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Gilead, With Two PRVs In Hand, Holds Options For Accelerating Late-Stage Pipeline

 
• By Joseph Haas

Likely candidates for use of Gilead's priority review vouchers include GS-4997, a Phase III candidate for NASH, and bictegravir, its second-generation integrase inhibitor for HIV. The virology specialist previously used a PRV successfully to accelerate approval of Odefsey.

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Sitting on a nest egg of $32.4bn in cash as of the end of 2016 and needing catalysts to boost sales while revenues from its industry-leading hepatitis C franchise decline steadily, Gilead Sciences Inc. has turned for a third time to the seller's market for priority review vouchers, obtaining Sarepta Therapeutics Inc.'s voucher for $125m.

Gilead's pipeline lists four Phase III programs with previously unapproved drug candidates, in a variety of therapeutic spaces – HIV,...

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BIO Notebook: IPO Window Stays Shut, PRVs Need To Be A Priority, And Focusing On Gene Therapy Safety

 
• By Mandy Jackson and Sarah Karlin-Smith

Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.

Sarepta Market Dynamics For Elevidys Imperiled By Second Patient Death

 
• By Joseph Haas

With two deaths in non-ambulatory DMD patients, Sarepta is attempting damage control and will ask the US FDA to advise, setting up a possible confrontation with CBER director Prasad.

Supernus Secures Sage With CVR-Supported Deal

 
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Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.

Early Blood Cancer Data Impresses As Incyte Plots Post-Jakafi Strategy

 
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First results for a first-in-class mutCALR-targeted therapy in essential thrombocythemia presented at EHA point to a lucrative future for the early-stage product.

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Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: breaking down big pharma’s executive pay; US vaccine panel upheaval; Merck’s RSV approval; MFN and Japan; and the future of Pfizer and Arvinas’s partnership.

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

 
• By Joseph Haas

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Finance Watch: Scorpion Spinout Antares Launches With $177m For Precision Medicines

 
• By Mandy Jackson

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