Therabron Therapeutics Inc., of Rockville, Md., said the FDA granted rare pediatric disease designation to rhCC10 (recombinant human club cell 10 kDa protein), the company's lead product candidate, for the prevention of bronchopulmonary dysplasia and chronic respiratory morbidity (CRM) in preterm infants. Read More

Aldeyra Therapeutics Inc., of Lexington, Mass., closed its underwritten public offering, netting about $12.6 million from the sale of 2.76 million common shares, including 360,000 shares sold to exercise in full the overallotment option to underwriters. Read More

In light of the growing interest in genomic research, the FDA proposed adopting an International Council for Harmonisation guideline that's intended to provide harmonized principles of genomic sampling and management of genomic data in clinical trials. Read More

LONDON – Mina Therapeutics Ltd. is laying claim to be first in the clinic with a novel RNA therapeutic that, in contrast to its more established siRNA gene silencing counterparts, activates dormant genes. Read More

Clearside Biomedical Inc. priced low but increased the shares in its IPO to take off about where it expected. The company offered 7.2 million common shares priced at $7 apiece to raise $50.4 million and granted underwriters a 30-day option to purchase up to 1.08 million additional shares to fill overallotments, potentially adding $7.56 million to the raise. Read More

A combination of retroviral gene therapy and chemotherapy administered as a prodrug significantly increased survival times of patients with recurrent high-grade glioma in a phase I trial. Read More

Dermira Inc. reported positive top-line results from its phase III ATMOS-1 and ATMOS-2 pivotal trials for DRM04 (glycopyrronium tosylate), a topical candidate for patients with excessive underarm sweating, also known as primary axillary hyperhidrosis. Read More

Roche Holding AG, of Basel, Switzerland, is the first company with an FDA-approved, blood-based genetic test to detect a gene mutation associated with the most common type of lung cancer. The agency approved the cobas EGFR Mutation Test v2 as a companion diagnostic for the cancer drug Tarceva (erlotinib). Read More

Addex Therapeutics SA, of Geneva, said results from its phase IIa study of dipraglurant in levodopa-induced dyskinesia associated with Parkinson's disease, published in Movement Disorders, suggested that the mGluR5 negative allosteric modulator improved dyskinesia and showed no major safety concerns. Read More