Mon.Mar 11, 2024

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FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard

Fierce Pharma

The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. | The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended. The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.

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What’s next for AAV gene therapies in 2024?

Pharmaceutical Technology

Upcoming regulatory events for pipeline AAV gene therapies, with a focus on neuromuscular and blood disorders, are setting high expectations for the space in 2024.

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Bluebird bio inks first Medicaid coverage agreement for sickle cell gene therapy, signing on with Michigan

Fierce Pharma

Bluebird Bio has secured its first Medicaid outcomes-based agreement for its sickle cell disease gene therapy Lyfgenia, signing on with Michigan.

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Amylyx plummets as confirmatory trial of ALS drug fails

pharmaphorum

Shares in Amylyx have cratered after the company reported a confirmatory trial of its amyotrophic lateral sclerosis (ALS) therapy Relyvrio missed all its objectives, putting its accelerated approval in jeopardy.

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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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Incyte's JAK cream Opzelura proves its worth in treating hidradenitis suppurativa in midstage study

Fierce Pharma

After a pair of approvals in recent years and as its sales continue to climb, Incyte's topical JAK inhibitor Opzelura is adding to its clinical case with trial results that demonstrate its benefits | The company presented positive data from a phase 2 study in mild-to-moderate hidradenitis suppurativa at the American Academy of Dermatology's annual meeting on Sunday.

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AAD: J&J’s oral IL-23 drug shows durability in psoriasis

pharmaphorum

J&J says oral IL-23 inhibitor JNJ-2113 shows a durable effect in psoriasis, making it a potential companion to its injectable Tremfya.

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More Trending

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FDA clears Wegovy’s label to include heart health benefits

pharmaphorum

Novo Nordisk’s Wegovy has been given a first-in-class approval by the FDA to reduce the risk of serious cardiovascular conditions in people who are overweight or obese

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5 years after initial FDA rejection, Lexicon prepares to resubmit Type 1 diabetes hopeful Zynquista

Fierce Pharma

Ever since its first FDA rejection five years ago, Lexicon Pharmaceuticals hasn’t given up hope on its Type 1 diabetes prospect sotagliflozin. | The company hopes its long and bumpy five-year journey will soon see an end with an FDA approval. Lexicon looks to resubmit the drug by the middle of the year.

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Boehringer licenses Sosei schizophrenia drugs in €755m deal

pharmaphorum

Boehringer Ingelheim has taken an option on a family of GPR52 agonist compounds with potential in schizophrenia from Sosei Heptares, in a €755m deal

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Legend CEO offers preview of high-stakes FDA adcomm for J&J-partnered Carvykti

Fierce Pharma

Ahead of a high-stakes FDA meeting to review CAR-T data in multiple myeloma, Legend Biotech CEO Ying Huang, Ph.D., laid out some of his expectations about the event. | J&J and Legend have submitted two more overall survival updates for Caryvkti since the original data release last year, Legend's CEO said on an analyst call. The FDA is expected to release more data on the CAR-T therapy later this week, ahead of an advisory committee meeting set for Friday.

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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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Innovaccer Previews Its New Provider AI Copilot at HIMSS24

MedCity News

On Monday at HIMSS24, Innovaccer unveiled a preview of its new AI copilot for providers, which is slated to go on the market by the end of 2024. The solution is a portable tablet device designed to provide clinicians with point-of-care support — it flags care and coding gaps, assists with clinical documentation and advises clinicians on possible diagnosis pathways.

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Taking a Closer Look at Medicare Part D’s Rising Drug Coverage Restrictions

Pharmaceutical Commerce

A USC study discovers that an increasing share of both generic and brand-name meds are being excluded from approval.

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What Drives Specialty Medication Enrollment Conversions? It’s Not What You Think.

MedCity News

We can no longer simply worry about the enrollment form as the only hurdle in therapy initiation. We must view the entire patient journey as an interconnected set of challenges that need solving. And I believe achieving that goal is within reach.

