23:44 , Oct 18, 2018 |  BC Innovations  |  Targets & Mechanisms

Volkow: why pain and addiction will go personalized

While addiction still carries a social stigma, neuroscience research not only supports the view that it is a disease, but is starting to paint a more nuanced picture of the variety of mechanistic pathways involved....
01:38 , Oct 6, 2018 |  BioCentury  |  Politics, Policy & Law

SUPPORTing FDA’s fight against opioids abuse

Legislation President Donald Trump is expected to sign soon gives FDA powers that are intended to blunt the opioid abuse epidemic and incentivize development of non-addictive pain treatments. The new authorities will give FDA tools...
01:14 , Oct 6, 2018 |  BioCentury  |  Finance

Large cap comeback

The biotech sector continued to be a stock pickers’ market for investors through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
17:39 , Sep 28, 2018 |  BC Week In Review  |  Company News

Indivior slashes Sublocade guidance on payer friction

Indivior plc (LSE:INDV) fell 42.40p (16%) to 215p on Sept. 26 when it sharply lowered its 2018 revenue guidance for Sublocade buprenorphine, saying it “substantially underestimated” how long it would take for payers to approve...
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 Therapeutics...
22:34 , Sep 26, 2018 |  BC Extra  |  Company News

Indivior slashes Sublocade guidance on payer friction

Indivior plc (LSE:INDV) fell 42.40p (16%) to 215p Wednesday when it sharply lowered its 2018 revenue guidance for Sublocade buprenorphine, saying it “substantially underestimated” how long it would take for payers to approve individual patients...
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) for...
18:26 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

FDA panel to discuss Alkermes' depression candidate

FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will meet Nov. 1 to discuss an NDA from Alkermes plc (NASDAQ:ALKS) for ALKS 5461 as an adjunct to treat major depressive...
16:39 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

Braeburn’s CAM2038 meets in Phase III for chronic low back pain

Braeburn Pharmaceuticals Inc. (Plymouth Meeting, Pa.) said CAM2038 met the primary endpoint in the Phase III HS-16-555 trial to treat moderate to severe chronic low back pain in patients previously on long-term daily opioid therapy....