02:43 , Nov 10, 2018 |  BioCentury  |  Regulation

Alkermes adcomm reveals SPCD paradox

Disagreement between FDA and Alkermes plc on how the data were analyzed took center stage at the panel meeting on the depression drug ALKS 5461. But the meeting also flushed out a chicken-and-egg problem for...
23:32 , Nov 2, 2018 |  BC Extra  |  Company News

More data could be key for Alkermes after FDA panel vote

After an FDA panel did not recommend approval of ALKS 5461 as an adjunct treatment for major depressive disorder (MDD), Alkermes plc (NASDAQ:ALKS) remained tight-lipped on next steps. Members of a joint advisory panel voted...
23:44 , Nov 1, 2018 |  BC Extra  |  Company News

FDA panel snubs Alkermes’ antidepressant

An FDA panel voted 21-2 that Alkermes plc (NASDAQ:ALKS) did not demonstrate a favorable benefit risk profile for ALKS 5461 to support approval for adjunct treatment of major depressive disorder. Panelists also voted 20-3 that...
19:08 , Oct 30, 2018 |  BC Extra  |  Company News

FDA reviewers question efficacy, abuse liability of Alkermes antidepressant

In briefing documents issued ahead of an advisory committee meeting, FDA reviewers expressed multiple concerns about efficacy analyses performed in studies of ALKS 5461 from Alkermes plc (NASDAQ:ALKS) to treat major depressive disorder (MDD), as...
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 through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18 saw investors...
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...