Fri.Jan 12, 2024

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Appeals court allows unique argument in Gilead's legal battle over HIV meds

Fierce Pharma

When a plaintiff raises allegations of negligence against a company, the claims typically center on defective products that can cause harm. | A group of 24,000 users of Gilead's TDF-based HIV meds argue that the company knowingly shelved a safer HIV med to increase its profits. Now, Gilead will have to prove that a manufacturer can't be held liable for its development timeline of an upgraded product.

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Why One CEO Thinks Drugs Won’t Be Able to Solve the Obesity Crisis

MedCity News

New research found that there are no racial disparities in weight loss results among patients taking obesity drugs. However, the study found that people of color have less access to services like behavioral care or surgical interventions, which are often needed in order for obese patients to lose weight and keep it off.

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FDA's early review finds no evidence linking Novo, Lilly weight-loss drugs to suicidal thoughts

Fierce Pharma

A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. | A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. regulator said.

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Boehringer plans €120m European manufacturing expansion

European Pharmaceutical Review

Using an investment of €120 million, Boehringer Ingelheim is set to expand and upgrade its production site in Koropi, Greece. New technologies at the facility will support the increased manufacturing capacity, the company stated on X. The expansion will boost exports of medicines from Greece to the US market. This will be the case particularly for Jardiance ® , a treatment for type 2 diabetes, chronic heart failure and chronic kidney disease (CKD), according to Boehringer Ingelheim.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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As donanemab nears FDA judgment day, Lilly embraces competition in Alzheimer's disease

Fierce Pharma

While the first-mover advantage is often critical in the realm of drug launches, Eli Lilly is often happy to split the pie with its peers. | While the first-mover advantage is often critical in the realm of drug launches, Eli Lilly is often happy to split the pie with its peers. That’s proven true in obesity, where the company recently introduced its dual-action GIP/GLP-1 agonist Zepbound against Novo Nordisk’s Wegovy.

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Reimbursement-Related Analytics and Reporting

Pharmaceutical Commerce

An overview of a structural approach that guides development of the analytics and related reporting that may assist brands in gaining or maintaining reimbursement positions and maximizing sales.

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Achieving optimal advanced process control in bioproduction

European Pharmaceutical Review

According to a paper published in Bioprocess Control , as an advanced process control method, Model Predictive Control (MPC) can optimise biomanufacturing operations and ensure consistent product yields. With biological systems becoming increasing complex, alongside expanding demand for precision in drug development and manufacturing, advanced process control methods that can ensure consistent product yields and high-quality outputs in bioproduction are becoming vital, the researchers acknowledg

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Manufacturing Issues Block Astellas From a First-in-Class Cancer Drug Approval

MedCity News

Astellas Pharma’s zolbetuximab was on track to become the first gastric cancer drug that targets claudin 18.1, a protein found on cancerous stomach cells. Others with clinical-stage programs addressing this this target include AstraZeneca and Bristol Myers Squibb.

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FDA starts review of Lantheus’ generic Lutathera

pharmaphorum

Lantheus has filed what it says is the first generic version of Novartis’ big-selling cancer radionuclide therapy Lutathera in the US, used to treat rare neuroendocrine tumours (NETs). The FDA has started a review of the generic and – if approved – Lantheus could be in line for 180 days of market exclusivity as the first company to bring a copycat version of Lutathera (lutetium Lu 177 dotatate) to the US market.

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The Case for Asset Stewardship: How Healthcare Wastes Millions of Dollars on Endoscope Ownership

MedCity News

U.S. healthcare is unnecessarily spending millions of dollars on scopes—dollars that could be better spent opening up new service lines, investing in medical equipment, or hiring nurses for improved patient care.

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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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Study finds hundreds of overlooked cancer drug targets

pharmaphorum

Researchers from the Wellcome Sanger Institute and partners have carried out a comprehensive analysis of cancer cells, identifying 370 ‘priority’ targets that could be used to develop new drug therapies.

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GenAI in pharma: where are we today?

European Pharmaceutical Review

A recent survey from the Pistoia Alliance revealed that AI and machine learning (ML) will be the top technology investment for 60 percent of life sciences companies over the next two years. 1 AI and machine learning (ML) will be the top technology investment for 60 percent of life sciences companies over the next two years” With this increased focus on AI/ML, EPR editor Caroline Peachey sat down with Henry Levy, President of Life Sciences at Clarivate, to discuss the status, challenges a

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Bayer unit takes heart failure gene therapy into phase 2

pharmaphorum

Bayer’s AskBio gene therapy unit has started recruiting patients into a phase 2 trial of its AB-1002 candidate for congestive heart failure.

