Mon.Sep 23, 2024

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UCB rapidly bolsters blockbuster potential for Bimzelx with 3 new FDA approvals

Fierce Pharma

Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease trea | Along with psoriasis, the biologic is now FDA approved to treat psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

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Real-World Data Salvage Biohaven Drug, Paving Way for FDA Filing in Neuro Disease With No Approved Meds

MedCity News

Biohaven’s troriluzole, which initially failed a pivotal study in spinocerebellar ataxia, is now being readied for an FDA submission in this rare neurodegenerative disease. The turnabout is based on positive results from a new study that incorporated real-world evidence. The post Real-World Data Salvage Biohaven Drug, Paving Way for FDA Filing in Neuro Disease With No Approved Meds appeared first on MedCity News.

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J&J hopes 3rd time's the charm for Texas two-step strategy as it lifts talc settlement offer to $8B

Fierce Pharma

Despite being thrown off its rhythm twice already, Johnson & Johnson is making another go of its “Texas two-step” strategy to wash its hands of tens of thousands of lawsuits claiming the compan | Johnson & Johnson is making another go of its “Texas two-step” strategy to wash its hands of tens of thousands of lawsuits claiming the company’s talc products caused users to develop cancer.

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Tackling Global Obesity: The New, Holistic Frontier for Clinical Trials

MedCity News

To conduct meaningful research, we must be sure to view these studies through patients’ eyes. The patient perspective — in all its diversity — must be embedded into clinical trials from the very start. The post Tackling Global Obesity: The New, Holistic Frontier for Clinical Trials 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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Appeals Court resurrects PhRMA's lawsuit challenging pricing provisions in IRA

Fierce Pharma

For trade group the Pharmaceutical Research and Manufacturers of America (PhRMA), the fight against pricing provisions in the Inflation Reduction Act isn’t over yet. | Late last week, the U.S. Court of Appeals for the Fifth Circuit reversed a previous dismissal of PhRMA’s Inflation Reduction Act (IRA) lawsuit from February, punting the complaint back to a lower Texas court.

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Navigating Economic Uncertainty in Biopharma

MedCity News

The biopharmaceutical industry clearly isn’t going anywhere, but we’ve been in a downward business cycle. We’ve learned a lot from the pandemic and have adopted novel approaches to development and this current economic challenge will also inform us. In the meantime, adopting these strategies can de-risk your development programs. The post Navigating Economic Uncertainty in Biopharma appeared first on MedCity News.

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3 Things To Keep In Mind About Tech Innovation In the Cardiac Space

MedCity News

Many new tech solutions, such as wearables and algorithms, have emerged in recent years to address the country’s heart disease problem. While it’s easy to get excited about technology’s potential to improve cardiac care, there are a few things that healthcare leaders must keep in mind, according to Dr. Sumeet Chugh, director of the Heart Institute and director of AI in medicine at Cedars-Sinai.

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Warren, others urge government to allow generics to Novo's blockbuster GLP-1s ahead of CEO hearing

Fierce Pharma

Ahead of a Senate hearing centered on high prices for Novo Nordisk’s in-demand semaglutide medications, lawmakers are pressing the government to use its “march-in” rights and allow generic versions | In a letter to HHS secretary Xavier Becerra, several lawmakers urged the government to allow generic licenses for Novo's GLP-1 medicines Ozempic and Wegovy.

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FDA clears first drug for Niemann-Pick disease

pharmaphorum

Zevra Therapeutics' Miplyffa is first drug approved by the FDA for ultra-rare disease Niemann-Pick type C.

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How North Carolina Made Its Hospitals Do Something About Medical Debt

MedCity News

In exchange for federal money, hospitals would wipe out billions of dollars of patient debt and adopt new standards to shield patients from crippling bills. The post How North Carolina Made Its Hospitals Do Something About Medical Debt 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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FDA clears RHYTHM AI's new algorithm for atrial fibrillation

pharmaphorum

RHYTHM AI has FDA approval for a new version of its algorithm for mapping areas of the heart that are affected by atrial fibrillation

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FDA approves AstraZeneca FluMist ‘flu vaccine for self-administration

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's FluMist, a needle-free nasal spray influenza vaccine for self-administration.

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How to Make Your Sales Enablement Strategy Actually Work

Integrity Solutions

Sales enablement has become an integral component of the modern sales organization, yet there is still confusion around what sales enablement actually is and, crucially, how to really make it deliver results for your salespeople and your business. As sales leaders grapple with continual volatility and complexity in the selling ecosystem, they’ve increasingly turned to sales enablement strategies to help improve sales outcomes and drive growth more efficiently.

