Mon.Oct 21, 2024

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Novo plots US, EU approval filings after oral semaglutide shows cardio benefits in certain diabetes patients

Fierce Pharma

As Novo Nordisk’s injectable diabetes-obesity duo Ozempic and Wegovy grab all the limelight, an oral version of the semaglutide drug showed it can provide heart-related benefits, too. | As Novo Nordisk’s injectable diabetes-obesity duo Ozempic and Wegovy grab all the limelight, an oral version of the semaglutide drug showed it can provide heart-related benefits, too.

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How the Move of Ablation Procedures into Surgery Centers Will Transform Electrophysiology

MedCity News

Within a matter of months, we’re likely to see substantial growth in the number of EP ablation procedures performed in surgery centers outside the hospital. Here’s what we can expect. The post How the Move of Ablation Procedures into Surgery Centers Will Transform Electrophysiology appeared first on MedCity News.

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Activist investor Starboard sets its sights on J&J spinout Kenvue: WSJ

Fierce Pharma

Activist investor Starboard Value, which picked up a $1 billion stake in Pfizer earlier this month, now reportedly has Johnson & Johnson’s consumer health spinout Kenvue in its sights. | Starboard, which recently pitched turnaround plans to Pfizer, reportedly thinks the J&J consumer health spinout's stocks have underperformed since its market debut over a year ago.

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Astellas Pharma Lands a First-in-Class Drug Approval in Rare Gastrointestinal Cancer

MedCity News

The FDA approved Astellas’s Vyloy as a treatment for advanced cases of gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for a protein called claudin 18.2. It’s the first FDA-approved therapy for this target. The post Astellas Pharma Lands a First-in-Class Drug Approval in Rare Gastrointestinal Cancer appeared first on MedCity News.

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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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Sanofi in 'exclusive negotiations' to sell 50% stake in €16B consumer health unit Opella

Fierce Pharma

Sanofi is now in “exclusive negotiations” with U.S. | Sanofi is now in “exclusive negotiations" with U.S. private equity firm Clayton, Dubilier & Rice to sell a 50% controlling stake in its consumer health business Opella, the company said. The deal values the consumer group at 16 billion euros.

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Roche trial confirms Vabysmo efficacy in minorities

pharmaphorum

A study has shown that Roche's diabetic macular oedema (DME) therapy Vabysmo is effective in patients who identify as African American, Black, Hispanic and Latino, plugging a gap in the data for the drug.Vabysmo (faricimab) has been approved by the FDA for treating DME since 2022, quickly becoming one of the Swiss pharma group's fastest-growing products with sales of $1.1 billion in the first half of the year.

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The Funding Model for Cancer Innovation is Broken — We Can Fix It

MedCity News

Closing cancer health equity gaps requires medical breakthroughs made possible by new funding approaches. The post The Funding Model for Cancer Innovation is Broken — We Can Fix It appeared first on MedCity News.

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Takeda details another round of layoffs in Massachusetts as restructuring drive rolls on

Fierce Pharma

Following a series of layoff rounds this year, Takeda is once again pruning its headcount in the Bay State. | As part of a new round of layoffs, certain Takeda staffers at two Massachusetts sites are set to lose their jobs. This marks the third round of job cuts Takeda has initiated in the state since it revealed a large restructuring drive in May.

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Expecting the Unexpected

Pharmaceutical Commerce

In this video interview with Pharma Commerce Editor Nicholas Saraceno, Jeffrey Bernstein, director of cybersecurity and data privacy for Kaufman Rossin’s risk advisory services, explains the top mistakes healthcare organizations make when building and maintaining their software.

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FDA’s GLP-1 decision kicks off ‘unprecedented’ tussle over shortage

PharmaVoice

After initially declaring the shortage of Eli Lilly’s diabetes and weight loss drugs over, the FDA changed its mind and re-opened the door for GLP-1 compounders.

FDA 59
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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AAPS PharmSci 360: Challenges and Trends in Softgel Formulations

PharmaTech

Karunakar Sukuru, RPh, PhD, the global vice-president-Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, spoke on recent challenges and trends in softgel formulations.

