Wed.Sep 04, 2024

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Biogen to seek approval for high-dose version of SMA stalwart Spinraza after trial win

Fierce Pharma

Over the last decade, three blockbuster drugs—Biogen’s Spinraza, Roche’s Evrysdi and Novartis’ gene therapy Zolgensma—have transformed the treatment landscape for spinal muscular atrophy (SMA). | Biogen revealed that a portion of its phase 2/3 DEVOTE study met its primary endpoint, as a higher dose of Spinraza improved the motor function of treatment-naive infants with spinal muscular atrophy.

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With Direct-to-Patient Zepbound, Eli Lilly Takes a Stand Against Compounders and PBMs

MedCity News

Eli Lilly now offers vials of obesity medication Zepbound directly to self-pay patients at a nearly 50% discount off the drug’s list price. But more than offering patients a lower-cost alternative, this move represents a strategic stance against certain pharmaceutical industry players. The post With Direct-to-Patient Zepbound, Eli Lilly Takes a Stand Against Compounders and PBMs appeared first on MedCity News.

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Astellas Gene Therapies to turn out the lights at South San Francisco production plant

Fierce Pharma

Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies is turning out the lights at a Californ | Several months after its parent company unveiled new labs and office space to unite cell and gene therapy research on the West Coast, Astellas Gene Therapies is turning out the lights at a California production plant.

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MedCity FemFwd: Inside WHAM & KPMG’s Women’s Health Partnership

MedCity News

In this episode, we’re joined by Carolee Lee, CEO and founder of Women’s Health Access Matters (WHAM), and Ash Shehata, KPMG U.S. sector leader for healthcare. The two discuss WHAM and KPMG’s new partnership that aims to advance women’s health research and investment. The post MedCity FemFwd: Inside WHAM & KPMG’s Women’s Health Partnership 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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DEA raises production limits on Takeda's ADHD drug Vyvanse and generics as shortages continue

Fierce Pharma

With a shortage of ADHD drugs persisting, the DEA has raised production limits on Takeda’s Vyvanse and its generic versions by 24%, the agency said.

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How Have Hospitals Fared Financially So Far in 2024?

MedCity News

Health systems’ financial results suggest the start of sustained recovery, but persistent challenges remain, including rising expenses and less-than-ideal reimbursement rates from payers. The post How Have Hospitals Fared Financially So Far in 2024? appeared first on MedCity News.

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Steady Trust: How Tom Frosina Empowers Leaders

ALULA

"There isn't a playbook for every challenge," says Tom Frosina, Operations Leader at TD Bank. Tom knows that leadership isn't about following a script. Instead, effective leaders must be able to adapt, innovate, and empower their teams to succeed.

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Web of Science Research Assistant elevates discovery with responsible AI

Clarivate

The Web of Science Research Assistant, a generative AI-powered tool built with and for researchers, is now available to the global research community. After extensive collaboration and testing with the research community that began in December 2023, we are pleased to announce the global launch of the Web of Science Research Assistant. The research assistant combines the power of generative artificial intelligence (AI), the Web of Science knowledge graph and an all-new chat interface to provide r

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How to optimize efficiencies at site-centric clinical trials

Pharmaceutical Technology

By integrating the best practices from decentralized trials, CROs can optimize efficiencies and streamline site-based operations, ensuring that site-centric trials remain effective and innovative.

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Roche trumpets new fenebrutinib data in relapsing MS

pharmaphorum

Data from a phase 2 trial of Roche's oral BTK inhibitor fenebrutinib have shown "near-complete suppression" of disease activity and disability progression in relapsing multiple sclerosis (MS).The full results of the FENopta open-label extension study are due to be reported in full at the ECTRIMS congress in Copenhagen later this month, but top-line findings include that 99% of patients treated with fenebrutinib were free of T1 gadolinium-enhancing lesions, markers of active inflammation, at 48 w

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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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Digital Biomarkers in Agitation Detection: Enhancing Care for Communication-Impaired Neurological Disorders

MedCity News

Wearable technology seems to offer great potential for early detection and management of agitation experienced by people with communication-impaired neurological disorders, allowing caregivers to provide personalized interventions that could significantly improve patients’ lives. The post Digital Biomarkers in Agitation Detection: Enhancing Care for Communication-Impaired Neurological Disorders appeared first on MedCity News.

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Actimed’s ALS candidate wins FDA orphan drug designation

Pharmaceutical Technology

Actimed says S-oxprenolol shares a similar pharmacology to its lead product S-pindolol, which is being studied in cachexia.

