Tue.Jul 02, 2024

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Game on: Lilly's Alzheimer's drug Kisunla, a challenger to Biogen and Eisai's Leqembi, gains full FDA nod

Fierce Pharma

After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Bioge | After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.

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Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi

MedCity News

Eli Lilly’s Kisunla is now FDA approved for treating patients in the early stages of Alzheimer’s disease. In addition to slowing cognitive decline and disease progression, clinical trial results showed that amyloid beta plaques were reduced to the point where some patients could stop taking the infused therapy. The post Eli Lilly Alzheimer’s Drug Lands FDA Approval, Introducing Competition to Eisai’s Leqembi appeared first on MedCity News.

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Emergent BioSolutions bags $250M in contract modifications to help boost US supply of medical countermeasures

Fierce Pharma

With four contract modifications totaling more than $250 million, the government is leveling up its agreements with long-time medical countermeasures supplier Emergent BioSolutions. | The drugmaker will supply its anthrax vaccine Cyfendus, its smallpox vaccine and two other drugs to help bolster the U.S. government's medical countermeasures stockpile.

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Why Are Primary Care Physicians Optimistic About AI?

MedCity News

Primary care physicians are generally pretty optimistic about AI’s potential to make care delivery more efficient, according to new survey results. In the past few years, automated dictation and scribing tools were the AI technologies that have been most impactful for primary care providers. The post Why Are Primary Care Physicians Optimistic About AI?

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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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BIOSECURE Act hurts US biopharma industry's confidence in Chinese partners: survey

Fierce Pharma

Even as the BIOSECURE Act charts an uncertain path through the legislative process, the draft bill has already seriously harmed the U.S. | Even as the BIOSECURE Act works its way through the legislative process, the draft bill has already caused a slide in U.S. life sciences companies' confidence in Chinese partners, a new survey has found.

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Sobi starts rolling FDA filing for chronic gout drug

pharmaphorum

Sobi starts rolling application for refractory gout drug SEL-212 in the US, hoping to take on Amgen’s Krystexxa in the market.

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Moderna Gets $176M From BARDA for Key Test of Bird Flu Vaccine

MedCity News

BARDA is contributing funding for a Phase 3 clinical test of a Moderna messenger RNA vaccine that could protect against the strains of bird flu virus now spreading in U.S. dairy cows. The Moderna vaccine is currently in Phase 1/2 testing. The post Moderna Gets $176M From BARDA for Key Test of Bird Flu Vaccine appeared first on MedCity News.

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J&J, Legend's Carvykti shows CAR-T can extend lives in multiple myeloma

Fierce Pharma

In a major win for Johnson & Johnson and Legend Biotech, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma. | In a major win for J&J and Legend, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma.

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EMA fast-tracks review of AstraZeneca’s sipavibart to stop Covid

Pharmaceutical Technology

The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.

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US FTC ramps up patent crusade with investigation into Teva's inhaler IP: report

Fierce Pharma

While certain other drugmakers have relented in the face of the U.S. | The FTC has launched an investigation into Teva over the Israeli-American drug giant's refusal to remove roughly two dozen patents for its asthma and chronic obstructive pulmonary disease inhalers, The Washington Post first reported, citing confidential agency documents.

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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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Transforming Hospital Discharge Processes Drives Better Patient Outcomes

MedCity News

A multifaceted solution that involves three complementary and overarching strategies The post Transforming Hospital Discharge Processes Drives Better Patient Outcomes appeared first on MedCity News.

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China-made injectable PD-L1 drug flunks pivotal trial, forcing US partner to seek strategic options

Fierce Pharma

The world’s first injectable immune checkpoint inhibitor likely won’t make it to the U.S. | The world’s first injectable immune checkpoint inhibitor likely won’t make it to the U.S. anytime soon, after the China-approved drug flunked a pivotal trial in a rare cancer, forcing its stateside developer Tracon to explore strategic alternatives.

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The power and potential of regenerative medicine

pharmaphorum

The field of muscle stem cell research has been tangibly developing over the decades and in today’s pharmaphorum podcast wed editor Nicole Raleigh speaks with Dr Michael Rudnicki, co-founder and CSO of Satellos Biosciences, a company dedicated to developing novel therapeutics based on this science for those who live with Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases.

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High-flying Samsung Biologics inks $1B production pact with unnamed US pharma

Fierce Pharma

As Korean CDMO giant Samsung Biologics continues to ink production pacts around the globe, the company has added another billion-dollar feather to its cap. | As Korean CDMO giant Samsung Biologics continues to ink production pacts around the globe, the company has added another billion-dollar feather to its cap.

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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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Apellis will appeal CHMP’s rejection of pegcetacoplan

pharmaphorum

Apellis Pharma has said it will seek a re-evaluation of its marketing application for Syfovre for eye disease geographic atrophy (GA) after the EMA’s human medicines committee turned it down for a second time.The CHMP said at its late June meeting that it was issuing a negative opinion for Syfovre (pegcetacoplan) for the treatment of GA secondary to age-related macular degeneration (AMD), a progressive disease leading to sight loss.