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Cereno partners with CordenPharma to scale up CS1 drug production

Pharmaceutical Technology

Cereno Scientific has announced a partnership with CordenPharma to scale up manufacture of its drug candidate CS1.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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FDA finds no link between GLP-1 drugs and suicide

pharmaphorum

The FDA says it can find no evidence of increased risk of suicidal thoughts and self-harm with GLP-1 drugs like Novo Nordisk's Ozempic and Wegovy

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Cambridge researchers begin new trial for oesophageal cancer screening

PharmaTimes

If successful, the new test could see routine screening introduced in the NHS

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Pharma execs sound off on trends and policies they’re tracking in 2024

PharmaVoice

From regulatory concerns to leadership skills, pharma leaders at JPM shared how they’re approaching the coming year.

Pharma 78
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Study reveals antibiotic use is not the only driver of antibiotic resistance

PharmaTimes

Researchers compared 20 years of antibiotic use on E.

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

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FDA Approves BrainSee, First-in-Class Test to Predict Progression of Alzheimer Disease

Pharmacy Times

BrainSee creates a new standard for progression prediction in Alzheimer disease, marking a step forward in brain health management with non-invasive screening.

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Emergent wins $235.8m US defence contract for Anthrax vaccine

Pharmaceutical Technology

The US Department of Defense procurement contract for Emergent’s BioThrax is comprised of an initial five-year base agreement.

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Overview of FDA Drug approvals in 2023 - Total Guide

Pharmatutor

Overview of FDA Drug approvals in 2023 - Total Guide admin Sat, 01/13/2024 - 11:38 In 2023, FDA approved 55 new drugs never before approved or marketed in the U.S., known as “novel” drugs. We also made other important approval decisions, such as expanding the use or patient population of previously approved drugs.

FDA 52
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From "Test Drive" to "Take the Keys": Proven Strategies to Close More Car Deals

Contrarian Sales Techniques

"Mr. Johnson gripped the steering wheel like a white-knuckled life raft, eyes wide as saucers as we navigated the dealership's obstacle course. 'Is this normal?' he croaked, as the shiny red SUV bounced over a speed bump like a startled gazelle. 'Because it feels like I'm about to launch us into orbit.' I chuckled, calming his nerves with a reassuring, 'Just testing the suspension, Mr.

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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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Patient Privacy in 2024

Penrod

Tracking Technologies and HIPAA OCR Guidelines In December 2022, OCR issued a Bulletin outlining health providers’ HIPAA obligations. An important aspect of this overview emphasizes that providers are not allowed to use tracking technologies in a way that would reveal Protected Health Information (PHI) in a manner inconsistent with HIPAA’s privacy standards.

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Emergent BioSolutions Awarded Contract to Supply US Military With Anthrax Vaccine

Pharmaceutical Commerce

The US Department of Defense awarded Emergent BioSolutions Inc. with a contract worth up to $235.8 million to supply all branches of the US military with BioThrax (Anthrax Vaccine Adsorbed) for use as pre-exposure prophylaxis against anthrax disease.

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How AI is supercharging clinical trials

pharmaphorum

Experts in clinical trial technology, design and execution will come together in a moderated discussion to explore these different facets of the opportunities created by AI, both traditional and generative.

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Neuralace Medical’s Axon Therapy Granted FDA Clearance for Diabetic Neuropathy

Pharmaceutical Commerce

Axon Therapy is a noninvasive system that sends magnetic pulses through the skin that stimulate damaged peripheral nerve cells involved in the body’s pain relief mechanism.

FDA 52
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Will Employers Support Demand for Coverage Expansion of GLP-1 Agonists into Weight Loss?

PharmExec

Although medications such as Mounjaro and Zepbound have shown efficacy in helping individuals lose weight, there are not yet enough results to fully support these claims.

Medical 52
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Investigational Ovarian Cancer Drug Granted FDA Fast Track Designation

Pharmaceutical Commerce

RemeGen Co. Ltd’s antibody-drug conjugate RC88 is being analyzed to treat platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.

FDA 52
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Foundational Questions in Data Reporting, Analytics to Meet Reimbursement-Directed Marketing Goals

PharmExec

Measuring the relationship between a product’s reimbursement position and performance begins with gathering key data points for as many products as possible.

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The Future of Employer Coverage for Glucagon-Like Peptide 1 Receptor Agonists in Weight Loss

Pharmaceutical Commerce

Morgan Company report makes the case for expanding coverage for GLP-1s beyond diabetes treatment and into the weight loss class, but are employers on board?

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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