Clinical Intelligence

Ocular Therapeutix publishes positive results of Dextenza following cataract surgery

Wednesday, March 15, 2017

Ocular Therapeutix, a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative therapies for diseases and conditions of the eye, has announced positive results of a patient experience study of Dextenza (dexamethasone insert) 0.4mg for intracanalicular use. The study, published in Patient Preference and Adherence, evaluated the overall patient experience and perceived value of Dextenza following cataract surgery.

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FDA grants Orphan designation to Boehringer Ingelheim’s BI 836858 for myelodysplastic syndromes

Thursday, March 9, 2017

Boehringer Ingelheim has announced that the FDA has granted Orphan Drug designation to its anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic syndromes (MDS). Orphan Drug designation is granted by the FDA to investigational compounds intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people.

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Stratasys opens enrollment is 3DHEART pediatric clinical study

Wednesday, March 8, 2017

Stratasys, a 3D printing and additive manufacturing solutions company, announced enrollment is now open for 3DHEART, an investigator initiated trial. 3DHEART, which stands for 3DHearts Enabling A Randomized Trial, is a randomized, single-blind clinical trial to study the use of patient-specific 3D printed models in pre-operative planning for pediatric heart surgery. Stratasys is providing in-kind support with printing of the models to be used in the trial.

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Merck, Pfizer announce FDA and EMA filing acceptances of three marketing applications

Wednesday, March 8, 2017

Merck, known as MSD outside the U.S. and Canada, and Pfizer, have announced that the FDA has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development to help improve glycemic control in adults with type 2 diabetes: one for monotherapy, one for the fixed-dose combination of ertugliflozin and JANUVIA (sitagliptin), and one for the fixed-dose combination of ertugliflozin and metformin. The Prescription Drug User Fee Act (PDUFA) action date from the FDA is in December 2017 for the three NDAs.

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