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Study reveals children with amblyopia are at higher risk of serious disease in adulthood

PharmaTimes

The neurodevelopmental condition affects up to four in 100 children

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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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Developing new treatment regimens for HIV

European Pharmaceutical Review

Since the HIV epidemic began in the early 1980s, more than 85 million people have been diagnosed worldwide and about 40 million have died as a result of complications from the virus. 1 Now, four decades later, 39 million people around the world are living with HIV, primarily due to advances in treatment. 1 With continued innovation on the horizon in terms of prevention and treatment methods, what was once a wishful hope of ending the epidemic has become a conceivable goal.

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Boehringer and Sosei Heptares partner on schizophrenia treatment

Pharmaceutical Technology

Boehringer Ingelheim has entered a deal with Sosei Heptares for the development of treatments for all schizophrenia symptoms.

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Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

In a review on fungal-contaminated compounded pharmaceuticals and medical devices, researchers have described how the contamination of these products can be due to breaches in sterile compounding procedures. The authors explained: “inadequate sterile compounding techniques or storage conditions, or exceeding the limit of a fungal count, can result in fungal contamination.

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Debunked Episode 2(audio): Discussing Unfair Hospital Pricing & How CA is Overseeing Large Transactions

MedCity News

Episode 2 of the Debunked (audio) show focuses on how hospitals are inflating prices for outpatient procedures and how California is looking at healthcare M&A and trying to address price increases and anti-competitive behavior.

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

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Manufacturer retracts acquisition deal due to “data integrity issues”

European Pharmaceutical Review

The manufacturer Olympus Corporation has announced the rescission of an earlier acquisition deal due to reported data integrity issues of medical device products from Taewoong Medical Co., Ltd. Olympus originally announced the closing of its agreed share acquisition of Taewoong Medical in January 2024. Data integrity issues The concerns around these products were found after the closing of the deal, Olympus noted.

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KCL joins new project launched by European consortium to improve newborn health

PharmaTimes

The HYPIEND project consists of 14 partners from eight European countries

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Sun Pharma initiates recall of Febuxostat for gout in US

Pharmaceutical Technology

Sun Pharma has announced a recall of 55,000 bottles of Febuxostat, a medication used to treat gout, from the US market

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Boehringer Ingelheim Places €25M Bet on Sosei’s Novel Approach to Schizophrenia

MedCity News

Sosei Heptares’ schizophrenia drug candidate addresses a novel, difficult-to-drug target for neurological disorders. Boehringer Ingelheim can exercise its option on the small molecule following a Phase 1 test expected to yield data in 2025.

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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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4D Molecular Therapeutics files patent for gene therapy for fabry disease using optimized alpha-galactosidase a sequence

Pharmaceutical Technology

Discover how 4D Molecular Therapeutics Inc. is revolutionizing gene therapy with a patent for delivering nucleic acids to treat disorders like Fabry disease.

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Let’s Make This the Last World Obesity Care Week

MedCity News

By eliminating the term “obesity” in favor of person-centric language, we pave the way for a more equitable healthcare system that prioritizes the well-being of all individuals, regardless of their size or shape.

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Why pharma should prioritize the patient journey: A survivor’s story

PharmaVoice

One rare disease survivor’s diagnosis experience highlights the need for pharma companies to better understand the patient journey.

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340B Auditing and Management in Contract Pharmacies

Pharmacy Times

Contract pharmacies should work to stay in a perpetual state of audit readiness

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Mesoblast eyes accelerated approval filing for heart failure cell therapy

Pharmaceutical Technology

The race for the first FDA-approved cell therapy for patients with heart failure heats up.

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FDA Approves sBLA to Extend Temperature Storage Conditions for Two IVIG Products

Pharmacy Times

The IVIG therapies were previously approved for 4-week room temperature storage conditions of 25º Celsius during the first 24 months of shelf life.

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Celltrion files XOLAIR biosimilar for chronic spontaneous urticaria BLA

Pharmaceutical Technology

Celltrion has filed a BLA with the US FDA for a biosimilar candidate to XOLAIR (omalizumab), CT-P39, for chronic spontaneous urticaria (CSU).

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Navigating Research in Psychedelics: Investigators Face a Mosaic of Regulations, False Perceptions, and Therapeutic Potential

Pharmacy Times

If clinical trials continue to show that psychedelics offer safe and long-lasting results, then psychedelic-assisted therapy could flourish as a treatment in the mental health space.

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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