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Today's Rundown

Featured Story

Pfizer returns rights to Flector topical pain drug to IBSA

Pfizer has returned the commercial rights to topical pain drug Flector to its original developer. The developer, IBSA Pharma, said it has lowered the price of Flector to make it one of the cheapest diclofenac topical systems available in the U.S.

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Top Stories

Amneal lands drug delivery platforms in $70M Kashiv Specialty buyout

Amneal Pharmaceuticals has struck a deal to buy a 98% stake in Kashiv Specialty Pharmaceuticals for $70 million upfront. The takeover will give Amneal control of drug delivery platforms and a pipeline of 505(b)(2) drugs and complex generics. 

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Arcutis moves rival to Pfizer eczema drug Eucrisa into phase 3 

Arcutis Biotherapeutics has begun phase 3 clinical trials of its topical roflumilast cream in patients with atopic dermatitis. The product consists of the active ingredient in AstraZeneca’s oral lung drug Daliresp formulated into a cream for use on the skin of patients with a common form of eczema. 

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Glaukos' glaucoma implant matches eye drops in 24-month analysis

Glaukos’ intraocular implant has performed comparably to topical timolol in the 24-month interim analysis of glaucoma patients enrolled in a phase 2b trial. The study is part of Glaukos’ preparations for a planned filing for FDA approval of the iDose TR sustained-release implant.

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Philips joins Merck KGaA to develop AI-guided fertility treatments

Philips and Germany’s Merck KGaA have launched a multi-year partnership to help bring digital technologies to fertility treatments—combining informatics and mobile ultrasound diagnostics.

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Resources

Webinar: Using SPOT™ & CHO-BC® During Cell Line Development for Titers up to 9 g/L

Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards.

Whitepaper: Success in Rare Diseases: Understanding the Rare Disease Ecosystem

Biopharma companies in rare diseases: How to maximize the odds of success by becoming a valued member of the unique “rare disease ecosystem.”

Infographic: 6 Ways Phenotypic Data Improves Decision-Making in Your Drug Development Program

Learn six ways metabolomics provides greater confidence, higher success rates and complements the work of your in-house teams for your drug development pipeline.

Whitepaper: The Future of Pharmacovigilance

Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality.

Whitepaper: Survey Reveals Demand for Clinical Trial Innovation in the Wake of COVID-19

The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement.

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This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments.

Whitepaper: Gene and Cell Therapy: Planning for Manufacturing Success Early

Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience.

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eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

Q&A: Planning Successful Launches

Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools.

eBook: CMC Considerations for Successful Early Drug Development

This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success.

Webinar: Phase Appropriate Expertise and Technologies to Accelerate Product Development to Commercialization

In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

Whitepaper: The Art of Recognizing Clinical Supply Risk Factors

In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management.