Wed.Sep 11, 2024

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Intercept's Ocaliva approval in jeopardy after FDA flags concerns in advisory committee briefing doc

Fierce Pharma

For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming. | Ahead of an advisory committee meeting slated for Friday, the FDA unleashed damning briefing documents calling into question the effectiveness and safety of Intercept’s rare liver disease drug Ocaliva. The regulator specifically raised an eyebrow at the post-marketing trials Intercept has used in a bid to keep hold of the accelerated approval it won back in 2016.

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300+ Provider Organizations Urge Feds to Prevent Leaked DEA Rule From Going into Effect

MedCity News

More than 330 provider organizations signed letters this week urging the White House and Congress to extend a pandemic-era telehealth prescribing flexibility. Failure to extend this policy would cause millions of Americans to lose access to treatment, they argued. The post 300+ Provider Organizations Urge Feds to Prevent Leaked DEA Rule From Going into Effect appeared first on MedCity News.

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J&J’s Tremfya, following in Stelara’s footsteps, enters crowded ulcerative colitis arena with FDA nod

Fierce Pharma

Johnson & Johnson already has a major presence in the crowded inflammatory bowel disease (IBD) space with its popular Stelara. | Tremfya will enter the UC space as J&J’s older Stelara, which is approved to treat both forms of IBD, nears biosimilar competition and Inflation Reduction Act-mandated price concessions.

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The New Role of Engagement: Surfacing Insights at the Point of Care and Beyond

MedCity News

By surfacing conversational, behavioral, and environmental insights at the point of care — and enabling data-driven operational decisions — AI has the power to transform individual patient experiences and drive systemic improvements in care quality and efficiency. The post The New Role of Engagement: Surfacing Insights at the Point of Care and Beyond appeared first on MedCity News.

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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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ESMO: Bristol Myers moves Opdualag into phase 3 trials in competitive first-line lung cancer field

Fierce Pharma

More than two years after an initial FDA approval in melanoma, Bristol Myers Squibb is moving its PD-1/LAG-3 combo Opdualag into registrational testing in one of the most important oncology disease | More than two years after an initial FDA approval in melanoma, Bristol Myers Squibb is moving its PD-1/LAG-3 combo Opdualag into registrational testing in one of the most important disease areas—first-line non-small cell lung cancer.

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Meet MILTON, AZ's AI that can predict 1,000+ diseases

pharmaphorum

A machine-learning tool developed by AstraZeneca and trained on UK Biobank data, called MILTON, can predict over 1,000 diseases, before diagnosis

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Highmark Covers AppliedVR’s Product for Chronic Low Back Pain

MedCity News

More than 4 million Highmark commercial members now have access to AppliedVR’s RelieVRx as a covered therapeutic. The post Highmark Covers AppliedVR’s Product for Chronic Low Back Pain appeared first on MedCity News.

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India's Zydus hit with warning letter as FDA flags glass contamination concerns and more

Fierce Pharma

Last week, Zydus Lifesciences confirmed the receipt of an FDA warning letter at its Waghodia plant in Gujarat, India, marking the latest in a string of production reprimands for the India | Last week, Zydus Lifesciences confirmed the receipt of an FDA Warning Letter at its Waghodia plant in Gujarat, India, marking the latest in a string of production reprimands for the Indian drugmaker.

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SEC Charges Ipsen Worker for Insider Trading Tied to $247M Epizyme Acquisition

MedCity News

Securities regulators say the role of Ipsen employee Dishant Gupta made him privy to details of the Epizyme acquisition. Gupta allegedly accumulated Epizyme shares while the deal was negotiated, then sold all of them hours after the transaction was announced. The post SEC Charges Ipsen Worker for Insider Trading Tied to $247M Epizyme Acquisition appeared first on MedCity News.

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Sanofi, Regeneron to seek approval for Dupixent in bullous pemphigoid after positive phase 3 study

Fierce Pharma

Sanofi and Regeneron’s superstar anti-inflammatory biologic Dupixent is on a roll. | It was a busy day for Sanofi and Regeneron as the Dupixent partners look to expand the reach of Dupixent into several new diseases.

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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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UK doctors sceptical of AI's role in treatment

pharmaphorum

One in two UK doctors would not use GenAI to treat patients, but there was more willingness to use it for diagnostic purposes, survey finds

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Prodrugs and patents: Enhancing therapy adherence and reducing side effects 

Pharmaceutical Technology

As the approval date for Bristol Myers Squibb’s schizophrenia drug KarXT looms, a prodrug approach emerges to potentially address dosing challenges.

