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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A Sneak Peek of INVEST 2025 Agenda

MedCity News

Among the topics INVEST will highlight are AI in life sciences, the investor perspective in healthcare and strategic priorities for hospitals. The post A Sneak Peek of INVEST 2025 Agenda appeared first on MedCity News.

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With US launch progressing, ARS inks another licensing deal for epinephrine spray Neffy worth up to $465M

Fierce Pharma

Although ARS Pharmaceuticals’ approval for its epinephrine nasal spray came later than expected, the company ultimately received a thumbs up from the FDA in August and is now moving fast to expand | ARS Pharmaceuticals said that Denmark’s ALK-Abelló is paying $145 million upfront for the rights to market Neffy in Europe, Canada and “other geographies outside of the U.S.

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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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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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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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How 4 Health Systems Are Partnering with Microsoft

MedCity News

Here’s how four different health systems are partnering with Microsoft to save time for clinicians. The post How 4 Health Systems Are Partnering with Microsoft appeared first on MedCity News.

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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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DTC Marketing for Medical Device and Other Healthcare Organizations

Healthcare Success

Could direct-to-consumer (DTC) healthcare marketing be the key to building deeper patient connections and driving growth in your organization? Find out in our latest podcast featuring Breanna Hunt, Founder Partner at HealthReach, LLC, a consulting firm specializing in healthcare patient activation strategies for medical devices. Together, we explore how medical device and other healthcare organizations can leverage DTC healthcare marketing to connect with patients, overcome challenges, and harne

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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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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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Closing Staffing Gaps in Healthcare by Utilizing Diverse Pipelines of Contingent Talent

MedCity News

By adopting a contingent workforce model and investing in the right data tools to power better informed decision-making and talent strategy, healthcare organizations can begin to address staffing challenges and turn their talent goals into reality. The post Closing Staffing Gaps in Healthcare by Utilizing Diverse Pipelines of Contingent Talent 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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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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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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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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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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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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Why Are Original Brands So Popular in Private Hospitals? Here’s What I’ve Seen.

Contrarian Sales Techniques

You know, I’ve always found it interesting that, even with so many affordable generics on the market, private hospitals here in Malaysia tend to stick with the original brands. It’s one of those things I noticed early on, and it got me wondering – why are original brands so preferred? Turns out, it’s a bit of a mix of trust, reputation, and just plain habit.

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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

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What is the Difference Between MedTech and TechMed?  

Legacy MEDSearch

I love working in the medical industry, watching its evolution and emerging trends. Just as job titles have grown over the years to include Innovation Officers, VP People and Culture, Head of Digital Strategy and more there are terms coming into common parlance. Since we work with early-stage companies, I thought I would share a term we are seeing more and more.

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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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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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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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BTC’s All-Time High on LUNO Malaysia: Time to Dive In or Sit Tight?

Contrarian Sales Techniques

Alright, Malaysia—today’s BTC news on our LUNO platform is pretty exciting: Bitcoin has just hit an all-time high of RM350,000 on LUNO Malaysia. It’s hard not to feel the thrill, right? Such news can make you feel like you’re on the edge of something big. And let’s face it, with crypto, it’s always a bit of a rollercoaster ride. One day you’re on top, and the next, you’re wondering what has just happened.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Dizal seeks FDA approval for NSCLC treatment sunvozertinib

Pharmaceutical Technology

Dizal has submitted sunvozertinib’s new drug application (NDA) to the US Food and Drug Administration (FDA) aiming to secure approval for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (exon20ins) mutations.

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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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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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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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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud