22:47 , Aug 5, 2019 |  BC Extra  |  Clinical News

Aug. 5 Clinical Quick Takes: Emgality meets for migraine with treatment failures; plus Verona, Alkahest-Grifols, Squarex and Denali-Sanofi

Emgality meets in Phase III in pretreated migraine patients  Eli Lilly and Co. (NYSE:LLY) reported that anti-CGRP mAb Emgality galcanezumab-gnlm met the primary endpoint in the Phase III CONQUER trial, reducing migraine headache days by...
21:57 , Aug 2, 2019 |  BioCentury  |  Regulation

Digital platforms that could make real-world data usable

As real-world data grows in importance so does the need to stitch together disparate data sources in a way that makes the information usable. A recent meeting co-hosted by FDA and the Duke Margolis Center...
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...
20:47 , Jun 21, 2019 |  BC Extra  |  Clinical News

AnaptysBio shares sag as Sanofi-Regeneron trial stokes IL-33 doubts

A 12% dip in AnaptysBio's share price Friday suggests investors are concerned that a Phase II readout for a rival IL-33 inhibitor could indicate that the drug class may not provide a differentiated clinical benefit...
22:19 , Jun 19, 2019 |  BC Extra  |  Company News

June 19 Company Quick Takes: Catalent takes over manufacturing site from BMS; plus Lynparza, Myriad, Amgen and more

Catalent buys Italian facility from BMS  Catalent Inc. (NYSE:CTLT) will buy an Italian manufacturing facility from Bristol-Myers Squibb Co. (NYSE:BMY) for an undisclosed amount. Catalent will manufacture oral solid, biologics and sterile products at the...
21:21 , Jun 14, 2019 |  BioCentury  |  Product Development

Despite senior management shake-up, Novartis’ pipeline is primed to deliver

A string of departures at Novartis AG and strategic shifts by new CEO Vasant Narasimhan have produced a fairly thorough makeover of the executive committee he inherited in 2018. The team gains a pipeline that...
00:28 , Jun 7, 2019 |  BioCentury  |  Product Development

How early biomarkers and constant iteration fuel Vertex's R&D efficiency

As Vertex prepares its fourth NDA for a cystic fibrosis drug in six years, EVP of Global Research and CSO David Altshuler credits the biotech’s R&D efficiency to a focus on agents that show more...
21:17 , Apr 23, 2019 |  BC Extra  |  Company News

Fulcrum gets rights to GSK's shelved p38 kinase inhibitor

Following the failure of late-stage trials conducted by GSK in acute coronary syndrome and chronic obstructive pulmonary disease, Fulcrum will seek to revive the pharma's losmapimod for a rare genetic disease with an exclusive, worldwide...
16:12 , Apr 5, 2019 |  BC Week In Review  |  Company News

FDA approves Circassia's COPD treatment, AZ gets $20M milestone

Circassia said FDA approved Duaklir Pressair aclidinium bromide/formoterol fumarate to treat chronic obstructive pulmonary disease. The agency also accepted for review an sNDA for Tudorza Pressair aclidinium bromide to include on its label clinical data...
13:06 , Mar 13, 2019 |  BC Innovations  |  Distillery Therapeutics

IKKβ inhibition for tendinopathy

DISEASE CATEGORY: Musculoskeletal INDICATION: Musculoskeletal Patient sample, cell culture and mouse studies suggest inhibiting IKKβ could help treat tendinopathy. In tendon tissues samples from patients with rotator cuff disease, levels of IKKβ protein were higher...