ANI Pharmaceuticals, Inc. announced that its ANDA collaboration partner Sofgen has received approval from the FDA of the Abbreviated New Drug Application (ANDA) for Nimodipine 30mg Capsules.
“This represents ANI's first ANDA approval with our partner Sofgen,” says Arthur S. Przybyl, president and CEO of ANI, in a released statement. “We are excited to have achieved this milestone and look forward to a successful launch.”
Novo Nordisk announced the FDA’s approval of FlexPro PenMate, designed for users of Norditropin FlexPro 5 mg, 10 mg, and 15 mg pens who dislike needles and prefer them to be hidden during the injection process.
CEA-Leti and Diabeloop announced their joint lab to develop an artificial pancreas to improve treatment for Type 1 diabetes patients. The lab builds on an earlier joint three-year research project that included clinical trials in hospitals and demonstrated the promise of a closed-loop system for treating diabetes.
Propeller Health announced the FDA cleared its Propeller platform to market in association with medications using GlaxoKlineSmith’s Diskus dry powder inhaler device for asthma and chronic obstructive pulmonary disease (COPD). The clearance follows 510(k) clearance to market the Propeller platform in association with medications using Boehringer Ingelheim’s Respimat inhaler for COPD received in March 2015.
There are not a lot of plastics-based contract manufacturers doing drug packaging, notes Phillips-Medisize Corporation Chief Technology Officer Bill Welch. “And we aren’t doing sterile filling or bulk handling. We’re taking drugs in vials, blister strips, or cartridges and integrating into a pen, auto injector, or inhaler,” he says.
Discussion of prescription to over-the-counter switches for inhaled products from a patient, business, and regulatory perspective was one of several topics on display at Respiratory Drug Delivery (RDD) Europe 2015, which hosted 450 pulmonary and nasal drug delivery experts from 31 countries at its latest conference in Antibes from May 5 to May 8.
In addition, RDD Europe celebrated its 10th anniversary, although its parent United States conference began in 1988.
As the market for self-administered drug-delivery devices continues to grow, there is a labor shortage affecting original equipment manufacturers (OEM). Phillips-Medisize CEO Matt Jennings discussed the impact of the shortage and strategies for OEMs to remain innovative at an industry briefing during Pharmapack North America and MD&M East.
Mylan announced the launch of the first bioequivalent alternative to GlaxoSmithKline’s Seretide Evohaler (salmeterol xinafoate/fluticasone propionate) in June under the brand name Sirdupla in the UK, reports 3M Drug Delivery Systems. It is a pressurized metered-dose inhaler to treat or prevent symptoms of asthma in adults 18 years of age and older.
The product is being manufactured by 3M.
Pharmapack North America was held June 9-10 at the Javits Center in New York City, featuring more than 30 exhibitors in the pharmaceutical packaging industry along with dozens of industry speakers. Click back through the coverage PMP News completed of its speakers and exhibitors for the 2015 show.
Here's a look at the show in photos:
Phillips-Medisize Corporation announced the opening of its new design and development center in Suzhou, China. Growth of the company’s design and development centers are claimed to help support customer needs for patient-administered biologics, pharmaceutical drug delivery, and diagnostics device design and development services.