Next up for Achaogen Inc. is a new drug application (NDA) filing with the FDA, expected in the second half of 2017, after the phase III EPIC (Evaluating plazomicin in cUTI) registration trial of lead candidate, plazomicin, met the agency's objective of non-inferiority compared to meropenem in patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). Read More

Ariad Pharmaceuticals Inc., of Cambridge, Mass., reported data on brigatinib, its anaplastic lymphoma kinase (ALK) inhibitor, from the pivotal ALTA trial in ALK-positive non-small cell lung cancer patients who experienced disease progression on crizotinib (Xalkori, Pfizer Inc.). Read More

Immunomedics Inc., of Morris Plains, N.J., announced an immuno-oncology agent, (E1)-3s, that can direct a patient's T cells, a type of white blood cells, to kill cancer cells with the cancer marker, the Trop-2 antigen, which can be enhanced by combining with an immune checkpoint inhibitor. Read More

Partners Bayer AG and Versant Ventures have committed $225 million in series A financing to launch Bluerock Therapeutics, a regenerative medicine company focused on developing induced pluripotent stem cell therapies for diseases with significant cell loss and diminished self-repair potential. Read More

LONDON – The ambition of accelerating access to innovative medicines will not be achieved unless payers have a say in selecting products and are involved from the start in discussions about what real world evidence will be collected to demonstrate efficacy after conditional approvals are granted. Read More

New York-based Ophthotech Corp. saw its shares plummet 86.4 percent in heavy trading Monday on news that the pre-specified primary endpoint of mean change in visual acuity at 12 months, measured as best corrected visual acuity (BCVA) in terms of additional letter gains, was not achieved in its two pivotal phase III trials investigating the superiority of Fovista (pegpleranib) anti-platelet-derived growth factor (PDGF) therapy in combination with Lucentis (ranibizumab) anti-VEGF therapy compared to Lucentis monotherapy for the treatment of wet age-related macular degeneration (AMD). Read More

The continuing budget resolution finally made its way past Capitol Hill as a government shut-down loomed, and President Obama gave the legislation his signature Dec. 10, hours after the bill cleared the Senate. The legislation provides more than $870 million for the 21st Century Cures Act, although $500 million of that amount would be applied to state efforts to push back on the opioid crisis. Read More

Comprehensive profiling of the antibody response to respiratory syncytial virus (RSV) has shown that more than half of the strongest antibodies bound to a site that had not previously been identified as a vaccine target. Read More

With only a few weeks remaining in 2016, the biopharmaceutical industry has welcomed 131 FDA approvals this year, including 19 for new molecular entities. Read More

Inspyr Therapeutics Inc., of Westlake Village, Calif., said it entered into definitive securities purchase agreements with institutional and accredited investors, for the private placement of shares of convertible preferred stock and warrants to purchase shares of common stock resulting in gross proceeds of approximately $1 million. Read More

Elite Pharmaceuticals Inc., of Northvale, N.J., said it filed an abbreviated new drug application with the FDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) in 2.5-mg/325-mg, 5-mg/325-mg, 7.5-mg/ 325-mg, and 10-mg/325-mg tablets. Read More