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Recognizing and Mitigating Cybersecurity Risks: Strategies for Healthcare Organizations

MedCity News

Healthcare organizations should work proactively with experts in the relevant domains to recognize and mitigate potential cybersecurity risks. Here’s what to do to mitigate risk. The post Recognizing and Mitigating Cybersecurity Risks: Strategies for Healthcare Organizations appeared first on MedCity News.

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EC approves Merck’s KEYTRUDA-Padcev combo for urothelial cancer

Pharmaceutical Technology

Merck has gained EC approval for KEYTRUDA plus Padcev for adults with unresectable or metastatic urothelial carcinoma.

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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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Lilly to hunt non-coding DNA for obesity drugs in $1bn deal

pharmaphorum

Swiss startup Haya Therapeutics has formed a $1bn partnership with Eli Lilly to look for new therapies for obesity in non-coding DNA

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Acepodia collaborates with Pfizer to advance antibody-cell conjugation therapies

Pharmaceutical Technology

Pfizer Ignite will support Acepodia in developing its pipeline cancer therapeutic candidates.

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Regeneron joins Koneksa Parkinson's digital biomarker study

pharmaphorum

Regeneron signs up for access to a study run by Koneksa exploring the use of digital biomarkers to track patients with Parkinson's.

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Pharma Pulse 9/4/24: How Do You Change a Chatbot’s Mind? Understanding the Current State of M&A & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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

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Pharma’s ‘it’ therapy — a new drug class gaining steam

PharmaVoice

More companies are investing in protein degraders, which leverage a unique approach to harnessing the immune system in cancer, neurological diseases and more.

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AI In Surgery: Balancing Technology And The Human Factor With Dr. Daniel McMahon

Evolve Your Success

Dr. Dan McMahon, a general surgeon with a remarkable blend of military service and expertise in surgical technology, joins us to unravel the future of medical sales. COVID-19 has driven a significant transformation in the industry, pushing digital interactions to the forefront. Dr. McMahon provides an in-depth look at how platforms like LinkedIn and podcasts are not just trendy but essential tools for medical sales reps and physicians striving to stay ahead.

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Steriline to Show New Robotic Vial Filling and Capping Machine at CPHI Milan 2024

PharmaTech

Among the design features of the machine is software-based tracking that is meant to ensure that products that are temperature-sensitive do not exceed their time limit in the solution.

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New WHO guidance to support manufacturers to reduce AMR risk

European Pharmaceutical Review

The World Health Organization (WHO) has published its first guidance on antibiotic pollution from manufacturing, to help the industry mitigate the global risk of antimicrobial resistance (AMR). It discusses the management of wastewater and solid waste for the manufacture of antibiotics. “Pharmaceutical waste from antibiotic manufacturing can facilitate the emergence of new drug-resistant bacteria… Controlling pollution from antibiotic production contributes to keeping these life-saving m

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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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High Dose Spinraza Significantly Improves Motor Function in Infants with Spinal Muscular Atrophy

PharmExec

Data from the Phase II/III DEVOTE study demonstrated that Spinraza showed significant motor function improvements at six months in infants with spinal muscular atrophy.

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A quick guide to transferring a commercial drug product to a new fill-finish CDMO  

Pharmaceutical Technology

Between 2012 and 2021, outsourcing propensity for FDA NDA injectables approvals averaged 40%, according to GlobalData’s Contract Injectable Packaging Trends…

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Kerendia Reduces Cardiovascular Deaths in Patients with Cardio-Kidney-Metabolic Conditions

PharmExec

Results from the FINE-HEART pooled analysis of three Phase III clinical trials highlighted the potential of finerenone in treating high-risk cardiovascular patients.

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FDA grants fast track status to Innovent’s IBI363 for melanoma

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted fast track designation to Innovent Biologics' IBI363 for treating melanoma.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Novartis' oral PNH drug Fabhalta rolls out in England, Wales

pharmaphorum

Novartis' Fabhalta is first oral monotherapy for paroxysmal nocturnal haemoglobinuria cleared by NICE for NHS use.

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Combating Pharmaceutical Crime with On-Dose Authentication

Pharmaceutical Technology

Despite the best efforts of pharmaceutical manufacturers and regulators to improve the security and traceability of drug products, counterfeits continue…

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A plucky biotech threatening Pfizer’s grip on the Prevnar vaccine market

PharmaVoice

Results from Vaxcyte’s clinical pneumococcal vaccine study showed the smaller company could take on Pfizer’s legendary blockbuster.

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Moderna Launches New Campaign to Promote COVID Boosters

PharmExec

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

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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