The star of Allergan's pipeline, a ketamine-like drug for depression, secured the FDA's coveted breakthrough therapy designation, guaranteeing the company access to top agency officials as it moves toward late-stage development.
Researchers say that persistent and high inflammation in the brain affects connections relating to important symptoms that are currently difficult to treat, triggering up to a third of all cases of depression. And they believe their discovery can point to other therapeutic remedies for depression
Researchers at the RIKEN Brain Science Institute say they were able to link a mutation with mitochondrial dysfunction that appeared to spur depression-like symptoms in mice.
The FGF9 protein plays a variety of roles in the body, influencing embryonic development, cell survival and tumor growth. But a team of investigators say they have nailed down some convincing animal and tissue data to suggest that in the brain it also could play a key role in depression, offering a new--very complex--target for a disease that afflicts millions.
The big news in biopharma this weekend is the unconfirmed report that Allergan is looking to sell its generics business to Teva. But Allergan execs didn't let the headlines distract them from another goal of CEO Brent Saunders': building the pipeline.
Otsuka and its partner Lundbeck snagged an FDA approval for Rexulti (brexpiprazole) to treat schizophrenia and as an add-on therapy for major depression, leaving the two companies prepping for an August launch into an increasingly crowded field.
Once again, a tiny open-label study using the potent anesthetic ketamine has kicked up stellar data for combating depression, grabbing headlines in some prominent publications. But this time a small, largely unknown private biotech company has seized on the study to tout its potential for gaining an FDA approval for a unique combination of drugs aimed at achieving a quick yet durable response for bipolar patients.
Developing new drugs for depression has become one of the most frustrating tasks in biotech as companies have struggled to demonstrate a positive effect against hard-to-control placebo responses in clinical trials or prove that dramatic and quick responses in small groups can translate into safe and broadly used drugs. Sage Therapeutics, though, is touting the results it's seen in just four patients.
Neuronetics has closed a $34.3 million Series F round to further commercialize its NeuroStar transcranial magnetic stimulation therapy system to treat drug-resistant major depressive disorder (MDD), as well as to fund a registration study for adolescent use of the device. NeuroStar was cleared by FDA in 2008 to treat MDD, but the company said it's just recently been gaining traction with payers.
Tal Medical has its roots in the serendipitous discovery that MRI imaging has a fast, mood-elevating effect. So far, it's managed to establish in the clinic that its low-field magnetic stimulation device built to recreate those conditions is rapid-acting. But now it's raised a $14 million Series B round to help establish the durability of that effect and the best dosage for depression treatment.