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Pharma Pulse 9/11/24: Cutting-Edge Tech is Fast-Tracking the Future of Medicine, It’s the Business Model, Stupid. & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Innovative medicine production site inaugurated in France

European Pharmaceutical Review

Sanofi has inaugurated a new production unit in France which utilises a world-first modular concept. The site, Modulus, located in Neuville-sur-Saône (Rhône-Alpes), is supported by an investment of nearly €500 million and will produce Sanofi’s next vaccines and biologic drugs. Modulus can adapt to manufacture up to four vaccines simultaneously. Notably, reconfiguration of the technological platform (live attenuated viral vaccines, recombinant protein or messenger RNA vaccines, as well as treatme

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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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AI-Powered chest X-Rays detect lung cancer early

PharmaTimes

New evidence highlights AI’s potential in early lung cancer detection

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Pharma’s Environmental Challenge: Tackling Carbon Emissions in the Supply Chain

Pharma IQ

Explore how the pharmaceutical industry is addressing its carbon footprint through sustainable sourcing, supply chain decarbonization, and data-driven strategy.

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Scotland first in UK to approve new myeloma treatment

PharmaTimes

Patients with relapsed multiple myeloma gain access to life-extending therapy

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Tower Cold Chain, CRYOPDP Collaborate on Growing Temperature-Controlled Offerings

Pharmaceutical Commerce

The parties’ want to provide customers with a “one-stop-shop,” with the hopes that their services will be easier to navigate.

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

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3 FDA approval dates to watch in the year’s final push

PharmaVoice

A handful of potential blockbusters are marching toward FDA review.

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Get Ready for HLTH 2024: A Preview Guide

MedCity News

HLTH 2024, scheduled for October 20-23 at the Venetian Expo Center in Las Vegas, will highlight new programming, a physicians roundtable, generative AI, the shifting landscapes of telemedicine, retail health, women’s health, and lots more. The post Get Ready for HLTH 2024: A Preview Guide appeared first on MedCity News.

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Why pharma should redefine ‘women’s health’

PharmaVoice

A broader approach recognizes the challenges disproportionately impacting women and could lead to better outcomes, according to Organon.

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EASD 2024: Are tetra-agonists the future of metabolic diseases treatment?

Pharmaceutical Technology

EASD 2024 participants are looking for the hottest efficacy data to make predictions on the next trend in the metabolic space.

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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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A Tailor-made Approach to Simplify Observational Research

MedCity News

A direct-to-patient model for observational research will ease the participation burden, better incorporate the patient voice, and empower individuals to take control of their health – all while meeting the growing demands for robust evidence in developing new drugs and therapeutics. The post A Tailor-made Approach to Simplify Observational Research appeared first on MedCity News.

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PDA/FDA Joint Regulatory Conference: Product Quality Risk in Aging Facilities

PharmaTech

During a presentation at the PDA/FDA Joint Regulatory Conference, Nicholas Violand of Johnson & Johnson and Paul Palmer of Paul R. Palmer Limited discussed how aging facilities can impact the quality of pharmaceutical products.

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Viridian takes aim at Amgen's Tepezza with veligrotug data

pharmaphorum

Viridian's thyroid eye disease drug veligrotug clears its first phase 3 trial, with data suggesting it could be competitive with Amgen's Tepezza

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From Opioids to Cannabis: The Impact of Cannabis Rescheduling on Pharmacy Revenue Streams

Pharmacy Times

The DEA will have a hearing in December 2024 regarding the potential reclassification of cannabis to Schedule III, which could significantly impact the regulatory environment for pharmacies and their involvement in the cannabis market.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Study backs role of Novo Nordisk obesity drug in children

pharmaphorum

A clinical trial has backed the safety and efficacy of Novo Nordisk's weight-loss drug Saxenda in children as young as six with obesity.

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FDA Grants Orphan Drug Designation to AISA-021 for Systemic Sclerosis

Pharmacy Times

The company also submitted data from the ongoing phase 2 study, demonstrating the improvements of the investigational drug for symptoms of overall disease severity.

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Roivant's new 'vant' emerges to advance Bayer lung drug

pharmaphorum

Roivant reveals its latest company, Pulmovant, which will develop a pulmonary hypertension drug licensed from Bayer in a $294m deal.

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Cutting-Edge Targeted, Cytotoxic, and Immunologic Therapies Form Next Generation of mNSCLC Treatments

Pharmacy Times

Pharmacy Times offers the latest news and insights for the pharmacy professional and solutions that impact the everyday practice of pharmacy.

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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