Akebia Therapeutics Inc.’s president and CEO, John Butler, told investors during a Monday conference call that it was the company’s goal to find a Japanese partner for phase III-ready vadadustat, an oral therapy for the treatment of anemia related to chronic kidney disease (CKD), by the end of 2015.
Barely three months after accepting a new drug application for Genentech Inc's Alecensa (alectinib), the FDA granted accelerated approval to the breakthrough therapy-designated drug for treating anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) patients who have progressed or are intolerant to Xalkori (crizotinib).
Implementing pathways to encourage competition and placing government regulation on generic drugs that lack competition were two suggestions offered during this week's Senate Special Committee on Aging to tackle a recent spate of off-patent drug hikes epitomized by Turing Pharmaceuticals Inc., which raised the price on a 62-year-old drug by nearly 5,500 percent and limited its access to specialty pharmacies.
The double phase III miss for hypoxia-activated prodrug evofosfamide likely will mean the end of Threshold Pharmaceuticals Inc.'s nearly four-year partnership with Merck KGaA, but the South San Francisco-based biotech isn't backing down from the premise that targeting hypoxia in the tumor microenvironment could tackle tumor progression, metastases and cancer treatment resistance.
A group of top-tier investors came together in a $53 million series B round for 2014 start-up ORIC Pharmaceuticals Inc., a company whose goal can be summed up neatly in its acronym: overcoming resistance in cancer.
The FDA Friday gave a faster-than-expected nod to Takeda Pharmaceutical Co. Ltd.'s Ninlaro (ixazomib), an oral proteasome inhibitor expected to eventually replace blockbuster Velcade (bortezomib), which is set to lose patent protection later this decade.
The FDA Friday gave a faster-than-expected nod to Takeda Pharmaceutical Co. Ltd.'s Ninlaro (ixazomib), an oral proteasome inhibitor expected to eventually replace blockbuster Velcade (bortezomib), which is set to lose patent protection later this decade.
Citing insufficient data, a too-small study and a patient population that was not clearly defined, an FDA advisory panel recommended the FDA reject the biologics license application (BLA) for Telesta Therapeutics Inc.'s bladder cancer drug, MCNA.
As expected, Neos Therapeutics Inc. received a complete response letter (CRL) for Cotempla XR-ODT, its orally disintegrating tablet (ODT) version of methylphenidate, delaying its commercial foray into the attention deficit hyperactivity (ADHD) space, though the Dallas-based firm is hoping to offset that delay with an earlier-than-expected introduction of an ODT version of Adderall XR (d-amphetamine).
The needs of the many outweighing the needs of the one might seem the acme of logic, at least for a Vulcan. For humans, it's not so simple, and it's only one of several thorny problems industry, government and society must resolve to establish clear guidance to provide dying patients with compassionate use access to experimental drugs.
