23:32 , Aug 7, 2019 |  BC Extra  |  Clinical News

Aug. 7 Clinical Quick Takes: Waylivra cuts triglycerides in Phase III; plus Lynparza, Moderna, Athenex and Opthea

Waylivra hits Phase II/III endpoint in FPL  Akcea Therapeutics Inc. (NASDAQ:AKCA) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) said Waylivra volanesorsen cut serum triglyceride levels by 88% vs. 22% for placebo (p<0.001) in patients with familial partial...
14:18 , May 20, 2019 |  BC Innovations  |  Distillery Techniques

RB1 alterations predict survival in mCRPC patients treated with Zytiga or Xtandi

TECHNIQUES CATEGORY: Biomarkers TECHNOLOGY: Gene profiling Alterations in RB1 could help predict survival in mCRPC patients treated with Zytiga or Xtandi. In 429 patients with mCRPC, analysis of whole-exome sequencing, gene expression, histopathology, survival and...
00:27 , Mar 16, 2019 |  BioCentury  |  Politics, Policy & Law

Spreading the costs and pain in Part D

The Trump administration’s proposed changes to Medicare Part D would shift costs from the federal government to patients, manufacturers and insurers, all of which are sure to lobby against it and derail it in Congress....
22:14 , Mar 1, 2019 |  BioCentury  |  Product Development

Prostate cancer disrupted

Two imminent disruptions threaten to upend the treatment landscape for prostate cancer, changing who gets anti-androgen therapies and ushering in the first new MOAs in decades. The launch of generic abiraterone means next generation anti-androgens...
15:59 , Feb 6, 2019 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Prostate cancer In vitro and mouse studies identified a chromenecarbaldehyde-based IRE1 inhibitor that could help treat prostate cancer. Optimization and in vitro binding assays of a family of tool compound IRE1 inhibitors yielded a...
03:14 , Dec 8, 2018 |  BioCentury  |  Regulation

Path to opioid-free pain relief

To jump-start development of analgesics that can help stem the opioid crisis, companies want FDA’s upcoming guidelines to reduce uncertainty around outcomes that constitute clinically meaningful opioid sparing. But while an advisory panel put some...
13:10 , Dec 4, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Prostate cancer Cell culture and mouse studies suggest inhibiting Hsp70 could help treat prostate cancer resistant to Xtandi enzalutamide and/or Zytiga abiraterone acetate. In human prostate cancer cell lines, high Hsp70 levels were associated...
21:38 , Nov 30, 2018 |  BC Week In Review  |  Company News

CAFC denies J&J's Zytiga patent protection appeal

The U.S. Court of Appeals on Nov. 21 denied a request for a temporary injunction against generic versions of Zytiga abiraterone acetate, filed by Johnson & Johnson (NYSE:JNJ) after a district court invalidated its patent...
19:56 , Nov 2, 2018 |  BC Week In Review  |  Company News

J&J appeals district court decision invalidating Zytiga patent

Johnson & Johnson (NYSE:JNJ) on Oct. 31 filed to appeal a district court decision that will permit generic versions of prostate cancer drug Zytiga abiraterone acetate to launch after Oct. 31, according to company spokesperson...
19:44 , Sep 14, 2018 |  BioCentury  |  Emerging Company Profile

Laekna’s jumping off place

Chinese biotech Laekna Therapeutics Shanghai Co. Ltd. is jump-starting its pipeline with a trio of clinical cancer compounds from Novartis AG. The safety of the lead candidate and its potential to synergize with the other...