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Today's Rundown

Featured Story

Novartis invests in Credence for injectable delivery scale-up

Novartis has invested in Credence MedSystems to support the development and scale-up of its drug delivery systems. Credence will use the money to advance an injectable system designed to improve the user experience and fit into existing biopharma processes. 

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Top Stories

Subcutaneous Velcade more tolerable in multiple myeloma trial

A phase 2 clinical trial has provided further evidence of the tolerability benefits of giving bortezomib subcutaneously rather than intravenously. The evidence comes from a multiple myeloma trial that tested the proteasome inhibitor in combination with histone deacetylase inhibitor Farydak.

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SinuSys accesses nano-emulsion platform to improve sinus delivery

SinuSys has partnered with Pressure BioSciences to improve the delivery of steroids to the sinuses of patients recovering from surgical treatment of chronic sinusitis. The collaborators will use PBI’s nano-emulsification platform to optimize steroid delivery and minimize the risk of overdose.  

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FDA sets approval decision date for Impel's nasal migraine drug

The FDA has accepted a filing for approval of Impel NeuroPharma’s INP104 for the acute treatment of migraine. If approved, INP104 will become the first commercial product based on Impel’s technology for delivering therapeutics to the upper nasal space.

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GSK's long-acting HIV injectable, Cabenuva, finally snags its FDA green light

More than a year after an FDA rebuff, GlaxoSmithKline’s ViiV Healthcare has finally won U.S. clearance for an injectable drug that could relieve HIV patients of the trouble of taking daily pills. The FDA today greenlighted Cabenuva, the world’s first complete long-acting, injectable HIV regimen.

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2020’s top 10 clinical trial flops

While big companies can shrug off a failure, the wasted investment and missed commercial opportunities can still be damaging. For smaller companies, flunking a trial can jeopardize the future of the business.

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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.”

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.

Infographic: Reducing Time to Clinic for Your Biomedical Applications

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

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.

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