BioCentury | Apr 10, 2020
Product Development

April 9 Quick Takes: BMS tops off CAR T patent win; plus approval for Braftovi plus Erbitux, Merck, BMS, Liquidia, Circassia-AZ, Bridge

Award swells to $1.2B, plus royalties, in Kite CAR T suit  Bristol Myers Squibb Co. (NYSE:BMY) and Memorial Sloan Kettering Cancer Center will receive at least $1.2 billion from Gilead Sciences Inc. (NASDAQ:GILD) after a...
BioCentury | Jun 29, 2019
Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
BC Week In Review | Apr 5, 2019
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...
BioCentury | Jan 17, 2019
Regulation

Products on shutdown standby

Products on shutdown standby On Jan. 14, FDA said it has reserves to continue drug reviews for five more weeks if the government shutdown continues. There are at least six PDUFA dates for new products...
BC Week In Review | Aug 17, 2018
Clinical News

FDA accepts applications for Circassia COPD products Duaklir, Tudorza

Circassia Pharmaceuticals plc (LSE:CIR) said FDA accepted for review an NDA for Duaklir Pressair aclidinium bromide/formoterol fumarate to treat chronic obstructive pulmonary disease (COPD). The company also said the agency accepted an sNDA for Tudorza...
BC Week In Review | Dec 1, 2017
Clinical News

Duaklir Genuair meets in Phase III to treat COPD

In September, AstraZeneca plc (LSE:AZN; NYSE:AZN) reported data from the Phase III AMPLIFY trial in about 1,595 patients with chronic obstructive pulmonary disease (COPD) showing that Duaklir Genuair aclidinium bromide/formoterol (Brimica, KRP-AB1102F, LAS40464) met the...
BioCentury | Apr 28, 2017
Finance

A different animal?

For the second time, macro factors will make it hard to divine how much impact, if any, a clinical failure at Circassia Pharmaceuticals plc will have on investor sentiment in the U.K. But at least...
BC Week In Review | Apr 21, 2017
Clinical News

HDM-SPIRE: Ph IIb data

Top-line data from a double-blind, international Phase IIb trial in 714 house dust mite allergic patients with moderate or severe allergy symptoms showed that 12 and 20 nmol HDM-SPIRE every 4 weeks for 12 weeks...
BC Extra | Apr 18, 2017
Clinical News

Circassia abandoning allergy field after Phase IIb miss

Circassia Pharmaceuticals plc (LSE:CIR) said it will no longer develop allergy therapeutics following the failure of dust mite program HDM-SPIRE in a Phase IIb trial. The company plans to focus on its respiratory business, including...
BC Week In Review | Mar 23, 2017
Company News

AZ, Circassia deal

AstraZeneca agreed to share rights to two chronic obstructive pulmonary disease therapies with Circassia. Circassia will lead promotion of AZ's Tudorza Pressair aclidinium bromide in the U.S., and may opt to acquire full U.S. rights....
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