Thu.Aug 22, 2024

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FDA weighs limiting PD-1 drugs in stomach cancer, calls on experts to discuss Merck, BMS and BeiGene meds

Fierce Pharma

The FDA is once again gathering external experts to scrutinize PD-1 inhibitors as a group. | The FDA will hold an advisory committee meeting on Sept. 26 to consider whether approvals for checkpoint inhibitors in advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma—as well as in esophageal squamous cell carcinoma (ESCC)—should be restricted based on a tumor’s PD-L1 expression.

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Bipartisan Effort Paves Way for Reviving Shuttered Hospitals in Georgia

MedCity News

The law amends the state’s “certificate of need” system, which allows existing hospitals and other health facilities to block would-be competitors’ plans to expand by arguing there’s insufficient need for their services. The post Bipartisan Effort Paves Way for Reviving Shuttered Hospitals in Georgia appeared first on MedCity News.

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With 36% increase, Eli Lilly leads industrywide sales boom in Q2

Fierce Pharma

Once again, fueled by booming sales of their GLP-1 products, Eli Lilly and Novo Nordisk were the top performers in the biopharma industry in the second quarter. | The momentum the biopharma industry showed in the first quarter of 2024 continued into the second quarter as 21 of the industry's top 25 companies achieved year-over-year revenue increases.

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Why Hospital EDs Are Adopting Cytovale’s Sepsis Test 

MedCity News

A third health system has started using Cytovale’s early sepsis detection test. Froedtert & the Medical College of Wisconsin Health Network announced its plans to deploy the diagnostic test this week. The post Why Hospital EDs Are Adopting Cytovale’s Sepsis Test 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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Despite looming BIOSECURE threat, pharma contracting giant WuXi Bio scoops up new projects

Fierce Pharma

Despite some Western drugmakers’ concerns around working with Chinese manufacturers in light of the looming BIOSECURE Act, WuXi Biologics continues to pick up a steady stream of new contracts. | Despite some Western drugmakers’ concerns around working with Chinese manufacturers in light of the looming BIOSECURE Act, WuXi Biologics continues to pick up a steady stream of new contracts, the company said.

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How Health Systems Can Prepare for the Winter Surge with Virtual Care 

MedCity News

For health systems that are already struggling with capacity and access issues, now is the time to consider specific actions to prepare for this season’s coming surge. The post How Health Systems Can Prepare for the Winter Surge with Virtual Care appeared first on MedCity News.

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MedCity Pivot Podcast: How Sentara Health is Applying Regard’s AI Platform

MedCity News

In this episode, we speak to a healthtech executive and a physician to see where AI tools can best be deployed in health systems The post MedCity Pivot Podcast: How Sentara Health is Applying Regard’s AI Platform appeared first on MedCity News.

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Eisai, Biogen's Leqembi nabs UK nod, but reimbursement remains elusive

Fierce Pharma

In a decision contrary to its European counterpart, the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Eisai and Biogen's Alzheimer's disease drug Leqembi—though tha | For Eisai and Biogen's Leqembi, the health regulator in the U.K. has approved the drug for early-stage Alzheimer's disease although only in a patient subgroup, while England's drug cost watchdog figured the drug's “relatively small benefits” doesn't warrant co

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Mindset Care Snags $13M to Simplify Disability Benefit Applications for Those with Serious Mental Illness

MedCity News

Mindset Care’s $13 million raise was led by Science Inc. and included participation from Wellington Management, Tubbs Ventures, Enable Ventures, XYZ and LivEdge Capital. The post Mindset Care Snags $13M to Simplify Disability Benefit Applications for Those with Serious Mental Illness appeared first on MedCity News.

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Breaking the Bottleneck: Streamlining Prior Authorizations and Unlocking Patient Access to Specialty Medications

Fierce Pharma

Breaking the Bottleneck: Streamlining Prior Authorizations and Unlocking Patient Access to Specialty Medications | Breaking the Bottleneck: Streamlining Prior Authorizations and Unlocking Patient Access to Specialty Medications

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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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Side Effects are Limiting GLP-1 Drug Efficacy: How Can Personalization Offer a Solution?

MedCity News

By integrating digitization and machine learning, there is an opportunity to deliver personalized care to all patients and scale precision dosing with minimal physician involvement, maximizing the effectiveness and accessibility of these drugs. The post Side Effects are Limiting GLP-1 Drug Efficacy: How Can Personalization Offer a Solution? appeared first on MedCity News.

