Latest Headlines

Latest Headlines

Depomed scores a win in its epic struggle to fend off Gralise copycats

On Tuesday, Depomed announced that it won its patent lawsuit against Actavis, which wanted to market a generic version of Depomed's shingles pain drug Gralise. Depomed's shares surged more than 13% in after-hours trading to $14.94.

Mallinckrodt's U.S. pain drug approval brings Depomed a $10M delivery tech milestone

Mallinckrodt scored FDA approval for its Xartemis XR oxycodone and acetaminophen tablet, known in development as MNK-795, an opioid treatment for acute pain. The approval is also a win for Depomed, which owns the controlled-release technology and collected $10 million in a milestone payment.

Mallinckrodt, Depomed win priority review for oral pain med

Mallinckrodt and Depomed welcomed the FDA's priority review acceptance of an application for the companies' new oral pain drug that makes use of Depomed's controlled-release Acuform technology.

Depomed slams brakes on hot-flash drug after FDA advisers vote to reject

Depomed took a 10% hit on its stock price mid-day Monday after FDA advisers turned thumbs down on their drug to ease symptoms of hot flashes in a lopsided "no" vote. By a vote of 12 to 2 the outside advisers voted against recommending an approval for Sefelsa, concluding that the company had failed to demonstrate that the drug worked as billed.

FDA staff scrutinizes new hot-flash remedies

Depomed shares spiked yesterday as the company races with Hisamitsu to garner the first FDA approvals of non-hormonal drugs for tempering hot flashes, even though Depomed's drug fell short of efficacy goals in trials.

Depomed dispenses with two more Gralise copycats

Depomed chalked up a couple of much-needed wins in its ongoing fight to protect its shingles pain drug Gralise from generic competition.

Depomed releases new analysis of Serada Breeze 3 data

Depomed has released full data from its Phase III Breeze 3 trial of Serada, a controlled-release, oral, non-hormonal treatment for menopausal hot flashes (or hot flushes, if you are from the U.K.). This includes a new statistical analysis of the data, which the company carried out after a discussion with the FDA.

Depomed sues FDA over 'additional hurdles' to orphan exclusivity

Depomed won FDA approval for its shingles-pain drug Gralise under the agency's Orphan Drug program. Now, the company wants the Orphan Drug exclusivity to go along with it.

Depomed licenses gastric delivery to J&J

In the latest of a series of licensing deals, Depomed ($DEPO) has licensed its Acuform gastric retentive drug delivery technology to Janssen Pharmaceuticals in a non-exclusive deal, leading to a premarket share jump of 8.6%, according to The Wall Street Journal. The polymers in Acuform swell in the stomach, releasing the active drug gradually over 8 or 9 hours.

UPDATED: Depomed shares crater on another Phase III miss for hot-flash drug

Depomed ($DEPO) disappointed in its third shot at a Phase III win for its drug Serada as a treatment for menopausal hot flashes, but the Menlo Park, CA-based firm's executives have given no