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...
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...
16:16 , Oct 4, 2018 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Tuberculosis Cell culture and mouse studies identified a M. tuberculosis qcrB inhibitor that could help treat tuberculosis (TB). Screening of a compound library in cell-based assays identified a morpholino-thiophene-based compound that inhibited the growth...
17:33 , Sep 26, 2018 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Clostridium Patient sample and mouse studies suggest fungal CYP51 inhibitors and other antifungal agents could enhance the efficacy of fecal microbiotal transplants to treat Clostridium difficile infection (CDI). In 16 CDI patients receiving fecal...
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...
19:32 , Sep 10, 2018 |  BC Innovations  |  Distillery Therapeutics

Pulmonary

INDICATION: Acute lung injury Mouse studies suggest inhibiting ZMPSTE24 with Kaletra lopinavir/ritonavir could help treat acute lung injury (ALI). In a mouse model of ventilator-induced ALI, systemic ZMPSTE24 knockout decreased markers of injury and increased...
17:59 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

FDA approves Biocodex's Diacomit for Dravet syndrome seizures

FDA approved Diacomit stiripentol from Laboratoires Biocodex (Gentilly, France) to treat seizures associated with Dravet syndrome in patients ages two and older who are taking clobazam. The anticonvulsant is a cytochrome P450 (p450) inhibitor. Laboratoires...
01:46 , Aug 17, 2018 |  BC Innovations  |  Targets & Mechanisms

Unsaturated remyelination

Enzymes downstream in cholesterol biosynthesis could provide new ways to stimulate remyelination that avoid the baggage of previously identified multiple sclerosis targets, according to a group at Case Western. The university is spinning out Convelo...
18:29 , Aug 10, 2018 |  BC Week In Review  |  Clinical News

Strongbridge's Cushing syndrome candidate meets in Phase III

Strongbridge Biopharma plc (NASDAQ:SBBP) said Recorlev levoketoconazole met the primary and secondary endpoints in the Phase III SONICS trial to treat endogenous Cushing syndrome. On the 94-patient trial's primary endpoint, 30% of patients achieved normalization...