Generon Corp., of Shanghai, reported that the first pivotal phase III study in the U.S. for F-627 (benegrastim) to treat chemotherapy-induced neutropenia in breast cancer patients met its primary endpoint. Read More

Xbiotech Inc., of Austin, Texas, highlighted the publication of “A Natural Human Monoclonal Antibody Targeting Staphylococcus Protein A Protects Against Staphylococcus aureus (S. aureus) Bacteremia.” in PLOS ONE. Read More

Asit Biotech SA, of Brussels, Belgium, said it raised €9.4 million (US$11.7 million) within the framework of the first phase of the private placement financing approved by the shareholders meeting Dec. 7. Read More

SHANGHAI – EOC Pharmaceutical Group, a specialty pharma with seven cancer assets in its pipeline, has started with the end in mind – not just getting its drugs approved by the CFDA but having them be commercially successful as well. Read More

HONG KONG – Amoy Diagnostics Co. Ltd. (Amoydx) received CFDA approval for its epidermal growth factor receptor (EGFR) mutation detection kit as a companion diagnostic for EGFR TKI (tyrosine kinase inhibitor)-based non-small-cell lung cancer (NSCLC) drugs. Read More

Biopharma’s financing frenzy continued Thursday, with eight firms pricing public offerings – six follow-ons and two IPOs – to raise a total of about $760.7 million before overallotments. Read More

PERTH, Australia – Australia’s Viralytics Ltd. is on its way to completing its phase Ib immunotherapy programs of lead candidate Cavatak following a A$29.6 million (US$23.9 million) private placement earlier this month with China’s Lepu Medical Group. Read More

Shares of Oxford, U.K.-based Summit Therapeutics plc (NASDAQ:SMMT) rose 12.9 percent to close at $13.78 Thursday on interim data showing that its Duchenne muscular dystrophy (DMD) candidate, ezutromid, appears to have helped reduce muscle fiber damage and increased levels of a protein called utrophin, seen to offer benefits in restoring and maintaining healthy muscle function. Read More

The FDA released a draft guidance Thursday to help sponsors develop fixed-dose combination drugs to treat hypertension. The guidance focuses on the clinical development of two-drug combinations of previously approved drugs. Read More