TG Therapeutics Inc. will seek to carry two candidates in its pipeline across the goal line in a single play after reaching agreement with the FDA on a special protocol assessment (SPA) for the design of a phase III study combining TG-1101 (ublituximab), its glycoengineered anti-CD20 monoclonal antibody, and TGR-1202, a glycoengineered once-daily phosphoinositide-3-kinase (PI3K)-delta inhibitor, to treat chronic lymphocytic leukemia (CLL). Read More
DUBLIN – Oryzon Genomics SA, one of Spain's flagship biotech firms, is seeking to give the country's sector greater national and international visibility by listing its shares on the main market of the Madrid Stock Exchange (Bolsa de Madrid) in the coming weeks, after which it plans to seek a listing on Nasdaq. Read More
Aerie Pharmaceuticals Inc. – as well as its share price – returned to its previous heights following positive results from the second phase III trial of its triple-action eye drop Rhopressa, which hit its endpoints in lowering intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Read More
BOSTON – Concluding with sessions devoted to regenerative medicine, Biopharm America hosted a panel talk on the state of gene and cell therapy, "a new frontier for all of us," said Frank Borriello, head of search and evaluation for Baxalta Inc., the spinout from Baxter International Inc., of Deerfield, Ill. Read More
SAN DIEGO – The Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) kicks off in full swing Friday, but conference-goers got a primer on pandemic diseases Thursday as ICAAC held a joint symposium with the International Society of Infectious Disease. Read More
Allergan plc, of Dublin, and Gedeon Richter plc, of Budapest, Hungary, said the FDA approved Vraylar (cariprazine) capsules, an atypical antipsychotic, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults. Read More
Hemispherx Biopharma Inc., of Philadelphia, said its board approved a patient assistance program for the open-label AMP-511 study of Ampligen in chronic fatigue syndrome. Read More