Pharma 52
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[Sponsored Content] Patient Engagement Throughout the Entire Product Lifecycle

PharmExec

In the pharmaceutical industry, patient engagement should be centered in health education, communication, and strategy during drug discovery and throughout the product lifecycle. Cheryl Lubbert, CEO of Reverba, discusses the importance of a patient-first mindset in the industry.

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Enabling site success: Key insights to reducing burden and increasing access

pharmaphorum

In a new webinar with Atlas Clinical Research’s Chief Executive Officer Mark Scullion and Terttu Haring, President of Sites & Patients at Syneos Health and former investigator, learn more about the site experience for clinical research sites – including the important need for a partner who understands the challenges and drives solutions that can ease burden, create a better experience, and expand access and representation in clinical research for patients.

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AAPS PharmSci 306: Trends in New Analytical Tools for RNA Characterization

PharmaTech

Bala Addepalli, PhD, Director, R&D New Modalities Portfolio, Waters Corporation, discussed trends in new analytical tools for RNA characterization and gave highlights of his talk at AAPS PharmSci 360.

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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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Will Pharma Increase Use of Personalized Audio Use in Marketing?

PharmExec

In this part of her video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One and Pharmaceutical Executive Advisory Board Member discusses how personalized audio will be utilized within the pharma marketing industry in 2025.

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PursueCare brings Pear addiction DTx apps back to life

pharmaphorum

Two digital therapeutics for addiction are available again through PursueCare, which acquired them from now-defunct Pear Tx last year

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Embedding into the provider’s workflow is key to a specialty drug’s success

PharmaVoice

Providers struggle with time-consuming processes. Patients are waiting for therapy. Embedded EMR system solutions can streamline therapy initiation and improve outcomes.

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Novo Nordisk closes on EU okay for haemophilia antibody

pharmaphorum

Novo Nordisk's TFPI drug concizumab has been backed for approval in the EU to prevent bleeding episodes in people with haemophilia and inhibitors

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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FibroBiologics and Charles River link for chronic disease therapies manufacture

Pharmaceutical Technology

FibroBiologics has entered a master services agreement with Charles River Laboratories to develop and manufacture cell-based therapies.

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FDA Approves Astellas’ Vylov for Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

PharmExec

Vylov is the first CLDN18.2-targeted therapy for advanced gastric and gastroesophageal junction adenocarcinoma to be approved in the United States.

FDA 52
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Sanofi’s $17bn sale of Opella to US investors advances following government deal

Pharmaceutical Technology

A stake by France-owned Bpifrance and promise of local job retention have allayed political backlash over the sale of Sanofi’s consumer health business.

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FDA Approves Allergan Aesthetics’ Botox Cosmetic for Moderate to Severe Vertical Platysma Bands

PharmExec

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

FDA 52
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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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FDA approves Astellas’ VYLOY for gastric cancer treatment

Pharmaceutical Technology

Astellas Pharma has received approval from the FDA for VYLOY in conjunction with chemotherapy, for the treatment of advanced gastric cancer.

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Pharma Pulse 10/21/24: Challenges of Proper GLP-1 Disposal, People Do Not Stick With GLP-1s for Weight Loss & more

PharmExec

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

Pharma 52
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Health Canada approves Arcutis’ ZORYVE foam for seborrheic dermatitis 

Pharmaceutical Technology

Arcutis Canada, has received Health Canada's approval for ZORYVE to treat seborrheic dermatitis in patients aged nine years and above.

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New Study Reveals How Much Family Caregivers Would Make if Paid a Salary

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

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AAO 2024: Nanoscope Therapeutics’ MCO-010 RESTOREs vision in RP patients

Pharmaceutical Technology

This trial investigated the potential of Nanoscope Therapeutics' MCO-010 to restore vision in patients with retinitis pigmentosa (RP).

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Eli Lilly Survey Reveals Major Concern for Patients with Ulcerative Colitis: Public Bathrooms

PharmExec

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

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Seaport raises $225m to advance portfolio of neuropsychiatric prodrugs

Pharmaceutical Technology

The funding will support Seaport’s technology platform, which helps drugs be absorbed more efficiently through the lymphatic system.

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Learna and University of Wolverhampton launch flexible healthcare courses

PharmaTimes

The five new programmes are designed to fit alongside full-time work and clinical practice

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.