As the first step toward putting together designs for drug trials in children, the FDA's Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC) questioned Abbvie Inc. about the epidermal growth factor receptor (EGFR) inhibitor ABT-414, an antibody-drug conjugate for glioblastoma multiforme (GBM), and sought input from Eisai Inc. regarding Lenvima (lenvatinib), the vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF) inhibitor that was approved by the FDA in February for differentiated thyroid cancer.
With a "groundwork of foundational support" for Aerosurf from top-line phase IIa data plus previous work, Discovery Laboratories Inc. is going into phase IIb development of the aerosolized KL4 surfactant for preventing respiratory distress syndrome in premature infants, CEO John Cooper said.
As pundits speculated about market turbulence that might dock IPOs, calm waters allowed three to price: Wave Life Sciences Ltd., with preclinical nucleic acid therapeutics bound for trials next year, sold about 6.37 million shares at $16 each to raise $102 million. Voyager Therapeutics Inc., moving along a partnered gene-therapy Parkinson’s disease (PD) candidate that has reached the phase I stage, also entered the IPO ring, dispensed 5 million shares at $14 each to collect $70 million.
Re-tooled Amplyx Pharmaceuticals Inc. garnered $40.5 million in series B funding for antifungal work with APX001, a new-mechanism therapy licensed from "an established pharma company" that "for strategic reasons decided to focus on later-stage programs," CEO Mike Grey told BioWorld Today.
Paratek Pharmaceuticals Inc. CEO Michael Bigham told BioWorld Today “it’s very hard to know at this point” how competitor Cempra Inc. will handle the pricing of late-stage solithromycin for community-acquired bacterial pneumonia (CABP), and what this will mean for omadacycline, which just started a pivotal phase III trial in the same indication.
With the hyperkalemia (HK) space hotter after Astrazeneca plc's $2.7 billion takeover of ZS Pharma Inc. to get the approval-ready ZS-9, eyes of handicappers turned to long-term safety data due at a scientific meeting over the weekend.
The cancer drug Abraxane (nab-paclitaxel) chalked up another weak showing in third quarter earnings for Celgene Corp., and Jacqualyn Fouse, global head of hematology and oncology, blamed the "big impact from the first wave" of immuno-oncology (I-O) therapies.
Acelrx Pharmaceuticals Inc.'s decision to go ahead with another phase III study to satisfy FDA jitters about dispensing errors with the patient-operated drug-device product Zalviso (sublingual sufentanil) pleased investors, even as attention – and some concern, albeit less – turned to ARX-04, another product for pain that could be the subject of a new drug application (NDA) after yielding data in the first quarter of next year.
