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2:44 PM, Feb 22, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Mesoblast's MSCs meet in Phase III for acute GvHD

Mesoblast Ltd. (ASX:MSB; NASDAQ:MESO) said remestemcel-L (MSC-100-IV) met the primary endpoint in a Phase III trial to treat steroid-refractory acute graft-versus-host disease (GvHD). The company said full data from the trial, which are expected next...
2:44 PM, Feb 22, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Aimmune's peanut allergy therapy meets in Phase III

Aimmune Therapeutics Inc. (NASDAQ:AIMT) said AR101 met the primary endpoint in the Phase III PALISADE trial to treat peanut allergy, but also reported that a greater proportion of patients in the active arm discontinued treatment...
4:05 PM, Feb 16, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

Affimed raises $26.5M in follow-on

Cancer company Affimed N.V. (NASDAQ:AFMD) raised $26.5 million through the sale of 13.2 million shares at $2 in a follow-on underwritten by Jefferies and Wells Fargo. The figures include the sale of a 1.7 million...
1:12 PM, Feb 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Sorrento, Yuhan JV to start Korean trials of anti-PD-L1 mAb

Sorrento Therapeutics Inc. (NASDAQ:SRNE) said the South Korean Ministry of Food and Drug Safety (MFDS) approved an IND to begin Phase I testing of STI-A1015 (IMC-001) to treat solid tumors. STI-A1015 is a mAb against...
1:00 PM, Feb 16, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA advisory committee votes against expanded indication for Pacira's Exparel

Pacira Pharmaceuticals Inc. (NASDAQ:PCRX) said FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 6-4 against approval of a resubmitted sNDA for Exparel bupivacaine (depobupivacaine) as a nerve block to produce regional analgesia. Its PDUFA...
1:00 PM, Feb 16, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Two firsts with FDA's Erleada approval

FDA approved an NDA for Erleada apalutamide (JNJ56021927) from Johnson & Johnson (NYSE:JNJ) to treat non-metastatic castration-resistant prostate cancer (CRPC), making it the first approved drug for the indication and the first approval based on...
12:59 PM, Feb 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

U.K. trial hold for Sarepta's SRP-4045 combo

Sarepta Therapeutics Inc. (NASDAQ:SRPT) said it halted dosing at U.K. study sites in the Phase III ESSENCE trial evaluating golodirsen (SRP-4053) and casimersen (SRP-4045) to treat Duchenne muscular dystrophy. In a statement, the company said the...
12:58 PM, Feb 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

U.K. trial hold for Sarepta's SRP-4053 combo

Sarepta Therapeutics Inc. (NASDAQ:SRPT) said it halted dosing at U.K. study sites in the Phase III ESSENCE trial evaluating golodirsen (SRP-4053) and casimersen (SRP-4045) to treat Duchenne muscular dystrophy. In a statement, the company said the...
12:56 PM, Feb 16, 2018  |  BC Week In Review | Clinical News  |  Regulatory

March 7 ODAC meeting for Amgen's Blincyto

Amgen Inc. (NASDAQ:AMGN) said FDA’s Oncologic Drugs Advisory Committee will meet on March 7 to discuss an sBLA for Blincyto blinatumomab to treat minimal residual disease (MRD)-positive B cell precursor acute lymphoblastic leukemia (ALL). The...
12:50 PM, Feb 16, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

Affimed raises $26.5M in follow-on

Cancer company Affimed N.V. (NASDAQ:AFMD) raised $26.5 million through the sale of 13.2 million shares at $2 in a follow-on underwritten by Jefferies and Wells Fargo. The figures include the sale of a 1.7 million...

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