BioCentury | Apr 9, 2020
Product Development

April 8 COVID-19 roundup: National Academy of Sciences says COVID-19 could continue through summer; plus HHS, SAb-CSL, Vanda-UIC, Avacta-Cytiva and more

As companies and academic groups continue to form new partnerships and identify new drug targets to combat COVID-19, a National Academy of Sciences committee has warned there’s no guarantee the pandemic will be completely contained...
BioCentury | Mar 27, 2020
Product Development

COVID-19 roundup: biopharmas scramble to reassess clinical timelines; plus CEPI-Dynavax, and emergency approvals for Vero, Fosun

More than a dozen biopharmas Thursday announced delays or disruptions to clinical programs and regulatory timelines as companies begin to turn their attention to managing their trials through the COVID-19 crisis. The setbacks came as...
BioCentury | Mar 13, 2020
Product Development

March 12 Quick Takes: WuXi AppTec’s Wuhan site back online; plus SOX relief, AZ, BMS, Nicox-Ocumesion, Tyligand-Context

All WuXi AppTec Chinese sites operating  WuXi AppTec Co. Ltd. (Shanghai:603259; HKEX:2359) said it has resumed operations at its Wuhan facility, which provides discovery chemistry services. The company has now restarted operations at all its...
BC Extra | Dec 24, 2019
Company News

Regulatory roundup: BioMarin poised to have first U.S., EU hemophilia gene therapy; plus Allergan, Eisai, FibroGen, ViiV and Vero

Monday's basket of regulatory news includes two landmark regulatory applications for BioMarin's hemophilia gene therapy in the U.S. and EU, and FDA approval of Allergan's migraine drug. BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) submitted a BLA to...
BC Extra | Aug 15, 2019
Clinical News

At last, a win for terlipressin -- and Mallinckrodt

Ten years after being rebuffed by FDA and with a failed Phase III trial squeezed in between, Mallinckrodt’s terlipressin finally hit the mark in treating patients with an acute form of kidney failure. On Thursday,...
BC Extra | Jun 28, 2019
Clinical News

June 28 Clinical Quick Takes: Imfinzi extends survival in Phase III SCLC study; plus LSK, Pfizer, FibroGen, Aclaris and more

AZ's Imfinzi shows survival benefit in Phase III for SCLC  AstraZeneca plc (LSE:AZN; NYSE:AZN) said an interim analysis of the Phase III CASPIAN trial showed Imfinzi plus etoposide and platinum-based chemotherapy met the primary endpoint...
BC Extra | May 7, 2019
Company News

May 7 Company Quick Takes: Akcea, Bicycle/DDF, Arbutus, Celgene/Sutro, MDGH, Pfizer, Sanofi/Regeneron

Akcea's Waylivra approved in EU  The European Commission granted conditional approval to Waylivra volanesorsen from Akcea Therapeutics Inc. (NASDAQ:AKCA) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) as an adjunct to diet in adult patients with familial chylomicronemia...
BC Week In Review | Dec 14, 2018
Company News

Shionogi invests in Vast, gains first rights to negotiate license for antimicrobial

Vast Therapeutics Inc. (Durham, N.C.) raised a series A round on Dec. 6 from Shionogi & Co. Ltd. (Tokyo:4507) and separately granted the Japanese company first right of negotiation to in-license Vast's BIOC51 and subsequent...
BC Innovations | Nov 30, 2018
Targets & Mechanisms

Revving up metabolism at ASH 2018

Cancer metabolism is a prominent theme at this year’s ASH meeting, with researchers broadening the tent from metabolic targets that drive hematologic malignancies to those that intersect with other hot topics, notably immuno-oncology and epigenetics....
BC Innovations | Oct 25, 2018
Distillery Therapeutics

Cancer

INDICATION: Prostate cancer Mouse studies suggest nitric oxide precursors could help treat castration-resistant prostate cancer (CRPC). In a xenograft mouse model of CRPC, the endogenous NO precursor S-nitrosoglutathione decreased tumor growth, tumor cell proliferation and...
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