Wed.Nov 08, 2023

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eCOA roadmap: Five key steps to patient-focused drug development

Pharmaceutical Technology

For clinical trial providers, the paper-based COA process has been rife with challenges and subject to error. Digitalisation offers a better way.

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What if a CRISPR cure isn’t such an easy choice?

Bio Pharma Dive

A gene editing therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.

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Huge Study Implicates Salt in Type 2 Diabetes, But Let’s Look At The Facts

AuroBlog - Aurous Healthcare Clinical Trials blog

When people think of foods related to type 2 diabetes, they often think of sugar (even though the evidence for that is still not clear). Now, a new study from the US points the finger at salt.

Research 245
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Lilly weight loss drug approved by FDA

Bio Pharma Dive

The pharmaceutical company will sell the GLP-1 drug, branded as Zepbound, at a list price about 20% lower than Novo Nordisk's competing drug Wegovy.

Drugs 312
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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US FDA India Office soon to initiate US FDA-Telangana DCA Regulatory Forum for future strategic collaborations

AuroBlog - Aurous Healthcare Clinical Trials blog

The US FDA India Office has proposed to initiate US FDA – Telangana Drugs Control Administration (DCA) Regulatory Forum for future strategic collaborations and initiatives during their recent visit to the Telangana DCA office in Hyderabad.

Drugs 183
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Bayer’s new CEO signals business shake-up, plans to slash management

Bio Pharma Dive

Company head Bill Anderson said Bayer may separate its consumer health or crop science business, and signaled “significant” layoffs are in the future.

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Biogen says growth is coming, but won’t specify when

Bio Pharma Dive

CEO Chris Viehbacher said the company has “the elements to think about a return to topline growth.” Yet, that goal hinges on the successful commercialization of multiple new products.

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Innoviva and GARDP reveal positive results for antibiotic to treat gonorrhoea

Pharma Times

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

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FTC challenges patents held by nine big drugmakers, citing unfair competition

Bio Pharma Dive

The agency claims intellectual property for emergency allergy shot EpiPen and asthma medication Advair was “improperly listed” in an FDA database.

Allergies 173
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New hubs receive over £32m to improve access to vaccines in LMICs

Pharma Times

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

Vaccine 148
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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What in the world has happened since COP27?

Pharmaceutical Technology

Since last year’s COP27 summit, what events and government acts, if any, have made a positive impression on the climate?

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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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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.

Research 147
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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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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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NICE expedites medicine evaluations by 17% in current year

Pharmaceutical Technology

NICE is also working on incorporating real-world and AI-generated evidence into medicine evaluation submissions.

Medicine 147
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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.

Sales 115
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Alfasigma opens new doors in the US with Intercept acquisition

Pharmaceutical Technology

Alfasigma will also gain access to Intercept’s severe alcohol-associated hepatitis (sAH) drug INT-787 currently in a Phase IIa study.

Drugs 130
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Paywalls threaten healthcare professional engagement on social media

pharmaphorum

Paywalls threaten healthcare professional engagement on social media Mike.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Telix strikes deal to distribute cancer imaging agent in the Nordics

Pharmaceutical Technology

The manufacturer of a prostate cancer imaging agent has struck a deal with the Danish Wiik Pharma to distribute its product across the Nordics.

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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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What does Biden’s executive order mean for worldwide AI regulation?

Pharmaceutical Technology

The executive order highlights the US sentiment towards AI regulation, but presents a fragmented approach with possibility of discord.

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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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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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OMERS snaps up drug royalties and milestones from Xencor for $215m

Pharmaceutical Technology

OMERS has gained financial upsides for Ultomiris and Monjuvi sales from July 2023, with Xencor retaining a portion of sales-based milestones.

Sales 130
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Novo to Discontinue Long-Acting Insulin Injection Levemir by the End of 2024

BioSpace

Citing manufacturing concerns and formulary losses, Novo Nordisk will discontinue its long-acting insulin Levemir by the end of next year amid strong pressure from U.S. lawmakers to lower insulin prices.

Insulin 109
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Biotech accelerator Blackbird Labs launches with $100m grant

Pharmaceutical Technology

Blackbird has already funded and established a portfolio, which includes small molecule therapeutics for schizophrenia.

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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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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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BIO-Europe 2023: EU HTA harmonisation may land off key for pharma

Pharmaceutical Technology

At the BIO-Europe Conference, an expert panel discussed challenges with the upcoming EU harmonisation of HTAs.

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How to use Google to stay up to date with your medical condition

Antidote

The medical research industry is fast-moving. Despite the fact that the average clinical trial lasts about 10 years , new discoveries are happening all the time. However, keeping up with new developments can be a challenge.

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Putting compliance and quality at the heart of pharmaceutical supply chains?

Pharmaceutical Technology

With an era of digital transformation promising to optimise pharmaceutical supply chains, how are companies learning to embrace the change?

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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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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.