Wed.Oct 18, 2023

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ESMO: Seagen, Astellas and Merck knock it out of the park with Padcev-Keytruda combo in bladder cancer

Fierce Pharma

Editor's Note: Please check back on Oct. 22 when the full data of EV-302 are presented at ESMO 2023. | The results are in for a phase 3 bladder cancer trial assessing the combination of Seagen and Astellas' Padcev, plus Merck's Keytruda, versus standard of care chemotherapy. The figures indicate that the combo can be transformative in the indication.

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Win Your Medical Device Sales interview

David Bagga

The final step of the interview process is usually meeting with a regional sales director or VP of sales, companies will determine who you need to meet with during a final interview. Medical Device Sales Career Home Blog Win Your Medical Device Sales Job… Win Your Medical Device Sales Job The Final Interview The Final […] The post Win Your Medical Device Sales interview appeared first on.

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Pfizer settles gender pay discrimination allegations at NYC headquarters

Fierce Pharma

Pfizer will cough up $2 million to settle allegations from the U.S. Department of Labor that it underpaid certain women who were employed at the company’s New York City headquarters. | The accusations centered on the company's compensation of 86 female employees in 2015 and 2016. Under the settlement with the Department of Labor, the company must also set aside $500,000 for potential future salary adjustments.

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Helping Doctors Help Patients: Digital Health’s Role in Reinventing How the Work That is Healthcare is Delivered

MedCity News

Investing in Friction-reducing tactics such as community building and providing benefits, training, and personalized support to employees will yield compounding long-term benefits while reducing churn rate.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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UCB's approval spree rolls on with FDA nod for Zilbrysq, its 2nd drug for myasthenia gravis

Fierce Pharma

UCB is on an approval roll. | UCB is on an approval roll. Within hours of each other, the Brussels-based company has scored FDA green lights for plaque psoriasis treatment Bimzelx and for generalized myasthenia gravis (gMG) drug Zilbrysq. Not only that, the Zilbrysq endorsement is UCB’s second in the indication this year, coming on top of the FDA signing off on UCB’s Rystiggo in June.

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In Same Day, UCB Lands Two FDA Drug Approvals in Autoimmune Diseases

MedCity News

FDA approval of UCB’s Bimzelx gives the Belgian drugmaker a contender in the crowded plaque psoriasis therapies market. In the rare disease generalized myasthenia gravis, the agency approved Zilbrysq, a UCB drug with advantages over two blockbuster AstraZeneca drugs addressing the same target.

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Hyloris wins painkiller approval amidst amplified anti-opioid efforts

Pharmaceutical Technology

The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.

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UCB's blockbuster hopeful Bimzelx overcomes manufacturing hurdles to win FDA nod

Fierce Pharma

UCB has been “eagerly awaiting” an FDA approval for its psoriasis therapy Bimzelx (bimekizumab) after manufacturing problems resulted in a rejection last May. Now, the wait is over. | The FDA rejected the drug last May after conducting an inspection at UCB's Belgian manufacturing plant. That followed a prior delay due to COVID-related inspection hold ups.

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Amazon Starts Delivering Medications via Drone

MedCity News

Amazon Pharmacy is now offering a drone delivery service for prescription medications in College Station, Texas. The service is free and allows patients to receive their medications within 60 minutes.

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After launch limitations, Johnson & Johnson exec touts manufacturing progress on CAR-T drug Carvykti

Fierce Pharma

After launch limitations, Johnson & Johnson exec touts manufacturing progress on CAR-T drug Carvykti fkansteiner Wed, 10/18/2023 - 14:44

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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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Heard at HLTH: Healthcare Execs Share Perspectives on AI, Virtual Health and Value-based Care [Sponsored]

MedCity News

As part of the Heard at HLTH video series, MedCity News Editor in Chief Arundhati Parmar and Senior Reporter Katie Adams interviewed healthcare executives about innovations in health tech at HLTH 2023 in Las Vegas earlier this month.

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The Evolution of Innovation: Realizing the Therapeutic Benefits of Cannabinoids

Fierce Pharma

By Robert Iannone, M.D., M.S.C.E.

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First-in-class phosphate absorption inhibitor approved by FDA

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. Ardelyx’s first-in-class oral treatment is indicated to reduce serum phosphorus in adults with chronic kidney disease ( CKD ) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant to phosphate binder therapy.

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Allara Snags $10M to Scale Its Platform for Women’s Chronic Hormonal Conditions

MedCity News

Allara raised $10 million in a Series A funding round led by GV. The startup offers membership-based virtual services to treat women’s chronic hormonal conditions, such as PCOS and endometriosis. CEO Rachel Blank — former executive at Ro and investor at General Catalyst — founded the company partly due to the difficulty she experienced arriving at her own PCOS diagnosis.

