In $75M to Accelerate Stroke Diagnosis

MedCity News

RapidAI recently closed a $75 million Series C funding round led by Vista Credit Partners. The company offers an AI platform that helps hospital care teams triage and treat stroke patients more quickly.

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FDA Refuses to Review Biohaven Drug for Rare Neuromuscular Disease With No Treatments

MedCity News

Biohaven’s bid to bring to market the first drug for rare neuromuscular disorder spinocerebellar ataxia has hit a setback. The FDA is refusing to review the drug’s application, a decision that could indicate the agency wants another clinical trial.

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Lapses at Catalent plant filling Novo's Wegovy forced 2 prior shutdowns: report

Fierce Pharma

Catalent’s Brussels factory, responsible for filling the self-injection pens for Novo Nordisk’s obesity blockbuster Wegovy, suffered a number of lapses in recent years and had to shut down twice, a | Catalent’s Brussels factory, responsible for filling the self-injection pens for Novo Nordisk’s obesity blockbuster Wegovy, suffered a number of lapses in recent years and had to shut down twice, according to a new Reuters report, which cites FDA documents stemming from a series of inspections.

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NorthShore Study Proves Hospitals Can Save Millions by Providing Post-Discharge Psychosocial Support

MedCity News

NorthShore University HealthSystem teamed up with Laguna Health in 2021 to study whether greater post-acute care support can improve patient recovery and reduce readmissions. The research partners recently released results of the study, which found that giving patients emotional and psychological support after their discharge hastens recovery, decreases costs and alleviates physician burnout.

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Despite big Q2 declines for Humira and Imbruvica, AbbVie still boosts earnings guidance

Fierce Pharma

As Humira biosimilars enter the U.S. market in a steady stream, AbbVie execs say they're pleased with how the situation is playing out. | As Humira biosimilars continue to swarm the market, AbbVie says the situation is playing out as it had expected—or even slightly better. Still, the company is weathering hefty sales declines.

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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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FDA Approves First Nonprescription Birth Control

PharmExec

Frederique Welgryn, global vice president for women's health, Perrigo, shares insight into the approval of Opill (norgestrel), a progestin-only contraception, in this exclusive Q&A.

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Bristol Myers slashes Revlimid sales projection by $1B, now sees overall revenue decline in 2023

Fierce Pharma

Securing FDA approvals last year for three drugs that each have peak sales potential of $4 billion bodes well for the long-term future of Bristol Myers Squibb. | Bristol Myers Squibb is entering a dark stage. In the second quarter, the company's three top-selling drugs—Eliquis, Revlimid and Opdivo—all meaningfully missed analysts’ expectations.

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Bio Startup Nexo Lands $60M to Climb to New Heights in Cancer Drug R&D

MedCity News

Nexo Therapeutics is developing cancer drugs that expand the scope of amino acids addressable by covalent chemistry. Versant Ventures founded the startup and led its Series A financing.

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Takeda hypes up dengue vaccine launch progress as Vyvanse generics loom

Fierce Pharma

With generics of the popular ADHD medication Vyvanse circling the gates, Takeda will have to depend on newer launches to grow going forward. | While it’s still early days for Qdenga’s launch, Takeda is “encouraged by the positive momentum” it’s seen in markets where the product is now available, the company’s CEO, Christophe Weber, said on a conference call Thursday.

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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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Senate Finance Committee Advances Bill Targeting PBMs

MedCity News

The Senate Finance Committee voted 26-1 to advance the Modernizing and Ensuring PBM Accountability Act. The bill has several provisions, including delinking PBM income from prescription drug prices under Medicare Part D and banning spread pricing in Medicaid.

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Facing potential $10B trial loss, Teva seeks appeal of recent ruling in kickbacks case

Fierce Pharma

A lawsuit from the U.S. government related to alleged kickbacks on Copaxone could prove to be "enterprise-threatening," Teva lawyers recently wrote.

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Progressive Medical, Inc’s PMI LAPSYSTEM™ Awarded Addition to National Agreement with Premier, Inc.

Progressive Medical

Progressive Medical Awarded Product Addition to National Agreement with Premier Inc. PMI is pleased to announce that PMI LAPSYSTEM™ […] The post Progressive Medical, Inc’s PMI LAPSYSTEM™ Awarded Addition to National Agreement with Premier, Inc. appeared first on Progressive Medical, Inc.

