Under the agreement and an associated supply and distribution agreement, Mylan is provided patent licenses and the right to market all three strengths of paroxetine hydrochloride extended-release tablets,
Otelixizumab has been evaluated in type 1 diabetes in two Phase II studies and in psoriasis in two Phase I studies. Under the terms of the agreement, Tolerx
Under the terms of the agreement, Dr Reddy’s will be responsible for the development, manufacturing and marketing of the drug product, which will utilize Scolr’s CDT technology. Scolr
The study met its primary endpoints of overall response rate and median duration of response, while demonstrating a manageable tolerability profile. The study evaluated the efficacy and safety
Amgen said that it will seek an injunction to prevent Roche from commercializing Mircera, which is used in the treatment of anemia, in the US in violation of
Ortec had filed the chemistry, manufacturing and control (CMC) section of the current pre-market approval (PMA) earlier in the year. Ortec also previously developed a statistical plan with
The phase I results show that 1-deoxynojirimycin was well-tolerated in healthy volunteers with good oral bioavailability and pharmacokinetic parameters. 1-deoxynojirimycin HCl (AT2220) is designed to selectively bind to
Long-term data (mean exposure = 71 weeks; maximum exposure = 148 weeks) from an integrated analysis of 383 patients with idiopathic pulmonary arterial hypertension (IPAH) or PAH associated
This is Morria’s first human study in allergic rhinitis (AR). The anti-inflammatory drug, MRX-4 is nasally administered as a single dose either with or without an allergen challenge
Preliminary data suggests that the combination is well tolerated, with a toxicity profile similar to known toxicities of each agent alone. The combination therapy has also shown promising
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