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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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Sanofi treatment could slow type 1 diabetes progression

European Pharmaceutical Review

TZIELD (teplizumab-mzwv) has demonstrated TZIELD’s potential to slow disease progression in newly diagnosed children and adolescents with Stage 3 type 1 diabetes. Data from the Phase III PROTECT clinical trial , presented at the 2023 Annual ISPAD Conference, showed that superior beta cell preservation was observed compared to placebo. As the primary endpoint, 94.9 percent of participants in the TZIELD group maintained peak C-peptide levels ≥0.2 pmol/mL.

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CCC Hires Duncan Campbell as Executive Director

Copyright Clearance Center

Oct. 18, 2023 – Danvers, Mass. – CCC , a pioneer in voluntary collective licensing and leading information solutions provider, announces Duncan Campbell has joined its Client Engagement and Business Development team as Executive Director. Campbell was most recently Senior Director, Global Sales Partnerships at John Wiley & Sons, where he led teams responsible for licensing and business development, agent relations, collective rights management, and permissions across the range of Wiley’s aca

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CIRM Picks Forge Biologics as AAV Manufacturing Partner

PharmaTech

The California Institute for Regenerative Medicine has partnered with Forge Biologics, which will manufacture AAVs to help accelerate gene therapy programs in California.

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Lisata receives orphan drug designation for pancreatic cancer therapy

Pharmaceutical Technology

Lisata has received orphan drug designation from the EMA's Committee for Orphan Medicinal Products for LSTA1 to treat pancreatic cancer.

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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.

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Datwyler Launches RFS Combiseals for Cartridges

Pharmaceutical Commerce

These components take the burden off drug manufacturers to prep packaging components for sterilization, while helping to enhance the drug filling and packaging process.

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Report: Annual Family Premiums for Employer Coverage Increase 7%

MedCity News

Annual family premiums for employer-sponsored coverage reached $23,968 in 2023, according to a new KFF survey. Of that family premium total, workers are contributing $6,575 annually.

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Sweden gets new pharmaceutical aseptic filling line

European Pharmaceutical Review

Swedish Health authorities have approved contract development and manufacturing organisation (CDMO) Sever Pharma Solutions’ state-of-the-art aseptic filling line. “We are thrilled to announce the approval of our new aseptic filling line for syringes, designed specifically for high potent injectable drugs,” stated Kenneth Stokholm, CEO at Sever Pharma Solutions.

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Ardelyx wins FDA approval for phosphate absorption inhibitor

Pharmaceutical Technology

The company also secured $50m in debt financing to support the commercial launch of Xphozah in November 2023.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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UKRI awards £10m in funding to tackle antimicrobial resistance

PharmaTimes

UK researchers can apply to receive a share of £3m to set up transdisciplinary networks - News - PharmaTimes

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FDA clears UCB’s ZILBRYSQ for generalised myasthenia gravis treatment

Pharmaceutical Technology

The FDA has granted clearance to UCB’s ZILBRYSQ for the treatment of generalised myasthenia gravis (gMG) in adults.

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NICE recommends Roche’s Columvi for advanced lymphoma in UK

PharmaTimes

Around 700 people in the UK could benefit from the new treatment - News - PharmaTimes

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Seagen wins future royalties in Enhertu patent dispute

pharmaphorum

Seagen wins future royalties in Enhertu patent dispute Phil.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Video Marketing for Pharma: Strategies for Impactful Storytelling

Pharma Marketing Network

Video marketing is a powerful tool for pharma companies to reach out to their target audience and promote their products in an engaging and impactful way. It is an effective way to communicate with customers, tell stories, and build relationships. Video marketing is becoming increasingly popular and is an essential part of any pharma company’s digital marketing strategy.

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Evident Vascular raises $35m, and other digital financings

pharmaphorum

Evident Vascular raises $35m, and other digital financings Phil.

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Mobile-First Approach: Designing Pharma Websites for the Modern User

Pharma Marketing Network

The mobile-first approach is an approach to web design and development that prioritizes the design and development of a website for mobile devices over other platforms. It is becoming increasingly important for businesses to have a website that is mobile-friendly, as more and more people are using mobile devices to access the internet. This is especially important for the pharmaceutical industry, where customers are looking for reliable and up-to-date information.

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Chan Zuckerberg Initiative to put $250M into new NYC Biohub

pharmaphorum

Chan Zuckerberg Initiative to put $250M into new NYC Biohub Jonah.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.