scPharmaceuticals gets FDA date for twice-rejected drug
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Today's Rundown

Featured Story

J&J program adds Ena's infectious disease nasal spray to roster

Ena Respiratory has landed a spot on the Blue Knight program set up by Johnson & Johnson and the U.S. Biomedical Advanced Research and Development Authority, positioning it to benefit from mentorship as it seeks to hustle its infectious disease nasal spray to market.

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Top Stories

Quickly turning $23M into $10M, Zealand offloads insulin delivery tech to MannKind

Zealand Pharma has found a buyer for its V-Go insulin delivery device. Weeks after lackluster sales led it to seek a partner for the device, Zealand has agreed to offload the technology and associated inventory and employees to MannKind for $10 million plus sales-based milestones.

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3rd time lucky? ScPharmaceuticals gets decision date for twice-rejected on-body drug delivery product

ScPharmaceuticals has an important new date for its calendar. With the FDA accepting an approval filing for its on-body infusor heart failure therapy, scPharmaceuticals is set to learn whether the candidate gets the green light to come to market by Oct. 8.

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RDT inks deals to push oral film tech to COVID-19 vaccine firms

Rapid Dose Therapeutics (RDT) has laid the groundwork for an attempt to woo COVID-19 vaccine developers, inking agreements intended to accelerate the development and commercialization of its QuickStripVax orally dissolvable film.

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Most influential people in biopharma—the entrepreneurs

The leaders in this week's Most Influential People in Biopharma category have led companies of all types in this industry⁠—and they're still building today. While they may have scientific and medical expertise, the Fierce team felt their contributions to the business aspects of biopharma made them worth featuring this week.

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'The Top Line' podcast: Big Pharma's M&A lull, the shake-up in top 10 highest paid R&D execs, plus this week's headlines

This week on "The Top Line," we talk about why Big Pharma is resisting the temptation to go on a biotech M&A spree. We also discuss the 10 biggest earners among R&D chiefs and the drastic changes from last year's list, plus the week's biggest headlines.

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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.

Events