BC Extra | Jan 13, 2020
Company News

Jan. 13 Company Quick Takes: AZ ends fish oil trial; plus Lynparza, Lilly-NextCure, Innovent, Amgen-Qiagen-Guardant, Axsome-Pfizer

AstraZeneca ends CV outcomes trial of Epanova  AstraZeneca plc (LSE:AZN; NYSE:AZN) discontinued the Phase III STRENGTH trial after an IDMC determined it is unlikely to show that Epanova improved cardiovascular outcomes in patients with mixed...
BioCentury | Jan 12, 2015
Finance

Buyside view XXIII: Milestones galore

Stephen Hansen, Associate Editor and Jennifer Rhodes, Staff Writer   Buyside view XXIII The maturation of the biotech sector over the past few years finds fund managers focusing on a slew of clinical milestones and...
BioCentury | Jul 14, 2014
Finance

2Q Stock Wrap-Up: Large and in charge

In contrast to the first quarter in which all market cap segments gained ground, only the large caps finished 2Q14 in the black. Gainers outnumbered decliners 20-12 in the over $5 billion segment, which was...
BC Week In Review | May 12, 2014
Clinical News

Epanova regulatory update

FDA approved an NDA from AstraZeneca for Epanova as an adjunct to diet and exercise to treat severe hypertriglyceridemia, defined as triglyceride levels >=500 mg/dL. AZ expects to launch Epanova in the U.S. in 4Q14,...
BioCentury | May 12, 2014
Strategy

Build up to break up

Pfizer Inc. continues to give signals that the grand plan is to break itself up, and the reality looks like it absolutely needs AstraZeneca plc 's assets to make it work. Pfizer already has internally...
BC Extra | May 7, 2014
Company News

FDA approves AZ's Epanova for severe hypertriglyceridemia

FDA approved an NDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) for Epanova as an adjunct to diet and exercise to treat severe hypertriglyceridemia, defined as triglyceride levels greater than or equal to 500 mg/dL. The pharma...
BioCentury | Apr 7, 2014
Finance

1Q Stock Wrap-Up: Small but mighty

Despite a correction at the end of March, all biotech market cap segments finished the first quarter in positive territory. Microcaps set the pace with a 10% gain, while large caps added 7% and were...
BioCentury | Feb 3, 2014
Regulation

Lipid advice in Europe

A lack of clarity about requirements for cardiovascular safety and outcomes data in updated EMA guidance means companies developing lipid-modulating therapies will need to seek individual advice from the European regulator as early as possible...
BioCentury | Jan 13, 2014
Finance

Buyside View XXII: 'Grown up' means growth

Stephen Hansen Senior Writer  An increase in regulatory approvals and new breakthrough therapies has money managers buying into the concept that biotech has entered a new product cycle that provides a strong fundamental basis for...
BC Week In Review | Sep 23, 2013
Clinical News

Epanova regulatory update

AstraZeneca said FDA accepted for review an NDA for Epanova to treat severe hypertriglyceridemia, defined as triglyceride levels >=500 mg/dL. The PDUFA date is May 5, 2014. Epanova is an ultra-pure mixture of the free...
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