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...
21:57 , May 10, 2019 |  BC Extra  |  Company News

May 10 Company Quick Takes: Red flags for Daiichi ahead of ODAC; plus JHL/Genentech, J&J, Gilead

FDA reviewers raise concerns about Daiichi’s quizartinib, pexidartinib  Despite both pexidartinib and quizartinib meeting the primary endpoints in their pivotal trials, FDA reviewers raised concerns about each agent from Daiichi Sankyo Co. Ltd. (Tokyo:4568) in...
00:04 , Apr 6, 2019 |  BioCentury  |  Finance

Everybody up

Biotech stocks were off to a strong start in 1Q19, with 71% of companies tracked by BioCentury seeing market cap growth in the quarter. Across all market cap bands, biotechs saw a median gain of...
23:53 , Mar 14, 2019 |  BC Week In Review  |  Company News

FDA pushes back PDUFA for Bavarian's smallpox vaccine

Bavarian Nordic said FDA extended by three months its review of a BLA for its smallpox vaccine, MVA-BN. The new PDUFA date is in September. Bavarian Nordic A/S (CSE:BAVA; Pink:BVNRY) said the agency needs more...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate...
18:52 , May 30, 2018 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Respiratory syncytial virus (RSV) Rat studies suggest vaccination during pregnancy with a vaccine based on RSV F and G proteins could help prevent RSV infection in offspring. The vaccine consists of Newcastle disease virus-like...
18:09 , May 11, 2018 |  BC Week In Review  |  Company News

Merck, J&J vaccines ready for Ebola outbreak

Merck & Co. Inc. (NYSE:MRK) and Johnson & Johnson (NYSE:JNJ) said they are ready to make their respective Ebola vaccines available to the World Health Organization (WHO), which announced an Ebola virus outbreak in the...
23:04 , May 9, 2018 |  BC Extra  |  Politics & Policy

Merck, J&J vaccines ready for Ebola outbreak

Merck & Co. Inc. (NYSE:MRK) and Johnson & Johnson (NYSE:JNJ) said they are ready to make their respective Ebola vaccines available to the World Health Organization (WHO), which announced Tuesday an Ebola virus outbreak in...
18:46 , Feb 9, 2018 |  BC Week In Review  |  Clinical News

Barvarian Nordic's smallpox vaccine meets in Phase III

Bavarian Nordic A/S (CSE:BAVA) reported data from an open-label Phase III trial showing that its Imvamune smallpox vaccine met the co-primary endpoints of non-inferiority to ACAM2000, an FDA-approved, second-generation smallpox vaccine from Emergent BioSolutions Inc....