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Leading Artificial Intelligence (AI) Companies in Pharma

Pharmaceutical Technology

View the top artificial intelligence (AI) companies in the pharmaceutical industry and download your free guide to AI in pharma here.

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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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J&J tries to push talc bankruptcy over the line once again

pharmaphorum

Johnson & Johnson's long-running effort to put litigation claiming its talc products caused cancer has continued with a third attempt to place a subsidiary company into bankruptcy. Red River Talc LLC was set up specifically to resolve the thousands of claims related to ovarian cancer arising from cosmetic talc litigation, separated from the group's core business and armed with billions of dollars in settlement money to provide compensation to alleged victims.

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Active Pharmaceutical Ingredients and Intermediates for the Pharmaceutical Industry

Pharmaceutical Technology

Download our free, extensive list of the leading Active Pharmaceutical Ingredients and Intermediates companies and suppliers today.

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Sanofi's Sarclisa gets one up on rival Darzalex in myeloma

pharmaphorum

Sanofi's Sarclisa has been an also-ran in the anti-CD38 antibody class behind Johnson & Johnson and Genmab's blockbuster Darzalex, but now has a chance to steal some of the spotlight. The FDA has approved Sarclisa (isatuximab) as a first-line therapy for blood cancer multiple myeloma as a combination regimen alongside bortezomib, lenalidomide, and dexamethasone (VRd), for people who are not eligible for an autologous stem cell transplant (ASCT).

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EMA Gives Approval to Several Cancer Treatments

PharmaTech

Approvals were recommended for treatments of ovarian cancer, lung cancer, bleeding disorders, respiratory disease, and more.

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

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FDA Grants Bimekizumab-Bkzx Approval for Treatment of Chronic Immune-Mediated Inflammatory Diseases

Pharmacy Times

Approved with 3 new indications, bimekizumab-bkzx is the first and only interleukin-17 inhibitor approved for these diseases.

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Transform Real-World Evidence (RWE) Insights with Innovative Data Solutions

PharmExec

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

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Favorable Outcomes Possible With IVIG Treatment for Multisystem Inflammatory Syndrome in Children

Pharmacy Times

Further trials are required to examine the long-term feasibility of intravenous immunoglobulin (IVIG) for multisystem inflammatory syndrome.

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Telesis Bio gets grant for methods for synthesizing dna molecules with defined sequences

Pharmaceutical Technology

Discover Telesis Bio Inc.'s groundbreaking patent for synthesizing specific DNA sequences. Learn how their innovative method enhances genetic engineering and biotechnology.

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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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LogiPharma USA 2024: DSCSA Compliance Preparation

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Mark Karhoff, supply chain & DSCSA consultant, National Association of Boards of Pharmacy, discusses insurances to the upcoming DSCSA deadline.

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Lyell Immunopharma gets grant for egfr-derived polypeptides for improved cell surface expression

Pharmaceutical Technology

Discover Lyell Immunopharma's groundbreaking patent for EGFR-derived polypeptides, enhancing cancer treatment through innovative nucleic acid technologies and engineered T cells.

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FDA Approves Bimzelx for Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis

PharmExec

Bimzelx is the first approved medication for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis that selectively inhibits IL-17A and IL-17F, both of which are key cytokines that drive inflammatory processes.

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Sanofi gains exclusivity rights to Ventyx’s CNS-penetrant drug in $27m deal

Pharmaceutical Technology

Under the terms of the agreement, Sanofi will gain an exclusive right to first negotiation for the CNS-penetrant, VTX3232.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Forging Ahead in Formulation

PharmaTech

New and existing technologies, as well as a patient-centric focus, are pushing drug formulation into exciting directions.

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Vicebio secures $100m to advance RSV and hMPV vaccine combo to Phase I

Pharmaceutical Technology

The company has initiated a Phase I trial of its bivalent RSV and hMPV-targeting vaccine called VXB-241.

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FDA Approves Bimzelx for Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis

Pharmaceutical Commerce

Bimzelx is the first approved medication for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis that selectively inhibits IL-17A and IL-17F, both of which are key cytokines that drive inflammatory processes.

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Teva touts safety profile of once monthly schizophrenia therapy

Pharmaceutical Technology

New safety data shows an absence of post-injection syndrome, a rare and serious side effect of long-acting olanzapine.

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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