Wed.Nov 08, 2023

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With FDA approval, Eli Lilly's weight-loss drug Zepbound arrives to challenge Novo Nordisk

Fierce Pharma

In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. | In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. Wednesday's FDA approval of Lilly's Zepbound to treat obesity closes the gap further. In addition, Lilly said it will charge 20% less than Novo for its obesity med in an attempt to provide increased access.

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Walgreens Exec: Reimbursement Models Need to Catch Up with GLP-1 Demand

MedCity News

Walgreens is seeing “an enormous amount of demand” for injectable weight loss drugs, its president of U.S. healthcare said during the Reuters Total Health conference in Chicago. He declared that the healthcare industry needs to come up with a reimbursement model “that correctly compensates pharmacists and others” to administer these drugs. In his view, reimbursement hasn’t caught up with the demand.

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Bayer CEO Anderson says 'radical realignment' is underway

Fierce Pharma

In three years as the pharma chief at Roche, Bill Anderson executed a massive overhaul of the division, lopping off layers of management and recharting its course. | In three years as the pharma chief at Roche, Bill Anderson executed a massive overhaul of the division, lopping off layers of management and recharting its course. Now in his fifth month as CEO at struggling conglomerate Bayer, Anderson is focused on an even larger renovation, saying the company is on its way to a “radical realignme

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FDA Approves Eli Lilly Weight Drug, Now Set to Compete Against Novo’s Wegovy

MedCity News

Eli Lilly weight management drug Zepbound landed its much anticipated FDA approval. The new Lilly product is in the same drug class as Novo Nordisk weight medication Wegovy, but it offers an additional mechanism of action and costs less.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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As Biogen's sales flatline, CEO Chris Viehbacher touts progress on Leqembi, Skyclarys and other launches

Fierce Pharma

While Biogen CEO Chris Viehbacher seems satisfied with the company's third-quarter financial metrics, the main question at the drugmaker isn’t so much how the company’s doing now, but what its plan | While Biogen CEO Chris Viehbacher seems satisfied with the company's third-quarter financial metrics, the main question at the drugmaker isn’t so much how the company’s doing now, but what its plans are for future growth, he said on a call with investors.

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Amazon Links Prime Membership With One Medical: Will This Improve Access?

MedCity News

Prime members can now get a One Medical membership for $9 a month or $99 a year. The benefit provides access to 24/7 on-demand virtual care through One Medical’s app. But health experts are split on whether the move will improve access to care.

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Better Patient Care and Operational Success: Seven Ways to Benefit From Generative AI in Healthcare

MedCity News

No matter what camp healthcare providers sit in, it’s important for them to understand how they can harness the power of responsible generative AI. Here we dive into some use cases to consider exploring and how it’s impacting healthcare – for the better.

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J&J books manufacturing space at Fujifilm Diosynth's upcoming mega-plant in North Carolina

Fierce Pharma

With a year and change still left before Fujifilm Diosynth cuts the ribbon on a massive biomanufacturing facility in North Carolina, the CDMO has already lined up its first client. | With a year and change still left before Fujifilm Diosynth cuts the ribbon on a massive biomanufacturing facility in North Carolina, the CDMO has already lined up its first client.

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FDA Approves Zepbound for Chronic Weight Management

PharmExec

Tirzepatide (Zepbound; Eli Lilly and Company) is expected to be available in the United States by the end of 2023 with a list price of $1,059.87.

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It's the end of the line for Bayer's P13K Aliqopa and Novo's insulin Levemir after 2 market pulls

Fierce Pharma

While Novo Nordisk struggles with manufacturing concerns and patient coverage on its long-acting insulin Levemir, Bayer missed a primary endpoint in a confirmatory trial for its P13K inhibitor Aliq | While Bayer's P13K Aliqopa couldn't prove its worth in a confirmatory trial, Novo's Levemir faced manufacturing issues and troubles with patient coverage, leading the two to separately withdraw their products.

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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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Emerging Technologies and It’s Impact On Global Food Insecurity

MedCity News

Food insecurity is a blight that affects many. According to the Department of Agriculture, 12.8 percent (17.0 million households) were food insecure. The percentage of food insecure household was statistically significantly higher than the 10.2 percent recorded in 2021 (13.5 million households) and the 10.5 percent in 2020 (13.8 million households).

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Oligonucleotides: The Next Therapeutic Wave on the Market? (AAPS PharmSci 360)

PharmaTech

Matthew Lauber, senior director—Cell and Gene Therapy, Consumables & Lab Automation, at Waters Corporation, considers that status of oligonucleotides on the market.

