19:15 , Feb 22, 2019 |  BC Week In Review  |  Clinical News

FDA issues handful of new PDUFA dates

With the government shutdown resolved, FDA has accepted a handful of applications for review during the beginning Feb. 18, according to company announcements. FDA granted Priority Review to two applications from Genentech Inc. for entrectinib...
22:39 , Feb 19, 2019 |  BC Extra  |  Company News

FDA issues handful of new PDUFA dates

With the government shutdown resolved, FDA has accepted a handful of applications for review, according to company announcements early this week. FDA granted Priority Review to two applications from Genentech Inc. for entrectinib and polatuzumab...
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...
02:33 , Dec 8, 2018 |  BioCentury  |  Product Development

Intermittent move beyond Blincyto

A swath of data at ASH shows that companies have been able to move beyond the 28-day continuous dosing of Amgen Inc.’s first-generation BiTE, Blincyto, to build next-generation antibodies with more convenient, intermittent dosing and...
21:52 , Jul 13, 2018 |  BioCentury  |  Strategy

Roche’s partnering priority

As James Sabry gets set to lead partnering for all of Roche pharma, his first order of business might be to build out the company’s late-stage pipeline ahead of an impending patent cliff that puts...
18:08 , May 11, 2018 |  BC Week In Review  |  Financial News

Provention plans IPO, reveals MacroGenics deal

Autoimmune and infectious disease company Provention Bio Inc. (Lebanon, N.J.) proposed on May 9 to raise up to $50 million in an IPO underwritten by MDB Capital Group. The company's pipeline includes several candidates in-licensed...
20:14 , May 10, 2018 |  BC Extra  |  Financial News

Provention plans IPO, reveals MacroGenics deal

Autoimmune and infectious disease company Provention Bio Inc. (Lebanon, N.J.) proposed to raise up to $50 million in an IPO underwritten by MDB Capital Group. The company's pipeline includes several candidates in-licensed from other companies...
18:22 , Apr 13, 2018 |  BC Extra  |  Preclinical News

NCI identifies new lymphoma subtypes

A New England Journal of Medicine paper out of NIH's National Cancer Institute revealed new subtypes of diffuse large B cell lymphomas (DLBCL) that could lead to more targeted therapeutic strategies. The report adds to...
19:53 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

Genentech's polatuzumab vedotin meets in Phase II for DLBCL

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) reported additional data from the Phase II portion of the Phase Ib/II GO29365 trial in 80 patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL)...
21:40 , Dec 1, 2017 |  BC Week In Review  |  Clinical News

Genentech reports Phase II data of polatuzumab vedotin in DLBCL

In an abstract released ahead of the American Society of Hematology (ASH) meeting, the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) reported data from 80 evaluable patients with relapsed or refractory diffuse large B cell...