Products & Tech | Page 50 of 63

Novo Nordisk Intends to Appeal Adverse Ruling in Prandin (repaglinide) Patent Case

Novo Nordisk announced it would appeal the US District Court for the Eastern District of Michigan's ruling regarding Novo Nordisk's US patent covering combination drugs Prandin and PrandiMet. The district court ruled that the patent, which covers the combination use of repaglinide and metformin for the treatment of type 2 diabetes, is invalid and unenforceable...

FDA Rejects Afrezza, Mannkind’s Inhaled Insulin

The FDA's Center for Drug Evaluation and Research has issued a complete response letter to Mannkind corp. regarding the New Drug Application (NDA) for Afrezza (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes...

Generic Version of Bayer’s Type 2 Diabetes Drug Precose Approved by FDA

The FDA has given final approval to Mylan Pharmaceuticals Abbreviated New Drug Application (ANDA) for Acarbose Tablets, 25 mg, 50 mg and 100 mg. Acarbose is the generic version of Bayer's Precose tablets, a treatment to be used with diet and exercise to improve glycemic control in adults with type 2 diabetes...

Biocon Oral Insulin Shows Promise in Type 2 Diabetes Patients

Biocon Ltd., India's largest biotechnology company, released preliminary data from a recently concluded clinical study conducted in India, on IN-105, its novel oral insulin candidate for the treatment of diabetes. The study included 264 patients poorly controlled on metformin, who were randomly chosen receive either IN-105 or placebo...

New Type 2 Diabetes Drug Kombiglyze XR Now Available Across the US

Bristol-Myers Squibb Company and AstraZeneca announced that type 2 diabetes drug Kombiglyze XR (saxagliptin and metformin HCl extended-release), approved by the FDA on November 5, 2010, is now available by prescription in pharmacies across the United States. Kombiglyze XR is the first and only once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering strong glycemic...

Positive Results for Oral Insulin Delivery in Pre-Clinical Trials

MonoSol Rx and Midatech Group Ltd. anounced positive results from pre-clinical proof-of-concept studies for oral insulin delivery in Rhesus monkey studies and hope to begin human trials in 2011. The two companies are developing insulin PharmFilm under a partnership that leverages MonoSol Rx’s...

FDA Informs Mannkind It Needs More Time to Review AFREZZA NDA

The FDA informed MannKind Corporation that it would not be able to complete the review of the New Drug Application (NDA) for AFREZZA (insulin human [rDNA origin]) Inhalation Powder by the action date of December 29, 2010. The FDA stated that it will require approximately four additional weeks to complete its review of the NDA...

New Novo Nordisk Insulin Reduces Risk of Nighttime Hypoglycemia, New Studies Show

Novo Nordisk's ultra long-acting basal insulin Degludec significantly reduces risk of hypoglycemia during the night compared to insulin glargine, according to two long-term studies. The company announced the clinical results from two 52-week phase 3a treat-to-target studies comparing Degludec to insulin glargine in basal-bolus treatment of type 1 and type 2 diabetes...

Amylin and Eli Lilly Seek FDA approval for Expanded Use of Byetta in Type 2 Diabetes Patients

Amylin Pharmaceuticals, Inc.and Eli Lilly and Company have submitted a supplemental New Drug Application (sNDA) to the FDA for the expanded use of Byetta (exenatide) injection as an add-on therapy to basal insulin for adults with type 2 diabetes...

Glucose Test Strips Recalled: Risk of False Low Blood Glucose Results

Abbott Diabetes Care and the FDA have recalled 359 different lots of glucose test strips marketed under the following brand names: Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima. The problem with these strips relates to a defect that inhibits sufficient absorption of blood into the test strip. Strips exposed to warm weather or prolonged storage may be more likely to provide a false result...