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Company Launches To Combat Loneliness Through Virtual Peer Support Groups

MedCity News

Forum, which launched Wednesday, is an online marketplace that offers peer support groups for a range of topics, including grief, loneliness, chronic conditions, substance use, caregiving and relationships. It has raised $5.3 million in seed funding led by NextView Ventures.

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Rapid HPLC method could improve formulation QC studies

European Pharmaceutical Review

A paper published by Research Square has described a rapid, simple, accurate and precise high-performance liquid chromatography with diode-array detection (HPLC-DAD) method for levofloxacin determination in liquid pharmaceutical formulations. The effectiveness of levofloxacin can be impacted by its stability in pharmaceutical formulations. This impacts the effective concentration of the drug, Mohammed et al. noted.

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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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Innoviva and GARDP reveal positive results for antibiotic to treat gonorrhoea

PharmaTimes

Zoliflodacin inhibits the vital bacterial enzyme for bacterial function and reproduction - News - PharmaTimes

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Innovative insomnia study aims to overcome major clinical trial bottleneck

European Pharmaceutical Review

For UK patients with severe insomnia, for whom existing therapies have not worked, a new, decentralised clinical trial is set to evaluate chloral hydrate as a short-term treatment. Evaluating chloral hydrate for insomnia While chloral hydrate is already an established treatment for insomnia, much of the published clinical data in adult patients is dated, according to clinical trials company Lindus Health and global lifecycle management healthcare company Pharmanovia.

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New hubs receive over £32m to improve access to vaccines in LMICs

PharmaTimes

Communicable diseases account for 50% of all deaths in LMICs - News - PharmaTimes

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Access Insights 2023: Biosimilars, Specialty Generics’ Impact on Sites of Care

Pharmaceutical Commerce

Session explores how on-market products have done, and what to expect from new biosimilars.

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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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To Build AI Maturity, Start With Quick Wins

PharmExec

Companies must determine the right ways to utilize AI.

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Preparing for patent litigation: how comprehensive patent research pays off when the stakes are high

Clarivate

For most defendants, patent litigation is a high stakes situation that justifies a significant investment in building an effective defense strategy. At the heart of any successful defensive strategy is comprehensive patent research. Recent legal decisions are heightening the need for, and in some ways, changing the focus of patent research when preparing for litigation.

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Concerns Raised Over False Claims in Direct-to-Consumer Online Marketing of Ketamine

PharmExec

The online promotion of intravenous infusions and oral forms of subanesthetic ketamine for the treatment of mental health conditions has been found to frequently carry misleading or false information.

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Network Innovations Webinar with Aetna, Contigo Health, and Clarify

Clarify Health

Healthcare strategy and innovation leaders from Aetna, Contigo Health, and Clarify recently hosted a webinar discussion about innovations in provider network design and management to drive higher-value, more affordable, and more accessible care for members. Watch the recording or read the transcript for unique perspectives on the intersection of technology, provider performance, and value-based contracting.

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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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Oligonucleotide-Enabling Technology Pushes Oligos to the Forefront (AAPS PharmSci 360)

PharmaTech

Matthew Lauber, senior director—Cell and Gene Therapy, Consumables & Lab Automation, at Waters Corporation highlights how current technologies are enabling oligonucleotide development.

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iCliniq Appoints Head of Sales Paige Dahlhausen to Lead U.S. Growth

PM360

iCliniq , a leading global provider of healthcare resources with operations in the U.S., U.K., UAE, India, Singapore and Germany, has named Paige Dahlhausen as its Head of Sales. The appointment of Dahlhausen marks a key milestone for the company’s dedication to female leadership with more than half of iCliniq’s 160+ global team identifying as female.

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Bayer to streamline management in cost-cutting drive

pharmaphorum

Bayer to streamline management in cost-cutting drive Phil.

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Gene Therapy Advances in Hemophilia A Treatment

Pharmacy Times

Atta Chowdhry, RPh, and Robert Sidonio Jr, MD, MSc, discuss the emergence of gene therapy as an exciting option for patients with hemophilia A and highlight benefits, limitations, and ongoing research in the field.

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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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France reported to be probing Sanofi over Dupixent launch

pharmaphorum

France reported to be probing Sanofi over Dupixent launch Phil.

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Jazz Pharmaceuticals and MD Anderson enter zanidatamab research deal

Pharmaceutical Technology

Jazz Pharmaceuticals and the University of Texas MD Anderson Cancer Center partnered to assess zanidatamab for HER2-expressing cancers.

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NICE backs 'artifical pancreas' tech for type 1 diabetics

pharmaphorum

NICE backs 'artifical pancreas' tech for type 1 diabetics Phil.

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An at-home flu vaccine? If approved, it could open the door to more DIY options

PharmaVoice

A new way to administer vaccines at home could help AstraZeneca reach a wider market for FluMist, the nasal influenza vaccine.

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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.