00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month's gains and losing $291.2 billion in aggregate value. Median losses...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
03:55 , Dec 14, 2018 |  BC Innovations  |  Product R&D

Gene therapy’s make or buy choice

Whether or not to bring manufacturing in-house for gene therapy companies is becoming a critical choice, as contract manufacturers struggle to keep up with demand. The trade-off for the upfront investment risk is control over...
03:50 , Dec 1, 2018 |  BioCentury  |  Product Development

Cell therapy momentum at ASH

This year’s American Society of Hematology (ASH) meeting will showcase a surge in clinical CAR T cell presentations. But gene therapies are not following the same trajectory, despite both modalities being fresh off their first...
18:24 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

Luxturna gets EU approval

The European Commission approved Luxturna voretigene neparvovec to treat patients with vision loss due to genetic mutation in both copies of the retinal pigment epithelium-specific protein 65kDa (RPE65) gene and who have enough viable retinal...
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...