BioCentury | Sep 5, 2020
Product Development

Sept. 4 Quick Takes: HiFiBiO in second cancer deal with Gilead; plus Bridgewest-Pfizer, Amarin, Intercept, Santhera-Idorsia, CMS, Ascendis

...is down $0.74 (15%) to $4.30 from its Wednesday close (see “Amarin Set to Appeal”).Intercept cutting staff Intercept Pharmaceuticals Inc....
...6ecdca, int-747, oca) Vamorolone (VBP15) Gilead Sciences Inc. Kite Pharma Inc. HiFiBiO Therapeutics Amarin Corp. plc Dr. Reddy's Laboratories Ltd. Hikma Pharmaceuticals plc Intercept Pharmaceuticals Inc. Santhera...
BioCentury | Sep 2, 2020
Deals

NASH therapy from Novartis adds 15th program to Boston Pharmaceuticals’ pipeline

...most advanced candidates: a complete response letter for Ocaliva obeticholic acid, an FXR inhibitor from Intercept Pharmaceuticals Inc....
BioCentury | Aug 28, 2020
Product Development

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

...issued a complete response letter for the most advanced NASH candidate, Ocaliva obeticholic acid from Intercept Pharmaceuticals Inc....
...Farnesoid X receptorPPAR ɑ –  Peroxisome proliferation activated receptor alphaPPAR ƍ –  Peroxisome proliferation activated receptor delta Amanda Micklus Intercept Pharmaceuticals Inc. Genfit...
BioCentury | Jul 10, 2020
Finance

How buysiders are sizing up commercial launches during the pandemic

...the pandemic will intensify the tendency to “short the launch.” Although Ocaliva obeticholic acid from Intercept Pharmaceuticals Inc....
BioCentury | Jul 6, 2020
Product Development

NASH ups and downs, COVID-19 vaccines & real-world data for diagnostics: a BioCentury podcast

...Martz discuss how endpoints factored into FDA’s complete response letter for obeticholic acid (OCA) from Intercept Pharmaceuticals Inc....
...diagnostic and serology tests for COVID-19 (see “Accelerating the Fight Against COVID-19” ). BC Staff Pfizer Inc. BioNTech AG Intercept Pharmaceuticals Inc. Akero...
BioCentury | Jul 1, 2020
Product Development

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

...The histology data come in the wake of a complete response letter issued to Intercept Pharmaceuticals Inc....
...Fibroblast growth factor 21 FXR (NR1H4) - Farnesoid X receptor Lauren Martz, Senior Editor AKR-001 Akero Therapeutics Inc. Intercept Pharmaceuticals Inc. Fibroblast...
BioCentury | Jun 29, 2020
Regulation

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

...non-alcoholic steatohepatitis, citing a risk-benefit profile that remains uncertain based on a surrogate efficacy endpoint. Intercept Pharmaceuticals Inc....
...Targets FXR (NR1H4) - Farnesoid X receptor Paul Bonanos, Associate Editor Ocaliva, obeticholic acid (DSP-1747, 6ecdca, int-747, oca) Intercept Pharmaceuticals Inc. Farnesoid...
BioCentury | Jun 17, 2020
Product Development

Daily Chart: Inventiva vs. Intercept in NASH

...18-month readout for obeticholic acid. Stephen Hansen, Associate Editor lanifibranor (iva337) Ocaliva, obeticholic acid (DSP-1747, 6ecdca, int-747, oca) Inventiva S.A. Intercept Pharmaceuticals Inc....
BioCentury | May 30, 2020
Management Tracks

Schneyer named Acadia CBO; plus Hansa, MaaT, iOnctura, First Light, Oligomerix, Galecto and Hyloris

...is CEO of Arena Pharmaceuticals Inc. (NASDAQ:ARNA). Shapiro was CMO and head of R&D at Intercept Pharmaceuticals Inc....
BioCentury | May 23, 2020
Product Development

Further delays at FDA for Intercept’s NASH therapy

...the company is now expecting a further delay in the agency’s review of obeticholic acid. Intercept Pharmaceuticals Inc....
...acid as Ocaliva for primary biliary cholangitis. Sandi Wong, Assistant Editor Ocaliva, obeticholic acid (DSP-1747, 6ecdca, int-747, oca) Intercept Pharmaceuticals Inc. Farnesoid...
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1 - 10 of 253
BioCentury | Sep 5, 2020
Product Development

