Mon.Aug 19, 2024

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FDA balks at standard approval of Liquidia's PAH rival to United's Tyvaso after lengthy court saga

Fierce Pharma

Liquidia and its dry powder Yutrepia is back in FDA limbo after the agency opted for a tentative approval as opposed to a standard nod. | The agency granted a broad regulatory exclusivity to rival United Therapeutics and its Tyvasvo DPI, leaving Liquidia's Yutrepia, which uses the same active drug, in FDA limbo until 2025.

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FDA Clears Gel That Can Stop Bleeding In Seconds

MedCity News

Cresilon snagged its second FDA clearance for human use. The FDA granted 510(k) clearance to Traumagel, the startup’s gel that can stop bleeding in just seconds, for temporary external use to control moderate to severe bleeding. The post FDA Clears Gel That Can Stop Bleeding In Seconds appeared first on MedCity News.

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Genmab shuffles C-Suite on commercialization, manufacturing as portfolio grows

Fierce Pharma

Genmab is revamping its executive team as the Danish antibody specialist expands its commercialization efforts and looks to evolve into “a fully integrated biotech innovation powerhouse.” | Genmab is revamping its executive team as the Danish antibody specialist expands its commercialization efforts and looks to evolve into “a fully integrated biotech innovation powerhouse.

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Digital Therapeutics Sector See Billing Codes as Key to Breaking Free of Reimbursement Rut

MedCity News

Medicare’s physician fee schedule includes billing codes for digital therapeutics for the first time. Stakeholders say these codes could help turn around reimbursement challenges weighing on the entire digital medicines sector. The post Digital Therapeutics Sector See Billing Codes as Key to Breaking Free of Reimbursement Rut 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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Were industry watchers too optimistic after IRA's price cut reveal? Analysts weigh in

Fierce Pharma

Industry watchers largely breathed a sigh of relief last week after the Medicare price cuts for certain costly drugs under the Inflation Reduction Act initially appeared better than expected. | The magnitude of price cuts under the Inflation Reduction Act initially appeared better than expected. However, that rosy view may have missed an important point, one analyst team contends.

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Three Ways Drug Pricing Should Work in a Functioning Market, But Isn’t

MedCity News

We can’t wait for others to find a solution to high drug prices. It’s clear what should happen in a functioning drug pricing market federally and in California, but it is not happening today. The post Three Ways Drug Pricing Should Work in a Functioning Market, But Isn’t appeared first on MedCity News.

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US govt taps Walgreens for decentralised trials

pharmaphorum

Walgreens has signed a $100m contract with the US government's BARDA agency for access to its decentralised clinical trials network

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After SPAC deal fell flat, Visiox acquired by fellow eye-focused biotech

Fierce Pharma

Eight months after Visiox Pharmaceuticals was all set to go public via a special purpose acquisition company (SPAC) deal, the company has been

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Report: MA Insurers Denied 3.4M Prior Authorization Requests in 2022

MedCity News

About 7.4% of prior authorization requests submitted to MA insurers were denied in 2022, according to a recent KFF report. Of these denials, only 9.9% were appealed. The post Report: MA Insurers Denied 3.4M Prior Authorization Requests in 2022 appeared first on MedCity News.

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Eli Lilly acquires Morphic in IBD portfolio expansion

Pharmaceutical Technology

Eli Lilly has concluded the acquisition of Morphic Holding at $57 per share, bolstering its inflammatory bowel disease portfolio.

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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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At Frankfurt: Programming Related to Artificial Intelligence

Copyright Clearance Center

The constantly evolving presence and role of AI in many parts of publishing will be a focus of several programming events at Frankfurt…

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South African president calls on WHO for better mpox response

Pharmaceutical Technology

Cyril Ramaphosa, the president of South Africa, has asked the WHO to ensure African countries have equitable access to mpox vaccines.

