Posts tagged Complete Response Letter
Titan Pharma in talks with Braeburn about future of Probuphine partnership

Titan Pharmaceuticals (NASDAQ:TTNP) is in discussions with Braeburn Pharmaceuticals about their partnership for the development and commercialization of Probuphine, the first six-month maintenance treatment of opioid dependence. 

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Maxim upgrades ADMA Biologics to buy

Maxim Group upgraded ADMA Biologics (NASDAQ:ADMA) to ‘buy” from “hold” and established a price target of $13 after the company agreed to acquire Biotest Pharmaceuticals’ immunoglobulin manufacturing facility in Florida. The stock was quoted at $5.54 in afternoon trading on Jan. 24.

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FDA accepts Adamis NDA resubmission

The FDA has accepted for review Adamis Pharmaceuticals’ (NASDAQ:ADMP) NDA for its Epinephrine Pre-filled Syringe (PFS) product candidate for the emergency treatment of anaphylaxis. 

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Ocular Therapeutix gets complete response letter

Ocular Therapeutix (NASDAQ:OCUL) received a complete response letter (CRL) from the FDA about its NDA for DEXTENZA for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery.

Concerns raised by the FDA pertain to deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the company’s manufacturing facility. The FDA’s letter did not provide any details as to which manufacturing deficiencies remain open since the last response submitted by the company.

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