Topical erectile dysfunction therapy hits phase 3 goal
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United Therapeutics lands blow in inhaled drug patent dispute, pushing back approval of generic rival

United Therapeutics has struck a blow to Liquidia Technologies’ generic formulation of Tyvaso. With a court ruling the generic infringes a United patent, Liquidia faces the prospect of being kept off the market until 2027—unless it gets the decision overturned or prevails in a related dispute.

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Top Stories

Targeting $500M opportunity, Amneal files for FDA approval of extended-release Parkinson's prospect

Amneal Pharmaceuticals has filed for FDA approval of an extended-release Parkinson’s disease prospect that is tipped to deliver peak U.S. sales of up to $500 million. With Amneal hitting its third quarter filing goal, the company is on track to bring the therapy to market around the middle of next year.

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Futura's topical erectile dysfunction therapy hits phase 3 goal, igniting race to FDA

Futura Medical has reported phase 3 data on its topical erectile dysfunction treatment MED3000, teeing it up to file for FDA approval of the therapy as an over-the-counter medicine by the end of the month.

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After buying in candidate, Mannkind wraps up phase 1 trial of inhaled lung infection prospect

MannKind has wrapped up a phase 1 clinical trial of an inhaled formulation of clofazimine, teeing it up to talk to the FDA about advancing the candidate as a treatment for bacterial lung infections.

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'The Top Line': Depth in the Alzheimer's pipeline, the staying power of 2012's Fierce 15 honorees and more

This week on "The Top Line," we discuss just how deep—and broad—the Alzheimer’s pipeline is despite major players dominating the headlines. We also chat about our research into the 2012 class of Fierce 15 and where those biotechs are now.

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Resources

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How can we predict the ability of a preclinical drug to inadvertently cause or intentionally inhibit cytokine secretion and T cell activation

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Whitepaper: Medical Affairs Metamorphosis, Part III: How Medical Affairs is Becoming a Key Hub for Evidence Generation

This paper explores how Medical Affairs is increasingly playing a key leadership role in evidence planning and generation (part 3 in a series).

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TwinRCTs require fewer patients and shorten trial timelines for rare neurodegenerative diseases.

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Whitepaper: Strategies for the Optimal Scale-up & Tech Transfer of Oral Small Molecules

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Read through this library of resources to find out how you can strengthen innovation and efficiency, improve safety and quality, and prioritize resources to support your long-term goals.

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: 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.

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