Fri.Mar 08, 2024

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Novo's obesity superstar Wegovy wins FDA nod to cut cardio risks in key label expansion

Fierce Pharma

Novo Nordisk’s fast-growing weight loss med Wegovy just added a new cardiovascular FDA approval to its label, likely enabling the med's superstar status to reach new levels. | The drug is the first weight loss treatment to win FDA approval to reduce the risk of severe cardiovascular outcomes, giving it an edge over rival Zepbound from Eli Lilly.

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After ALS Drug Fails in Phase 3, Amylyx Weighs Pulling the Product From Market

MedCity News

Amylyx Pharmaceuticals co-CEO Justin Klee previously said the company would withdraw ALS drug Relyvrio from the market if it failed its Phase 3 clinical trial. The biotech has set an eight-week timeline to evaluate its next steps.

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PhRMA seeks to revive Medicare price negotiations lawsuit, blasts Biden's request for IRA expansion

Fierce Pharma

As President Joe Biden doubles down on the price negotiation meas | As President Joe Biden doubles down on the price negotiation measures in the Inflation Reduction Act, prominent industry lobbying group the Pharmaceutical Research and Manufacturers of America isn’t letting its legal challenge go down without a fight.

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AD/PD 2024: TauRx’s HMTM promising despite lacking primary endpoint data

Pharmaceutical Technology

Participants cannot remain blind to their treatment arm due to the properties of TauRx's drug, which causes urinary discoloration.

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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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Bristol Myers, overshadowed by ADC rival, wins FDA nod for Opdivo combo in bladder cancer

Fierce Pharma

Bristol Myers Squibb’s Opdivo has won the FDA’s go-ahead in previously untreated bladder cancer. But the drug’s market potential in this indication may be limited as its PD-1 rival, Merck &amp | Bristol Myers Squibb’s Opdivo has won the FDA’s go-ahead in previously untreated bladder cancer. But the drug’s market potential in this indication may be limited as its PD-1 rival, Merck & Co.’s Keytruda, has impressed in a high-profile treatment combo.

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Semaglutide could provide novel dual benefit in diabetes and kidney disease

European Pharmaceutical Review

Headline results from Novo Nordisk AS’s kidney outcomes FLOW trial reveal that injectable semaglutide 1.0mg demonstrated a statistically significant and superior reduction in kidney disease progression as well as cardiovascular and kidney death of 24 percent. This was based on treatment policy estimand: treatment effect regardless of treatment adherence, Novo Nordisk confirmed.

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The role of GAMP 5, data integrity and QbD in pharmaceutical quality assurance

European Pharmaceutical Review

Researchers have described the impact of data integrity, GAMP 5 and quality by design (QbD) principles on pharmaceutical quality assurance (QA) , highlighting the importance of data integrity through various case studies. The authors explained first that “a robust quality assurance framework” is needed to ensure medicinal products are safe and efficient.

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Johnson & Johnson acquires Ambrx Biopharma for $2bn

Pharmaceutical Technology

Johnson & Johnson (J&J) has concluded the acquisition of Ambrx Biopharma in a transaction valued at approximately $2bn.

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Digital Therapeutics Find Opportunity in Healthcare Economics Outcomes

MedCity News

Regardless of the path to market they ultimately take, DTx companies must be poised to harness and deploy data and information that can prove their products’ economic value. Without it, the innovative treatments that they produce will continue to struggle to find success.

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BeiGene secures accelerated FDA approval for follicular lymphoma treatment

Pharmaceutical Technology

The FDA has already granted accelerated approvals to several third-line treatments, with big pharma being prominent in the landscape.

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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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Novo Nordisk’s oral amycretin tops Wegovy in obesity trial

pharmaphorum

Amongst Novo Nordisk's comprehensive business update to investors, attention latched onto early data for an oral obesity therapy that outperformed the company’s big-selling GLP-1 agonist Wegovy in a clinical trial. The drug, called amycretin and codenamed NN9487, is a dual agonist that targets both GLP-1 and amylin and is being developed in both oral and subcutaneous injection formulations.

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US Government Considers Banning Dealings with WuXi AppTec, Affiliates

Pharmaceutical Commerce

A proposed Senate bill is intended to protect citizens’ private health and genetic information.

