PARIS – Genentech Inc.'s Dan Chen has described the advent of checkpoint blockers as "cancer's penicillin moment," when a drug came along that was not itself able to cure everything, but that signaled the onset of an era where a whole class of diseases, for a time, went from often deadly to mostly harmless. Read More

What chief medical officer Patrick Horn called "the last piece of data that we need" to make an NDA submission arrived for Tetraphase Pharmaceuticals Inc. in the form of positive topline data from the phase III trial called IGNITE4, testing the company's intravenous (I.V.), twice-daily flourocycline antibiotic eravacycline compared with meropenem for complicated intra-abdominal infections (cIAI). Read More

Having spent the last several years advancing its potentially disease-modifying nitrated fatty acid cell signaling approach targeting inflammatory and fibrotic indications, privately held Complexa Inc. is gearing up for phase II proof-of-concept trials after closing a $62 million series C round, by far its most substantial fundraising to date. Read More

HONG KONG – Tokyo-based Peptidream Inc. is partnering with New Haven, Conn.-based Kleo Pharmaceuticals Inc. to develop immuno-oncology (IO) products in multiple indications. Read More

HONG KONG – A new Korean study has identified a novel cellular mechanism underlying presynaptic dysfunction in Alzheimer's disease (AD), which could represent an urgently needed new drug target for early stage AD. Read More

Citing a lack of data and failure to conduct category 2 and 3 tests on abuse deterrent properties, two FDA advisory committees voted 22-1 Wednesday against recommending approval of Intellipharmaceutics International Inc.'s IPC Oxy extended-release tablets. Intellipharmaceutics, of Toronto, was seeking IV abuse-deterrent labeling for its oxycodone hydrochloride tablets intended to manage moderate-to-severe pain when a continuous analgesic is needed for an extended period. Read More

Oragenics Inc., of Tampa, Fla., said it completed the second closing of a previously-announced securities purchase agreement with three accredited investors to purchase a total of $3 million of series A convertible preferred stock at a price of 25 cents per share. Read More

Astrazeneca plc, of London, said the European Commission approved Faslodex (fulvestrant) for the treatment of estrogen receptor (HR)-positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. Approval was based on data from the phase III FALCON study, which demonstrated the superiority of Faslodex 500 mg over anastrozole 1 mg as a first-line treatment for postmenopausal women with locally advanced or HR-positive metastatic breast cancer who had not received prior hormone-based therapy. Faslodex first gained approval in 2002. Read More

Biocardia Inc., of San Carlos, Calif., completed treatment of patients in the 10-patient roll-in cohort for its pivotal phase III Cardiamp Heart Failure Trial testing Cardiamp cell therapy system, designed to deliver a patient's own bone marrow cells directly to the heart after a heart attack. Read More

Amgen Inc., of Thousand Oaks, Calif., reported revenue of $5.81 billion in the second quarter, up 2 percent year over year and beating consensus of $5.69 billion. Sales of top-selling anti-inflammatory Enbrel (etanercept) slipped 1 percent year over year to $1.47 billion while sales of bone marrow stimulant Neulasta (pegfilgrastim) decreased 5 percent to $1.09 billion. Read More