Petros picks 505(b)(2) path for Endo challenger
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Editor's Note: We're excited to announce that we've officially launched our new Fierce Life Sciences podcast, The Top Line. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma will recount the latest industry trends and why they matter. We’ll also analyze the week’s biggest business news – from mergers and marketing to drug R&D and device development. You'll find the first installment below.

Today's Rundown

Featured Story

Gerresheimer invests in Portal's needle-free drug delivery, teeing Takeda partner up to advance tech

Gerresheimer has signed up to support development of Portal Instruments’ needle-free drug delivery platform, taking a stake in its new partner and agreeing to throw its weight behind a technology that has attracted the attention of Takeda.

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Top Stories

Stevanato inks auto-injector deal to continue drug delivery push

Stevanato has added another drug delivery technology to its portfolio, teaming up with Owen Mumford to provide customers with a two-step, single-use auto-injector that automatically adapts to a range of fill volumes.

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Petros picks 505(b)(2) pathway for topical rival to Endo therapy

Petros Pharmaceuticals has decided on the way forward for its topical treatment of a connective tissue disorder of the penis. After talking to the FDA, Petros plans to follow the 505(b)(2) pathway, enabling it to leverage data on approved drug products to support its application.

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Hovione's drug delivery tech lands eye disease licensing deal

Hovione’s drug delivery strategy has delivered a win, with Ji Xing Pharmaceuticals picking up the global license for the preclinical eye disease program JX08.

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'The Top Line' podcast: Biogen's overhaul reaches CEO level; the most influential people in biopharma; plus this week's headlines

This week on "The Top Line," we discuss why Biogen’s overhaul reached the CEO level and dive into next steps at the company. We also discuss the most influential people in biopharma and the week's biggest headlines.

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The top 10 highest paid biopharma R&D executives in 2021

The top 10 list of the highest-paid biopharma R&D execs looks a little bit different in 2021 than the year before after a number of pendulum swings in pay. And the new top 2 earners have since left their top research posts for CEO roles elsewhere.

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Resources

Executive Summary: PBPK Modelling for Optimizing Controlled Release Dosage Form Development

In this executive summary, we describe the benefits of controlled release, look at how to determine whether a drug is suitable for controlled release, review the application of PBPK modelling in controlled release formulation development and discuss how modified release products can be developed to deliver optimal patient outcomes.

Whitepaper: Gain Operational Speed and Velocity by Sharing Quality Incident Data

Quality operations guide your organization through regulatory compliance processes and safeguard your products, processes, and reputation. But your team is capable of so much more. Quality incident data and processes can be a driver of significant business value if shared with other stakeholders.

Whitepaper: Medical Affairs Metamorphosis: Trends Driving Change & What They Mean

Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve.

eBook: Streamline HCP interactions management

Don’t miss these critical considerations when evaluating your HCP interactions management program.

Research: Healthcare Has No Borders: The Role of Rescue Sites in Times of Global Calamity

More than 570 clinical trials in Ukraine have been disrupted. Unanticipated disruptions to medical testing and clinical trials impede progress toward new breakthroughs and new therapies that millions of patients around the world hang their hope on. What role do rescue sites play?

Infographic: United Cargo: Providing Comprehensive Solutions For the Most Critical Shipments

The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now.

Events