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1:44 PM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Alexion submits BLA for long-acting C5 inhibitor for PNH

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) submitted a BLA to FDA for ALXN1210 to treat paroxysmal nocturnal hemoglobinuria (PNH) using a rare disease Priority Review voucher. The submission is based on data from the Phase III ALXN1210-PNH-301 and...
1:44 PM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves Suboxone generics from Mylan, Dr. Reddy

FDA approved two generic buprenorphine/naloxone sublingual film products from Mylan N.V. (NASDAQ:MYL) and Dr. Reddy's Laboratories Ltd. (NYSE:RDY), respectively, to treat opioid dependence. FDA said they are the first approved generic versions of Suboxone sublingual...
1:44 PM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

ObsEva's linzagolix meets in Phase IIb for endometriosis-associated pain

ObsEva S.A. (NASDAQ:OBSV) said three of four doses of linzagolix (OBE2109, KLH-2109) met the primary endpoint in the Phase IIb EDELWEISS trial to treat moderate to severe endometriosis-associated pain. The company plans to present additional...
1:43 PM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Nanobiotix’s NBTXR3 meets in Phase II/III for STS

Nanobiotix S.A. (Euronext:NANO) said NBTXR3 (PEP503) met the primary and secondary endpoints in the Phase II/III act.in.sarc trial to treat locally advanced soft tissue sarcoma. The compound comprises crystalline nanoparticles of hafnium oxide activated in...
12:48 PM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

PTC's oral SMA candidate improves motor development scores in pivotal trial

PTC Therapeutics Inc. (NASDAQ:PTCT) reported updated interim data from part 1 of the pivotal Phase II/III FIREFISH trial showing that oral risdiplam (RG7916) improved motor development scores in infants with spinal muscular atrophy (SMA) type...
12:20 PM, Jun 22, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

Eidos raises $106M in IPO priced at top of range

Eidos Therapeutics Inc. (NASDAQ:EIDX) added $6.12 (36%) to $23.12 June 20 after raising $106.3 million through the sale of 6.3 million shares at $17 in an IPO underwritten by J.P. Morgan, BofA Merrill Lynch and...
12:19 PM, Jun 22, 2018  |  BC Week In Review | Company News  |  Other News

Daewoong restructuring R&D

Daewoong Pharmaceutical Co. Ltd. (KSE:069620) said it is restructuring its R&D group. The company said the goal is to "expedite new drug development" and to strengthen three newly announced centers. The three centers will focus on...
12:19 PM, Jun 22, 2018  |  BC Week In Review | Company News  |  Deals

AHA, ADA partner with industry to launch diabetes, cardiovascular disease initiative

The American Heart Association and American Diabetes Association partnered with Boehringer Ingelheim GmbH (Ingelheim, Germany), Eli Lilly and Co. (NYSE:LLY) and Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) to launch a 3.5 year initiative to help...
12:15 PM, Jun 22, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

Calliditas raises over $70M in Swedish IPO

Renal disease company Calliditas Therapeutics AB (SSE:CALTX) raised SEK650 million ($73.4 million) on June 15 through the sale of 14 million shares at SEK45 in an IPO on NASDAQ Stockholm. The company expects to begin...
12:15 PM, Jun 22, 2018  |  BC Week In Review | Company News  |  Deals

UCSD launches bacteriophage treatment center

The University of California San Diego launched the Center for Innovative Phage Applications and Therapeutics (IPATH) to develop bacteriophages to fight multidrug-resistant bacteria. The initial focus will be on treating chronic infections associated with cystic...

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