20:49 , May 24, 2019 |  BioCentury  |  Finance

How Europe’s hotspots of innovation could fuel its rise as a global player in new modalities

It is clear that Europe has hotspots of innovation that are discovering and developing the next wave of new therapeutic modalities. Nearly every category of new modality has a European champion, with clusters forming around...
22:18 , May 20, 2019 |  BioCentury  |  Product Development

Making Orphan drug prices work for society

The Orphan Drug Act worked too well. It didn’t just stimulate development of therapies for rare diseases, it reoriented huge swaths of the industry to the pursuit, all attracted by the high prices and product...
14:20 , May 20, 2019 |  BC Innovations  |  Distillery Therapeutics

The OXPHOS complex I inhibitor IACS-010759 for mantle cell and B cell lymphoma

DISEASE CATEGORY: Cancer INDICATION: Mantle cell lymphoma (MCL); B cell lymphoma Patient sample, cell culture and mouse studies identified an OXPHOS complex I inhibitor that could help treat MCL and B cell lymphoma that are...
20:53 , May 17, 2019 |  BC Extra  |  Clinical News

AbbVie's antibody-drug conjugate misses mark in Phase III GBM trial

In a second setback for glioblastoma multiforme patients this month, AbbVie said its depatuxizumab mafodotin missed the primary endpoint of improving overall survival in the Phase III INTELLANCE-1 for newly diagnosed EGFR-amplified GBM. AbbVie Inc....
22:43 , May 15, 2019 |  BC Extra  |  Company News

May 15 Company Quick Takes: Approvals for Bavencio in RCC, Venclexta-Gazyva combo; plus Adaptimmune, Alpine, Advaxis

Bavencio gets RCC approval with Inlyta  FDA approved Bavencio avelumab from Merck KGaA (Xetra:MRK) and Pfizer Inc. (NYSE:PFE) for first-line treatment of advanced renal cell carcinoma in combination with Pfizer's Inlyta axitinib, making Bavencio the...
22:34 , May 14, 2019 |  BC Extra  |  Clinical News

May 14 Clinical Quick Takes: Myovant, Solid, Minerva, Modus, Zealand

Myovant tumbles after Phase III uterine fibroid data  Myovant Sciences Ltd. (NYSE:MYOV) lost $4.39 (25%) to $12.83 Tuesday despite reporting that relugolix (TAK-385) met the primary endpoint of a better response rate than placebo in...
21:02 , May 14, 2019 |  BC Extra  |  Company News

May 14 Company Quick Takes: F-star rejiggers Merck KGaA deal; plus Roche/Spark, AbbVie/Boehringer, Ipsen

F-star to keep lead bispecific in new deal with Merck KGaA   F-star Biotechnology Ltd. (Cambridge, U.K.) reconfigured its 2017 bispecific antibody deal with Merck KGaA (Xetra:MRK) and will now retain rights to lead candidate...
21:32 , May 13, 2019 |  BC Extra  |  Financial News

Philogen bypasses VCs, taps Italian syndicate for €62M to fuel late stage cancer programs

With €62 million ($69.6 million) in series A cash to carry its two late-stage candidates through clinical development, Philogen will soon have to decide whether to rely on additional deals to find commercialization partners, or...
19:15 , May 10, 2019 |  BioCentury  |  Emerging Company Profile

HopeMed: Targeting PRLR for chronic diseases

HopeMed spun out of Peking University last month with a mAb against the prolactin receptor from Bayer that could provide a safe alternative to competing therapies for endometriosis and alopecia. Hope Medicine Inc. has exclusive...
18:21 , May 10, 2019 |  BC Extra  |  Politics & Policy

Final interchangeability guidance allows non-U.S.-licensed comparators

FDA has released its final guidance on the interchangeability of biosimilars with one notable change from the draft version: sponsors may now use data from non-U.S.-licensed comparator products to demonstrate interchangeability. The agency said sponsors...