Health Canada accepts Cipher acne filing for review

Health Canada has accepted for review a New Drug Submission by Cipher Pharmaceuticals (TSX: DND) for its CIP-Isotretinoin, a novel, patented formulation of the acne medication isotretinoin. The company expects a response from Health Canada in the first quarter of 2013. “Health Canada’s acceptance moves us a step closer to the commercialization of CIP-Isotretinoin in [...]

Diamedica forms advisory group for diabetes products

Diamedica (TSX:DMA) has formed a development advisory group for its DM-199 and DM-204 products for the treatment of Type 1 and Type 2 diabetes, consisting of Dr. Joy Cavagnaro, Dr. Patrick Gearing and Larry Johnson. They are industry experts in the areas of pharmacology and toxicology, manufacturing and regulatory affairs. The new group brings together [...]

Cipher readies regulatory filings for acne product

Cipher Pharmaceuticals (TSX:DND) is on track to file Health Canada and FDA submissions this quarter for its high-potential acne product, CIP-Isotretinoin, which is expected to trigger a $1 million milestone payment from its U.S. partner. The FDA review under PDUFA is expected to be six months. “With Lipofen generating steady revenue and our tramadol product [...]

Cipher’s tramadol cleared by Health Canada

Cipher Pharmaceuticals (TSX:DND) has received Health Canada approval for its CIP-Tramadol ER, an extended-release treatment of moderate to moderately severe chronic pain in adults. “This represents the second regulatory approval for our extended-release tramadol and another important milestone for the company,” CEO Larry Andrews said in a statement. “We believe our product’s unique attributes, including [...]

Health Canada clears D. Medical’s infusion sets

D. Medical Industries (NASDAQ, TASE:DMED) has received a medical device license in Canada to market its Spring Universal Infusion Sets, which are compatible with most insulin pumps currently available on the market. “We continue to successfully execute on our low-risk and low-cost strategy of introducing and promoting the Spring brand name to and across various [...]

Innovotech targets personalized medicine for bacteria

Ken Boutilier doesn’t mince words. “We believe we are pursuing the greatest opportunity in microbiology since penicillin,” the CEO of Innovotech (TSX-V:IOT) says in an exclusive interview with biotuesdays.com. “That’s our fundamental belief. For as good as penicillin and subsequent antibiotics after it were, they missed a very important fact about bacteria: bacteria exist and [...]

Wex may modify cancer pain trial

A data monitoring committee analyzing Wex Pharmaceuticals’ (TSX:WXI) Phase 3 clinical trial of  Tetrodotoxin (TTX) in patients with cancer-related pain has  found no safety concerns to stop or modify the trial based on an interim analysis of 60 patients. However, the committee informed Wex that the trial was “unlikely to demonstrate a clinically meaningful treatment-effect [...]

Health Canada accepts Cipher tramadol filing

Cipher Pharmaceuticals’ (TSX:DND) new drug submission to Health Canada for cip-tramadol ER, its extended-release formulation of tramadol, has been accepted for review. Cipher expects the review to be completed by early 2011. “The Canadian market for tramadol is strong and growing, with sales of approximately $50 million last year, a 30 per cent increase over [...]

Health Canada gives Paladin priority review

Paladin Labs’ (TSX:PLB) new drug submission for sublingual fentanyl has been accepted for priority review by Health Canada, which provides for a 180-day review cycle. “Abstral is an innovative product that will fulfill an unmet need for cancer patients in Canada and will complement our growing promoted pain portfolio, which includes Tridural, Metadol and Pennsaid,” [...]