Adding the investigational advanced breast cancer candidate, abemaciclib, to the already-approved drug fulvestrant, reduced the risk of disease worsening or death for women with hormone-receptor-positive, HER2-negative disease more than adding a placebo, Eli Lilly and Co. reported.
Circassia Pharmaceuticals plc has agreed to pay Astrazeneca plc up to $230 million in cash and stock to lead U.S. promotion of two chronic obstructive pulmonary disease (COPD) therapies in a deal that Circassia CEO Steve Harris told BioWorld Today will immediately add a second product to its portfolio and drive a short-order doubling of its sales force to 200 reps.
Jazz Pharmaceuticals plc enrolled the first patient in a phase III trial of JZP-258, a follow-on to its banner drug for narcolepsy symptoms, Xyrem (sodium oxybate). With 90 percent less sodium than Xyrem, the candidate is just one piece of the Dublin-based company's multifaceted defense of its substantial share of the narcolepsy therapy market.
Allergan plc has agreed to front the genome editing company Editas Medicine Inc. $90 million plus potential milestone payments for an exclusive option to license up to five ocular programs during a seven-year term.
Novartis AG has gained FDA approval to market Kisqali (ribociclib), in combination with an aromatase inhibitor, as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced or metastatic breast cancer.
San Diego-based brain cancer therapy developer Tocagen Inc. filed to raise gross proceeds of up to $86.3 million in an IPO intended to help advance its FDA breakthrough-designated candidates, Toca 511 and Toca FC, currently part of a phase II/III trial that could potentially support registration.
Drugmakers looking to the FDA's 505(b)(2) pathway for shorter approval times may want to think again. A new report says the filings, generally expected to streamline development and review, instead took an average of about five months longer than those for new molecular entities (NMEs) in recent years.
Roche Holding AG plans to initiate a pair of new pivotal phase III studies testing the beta-amyloid-targeting monoclonal antibody gantenerumab in patients with prodromal to mild Alzheimer's disease (AD) in hopes that a higher dose of the drug might yield benefits that lower doses did not.
Previously treated high-risk chronic lymphocytic leukemia patients saw a significantly better overall response rate when adding TG Therapeutics Inc.'s glycoengineered anti-CD20 candidate, TG-1101 (ublituximab), to Imbruvica (ibrutinib) during a phase III study called Genuine.
Johnson & Johnson's anti-interleukin 23 candidate, guselkumab, has outperformed Abbvie Inc.'s Humira (adalimumab) in a second pivotal plaque psoriasis trial, firming up the foundation for potential U.S. and European regulatory approvals late this year.
