BioCentury | Nov 30, 2020
Management Tracks

New CMO and Takeda alum Palmer adds to Ascletis’ push into NASH

Ascletis is looking to Takeda veteran Melissa Palmer to move its pipeline of in-licensed and homegrown NASH programs forward. Ascletis Pharma Inc. (HKEX:1672) announced Monday that Palmer, the former head of liver disease clinical development at...
BioCentury | Oct 28, 2020
Distillery Therapeutics

Targeting the NMDA receptor-TRPM4 complex for neurodegeneration

DISEASE CATEGORY: Neurology INDICATION: Stroke; neurology Disruption of the NMDA receptor-TRPM4 complex could treat ischemic stroke and other neurodegenerative diseases with NMDA receptor involvement. In mouse hippocampal neurons deprived of oxygen and glucose or treated...
BioCentury | Aug 28, 2020
Product Development

Data Bytes: NASH pipeline still full despite high-profile setbacks

NASH is still any company’s game after two of the most advanced candidates experienced setbacks this year, and both the programs have candidates behind them in their classes: FXR inhibitors and PPAR ɑ/ƍ agonists. In...
BioCentury | Jul 1, 2020
Product Development

Histology data builds on growing confidence around Akero’s NASH candidate

Akero’s biopsy data is the positive news the NASH field needed after FDA declined to approve what would have been the first drug for the indication earlier this week. Akero Therapeutics Inc. (NASDAQ:AKRO) rose $8.45...
BioCentury | Jun 29, 2020
Regulation

Intercept: Surrogate endpoint not enough for FDA to approve NASH therapy

Intercept believes FDA’s “evolving” thinking on efficacy endpoints for NASH therapies led to the complete response letter for Ocaliva that destroyed about two-fifths of the company’s market value on Monday. The company said FDA declined...
BioCentury | May 29, 2020
Distillery Therapeutics

Inhibitors of an orphan nuclear receptor for prostate cancer

DISEASE CATEGORY: Cancer INDICATION: Prostate cancer Small molecule inhibitors of NR2F2, an orphan nuclear receptor, could treat prostate cancer. High throughput screening of >370,000 compounds for NR2F2 inhibitors yielded two dimethoxybenzene-based molecules that blocked the...
BioCentury | May 23, 2020
Product Development

Further delays at FDA for Intercept’s NASH therapy

Four months after Intercept disclosed FDA had pushed out the PDUFA date for its non-alcoholic steatohepatitis therapy to June 26, the company is now expecting a further delay in the agency’s review of obeticholic acid....
BioCentury | May 6, 2020
Product Development

Phase II data show Novo’s semaglutide leads the pack on NASH resolution

Novo Nordisk disclosed top-line Phase II data in NASH for semaglutide that puts the GLP-1 agonist in pole position with respect to mechanisms addressing NASH resolution. The readout came as Novo Nordisk A/S (CSE:NOVO B;...
BioCentury | Apr 30, 2020
Distillery Therapeutics

Inhibiting an NMDA receptor to reduce lupus neurological symptoms

DISEASE CATEGORY: Autoimmune disease INDICATION: Lupus Antagonists of the NMDA receptor GRIN2A could treat systemic lupus erythematosus (SLE), an autoimmune disease that can cause neuropsychiatric symptoms including memory impairment. Cell-based assays revealed that a patient-derived...
BioCentury | Apr 24, 2020
Product Development

Sanofi sets MS submission goals for Principia-partnered Btk inhibitor, details Phase II data

Two months after Sanofi announced plans to send its oral multiple sclerosis therapy into Phase III testing, the company unveiled the detailed Phase IIb data from recurring MS patients driving the Btk inhibitor’s clinical advancement....
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