BioCentury | Apr 29, 2020
Product Development

April 28 Quick Takes: Syndax gains on leukemia data; plus Supernus, Neurocrine, Avadel, Insilico-Astellas, Innovent-Lilly, Chimerix

AACR data propel Syndax shares Syndax Pharmaceuticals Inc. (NASDAQ:SNDX) rose $7.99 (69%) to $19.50 on Tuesday after presenting initial data from the Phase I/II AUGMENT-101 trial of SNDX-5613 that showed responses in two out of...
BioCentury | Mar 27, 2020
Product Development

March 26 Quick Takes: Pear’s digital therapeutic approved for insomnia; plus Medimetriks-Otsuka, Merck KGaA, Jazz, Roche, EpiVax

FDA approves Pear’s cognitive behavioral insomnia therapy  FDA approved Somryst from Pear Therapeutics Inc. to treat chronic insomnia. The prescription digital therapeutic is the first to be approved via simultaneous review under the standard 510(k)...
BC Extra | Dec 19, 2019
Company News

PharmaMar deal adds late-stage asset to Jazz’s growing cancer pipeline

Jazz’s deal to gain exclusive, U.S. rights to PharmaMar’s Zepsyre marks the company’s third cancer partnership of the year, adding a late-stage asset in small cell lung cancer as it continues to expand its pipeline...
BC Extra | Dec 4, 2019
Clinical News

Axsome plans Phase III trial for narcolepsy therapy following positive Phase II data

Axsome is readying for a Phase III trial next year of narcolepsy therapy AXS-12 after the candidate met the primary endpoint of a Phase II trial, sending the company's stock up $5.99 (15%) to $45.61...
BC Extra | Aug 15, 2019
Company News

Harmony crosses finish line with Wakix for narcolepsy

FDA approved Wakix pitolisant Thursday, almost two years after Harmony gained U.S. rights to the narcolepsy drug. During 2017-18, Harmony raised $295 million to push it through registration. In October 2017, Harmony Biosciences LLC (Plymouth...
BC Extra | Apr 5, 2019
Politics & Policy

DOJ releases details on biopharma settlements for alleged kickbacks to co-pay charities

Alexion has been added to the list of biopharma companies that have settled allegations of kickbacks to charitable patient assistance programs, according to a Department of Justice statement released Thursday. United Therapeutics Corp. (NASDAQ:UTHR), Actelion...
BC Week In Review | Apr 5, 2019
Clinical News

Jazz planning NDA for narcolepsy therapy JZP-258

Jazz said JZP-258 met the primary endpoint in a Phase III trial to treat cataplexy and excessive daytime sleepiness in adults with narcolepsy. Jazz Pharmaceuticals plc (NASDAQ:JAZZ) will meet with FDA to discuss the data...
BC Week In Review | Nov 2, 2018
Clinical News

Jazz's Xyrem approved for pediatric narcolepsy with cataplexy

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) said FDA approved an sNDA for Xyrem sodium oxybate to treat cataplexy, or excessive daytime sleepiness, in narcolepsy patients ages seven and older. The drug was previously approved only for adults....
BioCentury | Oct 6, 2018

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...
BC Extra | Mar 1, 2018
Politics & Policy

Biopharma wants another bite at the donut hole

Lobbyists for the biopharmaceutical industry are scrambling to use a must-pass spending bill as a vehicle to roll back provisions in a recently enacted law that would impose tens of billions of dollars in costs...
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