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SMS Marketing in Healthcare: Revolutionizing Patient Engagement and Outcomes

Healthcare Success

As healthcare leaders, you are under immense pressure to deliver exceptional care amid rising costs and operational complexities. That’s why so many businesses leverage the power of SMS marketing. Text messaging is a fast and easy way to reduce missed appointments and medication non-compliance. Plus, 20% of patients prefer receiving health information via text message, according to the HIPAA Journal.

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Sound Pharmaceuticals plans to stick with WuXi amid BIOSECURE Act rumblings

Pharmaceutical Technology

Looking to potentially market their flagship drug SPI-1005, Sound CEO Jonathan Kil is keen to retain WuXi AppTec as a partner.

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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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EU starts review of Enhertu in HER2-ultra-low breast cancer

pharmaphorum

The EMA has started a review of AstraZeneca and Daiichi Sankyo's antibody-drug conjugate (ADC) that could see the drug being used in advanced breast cancer with even lower levels of the HER2 biomarker.

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BMS’ KarXT nears schizophrenia approval, but AbbVie and others wait in the wings

PharmaVoice

With fewer side effects, the new wave of upcoming drugs could improve patient adherence, and the competition for a large projected market is getting fierce.

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Nature publishes new research on genetic causes of colorectal cancer

PharmaTimes

In the UK study, researchers analysed 2,023 bowel cancers from the 100,000 Genomes Project

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Pfizer and BioNTech's COVID/flu vaccine hits a hurdle

pharmaphorum

Pfizer and BioNTech have a phase 3 mishap with their combined COVID-19 and influenza vaccine, handing Moderna an advantage

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

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Oncimmune announces new contract with global pharma company

PharmaTimes

The contract concerns profiling Immunoglobulin E autoantibodies in blood serum

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Leveraging AI for the Benefit of Patients

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Matt Hawkins, CaryHealth’s Chief Technology Officer, describes how artificial intelligence can not only diagnose patients, but also deliver accurate medical advice.

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FDA Approves AstraZeneca’s Imfinzi in Combination with Chemotherapy for Resectable Early-Stage Non-Small Cell Lung Cancer

PharmExec

The combination treatment involves administering Imfinzi with neoadjuvant chemotherapy for non-small cell lung cancer before surgery and as monotherapy post-surgery.

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DeepCure links with Leeds Institute to bring AI-based RA drug to clinic  

Pharmaceutical Technology

The partners will conduct a study using blood samples and joint biopsies from various patient subgroups, focusing on those resistant to current treatments.

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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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FDA Approves Incyte and Syndax Pharmaceuticals’ Niktimvo for Treating Chronic Graft-Versus-Host Disease

PharmExec

Approval of Niktimvo was based on positive data from the AGAVE-201 study, which demonstrated a 75% response rate in patients with chronic graft-versus-host disease.

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FDA Approves Pediatric Indication for Non-Surgical Severe Thermal Burn Treatment

PharmaTech

NexoBrid, a topically administered biological product, is now authorized for use in all age groups in the United States, European Union, and Japan.

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Novo plans new plant as it races to meet drug demand

PharmaVoice

The new factory, which Novo is committing some $220 million to build, will supply raw materials for the company’s chronic disease medicines.

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Sharing Failure to Find Success: Q&A with Katsuyoshi Sugita

PharmExec

Astellas Pharma’s chief people officer and chief ethics & compliance officer discusses the unique ways he’s brought DE&I to the workplace.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Novo Financially Commits $220 Million Toward New Plant in Denmark

Pharmaceutical Commerce

The 86,000 square-foot Køge facility will be fully functional by 2027.

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Phanes acquires second FDA orphan designation for bispecific antibody

Pharmaceutical Technology

PT217 has received orphan drug designations from the FDA for the treatment of neuroendocrine carcinoma in addition to small cell lung cancer.

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FDA Grants Marketing Authorization to NOWDiagnostic’s At-Home Syphilis Test

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Daiichi Sankyo-AstraZeneca’s ENHERTU gains BTD for breast cancer

Pharmaceutical Technology

Daiichi Sankyo and AstraZeneca's ENHERTU has received FDA BTD status for the treatment of specific types of metastatic breast cancer.

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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