CHICAGO – Bristol-Myers Squibb Co.'s Opdivo (nivolumab), approved in March to treat certain patients with squamous non-small-cell lung cancer (NSCLC), can also provide significant benefit to patients with the more common nonsquamous form of NSCLC, especially those with tumors expressing high levels of tumor programmed death-ligand 1 (PD-L1), according to findings from the phase III CheckMate-057 study, presented Friday at the American Society of Clinical Oncology (ASCO) meeting. Read More
CHICAGO – Genomics may matter more than histology in predicting the response rate of patients treated with the programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab, Merck & Co. Inc.), as a phase II study has turned up the first genomic marker – mismatch repair (MMR) deficiency – that foretells success, results showed at the American Society of Clinical Oncology (ASCO) annual meeting. Read More
Investors in Heron Therapeutics Inc. received the good news they were awaiting when the phase III MAGIC study of Sustol (granisetron injection, extended release) hit its primary endpoint as part of a three-drug regimen together with the intravenous (I.V.) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the I.V. corticosteroid dexamethasone to prevent delayed-onset chemotherapy-induced nausea and vomiting (CINV) following administration of highly emetogenic chemotherapy (HEC) agents. Read More
LONDON – Nucana Ltd. is poised to start phase III development of its lead product Acelarin after reporting what it claimed as "groundbreaking" phase I/II data for the modified version of gemcitabine at the American Society of Clinical Oncology meeting in Chicago on Saturday. Read More
DUBLIN – Glactone Pharma AB, an early stage Swedish firm, is lining up with the big guns of the cancer world at the American Society of Clinical Oncology meeting this week with preclinical proof-of-concept data that could pique some partnering interest. Read More
Strand Life Sciences is hoping for a bigger seat at the table in the U.S. next-generation sequencing (NGS) market with the launch of an expanded version of its Stranddvantage pan-cancer genomic profiling test. Read More
The FDA issued a notice in the Federal Register announcing the availability of a draft guidance for industry, titled "Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products." Read More
Cesca Therapeutics Inc., of Rancho Cordova, Calif., said it received a letter from Nasdaq stating that it does not comply with Nasdaq Listing Rule 5250(c)(1) because the regenerative medicine company has not yet filed its Form 10-Q for the period ended March 31. Read More
Viking Therapeutics Inc., of San Diego, said the underwriters for its recent IPO exercised in full their option to purchase an additional 450,000 shares at the IPO price of $8 per share. Read More
Alkermes plc, of Dublin, said data from its phase I study of ALKS 8700, a monomethyl fumarate (MMF) molecule in development for the treatment of multiple sclerosis, showed the drug was generally well tolerated and provided MMF exposures comparable to Tecfidera (dimethyl fumarate, Biogen Inc.), with less variability and favorable gastrointestinal (GI) tolerability. Read More
Affimed NV, of Heidelberg, Germany, provided details on preclinical data from a combination study of lead candidate AFM13 with checkpoint modulators, including checkpoint inhibitor PD-1. Read More
Scientists from the Massachusetts Eye and Ear Infirmary have shown that vancomycin-resistant enterococci (VRE), one of the ESKAPE pathogens that are considered the greatest threats to public health by the Infectious Disease Society of America, can be killed by pheromones secreted by commensal enterococci. Read More
