21:31 , Aug 19, 2019 |  BC Extra  |  Clinical News

Aug. 19 Clinical Quick Takes: Kalytera's cannabidiol shows promise for transplant, plus Abbisko and Brigham and Women's

Kalytera's CBD prevents graft-vs-host disease  Kalytera Therapeutics Inc. (TSX-V:KLY; OTCQB:KALTF) announced plans to start a Phase III registrational trial of cannabidiol after low and medium doses reduced the incidence of Grade 2-4 acute graft-versus-host disease...
23:44 , Aug 6, 2019 |  BC Extra  |  Company News

Aug. 6 Company Quick Takes: Sales updates from Alnylam, Sage, Regeneron and GW; plus regulatory updates from MorphoSys and more

Alnylam's Onpattro bests consensus  Sales of amyloidosis therapy Onpattro patisiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) reached $38.2 million in 2Q19, the drug's third full quarter on the market. The figure beat analysts' consensus of $32...
00:05 , Jul 27, 2019 |  BC Extra  |  Company News

Vitrakvi set to become EU’s first tissue-agnostic cancer drug

EMA's CHMP delivered its first positive recommendation for a tissue-agnostic cancer therapy to Vitrakvi in its monthly basket of positive opinions, which also included one for GW’s Epidyolex. CHMP backed approval of an MAA from...
00:47 , Jun 29, 2019 |  BioCentury  |  Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
19:37 , May 6, 2019 |  BC Extra  |  Company News

May 6 Company Quick Takes: Esperion, BioMarin, WuXi AppTec, Axsome, Harbour BioMed/CTTQ, GW, Adynxx

FDA accepts Esperion NDAs for LDL-C-lowering indications  Esperion Therapeutics Inc. (NASDAQ:ESPR) gained $5 (12%) to $48.24 on Monday after FDA accepted for review a pair of NDAs for bempedoic acid (ETC-1002) and a bempedoic acid/ezetimibe...
21:58 , Apr 26, 2019 |  BioCentury  |  Product Development

Rise of the independents, biotechs go to market

While product launch and commercialization has largely been the province of big biotech and big pharma, with smaller companies partnering to get their products over the finish line, BioCentury’s analysis of recent FDA approvals finds...
00:06 , Apr 6, 2019 |  BioCentury  |  Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
12:44 , Mar 27, 2019 |  BioCentury  |  Product Development

GW’s next act

As Epidiolex’s launch continues to ramp up, GW Pharmaceuticals’ next act will be to take the plunge with its cannabinoid platform into larger, more complex neurobehavioral indications, and even cancer. Not surprisingly, the rise of...
21:35 , Mar 18, 2019 |  BC Extra  |  Company News

Biohaven spends $105M for faster review of oral CGRP inhibitor

Biohaven bought a $105 million Priority Review voucher from GW Pharmaceuticals to expedite the entry of its oral migraine therapy into the CGRP inhibitor market. It plans to use the voucher on an NDA for...
01:36 , Mar 1, 2019 |  BC Week In Review  |  Company News

GW gains on first sales figure for Epidiolex

GW Pharmaceuticals plc (NASDAQ:GWPH) added $21.10 (14%) to $173.99 on Feb. 27 after reporting that sales of Epidiolex cannabidiol reached $4.7 million in the two-month period since the marijuana-derived drug's launch on Nov. 1. FDA...