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21129 items
4:34 PM, Nov 20, 2018  |  BC Extra | Company News

Deal with Idorsia gives Santhera shot at second DMD candidate

In a deal that will make Idorsia Ltd. (SIX:IDIA) its largest shareholder, Santhera Pharmaceuticals Holding AG (SIX:SANN) gained an option to exclusively in-license a second Duchenne muscular dystrophy candidate: vamorolone (VBP15). Santhera CEO Thomas Meier told...
3:46 PM, Nov 20, 2018  |  BC Extra | Company News

ICER to review peanut allergy therapies from Aimmune, DBV

The Institute for Clinical and Economic Review (ICER) will review peanut allergy therapies AR101 from Aimmune Therapeutics Inc. (NASDAQ:AIMT) and Viaskin Peanut from DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT). ICER announced the review in a scoping...
3:35 PM, Nov 20, 2018  |  BC Extra | Company News

Merck KGaA, Palantir team up to drive cancer research data sharing and integration

Merck KGaA (Xetra:MRK) and big data company Palantir Technologies (Palo Alto, Calif.) plan to create a JV under the name Syntropy to help facilitate collaboration among cancer researchers. Syntropy will offer a data integration software platform...
2:05 PM, Nov 20, 2018  |  BC Extra | Company News

Ascletis adds marketed HBV drug from Roche to Chinese portfolio

With one marketed HCV therapy in China and another under review, Ascletis Pharma Inc. (HKSE:1672) extended its commercial viral hepatitis footprint in the country on Tuesday with exclusive rights to marketed HBV drug Pegasys peginterferon...
12:57 PM, Nov 20, 2018  |  BC Extra | Company News

Pear, Sandoz launch first FDA-approved digital therapeutic

Pear Therapeutics Inc. (Boston, Mass.) and Sandoz launched reSET, the first FDA-authorized prescription digital therapeutic, in the U.S. FDA approved reSET in September to treat substance use disorder in conjunction with outpatient clinician-delivered care. The therapy...
12:53 PM, Nov 20, 2018  |  BC Extra | Company News

On heels of Sobi deal, Novimmune's emapalumab gets FDA approval

FDA approved Gamifant emapalumab-lzsg from Novimmune S.A. (Plan-les-Ouates, Switzerland), giving Novimmune a Priority Review voucher and the first U.S.-approved drug for hemophagocytic lymphohistiocytosis (HLH). The approval comes just four months after Swedish Orphan Biovitrum AB...
11:13 AM, Nov 20, 2018  |  BC Extra | Company News

REMS prep pushes back Sage's Zulresso timeline

Sage Therapeutics Inc. (NASDAQ:SAGE) anticipates a June 2019 launch of postpartum depression candidate Zulresso brexanolone after FDA pushed back the PDUFA date three months to March 19. Sage has said Zulresso could become the first...
3:06 AM, Nov 20, 2018  |  BC Extra | Company News

Leo Pharma invests in PellePharm to develop rare skin disease therapy

Dermatology company Leo Pharma A/S (Ballerup, Denmark) gained an option to acquire PellePharm Inc. (Menlo Park, Calif.) and will help fund development of PellePharm's patidegib to treat rare skin cancer Gorlin syndrome. PellePharm will receive $70...
3:44 PM, Nov 19, 2018  |  BC Extra | Company News

Management tracks: Brickell, Genevant

Dermatology company Brickell Biotech Inc. (Boulder, Colo.) hired Robert Brown as CEO, effective Jan. 1. He will replace co-founder and CEO Reginald Hardy, who will remain on the board and serve as special adviser to...
3:15 PM, Nov 19, 2018  |  BC Extra | Company News

Immunocore, Genentech team up to bring soluble TCR therapy into clinic

Despite losing at least five key executives this year, Immunocore Ltd. (Abingdon, U.K.) has teamed up with Genentech Inc. to advance the first soluble TCR-based therapy from their existing deal into clinical testing for solid...