Sept. 4 Quick Takes: HiFiBiO in second cancer deal with Gilead; plus Bridgewest-Pfizer, Amarin, Intercept, Santhera-Idorsia, CMS, Ascendis

...is down $0.74 (15%) to $4.30 from its Wednesday close (see “Amarin Set to Appeal”).Intercept cutting staff Intercept Pharmaceuticals Inc....
...6ecdca, int-747, oca) Vamorolone (VBP15) Gilead Sciences Inc. Kite Pharma Inc. HiFiBiO Therapeutics Amarin Corp. plc Dr. Reddy's Laboratories Ltd. Hikma Pharmaceuticals plc Intercept Pharmaceuticals Inc. Santhera...
BioCentury | Sep 2, 2020
Deals

NASH therapy from Novartis adds 15th program to Boston Pharmaceuticals’ pipeline

...most advanced candidates: a complete response letter for Ocaliva obeticholic acid, an FXR inhibitor from Intercept Pharmaceuticals Inc....
BioCentury | Aug 28, 2020
Product Development

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

...issued a complete response letter for the most advanced NASH candidate, Ocaliva obeticholic acid from Intercept Pharmaceuticals Inc....
...Farnesoid X receptorPPAR ɑ –  Peroxisome proliferation activated receptor alphaPPAR ƍ –  Peroxisome proliferation activated receptor delta Amanda Micklus Intercept Pharmaceuticals Inc. Genfit...
BioCentury | Jul 10, 2020
Finance

How buysiders are sizing up commercial launches during the pandemic

...the pandemic will intensify the tendency to “short the launch.” Although Ocaliva obeticholic acid from Intercept Pharmaceuticals Inc....
BioCentury | Jul 6, 2020
Product Development

NASH ups and downs, COVID-19 vaccines & real-world data for diagnostics: a BioCentury podcast

...Martz discuss how endpoints factored into FDA’s complete response letter for obeticholic acid (OCA) from Intercept Pharmaceuticals Inc....
...diagnostic and serology tests for COVID-19 (see “Accelerating the Fight Against COVID-19” ). BC Staff Pfizer Inc. BioNTech AG Intercept Pharmaceuticals Inc. Akero...
BioCentury | Jul 1, 2020
Product Development

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

...The histology data come in the wake of a complete response letter issued to Intercept Pharmaceuticals Inc....
...Fibroblast growth factor 21 FXR (NR1H4) - Farnesoid X receptor Lauren Martz, Senior Editor AKR-001 Akero Therapeutics Inc. Intercept Pharmaceuticals Inc. Fibroblast...
BioCentury | Jun 29, 2020
Regulation

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

...non-alcoholic steatohepatitis, citing a risk-benefit profile that remains uncertain based on a surrogate efficacy endpoint. Intercept Pharmaceuticals Inc....
...Targets FXR (NR1H4) - Farnesoid X receptor Paul Bonanos, Associate Editor Ocaliva, obeticholic acid (DSP-1747, 6ecdca, int-747, oca) Intercept Pharmaceuticals Inc. Farnesoid...
BioCentury | Jun 17, 2020
Product Development

Daily Chart: Inventiva vs. Intercept in NASH

...18-month readout for obeticholic acid. Stephen Hansen, Associate Editor lanifibranor (iva337) Ocaliva, obeticholic acid (DSP-1747, 6ecdca, int-747, oca) Inventiva S.A. Intercept Pharmaceuticals Inc....
BioCentury | May 30, 2020
Management Tracks

Schneyer named Acadia CBO; plus Hansa, MaaT, iOnctura, First Light, Oligomerix, Galecto and Hyloris

...is CEO of Arena Pharmaceuticals Inc. (NASDAQ:ARNA). Shapiro was CMO and head of R&D at Intercept Pharmaceuticals Inc....
BioCentury | May 23, 2020
Product Development

Further delays at FDA for Intercept’s NASH therapy

...the company is now expecting a further delay in the agency’s review of obeticholic acid. Intercept Pharmaceuticals Inc....
...acid as Ocaliva for primary biliary cholangitis. Sandi Wong, Assistant Editor Ocaliva, obeticholic acid (DSP-1747, 6ecdca, int-747, oca) Intercept Pharmaceuticals Inc. Farnesoid...
Items per page:
1 - 10 of 253