Mon.Nov 11, 2024

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Autolus readies its CAR-T Aucatzyl to go after heavy hitter competition following FDA nod

Fierce Pharma

Watch out, Gilead and Novartis: there's a new CAR-T in town. | Autolus' Aucatzyl has become the first CAR-T approved by the FDA without a REMS mandate. And the company is ready to hit the ground running, facing Gilead and Novartis as its competitors.

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AI tool spots long COVID in electronic health records

pharmaphorum

Mass General Brigham researchers have developed an AI that can spot hidden cases of long COVID from electronic health records

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Assertio fires back at activist investor's 'baseless allegations' over Rolvedon

Fierce Pharma

Four months after calling for the resignation of four board members from Assertio Holdings, New York investment advisory firm Buxton Helmsley Group has flipped its long equity position into a short | Answering allegations from activist investor Buxton Helmsley that it misled investors about its acquisition of Spectrum Pharmaceuticals and its cancer drug Rolvedon, Assertio called the claims "baseless.

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Spravato is just the beginning in a new wave of depression meds

PharmaVoice

Psychiatry is getting more targeted as drugmakers develop a new range of treatments for depression.

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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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How One Massachusetts Maternal Mental Health Program Scaled Across the Country

MedCity News

During a recent panel, experts discussed the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms and how it achieved scale. The post How One Massachusetts Maternal Mental Health Program Scaled Across the Country appeared first on MedCity News.

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Autolus secures FDA approval for CAR-T cell therapy use in ALL  

Pharmaceutical Technology

Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy (REMS) programme.

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Advantage BMS as AbbVie drug fails schizophrenia trials

pharmaphorum

AbbVie's $8.7bn play for Cerevel looks like a poor bet as its lead schizophrenia drug flunks two phase 2 trials, but which rival stands to benefit?

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Pharmaceutical Technology Excellence Awards 2024: BostonGene 

Pharmaceutical Technology

BostonGene is a winner in four categories in the 2024 Pharmaceutical Technology Excellence Awards.

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Autolus bags FDA approval for leukaemia cell therapy

pharmaphorum

Autolus gets its first product approval, an FDA green light for anti-CD19 CAR-T Aucatzyl for B-cell acute lymphoblastic leukaemia

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AbbVie Drug Expected to Rival Bristol Myers’s New Schizophrenia Med Flunks Phase 2 Test

MedCity News

AbbVie schizophrenia drug candidate emraclidine failed to beat a placebo in two Phase 2 clinical trials. The drug, once projected to compete with Bristol Myers Squibb’s Cobenfy, is from AbbVie’s $8.7 billion acquisition of Cerevel Therapeutics. The post AbbVie Drug Expected to Rival Bristol Myers’s New Schizophrenia Med Flunks Phase 2 Test appeared first on MedCity News.

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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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Scottish medicines consortium approves CAR T-cell therapy for blood cancer

PharmaTimes

First car t-cell therapy accepted for second-line treatment in Scotland

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Unicycive eyes June FDA verdict for hyperphosphataemia drug

pharmaphorum

FDA starts review of Unicycive's drug for hyperphosphataemia in patients with chronic kidney disease on dialysis, aiming to improve on onerous phosphate binder therapy

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MD Anderson Launches Cell Therapy Institute

PharmaTech

The new Institute for Cell Therapy Discovery and Innovation will utilize expertise to develop cell therapies for cancer, autoimmune diseases, and infections.

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SMC recommends Yselty for treating uterine fibroids

PharmaTimes

New treatment option approved for women in Scotland

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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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An Integrated Approach to Optimizing Specialty Pharmacy and Accelerating Performance

MedCity News

Top challenges impacting specialty pharmacy outcomes, and how health systems may achieve efficiencies and enhance performance for optimal outcomes. The post An Integrated Approach to Optimizing Specialty Pharmacy and Accelerating Performance appeared first on MedCity News.

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Moderna’s mRESVIA vaccine gains Health Canada approval

Pharmaceutical Technology

Moderna has received Health Canada's approval for its respiratory syncytial virus messenger ribonucleic acid (mRNA) vaccine mRESVIA, designed to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals aged 60 and over.

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Major immunotherapy trial sees survival benefit in solid tumours

European Pharmaceutical Review

The biggest T cell therapy clinical trial for solid tumours has been completed. It represents a significant milestone, according to Professor Cliona Rooney, Baylor College of Medicine, US. “The delivery of high-quality T cells at large scale has been a major barrier for extending the applications of these therapies. To have achieved this goal when T cell therapy was in its infancy makes this Singapore-led achievement even more commendable”.

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LogiPharma Europe to Celebrate 25 Years

Pharmaceutical Commerce

The conference returns to Lyon, France and promises a timely and relevant agenda that attendees will resonate with.

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

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FDA Approves Obecabtagene Autoleucel for Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Pharmacy Times

The regulatory approval corresponds with positive safety and efficacy data from the FELIX trial.

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Pharma Pulse 11/11/24: Advertising/Marketing Trends to Expect in Q1 of 2025, Understanding the Burnout Crisis & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Semaglutide Improves Liver Fibrosis in Patients with Metabolic Dysfunction-Associated Steatohepatitis

Pharmacy Times

Glucagon-like peptide-1 agonists have increasingly showed potential for treating liver fibrosis in patients, which disproportionately affects those who are overweight or have obesity.

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Transforming Oral Drug Products for Late-Phase and Commercial Excellence

PharmaTech

Webinar Date/Time: Tue, Dec 3, 2024 11:00 AM EST

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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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Lumateperone Demonstrates Positive Efficacy for Schizophrenia Relapse Prevention

Pharmacy Times

In the trial, lumateperone had a significantly longer time to relapse in patients treated compared to placebo.

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Picodroplets for Biologics Discovery and Scale-up: A Novel Automation Approach

PharmaTech

Webinar Date/Time: Wed, Dec 4, 2024 11:00 AM EST

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Building Supply Chain Visibility

Pharmaceutical Commerce

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jonathan Colehower, managing director, global operations & supply chain practice at UST, offers his observations as to how stakeholders are building out their networks.

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FDA Lifts Clinical Hold on Novavax’s Trials for COVID-19-Influenza Combination, Standalone Influenza Vaccines

PharmExec

The FDA’s clinical hold for the COVID and influenza vaccine trials was a result of a report of a serious adverse event involving motor neuropathy in a participant from a prior Phase II trial.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Did You Buy a Version of Someone Else’s LD Program?

ALULA

It was only my first day at work, but I could already tell that my boss wasn’t happy to see me. I had been hired by an organization to help improve their leadership development (LD) programs. On my first day, I was asked to meet with a senior executive who would oversee my work.

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AbbVie’s Emraclidine Fails to Reduce Schizophrenia Symptoms Compared to Placebo

PharmExec

Results from the Phase II EMPOWER trial found that emraclidine failed to meet its primary endpoint of reducing Positive and Negative Syndrome Scale scores after six weeks of treatment for schizophrenia.

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AlloVir and Kalaris enter merger to advance retinal disease therapies

Pharmaceutical Technology

AlloVir has entered into a definitive agreement for the acquisition of the complete outstanding shares of Kalaris Therapeutics, to create a new entity focused on developing therapies for retinal diseases.

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Pharma Pulse 11/11/24: The Importance of Improving DE&I in Clinical Trials, Financial Toxicity About More Than Just Affording Treatment & more

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