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BioMarin revamps leadership with ex-Roche, Amgen execs

pharmaphorum

BioMarin names Amgen's Greg Friberg to lead its R&D and former Roche exec James Sabry as its chief dealmaker amid a strategy change

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In the Fight for Women’s Health Equity, Entrepreneurs Are Crucial

MedCity News

The eBook Femtech Revolution: How Entrepreneurs Are Championing Women’s Health Equity highlights femtech to help track menstruation, how femtech can support access to care, data privacy concerns, and more. The post In the Fight for Women’s Health Equity, Entrepreneurs Are Crucial appeared first on MedCity News.

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An Extra Layer of Transparency and Accountability

Pharmaceutical Commerce

In the final part of his Pharma Commerce video interview, Matt Hawkins, CaryHealth’s Chief Technology Officer, comments on the importance of mitigating security risks, along with ways to take action.

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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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BMS eyes April FDA verdict on Opdivo/Yervoy in liver cancer

pharmaphorum

BMS looks ahead to April verdict from FDA on Opdivo/Yervoy combination as first-line treatment for unresectable hepatocellular carcinoma.

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Fujifilm Opens Billingham Production Facility

Pharmaceutical Commerce

The unveiling of the microbial fermentation manufacturing plant is headlined by a $131 million financial commitment.

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US insomniacs have a new prescription DTx option

pharmaphorum

US insomniacs have a new prescription DTx option Phil.

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New drug trial to investigate treatment for patients with bronchiectasis

PharmaTimes

200,000 people in the UK have what is considered a ‘hidden’ lung condition

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

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Pharma Pulse 8/22/24: OM1 Appoints New President, Navigating Global Regulatory Hurdles & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharma 100
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Secondary packaging for sterile injectables: Overcoming today’s design challenges

Pharmaceutical Technology

Packaging experts discuss emerging challenges in secondary packaging design for injectables that balance sustainability with end-user needs.

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UK first country in Europe to clear Alzheimer's drug Leqembi

pharmaphorum

UK is first European country to approve Eisai and Biogen's Alzheimer's drug Leqembi, after EU advisors say safety concerns outweigh its benefits.

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SynaptixBio awarded £2m BioMedical Catalyst grant from Innovate UK

PharmaTimes

The grant will support clinical trials of rare disease therapy for leukodystrophy

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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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Rare disease drug from LEO's Timber felled by failed study

pharmaphorum

Just a few months after buying Timber Pharma, LEO Pharma has revealed that the main drug it acquired as part of the deal has failed a phase 3 trial.Timber's lead candidate TMB-001 for rare skin disease congenital ichthyosis failed to meet its efficacy objectives across the board in the ASCEND trial and will not support a planned regulatory filing, said LEO in a statement.

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Submitting Regulatory Applications Connects to Quality

PharmaTech

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss submitting biologics license applications and working with suppliers.

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Harnessing the GLP-1R medicine wave

European Pharmaceutical Review

Based on their rising popularity to treat type 2 diabetes and obesity, GlobalData has predicted that sales of glucagon-like peptide-1 receptor (GLP-1R) drugs will increase fourfold to an estimated $142 billion by 2030. 1 Considering the 11 approved GLP-1R drugs “generated $37.2 billion” last year, two key players in the market, namely Novo Nordisk and Eli Lilly and Company, are set to lead the market, the analytics company forecasts: “collectively capturing 94 percent of the total 2030 GLP-1R sa

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FDA Approves, Grants EUA for Updated 2024–2025 mRNA COVID-19 Vaccines

PharmaTech

The approvals and authorizations come amid a late summer surge in the virus that is tracking a bit earlier than the early fall wave in the US in 2023.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Avadel Pharmaceuticals gets grant for gamma-hydroxybutyrate formulations for treating narcolepsy symptoms

Pharmaceutical Technology

Discover Avadel Pharmaceuticals' new patent for GHB formulations, enhancing narcolepsy treatment with a tailored dosage regimen for effective symptom relief.

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Beyond Jet Milling: A Deep Dive into Carrier-Based Formulation and Process Optimization

PharmaTech

Webinar Date/Time: Fri, Sep 13, 2024 10:00 AM EDT

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Antisense Therapeutics gets grant for method for treating muscular dystrophy using oligonucleotides

Pharmaceutical Technology

Discover Antisense Therapeutics' groundbreaking patent for treating muscular dystrophy, enhancing muscle function with a unique oligonucleotide method.

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Study Suggests Promise of Psilocybin in Treating Depressive Symptoms

PharmExec

Findings from a recent study demonstrated that high-dose psilocybin provided a superior reduction in depressive symptoms compared to both placebo and escitalopram in patients with major depressive disorder.

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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