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The regulator cited deficiencies at a third-party manufacturing facility. Camurus is seeking approval for its extended-release subcutaneous formulation of octreotide, which would allow more convenient once-monthly dosing for patients with acromegaly.

The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT inhibitor for use alongside insulin in type 1 diabetes and chronic kidney disease.

Camurus announced topline, interim data from an open-label, long-term safety and extension trial, ACROINNOVA 2, assessing CAM2029, octreotide subcutaneous depot, in 135 adult patients with acromegaly.

Camurus announces that the US Food and Drug Administration has approved Brixadi™ extended release injection for subcutaneous use, a weekly and monthly medication for the treatment of moderate to severe opioid use disorder, in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a daily buprenorphine product.

Camurus (NASDAQ STO: CAMX) today announced the publication in JAMA Network Open of a new post hoc analysis from a 24-week randomized, double-blind, Phase 3 study1 comparing weekly and monthly subcutaneous (SC) buprenorphine injections (Buvidal®/Brixadi®) to daily sublingual buprenorphine/naloxone (SL-BPN/NX).

Camurus announced that the New Drug Application by Camurus’ US licensee Braeburn for Brixadi™ extended-release weekly and monthly injection for subcutaneous use for moderate to severe opioid use disorder was accepted for review by the US Food and Drug Administration.

Camurus AB (NASDAQ STO: CAMX) today announced that its US licensee Braeburn has resubmitted the New Drug Application (NDA) for Brixadi 1 (buprenorphine) extended-release weekly and monthly injections for the treatment of moderate to severe opioid use disorder to the US Food and Drug Administration (FDA).

Camurus announces strong first quarter demand for Buvidal and reiterates the financial outlook for 2020 with expected revenues in the higher interval

Camurus today announced revised full year 2020 guidance for the company’s revenue and product sales. Camurus’ guidance for net revenue is increased to SEK 340 -380 million from SEK 290 -330 million with estimated product sales of SEK 310 -340 million, previously SEK 240 -280 million. The improvements are driven by increasing market

Camurus today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA) has issued a positive opinion recommending marketing authorization for a new, 160mg, monthly dose of Buvidal®