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12:22 PM, Feb 23, 2018  |  BC Week In Review | Financial News  |  Proposed Offerings

BioXcel Therapeutics proposes $69M IPO

Artificial intelligence company BioXcel Therapeutics Inc. (Branford, Conn.) proposed on Feb. 13 to raise up to $69 million in an IPO on NASDAQ underwritten by Barclays, UBS Securities, BMO Capital Markets and Canaccord Genuity. BioXcel...
12:21 PM, Feb 23, 2018  |  BC Week In Review | Company News  |  Other News

MiMedx delays earnings filing due to internal audit

Regenerative medicines company MiMedx Group Inc. (NASDAQ:MDXG) said it will delay the release of its fourth quarter and fiscal-year 2017 financial results as the company conducts an internal investigation into “current and prior-period matters relating...
12:20 PM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Regulatory

CDC panel recommends AZ's FluMist for 2018-19 season

The CDC's Advisory Committee on Immunization Practices (ACIP) voted 12-2 in favor of recommending FluMist Quadrivalent from AstraZeneca plc (LSE:AZN; NYSE:AZN) as an age-appropriate option for flu prevention for the 2018-2019 influenza season, according to...
12:20 PM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves AZ's Imfinzi for NSCLC that has not progressed

FDA approved Imfinzi durvalumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat stage III unresectable non-small cell lung cancer that has not progressed following chemoradiation. The agency said this is the first drug approved for the...
12:19 PM, Feb 23, 2018  |  BC Week In Review | Company News  |  Other News

Merck KGaA invests €40M in Asia manufacturing centers

Merck KGaA (Xetra:MRK) said it will invest €40 million ($49.6 million) to build two new manufacturing and distribution centers in Songdo, South Korea and Mumbai, India. Merck will also put the money towards the completion...
12:19 PM, Feb 23, 2018  |  BC Week In Review | Company News  |  Other News

USAID unveils project to prevent viral pandemics

In a policy paper published in Science, the U.S. Agency for International Development (USAID) and others announced plans to start the Global Virome Project (GVP) which aims to take a pro-active approach to identifying viruses...
12:19 PM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Positive CHMP vote likely for Clovis' PARP inhibitor

Clovis Oncology Inc. (NASDAQ:CLVS) said EMA's CHMP communicated a "positive trend vote" for an MAA for rucaparib (CO-338) to treat platinum-sensitive, BRCA-mutant advanced ovarian cancer. Clovis expects a formal vote on the MAA at CHMP's...
12:18 PM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Portola expects CHMP to recommend andexanet alfa, but not betrixaban

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said EMA's CHMP communicated a "positive trend vote" for an MAA for AndexXa andexanet alfa (IndexXa, PRT4445, PRT064445) to reverse the anticoagulant effects of Factor Xa inhibitors. However, Portola said the...
12:18 PM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA accepts NDA from Acorda for PD candidate Inbrija

Acorda Therapeutics Inc. (NASDAQ:ACOR) said FDA accepted for review an NDA for Inbrija levodopa inhalation powder (CVT-301) to treat "off" periods in Parkinson's disease patients receiving a carbidopa/levodopa regimen. The PDUFA date is Oct. 5. The...
12:18 PM, Feb 23, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Guardant gets EAP from FDA for NGS-based liquid biopsy

Guardant Health Inc. (Redwood City, Calif.) said FDA granted Expedited Access Pathway (EAP) designation to its Guardant360 assay, a comprehensive next-generation sequencing (NGS)-based liquid biopsy test for advanced cancer. The company plans to submit a...

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