Avadel gets tentative FDA nod for rival to Jazz narcolepsy drug
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Today's Rundown

Featured Story

J&J's switch from IV to subcutaneous Darzalex is 85% complete in the US

Johnson & Johnson’s attempt to switch physicians from intravenous to subcutaneous Darzalex is almost complete. Having won FDA approval for Darzalex Faspro in May 2020, J&J has converted 85% of its U.S. business to the subcutaneous formulation of the cancer treatment.

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Top Stories

As Silverback admits defeat, ARS troops forward to fund commercialization of epinephrine nasal spray

ARS Pharmaceuticals is backing onto Nasdaq through a reverse merger with Silverback Therapeutics to bag cash to commercialize an epinephrine nasal spray and win market share from the incumbent EpiPen.

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Avadel gets tentative FDA nod for rival to Jazz narcolepsy drug

Avadel Pharmaceuticals has taken a step toward challenging Jazz Pharmaceuticals for the narcolepsy market. The FDA granted tentative approval to the company’s extended-release rival to Xyrem, leaving a patent as the last barrier between it and the market.

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Large-scale screen shows how cancer cells respond to drug delivery nanoparticles

What factors determine the effectiveness of drug delivery nanoparticles in different settings? The lack of a good way to answer that question has potentially held back a technology with the potential to improve the risk-benefit profile of cancer therapies. Recognizing that, researchers at Massachusetts Institute of Technology have run a large-scale screen to show how cancer cells respond to nanoparticles.

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Pfizer, BioNTech rebuff CureVac's 'groundless' patent infringement claims against COVID-19 shot Comirnaty

After developing the massively successful COVID shot, Comirnaty, Pfizer and BioNTech are responding to CureVac's litigation, saying they are facing what they call “threats of a groundless patent infringement suit by a company, CureVac, who has been unable to bring to market any product to help in the fight against COVID-19.”

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'The Top Line' podcast: Biotech layoffs trend up, the pandemic's impact on generic drug sales, plus this week's headlines

This week on "The Top Line," we discuss the significant increase in layoffs and what that means for the biotech industry. Also under discussion is our special report on the top 10 companies by generic drugs sales.

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Resources

Whitepaper: Through a CRO's Perspective: Innovative, Agile Solutions In Vaccine Efficacy Testing

Discover Nexelis’ first-hand perspective on how to develop innovative, agile solutions in vaccine efficacy testing in this exclusive e-book.

Case Study: Roche cuts feasibility process by 36%

Explore how Cognizant SIP helped Roche streamline its global feasibility process.

eBook: 12 Pitfalls in Europe

This e-book covers the 12 most common pitfalls for companies entering European markets for the first time, offering guidance to help growing companies avoid them and succeed.

Whitepaper: The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?

Article: Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

Whitepaper: Catalent Pulmonary & Nasal Delivery Capabilities Sheet

Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays?

eBook: Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Whitepaper: Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?

Case Study: Versatility of Softgel Technology - Encapsulation of a Volatile Compound

Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound.

Article: Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market?

eBook: Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Carla Vozone discusses the significant trends in the OINDP segment including large molecules and novel indications, changes within CDMOs and various challenges facing the industry.

Whitepaper: Catalent Pulmonary & Nasal Delivery Capabilities Sheet

Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays?

On-Demand Webinar: The Faster Path From Pre-Filled Syringe to Auto-Injector

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.

Events