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Viatris unit Mylan, former President Rajiv Malik cleared in DOJ price-fixing probe

Fierce Pharma

It's been nearly seven years since former Mylan President Rajiv Malik was first implicated in an industrywide generic drug price-fixing investigation. | Mylan and its former president Rajiv Malik are no longer considered to be "subjects of interest" in a federal generic industry antitrust probe, Viatris said in a release. Mylan has since merged with another company to form Viatris.

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Eisai and Bristol Myers Squibb terminate ADC development deal

Pharmaceutical Technology

Eisai has announced the termination of a deal with Bristol Myers Squibb to jointly develop and commercialise farletuzumab ecteribulin (FZEC).

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Takeda to cut another 220 jobs in Massachusetts, while Merck KGaA plots its own layoffs

Fierce Pharma

Just two months after telegraphing plans to lay off 641 staffers at two of its Massachusetts sites, Takeda is parting ways with another group of its workforce with more layoffs in the state. | Takeda will cut 220 staffers across two of its Massachusetts sites, while Merck KGaA's EMD Serono plans to lay off an unspecified number of employees as it moves its headquarters to the Boston area.

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

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FTC launches probe of Teva over ‘improper’ patents; report

pharmaphorum

The FTC is reported to have opened an investigation into Teva focusing on improperly listed patents in the FDA’s Orange Book

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Beating Healthcare Growth Challenges Depends on a New Nurse Staffing Approach

MedCity News

Health systems need to leverage new approaches to healthcare staffing to make sure patients receive the care they need, when and where they need it. The post Beating Healthcare Growth Challenges Depends on a New Nurse Staffing Approach appeared first on MedCity News.

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Researchers find whole genome sequencing improves care for paediatric cancer

PharmaTimes

Affecting around 3,755 young people in the UK every year, leukaemia is the most commonly diagnosed cancer in children

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Eli Lilly’s donanemab wins FDA approval for Alzheimer’s disease

Pharmaceutical Technology

Leqembi will now face a challenger as donanemab enters the market under the brand name Kisunla.

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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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Digital simulations could advance nanoparticle drug delivery

European Pharmaceutical Review

Researchers have developed a technique to optimise drug delivery using nanoparticles. They applied computer simulations based on blood flow dynamics, to investigate the effects of blood flow on the adhesion and retention of nanoparticle drug carriers. Studies investigating drug delivery via the bloodstream to diseased tissues “have been effective” when “using mouse models and in vitro tissue models”, yet these have used nanoparticles designed “mostly by trial and error”, the researchers emphasis

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Sales Pitch Improvement Strategies

Quantified

Introduction Delivering an effective sales pitch is both an art and a science. A well-crafted sales pitch has the power to captivate potential clients, address their pain points, and drive conversions. This blog explores the key elements of a successful sales pitch and offers practical tips for improvement, leveraging both traditional techniques and modern technologies, such as those from Quantified.

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Post-Warning Letter Interaction with FDA

PharmaTech

Communication and meetings with FDA after receiving a warning letter demonstrates a serious response, says Siegfried Schmitt, vice president, Technical at Parexel.

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Female cancer survivors at low risk of developing obstetric complications

PharmaTimes

According to WHO, around 15% of pregnant women will develop an obstetric complication

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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The pathway to preventative health: How pharma can support the NHS Long Term Plan

Pharmaceutical Technology

Utilising innovative digital tools and access to real-time data, the pharmaceutical industry could offer invaluable support to the NHS’s preventative care mission.

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Carvykti Demonstrates Clinically Meaningful Improvement in Patients with Relapsed or Lenalidomide-Refractory Multiple Myeloma After One Line of Prior Therapy

PharmExec

Results of the Phase III CARTITUDE-4 study showed that treatment with Carvykti achieved a more significant improvement in overall survival (OS) compared to standard therapies.

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EAN 2024: anti-CGRPs more effective than onabotulinumtoxinA in chronic migraine prevention in real world

Pharmaceutical Technology

On 30 June 2024, at the tenth Congress of the European Academy of Neurology (EAN) 2024, during an e-presentation session on the topic of 'Headaches', Danilo Antonio Montisano, MD, presented real-world evidence findings from a retrospective, observational multicentre cohort study (RAMO) comparing the effectiveness of monoclonal antibodies against calcitonin gene-related proteins (anti-CGRP mAbs) to onabotulinumtoxinA (BoNT-A) for chronic migraine prevention.

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FDA Grants Fast Track Designation to Inozyme Pharma’s INZ-701, a Treatment for Patients with ABCC6 Deficiency

PharmExec

The Fast Track designation for INZ-701 was based nonclinical pharmacology data and preliminary safety and efficacy data from the ongoing Phase I/II trial of INZ-701 in adults with ABCC6 Deficiency.

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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