23:07 , Jul 20, 2018 |  BioCentury  |  Regulation

FDA’s positive reinforcement

Companies are still sifting through a half dozen gene therapy guidance documents issued by FDA, but so far it appears the recommendations support the paths taken by some of the most advanced clinical candidates for...
13:30 , Jul 11, 2018 |  BC Extra  |  Politics & Policy

FDA releases gene therapy guidance documents

FDA Wednesday released six draft guidance documents on gene therapy: three advising companies on how to use the technology to treat certain diseases, two about manufacturing and one on the design of long-term follow-up studies. The...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate of...
15:32 , Jun 8, 2018 |  BC Week In Review  |  Company News

Axovant reboots with gene therapy deal

Months after a clinical failure in Alzheimer's disease destroyed most of its value, Axovant Sciences Ltd. (NASDAQ:AXON) is seeking a path forward by obtaining rights to a gene therapy for Parkinson's disease. Oxford BioMedica plc (LSE:OXB)...
14:00 , Jun 6, 2018 |  BC Extra  |  Company News

Axovant reboots with gene therapy deal

Months after a clinical failure in Alzheimer's disease destroyed most of its value, Axovant Sciences Ltd. (NASDAQ:AXON) is seeking a path forward by obtaining rights to a gene therapy for Parkinson's disease. Oxford BioMedica plc (LSE:OXB)...
22:26 , May 4, 2018 |  BioCentury  |  Finance

Voucher equilibrium

At $110 million, the sticker price on a Priority Review voucher from Spark Therapeutics Inc. (NASDAQ:ONCE) appears to be the new normal. Jazz Pharmaceuticals plc (NASDAQ:JAZZ) purchased the voucher on April 30; Spark received it in...
15:32 , May 4, 2018 |  BC Week In Review  |  Company News

Jazz buys Priority Review voucher from Spark

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) purchased a rare pediatric disease Priority Review voucher from Spark Therapeutics Inc. (NASDAQ:ONCE) for $110 million on April 30. Jazz spokesperson Andrew Civers-Davis told BioCentury the company has not yet decided how...
18:42 , Apr 30, 2018 |  BC Extra  |  Company News

Jazz buys Priority Review voucher from Spark

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) purchased a rare pediatric disease Priority Review voucher from Spark Therapeutics Inc. (NASDAQ:ONCE) for $110 million. Jazz spokesperson Andrew Civers-Davis told BioCentury the company has not yet decided how to use the...
13:40 , Apr 13, 2018 |  BC Week In Review  |  Company News

Novartis to acquire AveXis for $8.7B

Novartis AG (NYSE:NVS; SIX:NOVN) is acquiring gene therapy company AveXis Inc. (NASDAQ:AVXS) for $218 per share, or about $8.7 billion. The price represents an 88% premium to AveXis' close of $115.91 on April 6, before...
19:43 , Apr 9, 2018 |  BC Extra  |  Company News

Novartis to acquire AveXis for $8.7B

Novartis AG (NYSE:NVS; SIX:NOVN) is acquiring gene therapy company AveXis Inc. (NASDAQ:AVXS) for $218 per share, or about $8.7 billion. The price represents an 88% premium to AveXis' close of $115.91 on Friday, before the...