Lung Therapeutics Inc., of Austin, Texas, said it enrolled the first patient in a phase Ia/Ib trial testing LTI-01, designed to treat loculated pleural effusions. Read More
Twoxar Inc., of Palo Alto, Calif., said its liver cancer candidate, TXR-311, demonstrated positive results in cell-based assays. In a panel of genetically diverse hepatocellular carcinoma (HCC) cell lines, TXR-311 was shown to be potently cytotoxic with an average half maximal inhibitory concentration (IC50) in the nanomolar range. Read More
Anthera Pharmaceuticals Inc., of Hayward, Calif., said it priced a public offering of 30 million shares of common stock at 50 cents per share and two tranches of warrants to purchase an aggregate of 60 million shares of common stock. Read More
The regulatory law firm of Epstein Becker Green (EBG) has petitioned the FDA to set a limit to the number of days the agency can take to review petitions regarding combo product designations, stating that as matters stand, the agency is “unaccountable for egregious delays in decision-making.” Read More
TOKYO – Despite being home to world-class biomedical research and large innovative drug and device companies, a lack of an entrepreneurial ecosystem has emerged as a significant challenge for the biotech and med-tech industries. That is a challenge that regulators are now trying to address and overcome. Read More
Although Seema Verma’s path through the Senate confirmation process was lined with partisan politics, a few Democrats joined their Republican colleagues to approve her as head of the Centers for Medicare & Medicaid Services (CMS) on a vote of 55-43 Monday. Read More
DUBLIN – The EMA’s big drive for transparency has received pushback from the Court of Justice of the European Union, which has dismissed two appeals the EMA brought against earlier court decisions that barred it from releasing trial data on two drug dossiers. Read More
Allergan plc has agreed to front the genome editing company Editas Medicine Inc. $90 million plus potential milestone payments for an exclusive option to license up to five ocular programs during a seven-year term. Read More
Peloton Therapeutics Inc. exercised an optional $22.2 million tranche of its series D round, closed in September 2016 at $52.4 million, to extend the runway for its hypoxia inducible factor-2 alpha (HIF-2 alpha) antagonists, which are targeting renal and other solid tumors. Read More
Comprehensive analysis of mutational patterns has demonstrated that roughly 20 percent of breast tumors showed a mutational signature that was characteristic of BRCA mutations. Even without BRCA mutations, the mutational pattern suggests such tumors might have the same sensitivity to poly ADP-ribose polymerase (PARP) inhibitors as tumors with detectable BRCA mutations. Read More
LONDON – The EMA is standing up to defend its orphan drug legislation in the face of personalized medicines that salami slice common diseases into rare-sized subsets. Read More
