Tue.Mar 26, 2024

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Merck scores key FDA approval for pulmonary arterial hypertension drug Winrevair

Fierce Pharma

After three years, the crown jewel of Merck’s $11.5 billion acqu | After three years, the crown jewel of Merck’s $11.5 billion acquisition of Acceleron is ready to pay dividends. With the FDA’s approval of Winrevair (sotatercept) to treat pulmonary arterial hypertension (PAH), Merck is set to launch the first disease-modifying treatment for the condition.

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Nanoscope preps filing for retinitis pigmentosa gene therapy

pharmaphorum

Nanoscope Therapeutics is on the brink of filing for FDA approval of what could be the first gene therapy for incurable eye disease retinitis pigmentosa (RP) that can be used regardless of underlying genetic mutations.

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Caring Cross, Brazil's Fiocruz team up to produce cell and gene therapies at a fraction of their cost in the US

Fierce Pharma

Maryland non-profit Caring Cross has unveiled a partnership with the Brazilian government that's designed to provide access to advanced cell and gene therapies for diseases like leukemia, lymphoma | Maryland nonprofit Caring Cross has unveiled a partnership with the Brazilian government which is designed to provide access to advanced CAR-T and gene therapies for diseases like leukemia, lymphoma and HIV infection—and in the process provide a manufacturing model that demonstrates how to reduc

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Merck Drug for Heart and Lung Disorder Wins a First-in-Class FDA Approval

MedCity News

Merck drug Winrevair is the first in a new class of pulmonary arterial hypertension therapies that address a key signaling pathway behind the disease. The drug comes from Merck’s $11.5 billion acquisition of Acceleron Pharma.

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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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Amgen, facing potential Enbrel price cap in Colorado, takes state's new drug affordability board to court

Fierce Pharma

Amgen’s arthritis blockbuster Enbrel already owns an undesirable spot on the list o | The state's new Prescription Drug Affordability Review Board voted to subject the blockbuster arthritis med to an upper price limit, which Amgen calls a violation of the company's constitutional rights.

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Next-gen Moderna COVID-19 vaccine shows promise

European Pharmaceutical Review

Moderna’s next-generation COVID-19 vaccine mRNA-1283 demonstrated a higher immune response against SARS-CoV-2, interim results from the company’s Phase III trial show. These findings were based on data comparing the treatment to mRNA-1273.222 (Spikevax ® ), Moderna’s licensed vaccine for the condition. “We are excited to announce our fourth infectious disease vaccine programme with positive Phase III data,” stated Stéphane Bancel, Chief Executive Officer of Moderna. “mRNA

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Are Adults With Diabetes Who Switch to High-Deductible Health Plans at Greater Risk for Complications?

Pharmaceutical Commerce

A study of patients with the long-term conditions who are required to switch to high-deductible health plans could potentially be more likely to experience diabetes complications than those who stay in standard insurance plans.

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Bristol Myers Squibb cuts hundreds of Mirati staffers months after closing $5.8B buyout

Fierce Pharma

Bristol Myers Squibb cuts hundreds of Mirati staffers months after closing $5.

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UNC Health CMIO: Clinicians and AI Must ‘Synergistically Work Together’

MedCity News

AI is meant to have a synergistic relationship with clinicians rather than replace them, pointed out David McSwain, chief medical information officer at UNC Health, during an interview at HIMSS24. In his view, both humans and AI are fallible, but their errors are usually of a different type — so both should be working together to reduce the overall error rate.

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High prices on GLP-1 meds, insulin pens raise barriers to access in lower-income countries: MSF

Fierce Pharma

Demand for GLP-1 medicines from Eli Lilly and Novo Nordisk has exploded across the globe, resulting in on-and-off shortages in the U.S. and beyond. | Médecins Sans Frontières urged GLP-1 drug makers to "relinquish their stranglehold" on the products and license the meds to generics makers to boost access.

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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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Nuvation Bio nears commercial stage with AnHeart buy

pharmaphorum

Nuvation Bio speeds up its path to becoming a commercial-stage biotech with a deal to acquire AnHeart Therapeutics and its late-stage lung cancer therapy taletrectinib

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Health Exec: Food-as-Medicine Will Change How Healthcare Is Delivered With or Without GLP-1s

MedCity News

During a panel discussion on GLP-1s at the Abarca Forward conference, one health executive stressed the importance of a food-as-medicine approach.

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MSD leaps on FDA approval of PAH drug sotatercept

pharmaphorum

MSD’s Winrevair (sotatercept) has become the first FDA-approved therapy for PAH that addresses the underlying mechanism behind the disease rather than its symptoms

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MedCity Pivot: A Conversation About Wearable Robots with Scott Davis

MedCity News

Scott Davis is the CEO of Ekso Bionics, an innovative medical device company making wearable exoskeletons for use in construction but perhaps, more importantly, to help people contending with spinal cord injury.

