Gelesis announced that the Food and Drug Administration (FDA) has cleared Plenity (Gelesis100) to aid in weight management for overweight and obese adults, in conjunction with diet and exercise. Available in capsule form, Plenity, a non-systemic, superabsorbent hydrogel, is intended for use in adults with a body mass index (BMI) of 25–40kg/m2 and is taken…
Drugs in the Pipeline
United Therapeutics reported that following disappointing results from the BEAT study (NCT01908699), the company has decided to discontinue the development of esuberaprost for the treatment of pulmonary arterial hypertension.
As part of the ongoing safety investigation of potentially carcinogenic impurities detected in angiotensin II receptor blocker (ARB) medications.
Sandoz announced the launch of Treprostinil Injection, the first AP rated generic version of United Therapeutics’ Remodulin.
PDL BioPharma has announced the availability of an authorized generic version of Tekturna (aliskiren hemifumarate; Noden Pharma).
In the summer of 2018, the FDA learned that some generic ARB medications, including valsartan, irbesartan, losartan and others contained nitrosamine impurities— including N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA)—posing a potential safety concern.
HeartGuide is designed as a wrist watch that uses the oscillometric cuff method, the standard for medical-grade personal blood pressure measurement.
Safety Alerts and Recalls, Uncategorized
A review of cases reported to the FDA Adverse Event Reporting System (FAERS) and 4 observational studies (between 2015 and 2018) showed an increased risk of aortic aneurysm or dissection associated with fluoroquinolone use.
Firdapse was previously granted Orphan Drug designation and Breakthrough Therapy designation, as well as Priority Review by the FDA.
Infections, hypertension, infusion-related reactions, and fever were the most common side effects reported in patients who received Gamifant.