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MindMed gets FDA breakthrough tag for LSD in anxiety

pharmaphorum

In another inflection point for the psychedelic medicines category, Mind Medicine (MindMed) has claimed breakthrough status from the FDA for its LSD-based treatment candidate MM120 as a treatment for anxiety.

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MIT study reveals non-invasive treatment holds promise for treating ‘chemo brain’

PharmaTimes

The gamma treatment also shows potential for treating patients living with neurological diseases

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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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NHS App updates ‘will tap into smart device data’

pharmaphorum

The UK government plans to link the NHS App to data generated by smart devices, including step counts and heart rate, according to Health Secretary Victoria Atkins.

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MHRA approves Marinus Pharmaceuticals’ Ztalmy for CDKL5 deficiency disorder

PharmaTimes

The rare epileptic seizure disorder currently affects around one in 42,000 people in the UK

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Register for MedCity INVEST Where Startups and Investors Connect

MedCity News

The boutique healthcare conference in Chicago is scheduled for May 21-22 at the Ritz Carlton hotel.

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BeiGene breaks new ground for BTK drugs in blood cancers

pharmaphorum

BeiGene’s BTK inhibitor Brukinsa has become the first drug in the class to be approved in the US for follicular lymphoma, giving it the broadest label among its rivals

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

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StartUPDATES: New Developments from Healthcare Startups

MedCity News

Check out news from Band Connect, Fijoya, Team8, and BrainCheck.

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FDA Approves Expanded Indication for Wegovy to Lower Cardiovascular Risk in Adults with Heart Disease, Obesity

PharmExec

FDA approves Wegovy (semaglutide) to lower the risk of major adverse cardiovascular events in adults with known heart disease and with either obesity or overweight, in addition to a reduced calorie diet and increased physical activity.

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The Biggest Impacts on the Future of the Biotech Industry

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Emma Banks, CEO of ramarketing, talks about what emerging scientific advancements will have the biggest impact on the future direction of the biotechnology industry.

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How Data Integrity Landscape Will Evolve Over the Five Years

PharmExec

In this Pharmaceutical Executive video interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics discusses how the data integrity landscape will evolve over the next five years and what extent bench scientists in the lab focused on data integrity.

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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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Steps that Inspire Inclusion

ALULA

International Women’s Day (IWD) is kicking off with local and global celebrations dedicated to the social, economic, cultural, and political achievements of women. This year’s theme is “ Inspiring Inclusion ,” and i t gives us an opportunity to recognize how everyone everywhere can take steps to inspire inclusion.

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Approval of Eli Lilly's Alzheimer Drug Donanemab Delayed as FDA Seeks More Information

PharmExec

Because of the unique trial design of the Phase III TRAILBLAZER-ALZ 2 study, the FDA is seeking additional input regarding the safety and efficacy of donanemab for the treatment of early symptomatic Alzheimer disease.

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Balancing Act: Tips for Achieving Work/Life Balance in Medical Sales

Rep-Lite

Work/life balance is crucial for medical sales personnel, yet often elusive due to demanding schedules and intense job pressures. Balancing client meetings, product knowledge updates, and administrative tasks with personal life commitments can lead to burnout and strained relationships. It’s vital as it ensures overall well-being, productivity, and job satisfaction.

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FDA Grants Accelerated Approval to Brukinsa Plus Gazyva for Relapsed or Refractory Follicular Lymphoma

PharmExec

BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FDA Approves Semaglutide for New Indication Involving Cardiovascular Disease

Pharmacy Times

Semaglutide (Wegovy; Novo Nordisk) reduces the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight when combined with the standard-of-care.

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Is There a Correlation Between Medical Debt and Health Status?

Pharmaceutical Commerce

With out-of-pocket healthcare costs resulting in financial issues for patients, a cross-sectional study closely examines whether they are linked to more premature deaths.

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Amylyx ALS drug fails crucial study, putting company’s future in doubt

PharmaVoice

The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.

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Relyvrio Falls Short of Primary Endpoint in Phase III PHOENIX Trial in Patients with ALS

PharmExec

Relyvrio did not significantly alter amyotrophic lateral sclerosis disease progression as measured by the ALSFRS-R total score at Week 48 compared to placebo.

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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