17:32 , Aug 14, 2018 |  BC Extra  |  Company News

Motif's antibiotic gets Priority Review

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said FDA accepted and granted Priority Review to an NDA for iclaprim (MTF-100) to treat acute bacterial skin and skin structure infections (ABSSSIs). Its PDUFA date is Feb. 13, 2019. The...
00:00 , Aug 11, 2018 |  BioCentury  |  Product Development

Exacerbation management

Based on work spearheaded by the Cystic Fibrosis Foundation, Corbus Pharmaceuticals Holdings Inc. will be the first company to attempt to gain approval in CF based on pulmonary exacerbations instead of FEV1. The company is...
19:24 , Aug 10, 2018 |  BC Week In Review  |  Clinical News

FDA requests additional trial for Ampio's osteoarthritis therapy Ampion

Ampio Pharmaceuticals Inc. (NYSE-M:AMPE) said FDA requested an additional randomized trial of Ampion to treat severe osteoarthritis (OA) of the knee prior to a BLA submission for the candidate. According to the company, FDA stated in...
19:02 , Aug 10, 2018 |  BC Week In Review  |  Financial News

Zogenix, Progenics raise follow-ons

Zogenix Inc. (NASDAQ:ZGNX) and Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) each priced follow-on offerings late Aug. 7th. Zogenix raised $312 million through the sale of 6 million shares at $52 in an offering underwritten by BofA Merrill Lynch,...
18:29 , Aug 10, 2018 |  BC Week In Review  |  Clinical News

Strongbridge's Cushing syndrome candidate meets in Phase III

Strongbridge Biopharma plc (NASDAQ:SBBP) said Recorlev levoketoconazole met the primary and secondary endpoints in the Phase III SONICS trial to treat endogenous Cushing syndrome. On the 94-patient trial's primary endpoint, 30% of patients achieved normalization of...
16:58 , Aug 10, 2018 |  BC Extra  |  Company News

Alnylam gets first RNAi drug approved

Twenty years after the scientific co-founders of Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) discovered RNAi, a drug using the modality has been approved. On Friday, FDA approved Onpattro patisiran to treat polyneuropathy caused by hereditary transthyretin (TTR)-mediated...
06:12 , Aug 10, 2018 |  BC Week In Review  |  Clinical News

FDA panel backs Insmed lung infection compound in narrow population

FDA's Antimicrobial Drugs Advisory Committee voted that ALIS (amikacin liposome inhalation suspension) from Insmed Inc. (NASDAQ:INSM) is effective and safe in the treatment of non-tuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). The...
00:20 , Aug 10, 2018 |  BC Week In Review  |  Clinical News

Ovid's Angelman syndrome candidate misses behavior, sleep and gait endpoints in Phase II

Ovid Therapeutics Inc. (NASDAQ:OVID) reported that gaboxadol (OV101) failed to significantly improve prespecified efficacy measures of behavior, sleep and gait in the Phase II STARS trial to treat Angelman syndrome. The company said one dose...
00:20 , Aug 10, 2018 |  BC Week In Review  |  Clinical News

Athenex's actinic keratosis ointment meets in pair of Phase III trials

Athenex Inc. (NASDAQ:ATNX) said KX2-391 (KX-01) met the primary endpoint of improving the proportion of patients who achieved complete clearance of actinic keratosis (AK) lesions within the face or scalp treatment areas at day 57...
00:20 , Aug 10, 2018 |  BC Week In Review  |  Clinical News

Cassiopea planning NDA for acne candidate after Phase III meets endpoints

Cassiopea S.p.A. (SIX:SKIN) said twice-daily topical Winlevi 1% clascoterone (CB-03-01) for 12 weeks met the three co-primary endpoints vs. placebo in both the Phase III Study 25 and Study 26 to treat acne. The company...