19:46 , Nov 1, 2018 |  BC Innovations  |  Emerging Company Profile

Secarna’s next-gen oligos

Secarna Pharmaceuticals GmbH’s antisense oligonucleotides for immuno-oncology could have better tissue penetration than small molecules and antibodies against the same targets. The company was established in 2015 by the founders and investors who launched antisense...
22:52 , Oct 26, 2018 |  BC Extra  |  Company News

Management tracks: Principia, Orexo, Polyphor, MeiraGTx

Immunology and oncology company Principia Biopharma Inc. (NASDAQ:PRNB) hired Dolca Thomas as CMO. She succeeds Steve Gourlay, who will remain as a senior medical adviser through mid-2019. Thomas was VP and global head of translational...
16:36 , Oct 26, 2018 |  BC Week In Review  |  Clinical News

Oyster Point's OC-01 dry eye nasal spray meets in Phase IIb

Oyster Point Pharma Inc. (Princeton, N.J.) said all three doses of OC-01 met the primary endpoint of improving tear production in the Phase IIb ONSET trial to treat dry eye disease. The company also reported...
18:02 , Oct 25, 2018 |  BC Innovations  |  Distillery Therapeutics

Neurology

INDICATION: Cognitive dysfunction Mouse studies suggest inhibiting microglial activation could help treat obesity-associated cognitive dysfunction. In hippocampal tissue from a mouse model of obesity-associated cognitive dysfunction, microglia activation scores were higher than in normal mice....
13:07 , Oct 24, 2018 |  BC Extra  |  Clinical News

Oyster Point's OC-01 dry eye nasal spray meets in Phase IIb

Oyster Point Pharma Inc. (Princeton, N.J.) said all three doses of OC-01 met the primary endpoint of improving tear production in the Phase IIb ONSET trial to treat dry eye disease. The company also reported...
17:28 , Sep 14, 2018 |  BC Week In Review  |  Company News

ICER finds opioid use disorder treatments not cost-effective

In a draft evidence report, ICER found that newer extended-release formulations of medication-assisted treatments (MATs) for opioid use disorder were not cost-effective compared with generic medicines. The institute compared the clinical effectiveness and value of...
18:42 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

China approves Hengrui breast cancer drug on Phase II data

Jiangsu Hengrui Medicine Co. Ltd. (Shanghai:600276) said China’s State Drug Administration conditionally approved pyrotinib (SHR-1258, HTI-1001) in combination with capecitabine to treat HER2-positive, advanced or metastatic breast cancer in patients previously treated with anthracycline or...
20:57 , Aug 22, 2018 |  BC Extra  |  Company News

China approves Hengrui breast cancer drug on Phase II data

Jiangsu Hengrui Medicine Co. Ltd. (Shanghai:600276) said China’s State Drug Administration conditionally approved pyrotinib in combination with capecitabine to treat HER2-positive, advanced or metastatic breast cancer in patients previously treated with anthracycline or taxane chemotherapy....
22:15 , Aug 2, 2018 |  BC Innovations  |  Tools & Techniques

Model firsts

By combining disparate data into coherent mechanistic models, quantitative systems pharmacology is becoming a key tool for picking the right dose for first-in-human trials and other early make-or-break decisions. Advocates see it as part of...
16:21 , Jul 20, 2018 |  BC Week In Review  |  Clinical News

FDA again reviewing Braeburn's opioid addiction candidate

Braeburn Pharmaceuticals Inc. (Princeton, N.J.) said FDA accepted and granted Priority Review to a resubmitted NDA for CAM2038 to treat opioid use disorder. The candidate, a ready-to-use prefilled syringe containing a lipid solution of buprenorphine,...