BioCentury | Nov 17, 2020
Regulation

Alkermes expects quick resolution to FDA setback for antipsychotic

...in November 2018 against approval of that therapy, which combines samidorphan with partial MOR agonist buprenorphine.Alkermes...
BioCentury | May 1, 2020
Product Development

April 30 Quick Takes: Pfizer to co-develop Valneva’s Lyme disease vaccine; plus Aravive-WuXi Biologics, Siga-BARDA, Pear, Capricor

...for substance use disorder; and reSET-O, which is for patients with opioid use disorder receiving buprenorphine...
BioCentury | Feb 11, 2020
Politics, Policy & Law

Senate bill introduced to close Orphan drug ‘loophole’

...its development and distribution costs. Controversy over Orphan exclusivity for opioid use disorder therapy Sublocade buprenorphine...
BioCentury | Jan 29, 2020
Politics & Policy

House bill seeks to tweak Orphan Drug Act, could pose threat to pathway

...recovery pathway, a recent controversy over Orphan exclusivity for an opioid use disorder therapy Sublocade buprenorphine...
BioCentury | Jan 3, 2020
Emerging Company Profile

Click: personalized digital therapeutics for cognitive, neurobehavioral disorders

...as an adjunct to pharmacotherapy and clinician care for patients with opioid use disorder receiving buprenorphine...
BioCentury | Nov 27, 2019
Company News

Nov. 27 Company Quick Takes: Orexo, GAIA in second deal for substance abuse digital therapy; plus PDUFA date for Verrica's skin infection candidate and $25M fol

...companies to develop a psychosocial support product intended to enhance the use of Orexo's Zubsolv buprenorphine/naloxone...
BioCentury | Nov 26, 2019
Politics & Policy

Pioneering FDA commissioner Frank Young dies at 88

...commissioner to lead the development and submission of an NDA, for Probuphine, a long-acting, implantable buprenorphine...
BioCentury | Oct 16, 2019
Company News

Pear gearing up to sell products solo as Sandoz backs out of digital deal

...as an adjunct to pharmacotherapy and clinician care for patients with opioid use disorder receiving buprenorphine...
BioCentury | Aug 31, 2019
Product Development

Digital tech meets the patient: first movers are bringing digital to biopharma

...yes $1,300 reSET-O Opioid use disorder 84-day cognitive behavior therapy program as adjunct to transmucosal buprenorphine...
...launch. reSET-O was tested in an unblinded, 12-week, 170-patient trial in which patients received supervised buprenorphine...
BioCentury | Aug 21, 2019
Company News

Orexo, GAIA to develop digital therapeutic for opioid use disorder

...GAIA, Orexo will develop a psychosocial support product intended to enhance the use of Zubsolv buprenorphine/naloxone...
...with OUD, Orexo President and CEO Nikolaj Sørensen told BioCentury. To prescribe products that contain buprenorphine...
...Mass.) and Sandoz, which provides cognitive behavioral therapy as an adjunct to outpatient treatment including buprenorphine...
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