Tue.Aug 13, 2024

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To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse events

Fierce Pharma

When the FDA approved Amgen’s Imdelltra in May, the T-cell engager was hailed as a breakthrough for the treatment of small cell lung cancer (SCLC) and as the first DLL3-targeting therapy of potenti | In granting an accelerated approval to Amgen's first-in-class DLL3 bispecific Imdelltra, the FDA had to work through a “large number” of missing adverse events from a pivotal trial.

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4 Things to Know About the McLaren Cyberattack & Its Aftermath

MedCity News

Last week, McLaren Health Care fell victim to its second major cyberattack in less than a year. The Michigan-based health system has been working to restore its IT and phone systems over the past week, but some of these systems still remain down. The post 4 Things to Know About the McLaren Cyberattack & Its Aftermath appeared first on MedCity News.

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Lexicon to lay off 50% of field force as it prioritizes heart failure drug, potential US diabetes launch

Fierce Pharma

Despite winning an FDA approval in 2023 and gaining clarity in May on the regulatory path forward for its Type 1 diabetes prospect sotagliflozin, Lexicon Pharmaceuticals hasn’t had an easy go of it | As part of a restructuring initiative, Lexicon Pharmaceuticals will lay off more than 75 staffers, or approximately 50% of its current field force, by the end of September.

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Remembering Paul Bannister, dear friend and finance manager

pharmaphorum

Our longtime Finance Director Paul Bannister was a part of the fabric of pharmaphorum almost from the beginning and an integral part of keeping the publication running. And, most importantly, he was the soul of the place and a friend to all.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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CORRECTED: After icodec rejection, Novo Nordisk won’t file application for once-weekly insulin and semaglutide combo in US

Fierce Pharma

CORRECTED: After icodec rejection, Novo Nordisk won’t file application for once-weekly insulin and semaglutide combo in US fkansteiner Tue, 08/13/2024 - 13:42

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Private Equity Buys Another Piece of Baxter as Carlyle Scoops Up Kidney Care Biz for $3.8B

MedCity News

Baxter International is selling its kidney care business for less than it was able to fetch for its much smaller biopharma solutions segment last year. A unit within kidney care took a goodwill impairment charge, Baxter’s financial reports show. The post Private Equity Buys Another Piece of Baxter as Carlyle Scoops Up Kidney Care Biz for $3.8B appeared first on MedCity News.

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People need to know how to use AI now

pharmaphorum

With the implementation of advancing technologies in industry comes the parallel need for suitable upskilling of the workforce – but this doesn’t as yet always pan out, and in today’s pharmaphorum podcast COO of Enthought Mike Connell discusses the growing skills gap in R&D in life sciences and the 80/20 rule with web editor Nicole Raleigh, as well as the need for correct education of people and machines, both.

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Investor activism resurfaces at Aurinia after CEO’s board role, exec pay lost majority support

Fierce Pharma

A deal to bring back former CEO Robert Foster, Ph.D., didn’t completely quell investors’ concerns about Aurinia Pharmaceuticals. | A deal to bring back former CEO Robert Foster, Ph.D., didn’t completely quell investors’ concerns about Aurinia Pharmaceuticals.

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Remembering Paul Bannister, our dear friend and finance manager

pharmaphorum

On Sunday 28th July, pharmaphorum lost a much-beloved member of the family. If you don’t work for or with pharmaphorum or Healthware, you probably don’t know the name Paul Bannister. Paul wasn’t a writer or a designer or a photographer. He never had a byline on the website. He didn’t interface with sponsors or advertisers.But as our longtime Finance Director, he was a part of the fabric of the company almost from the beginning and an integral part of keeping the publication running.

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Itching for leadership in 'therapeutic dermatology,' Galderma wins FDA nod for Nemluvio to treat prurigo nodularis

Fierce Pharma

Itching for leadership in 'therapeutic dermatology,' Galderma wins FDA nod for Nemluvio to treat prurigo nodularis kdunleavy Tue, 08/13/2024 - 10:38

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

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Modern Health Boosts AI Capabilities by Acquiring Anvil Health’s Tech

MedCity News

Modern Health has acquired Anvil Health’s AI technology. It has also hired Anvil’s co-founder, Paul Clark, as head of AI strategy. The post Modern Health Boosts AI Capabilities by Acquiring Anvil Health’s Tech appeared first on MedCity News.

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FDA approves Ascendis Pharma’s YORVIPATH for hypoparathyroidism

Pharmaceutical Technology

Ascendis Pharma has obtained US Food and Drug Administration (FDA) approval for its YORVIPATH to treat hypoparathyroidism in adults.

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INVEST Digital Health Pitch Perfect Judge Shares Healthcare Startup Investment Insights

MedCity News

Dan Easton, Unorthodox Ventures Principal, is one of the judges for the INVEST Pitch Perfect startup contest, which will focus on pediatric mental health. In response to emailed questions, Easton shared the firm’s approach to healthcare startups. The post INVEST Digital Health Pitch Perfect Judge Shares Healthcare Startup Investment Insights appeared first on MedCity News.

