01:55 , Oct 13, 2018 |  BioCentury  |  Product Development

Bourla’s breadcrumbs to value

Incoming CEO Albert Bourla has spent only a few of his 25 years at Pfizer Inc. in the pharma’s innovative drugs business, but there are signs he already has laid the groundwork for innovating how...
17:25 , Sep 28, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP on Sept. 21 recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta...
21:45 , Sep 21, 2018 |  BC Extra  |  Company News

CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere

EMA's CHMP Friday recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam. CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta Therapeutics (NASDAQ:SRPT)...
02:37 , Sep 14, 2018 |  BC Innovations  |  Product R&D

Academia’s manufacturing problem

With backups at academic manufacturing centers beginning to hamper translation of early stage gene therapies, pushing those who can afford it to CMOs, at least one non-profit has stepped in with a model to deliver...
18:37 , Aug 17, 2018 |  BC Week In Review  |  Company News

Express Scripts wants blood disorder gene therapies exclusively

Express Scripts Holding Co. (NASDAQ:ESRX) said it is in discussions with gene therapy companies to become the exclusive distributor for blood disorder treatments, which could enable the PBM to test a payment-over-time reimbursement model. The...
22:50 , Aug 15, 2018 |  BC Extra  |  Company News

Express Scripts wants blood disorder gene therapies exclusively

Express Scripts Holding Co. (NASDAQ:ESRX) said it is in discussions with gene therapy companies to become the exclusive distributor for blood disorder treatments, which could enable the PBM to test a payment-over-time reimbursement model. The...
19:51 , Aug 10, 2018 |  BioCentury  |  Finance

Sound story

Preclinical data supporting Akouos Inc.’s hearing loss program convinced 5AM Ventures to re-up for a $50 million series A round, and those funds plus additions to the Akouos team have the company poised to take...
22:00 , Aug 9, 2018 |  BC Extra  |  Politics & Policy

China releases list of overseas drugs eligible for Priority Review

China’s Drug Evaluation Center posted a list of 48 drugs already approved in the U.S., EU or Japan that could be eligible for Priority Review in China. Last December, China's State Drug Administration released guidance...
00:47 , Jul 27, 2018 |  BC Innovations  |  Product R&D

Syncona’s sister act

With the final pieces of its gene therapy portfolio in place, Syncona Investment Management Ltd. thinks its five “sister companies” are poised to capitalize on recent regulatory and technological advances in gene therapy, and push...
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...