02:03 , Feb 23, 2019 |  BioCentury  |  Product Development

Benchmarks for NASH

Benchmarking clinical value in NASH will require more than the topline data reported this week by Intercept Pharmaceuticals Inc. The readout gained Ocaliva obeticholic acid the title of first NASH therapy to meet in Phase...
22:19 , Feb 22, 2019 |  BC Extra  |  Company News

Karyopharm down as FDA reviewers cast doubt on selinexor's benefit

Karyopharm Therapeutics Inc. (NASDAQ:KPTI) lost $3.90 (43%) to $5.07 on Friday after FDA reviewers wrote in briefing documents that it is unclear whether treatment with selinexor provides a clinically meaningful benefit that outweighs the risks...
16:57 , Feb 22, 2019 |  BC Week In Review  |  Clinical News

Intercept's NASH therapy heads for submissions after meeting Phase III endpoint

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) intends to submit regulatory applications next half for obeticholic acid (OCA) after new data showed the compound met one of two primary endpoints in the Phase III REGENERATE trial to treat...
22:35 , Feb 21, 2019 |  BC Extra  |  Company News

JPM, Berkshire, Amazon venture to test how best to shake up benefits scheme

The ABC healthcare venture will test this year how changes in traditional healthcare could drive patient satisfaction, lower costs and improve value -- before it implements any strategy. Details on the secretive venture, launched last...
17:52 , Feb 19, 2019 |  BC Extra  |  Clinical News

Intercept's NASH therapy heads for submissions after meeting Phase III endpoint

Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) intends to submit regulatory applications next half for obeticholic acid (OCA) after new data showed the compound met one of two primary endpoints in the Phase III REGENERATE study to treat...
03:20 , Feb 16, 2019 |  BioCentury  |  Product Development

ADCs’ inflection point

Industry is writing a new rule book for antibody-drug conjugates that could take the modality beyond the one-size-fits-all approach that has limited its success. By 2Q20, late-stage data from at least four ADCs testing new...
01:20 , Feb 16, 2019 |  BC Extra  |  Company News

Judge skeptical of JHL's defense in Genentech case

U.S. District Judge William Alsup met with skepticism arguments made by lawyers for JHL Biotech Inc. (Zhubei, Taiwan) during a motion hearing Thursday for Genentech Inc.'s civil case against the Taiwanese company. Genentech filed the...
20:03 , Feb 15, 2019 |  BC Week In Review  |  Clinical News

GenSight's GS010 misses in second Phase III for Leber hereditary optic neuropathy

GenSight Biologics S.A. (Euronext:SIGHT) reported that GS010 (rAAV2/2-ND4) missed the primary endpoint of improving visual acuity in the Phase III RESCUE trial to treat Leber hereditary optic neuropathy (LHON). On the 39-patient trial's primary endpoint,...
18:23 , Feb 15, 2019 |  BC Week In Review  |  Financial News

Andera, Canaan lead Grey Wolf £10M A round

Cancer immunotherapy company Grey Wolf Therapeutics closed the second tranche of its total £10 million ($12.9 million) series A round to fund development of its immuno-oncology therapies to increase tumor visibility. The round was led...
18:21 , Feb 15, 2019 |  BC Week In Review  |  Company News

Clinigen adds U.S. rights to Proleukin

Clinigen Group plc (LSE:CLIN) jumped 134.5p (18%) to 872p on Feb. 13 after the U.K. specialty pharma said it will acquire U.S. rights to Proleukin aldesleukin from Novartis AG (NYSE:NVS; SIX:NOVN), giving Clinigen worldwide rights...