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4:42 PM, Feb 16, 2018  |  BC Extra | Preclinical News

Stem cell-based vaccine could give broad immunity against cancers

A Stanford University team published a paper in Cell Stem Cell showing a stem cell-based vaccine prevented tumor growth and reactivated the immune system in several cancer models. The therapy could grant broad immunity against...
4:27 PM, Feb 16, 2018  |  BC Extra | Company News

FDA grants EAP designation to Guardant's NGS-based liquid biopsy

Guardant Health Inc. (Redwood City, Calif.) said FDA granted Expedited Access Pathway (EAP) designation to its Guardant360 assay, a comprehensive next-generation sequencing (NGS)-based liquid biopsy test for advanced cancer. The company plans to submit a...
4:23 PM, Feb 16, 2018  |  BC Extra | Politics & Policy

FDA to hold patient meeting on opioid use disorder

FDA is asking individuals with opioid use disorder to testify at a public meeting April 17. The event is part of the agency's Patient Focused Drug Development (PFDD) initiative, which includes a series of public...
4:21 PM, Feb 16, 2018  |  BC Extra | Company News

FDA approves Imfinzi for NSCLC that has not progressed

FDA approved Imfinzi durvalumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat stage III unresectable non-small cell lung cancer that has not progressed following chemoradiation. The agency said this is the first drug approved for the...
4:20 PM, Feb 16, 2018  |  BC Extra | Financial News

Addex proposes CHF40M private placement

Addex Therapeutics Ltd. (SIX:ADXN) proposed Thursday to raise up to CHF40 million ($42.7 million) through the sale of 12.8 million shares at CHF3.43 in a private placement. The company said CHF30 million of the offering...
4:08 PM, Feb 16, 2018  |  BC Extra | Financial News

Alkermes hits high following IL-2 deal

Alkermes plc (NASDAQ:ALKS) hit a 52-week high of $71.22 on Friday on the heels of Wednesday's multibillion dollar deal between Nektar Therapeutics (NASDAQ:NKTR) and Bristol-Myers Squibb Co. (NYSE:BMY) involving NKTR-214. A note from Jefferies analyst...
3:49 PM, Feb 16, 2018  |  BC Extra | Preclinical News

Improved dopamine receptor agonists for Parkinson’s

A study published in Nature Communications showed that non-catechol dopamine D1 receptor agonists reduced receptor desensitization, suggesting the compounds could help treat Parkinson's disease better than available dopamine replacement therapies. Marketed D1 receptor selective agonists contain...
2:12 PM, Feb 16, 2018  |  BC Extra | Company News

FDA panel to review volanesorsen from Akcea, Ionis

Akcea Therapeutics Inc. (NASDAQ:AKCA) said FDA's Division of Metabolism and Endocrinology Products will hold an advisory committee meeting to review an NDA for volanesorsen (IONIS-APOCIIIRx) to treat familial chylomicronemia syndrome (FCS), a rare lipid disorder...
10:08 AM, Feb 16, 2018  |  BC Extra | Financial News

Amicus raises $300M in bumped-up follow-on

Amicus Therapeutics Inc. (NASDAQ:FOLD) raised $300 million through the sale of 19.4 million shares at $15.50 in an upsized follow-on underwritten by J.P. Morgan, Goldman Sachs, Cowen, Leerink and BofA Merrill Lynch. The price is...
4:42 PM, Feb 15, 2018  |  BC Extra | Company News

Vertex: ball is in France’s court

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said it has tried six times to land on a reimbursement price with French authorities for its cystic fibrosis drug Orkambi ivacaftor/lumacaftor. Negotiations reached an “impasse” when the government made a...

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