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Clinical Trials Have A Data Problem. Here’s How The Industry Can Solve It.

MedCity News

To maximize the digital clinical trial opportunity, it is imperative to establish a solid foundation of data collection and management best practices and capitalize on the advancements in data management technologies.

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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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Maximize Collection Management at your Library: the Power of Citation Analysis + Integrated Evaluation Tools

Clarivate

Citation analysis is a data-driven method that enhances library collection management – enhanced by new integrated tools. Library collections are fundamental to the outcomes of teaching and research at an institution. They provide valuable resources that enable students and faculty to operate at an excellent standard. Despite their importance, university libraries face challenges and constraints – they are vulnerable to budget cuts , but have become adept at doing more with less for decad

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Innovative solid-state storage for biologics developed

European Pharmaceutical Review

A paper published in ACS Synthetic Biology has demonstrated a novel method for storing biological materials such as RNA and proteins via solid-state storage. This would be as a pill or a tablet, which can be dissolved in water for on-demand use. The innovation by researchers at California Polytechnic State University in the US could help overcome current limitations in the storage and handling of products derived from living cells.

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GoodRx Launches Solution To Help Consumers Manage Their Prescriptions

MedCity News

Medicine Cabinet, a new solution by GoodRx, gives users reminders to take their medications and refill prescriptions and recommends pharmacies based on prescription costs. It also has a rewards system for using GoodRx coupons and picking up prescriptions on time.

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ADC demonstrates meaningful survival data for HER2 cancers

European Pharmaceutical Review

ENHERTU ® (trastuzumab deruxtecan) has demonstrated clinically meaningful progression-free survival (PFS) and overall survival (OS) in topline results from the primary analysis of the ongoing DESTINY-PanTumor02 Phase II trial. The data was for previously treated patients across multiple HER2 expressing advanced solid tumours, two secondary endpoints.

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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.

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6 Ways Providers Can Better Manage 3rd-Party Cybersecurity Risks

MedCity News

The Health3PT Initiative recently released recommendations on how providers can better address the cybersecurity risks linked to their third party reliance. Some of the group’s recommendations included ensuring that contract language ties financial terms to a vendor’s data management transparency and establishing metrics and reporting requirements for organization-wide vendor risks.

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Approval expanded for generalised myasthenia gravis medicine

European Pharmaceutical Review

The first targeted therapy approved for paediatric patients with generalised myasthenia gravis (gMG) has been approved in the EU. Soliris (eculizumab) has been authorised for expanded use in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive (Ab+). This decision by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP).

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Medical Devices Are Evolving Toward Specialized Solutions

MedCity News

Medical devices have existed in some form for centuries, resulting in thousands of innovative implementations over the years. Throughout history, medical devices have addressed a wide array of disease states – often, one device has purpose across different disease states. Devices fall into categories including single use devices, implantables, imaging equipment, medical supplies, software and surgical instruments.

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ABPI reacts to new vital vaccination report

PharmaTimes

New HSCC document deems the UK’s vaccination position to be at risk - News - PharmaTimes

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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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GSK reports rise in profit in Q2 2023

Pharmaceutical Technology

GSK has reported an adjusted operating profit of £2.17bn in Q2 2023, which is an almost 8% increase from the £2.

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First dose completed in phase 1 cannabinoid study

PharmaTimes

OCTP aims to demonstrate the lead candidate’s safety, tolerability and pharmacokinetic profile - News - PharmaTimes

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How Salesforce Territory Management & SPOTIO Turbocharge Sales

Spotio

One of the biggest challenges in field sales management is that most of the sales process happens outside the office, beyond the view of sales managers. So when sales revenue is lagging, or deals are slow to close, it can be difficult to understand what’s causing those problems. A good first step to troubleshooting sluggish sales is to reassess your territory management strategy.

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Navigating the Future of Medical Device Sales: Insights, Evolution, and Talent Acquisition Strategies

Rep-Lite

In today’s fast-evolving world, the medical sales industry stands at the forefront of innovation, with medical devices playing a pivotal role in patient care and treatment. The demand for these life-saving technologies continues to surge, presenting an exciting opportunity for growth and success in medical device sales. Recent statistics indicate that the global medical device market is projected to reach an astounding $612.7 billion by 2025.

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Accelerating Clinical Supply Through Integrated Drug Development

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.