FDA panel gives thumbs down to Columbia Labs reproductive drug
PARSIPPANY, N.J. — A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug’s manufacturers said.
Columbia Labs and Watson Pharmaceuticals announced that the FDA’s Reproductive Health Drugs Advisory Committee did not recommend approval for progesterone vaginal gel in the 8% strength. The drug is designed to reduce the risk of preterm birth in women with short uterine cervical length in the middle trimester of pregnancy.
The FDA takes advisory committees’ recommendations into account when deciding whether to approve a drug, and while the recommendations are not binding, the agency doesn’t usually go against them. The FDA’s Division of Reproductive and Urologic Products is expected to take action on the drug by Feb. 26. Nevertheless, Columbia president and CEO Frank Condella said the company was confident that a late-stage clinical trial of the drug showed it to be safe and effective.
Shopko joins ranks with Rx mobile app
A mass merchandise retailer based in the Midwest has become the latest chain to join the move toward smartphone apps that allow customers to manage their pharmacy prescriptions. Fresh off the heels of its merger with Omaha, Neb.-based Pamida, Shopko announced the launch of an app for BlackBerry, Android and iPhone users that will allow customers to refill and manage their pharmacy prescriptions.
Customers using the app can request refills, review active prescription details — including expiration dates, refills remaining and overdue refills — set up dosage reminders, and receive email and text notifications when a refill is ready. It also includes a pharmacy locator that allows customers to locate and get driving directions to a pharmacy while checking hours of operation.
“We are always exploring new ways to improve customer service and make our pharmacy services more convenient, and this app makes finding our stores and filling prescriptions on their mobile devices quick and easy for our customers,” Shopko president, chairman and CEO Paul Jones said.
Several other retailers also have launched pharmacy apps recently. In October, Walgreens unveiled “Refill by Scan,” which allows patients to scan the bar code of a prescription and order refills in seconds, in addition to such previous technology as refill reminder text alerts and other apps for Apple, Android and BlackBerry devices. Meanwhile, supermarket chain Winn-Dixie launched a smartphone app and mobile website, m.WinnDixieRx.com. Customers can track their refill status and manage health information while locating Winn-Dixie pharmacies. An app for the Android and iPhone from CVS Caremark gives users access to the Drug Information Database and prescription management tools.
Generics cos. turn to biosimilars as patent cliff approaches
With the patent cliff and subsequent innovation drought moving closer, generic drug makers are looking to move up the value chain and pursue new sources of revenue, and of all the piles of pay dirt out there, biosimilars represent one of the closest things to an El Dorado, though regulations won’t take their final form for a while.
Currently, follow-on biologics manufacturers are restricted to a small group of companies making them for the European market — namely Sandoz, Teva Pharmaceutical Industries and Hospira — as well as companies making them for other markets, such as Dr. Reddy’s Labs. But other drug makers with piles of cash are looking to get in on the action, and it’s a lot more complicated than simply building a new lab and hiring a few more people.
Watson Pharmaceuticals announced last month a deal with Amgen to develop follow-on biologics. The deal would combine Amgen’s expertise as a biotech drug maker and Watson’s deep industry connections as a generic drug maker. Under the deal, Watson will contribute $400 million in co-development costs with Amgen and take responsibility for marketing and commercialization.
Also last month, Baxter and Momenta announced a deal to develop biosimilars for cancer, autoimmune disorders and other chronic conditions, with Baxter using its expertise in clinical development and manufacturing of biologics, sterile injectables and global commercialization and Momenta using its experience in high-resolution analytics, characterization and product and process development.