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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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At second ask, FDA clears AZ’s Ultomiris for NMOSD

pharmaphorum

AstraZeneca’s Ultomiris has been approved by the FDA to treat rare autoimmune disease neuromyelitis optica spectrum disorder (NMOSD), six months after an earlier application was turned down with a request for changes to the risk evaluation and mitigation strategy (REMS) for the drug.

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US FDA grants approval for Alexion’s NMOSD treatment

Pharmaceutical Technology

The US FDA has approved Alexion’s Ultomiris to treat adults with AQP4 Ab+ neuromyelitis optica spectrum disorder (NMOSD).

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Ex-BioMarin CEO Bienaimé re-emerges at Owkin

pharmaphorum

Just four months after ending an 18-year stint as chief executive of BioMarin, Jean-Jacques Bienaimé has been named chairman of Owkin, a specialist in applying artificial intelligence to the discovery and development of drugs and diagnostics. Owkin said Bienaimé will help to grow the company, including taking it through its next fundraising round and expanding its drug discovery, drug development and diagnostics capabilities.

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MedCity FemFwd: Inside the EveryBODY Covered Campaign Aiming To Improve Obesity Care Coverage

MedCity News

In this episode, we’re joined by Millicent Gorham, CEO of the Alliance for Women’s Health and Prevention (AWHP). AWHP recently launched the EveryBODY Covered campaign, which is advocating for comprehensive coverage of obesity care. Gorham discusses the current state of obesity treatment for women and her goals for the campaign.

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

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Astellas secures approval for gastric cancer antibody in Japan

Pharmaceutical Technology

The approval from Japan’s Ministry of Health, Labour, and Welfare (MHLW) is based on positive results from two studies.

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GenAI and Pharmacovigilance: Perfect is the Enemy of Good

MedCity News

Disregarding novel developments on account of imperfection will postpone the advancement of scientific discovery.

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Researchers identify group of biological markers found in high levels in TB patients

PharmaTimes

According to the World Health Organization, TB is responsible for over one million annual deaths

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GlycoMimetics files patent for treating cancer and related conditions with compound of formula (i)

Pharmaceutical Technology

Discover GlycoMimetics Inc.'s groundbreaking patent for treating cancer and related conditions with Formula (I) compound. Learn how this method can reduce chemotherapy side effects and improve patient outcomes.

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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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Inizio Engage and Applied Driving partner to support clinical workers with safety app

PharmaTimes

The Companion+ Mobile Safety App will be rolled out to a further 115 users within the UK and US

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Alnylam turns to genealogy to find rare disease patients through family trees

PharmaVoice

A vastly underdiagnosed rare disease presents a challenge to Alnylam’s commercial team, but a family health road trip has patients talking about their hereditary risk.

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How hospital leaders can enrich price transparency data to demonstrate value

Clarify Health

Historically it has been difficult, if not impossible, for patients to figure out prices for hospital services and procedures ahead of time. However, new regulations from the Centers for Medicare & Medicaid Service in 2021 aim to change that. Under these requirements, hospitals must provide clear prices for the items and services they offer and make them accessible online.

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Do Mixed Results Impact Potential Real-World Effectiveness and Potential Market Adoption?

PharmExec

In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, explore mixed trial results impact the confidence in their potential real-world effectiveness and potential market adoption.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Syros Pharmaceuticals files patent for treating cancer with compound of formula (i)

Pharmaceutical Technology

Discover Syros Pharmaceuticals' groundbreaking patent for treating cancer by targeting CDK7 with compounds of Formula (I). Learn about the innovative method and potential new treatment options for solid tumors.

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SQZ, Portal founder Armon Sharei on starting over in biotech

PharmaVoice

After his first biotech startup was sold off in parts, Sharei is applying the lessons he’s learned to a new company with a different business model.

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Nurix Therapeutics files patent for bifunctional compounds for hpk1 degradation in disease treatment

Pharmaceutical Technology

Discover how Nurix Therapeutics' patent for bifunctional compounds targeting HPK1 activity offers a groundbreaking method for treating diseases, including cancer. Learn more about this innovative approach in pharmaceutical compositions.

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Roche Sells Large-Scale Biologics Manufacturing Site in US to Lonza for $1.2 Billion

PharmaTech

The Vacaville, Calif., site acquisition gives Lonza one of the largest biologics manufacturing sites for mammalian cell-based therapies worldwide.

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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