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Neurocrine Will Delay Ongentys Launch, But It Thinks Differentiation Is Clear

 
• By Joseph Haas

Ongentys, now approved as adjunctive therapy in Parkinson’s disease, will offer a convenience advantage over generic COMT inhibitors. The company will delay launch due to pandemic and manufacturing issues.

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Neurocrine's Ongentys will take on entrenched generics, but has differentiating factors

When Ongentys (opicapone) actually reaches the US market, Neurocrine Biosciences Inc. will push its Parkinson’s therapy on price and differentiation, but first it needs to get past both the COVID-19 pandemic and a manufacturing issue in Europe. Neurocrine announced US approval of the once-daily catechol-O-methyltransferase (COMT) inhibitor on 27 April and outlined plans to make the drug broadly affordable by pricing below the Medicare specialty drugs tier.

Ongentys is intended to extend the durability of the gold standard Parkinson’s therapy levodopa/carbidopa by inhibiting an enzyme that breaks...

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UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

Nuvation Set For First Launch With Ibtrozi In Lung Cancer

 
• By Jessica Merrill

The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.

Pipeline Watch: ASCO Dominates Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Santen Sees Potential In Myopia Market After Ryjunea Approval

 
• By Kevin Grogan

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

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AstraZeneca Taps Into China’s R&D Engine With CSPC Alliance

 
• By Andrew McConaghie

After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.

Executives On The Move: New CMOs At Instil Bio, Nkarta & Catalyst Pharma

Recent moves in the industry include changes at the top at iOnctura and Orca Bio, plus Sutro Biopharma, Tenpoint Therapeutics and Helix BioPharma get new CFOs.

In Brief: Starton Moves Low-Dose Lenalidomide To Phase IIa For Multiple Myeloma

 
• By Sushmita Panda

Study to add to safety and tolerability data for infused formulation and may help identify optimal dose for future pivotal trial.