Fresenius Kabi introduced Bivalirudin; Envigo Launches; Mylan’s MAA accepted; Pricing hit pharma

Fresenius Kabi introduced Bivalirudin for Injection

Fresenius Kabi announced that it has introduced Bivalirudin for Injection in the United States, which is an anticoagulant, and a generic alternative to Angiomax. Fresenius Kabi’s Bivalirudin was approved by the U.S. Food and Drug Administration in October. The U.S. market for Bivalirudin for Injection is approximately $240 million. Fresenius Kabi’s Bivalirudin for Injection is available in single-dose vials, each containing 250 mg of Bivalirudin.

Envigo Launches Hepatotoxicity Testing

Envigo has launched a program of in vitro technologies aimed at helping to predict the likelihood of compounds causing Drug Induced Livery Injury (DILI) – one of the major causes of drugs being withdrawn from the market. The new DILI Assessment program can help identify whether a drug exhibits possible risk factors associated with hepatotoxicity. The program can be run in full, using all of its tests, or can be conducted using single assays as required.

Mylan’s MAA accepted by EMA for insulin glargine.

European Medicines Agency (EMA) has accepted review of Mylan’s Marketing Authorisation Application (MAA) for insulin glargine, a long-acting insulin analog used to treat adults with type 2 diabetes and adults and pediatric patients (children aged six and older) with type 1 diabetes for the control of high blood sugar. Mylan and Biocon have co-developed insulin glargine. The firms plan to offer another insulin treatment option for diabetic patients, who often face significant expense to manage their disease.

Pricing pressure may hit Indian pharma

Indian pharma companies like Sun Pharma, Dr Reddy’s, Lupin and Zydus may face erosion in margins and a slower growth over the next few months due to pricing pressure and an uncertain regulatory environment in the US. This comes even as some generic companies are already facing trouble on account of an anti-trust investigation by the US Department of Justice (DoJ) over generic drug pricing. Certain companies have already been facing the heat over the last few weeks, while global and Indian generics’ stocks went for a free fall on November 4 following news that the DoJ investigation is likely to result in charges being filed before the year-end.