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A biotech’s difficult journey to bring a new kind of Parkinson’s drug to patients

PharmaVoice

A series of executive turnovers at Gain Therapeutics this year precedes important early-stage Parkinson’s results that could change how the disease is treated.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

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How Digital Delivery Can Empower Staff and Shape the Future of Pharmacy 

MedCity News

if we can shift the way we deliver information, we can change the entire culture of pharmacy in a way that relieves some of the burden on the pharmacists and improves patient outcomes at the same time. The post How Digital Delivery Can Empower Staff and Shape the Future of Pharmacy appeared first on MedCity News.

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A potential MS ‘game changer’ could bring more safety to the table — even against viruses

PharmaVoice

Immunic’s treatment has anti-inflammation, neuroprotection and antiviral effects plus a ‘benign’ safety profile that even seems to lower the risk of COVID-19 infection.

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What’s Keeping Healthcare CIOs Up at Night: How to Improve Patient Satisfaction by Handling Calls More Efficiently

MedCity News

Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat. The post What’s Keeping Healthcare CIOs Up at Night: How to Improve Patient Satisfaction by Handling Calls More Efficiently appeared first on MedCity News.

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Why You Shouldn't Blindly Trust Google to Automate Your Google Ads Account

Healthcare Success

As a leading Google Premier Partner managing millions of dollars in annual Google Ads spend, we strongly advocate for the platform. Our digital team collaborates closely with Google's enterprise team to implement best practices for all our clients. However, we’ve discovered that not all Google recommendations are equally effective. Many of our new clients come to us with ad campaigns that over rely on Google's automated solutions, resulting in costly performance problems.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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To Advance Health Equity, We Must Stop Shaming Fax

MedCity News

The disdain for fax in all its forms isn’t new. But at a time when small healthcare organizations struggle to afford an EHR, the question remains: Who are the digital haves to judge the digital have-nots? The post To Advance Health Equity, We Must Stop Shaming Fax appeared first on MedCity News.

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Judge rebuffs Novartis bid to block generic Entresto

pharmaphorum

Novartis' attempt to stop MSN Pharma from launching a generic version of heart failure blockbuster Entresto is blocked in a US court

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Pharma Pulse 8/13/24: How Should Biotechs Strategize for 2025, Pfizer Announces Top-Line Results of ABRYSVO for RSV & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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FDA okays Ascendis hypoparathyroidism drug at second attempt

pharmaphorum

After turning it down a year ago, the FDA has cleared once-daily injectable Yorvipath for hypoparathyroidism from Ascendis Pharma.Yorvipath (palopegteriparatide) – previously known as TransCon PTH – has been approved to treat adults with hypoparathyroidism, a rare condition defined by a deficiency of parathyroid hormone (PTH) that affects 70,000 to 90,000 people in the US.

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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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CMT Research Foundation invests in research project to develop treatments for CMTs

PharmaTimes

The rare, peripheral neuropathy disease affects nearly three million people globally

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Digital health fund makes debut with $21m for startups

pharmaphorum

A group of healthcare industry veterans have launched a new investment fund – called Create Health Ventures – with $21 million in the pot to support early-stage companies with tech that can support payers and pharma companies.

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Francis Crick scientists reveal how cells ‘raise the alarm’ when damaged or infected

PharmaTimes

The V-ATPase protein, V1H, was found to be involved in the process of raising the alarm

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First Nasal Spray for Anaphylaxis Approved by FDA

PharmaTech

The epinephrine nasal spray was approved for the emergency treatment of type 1 allergic reactions in adults and children.

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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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Digital health fund makes debut with $21m for start-ups

pharmaphorum

New digital health fund Create Health Ventures debuts with $21m to support start-ups with enabling tech for payers and pharma companies.

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The Role of the BC Doctors Directory in Improving Patient-Doctor Connections

Scott’s Directories

Establishing strong patient-doctor connections is vital for effective healthcare delivery in British Columbia. With the increasing demand for personalized care, patients need quick access to medical professionals who can address their health needs. The BC Physician Directory significantly bridges this gap, ensuring patients can easily find the right healthcare provider.

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Madrigal plans to solidify Rezdiffra’s position in MASH despite start being slower than expected

Pharmaceutical Technology

In March 2024, Madrigal Pharmaceuticals had a breakthrough moment when, after years of research and anticipation, the US Food and Drug Administration (FDA) granted approval for its Rezdiffra (resmetirom), a pioneering treatment for adults with F2-F3 metabolic dysfunction-associated steatohepatitis (MASH).

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A Look into Promising AstraZeneca Oncology Agents

PharmExec

In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, Head of Medical Affairs, US Oncology Business Unit, AstraZeneca, discusses a number of oncology targets in the works at AstraZeneca.

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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.