FDA cancels meeting but review of Isotechnika’s voclosporin continues

The FDA has cancelled a June 28 dermatology and ophthalmology drugs advisory committee review of a new drug application by Isotechnika Pharma’s (TSX:ISA) partner Lux Biosciences for their voclosporin drug as a treatment of non-infectious uveitis. On its website, the FDA said the meeting was cancelled to allow time for the “resolution of several outstanding [...]

Stellar allowed Uracyst patent in U.S.

Stellar Pharmaceuticals (OTCBB: SLXCF) has received a Notice of Allowance from the U.S. Patent and Trademark Office for intellectual property central to its Uracyst treatment of interstitial cystitis/painful bladder syndrome.  The patent will expire in 2024. The issuance of the patent triggers a milestone payment of $1.3 million (U.S.) from Stellar’s U.S. marketing and distribution [...]

Bioniche and Trophogen in license pact

Bioniche Life Sciences (TSX: BNC) has signed an exclusive veterinary license agreement with closely held Trophogen of Rockville, MD that gives Bioniche commercial access to a patented, proprietary superagonist hormone technology platform developed by Trophogen and originally licensed from the National Institutes of Health. The technology will initially be developed into a next-generation follicle stimulating [...]

Medicago in funding talks for U.S. vaccine plant

Medicago (TSX:MDG) has begun negotiating final terms and conditions with the U.S. Defense Advanced Research Projects Agency (DARPA) for a financing package to build a scalable plant to make plant-expressed, virus-like particles (VLP) vaccines. Medicago submitted its proposal for the plant in March, 2010.  ”Our proposal being selected by DARPA for potential funding demonstrates our [...]

IntelGenx to file NDA amendment in first quarter

IntelGenx Technologies (TSX-V:IGX) has met with the FDA to discuss a complete response letter received in February about its new drug application for its antidepressant CPI-300 and expects to file an amendment to the NDA in the first quarter of 2011. CPI-300 is a novel, high strength of Bupropion HCl, the active ingredient in Wellbutrin [...]

Biovail and Valeant to merge

Biovail (NYSE:BVF; TSX:BVF) and California-based Valeant Pharmaceuticals (NYSE:VRX) have agreed to merge through a stock swap that will create one of North America’s biggest specialty drug makers to be called Valeant Pharmaceuticals International. Under the accord, Valeant stockholders will receive 1.7809 shares of Biovail common stock in exchange for each share of Valeant common stock [...]

OncoGenex begins pivotal prostate cancer trial

OncoGenex Pharmaceuticals (NASDAQ: OGXI) has initiated a Phase 3 trial of its OGX-011/TV-1011 drug candidate for the treatment of castrate-resistant prostate cancer (CRPC), the first of three pivotal trials under a collaboration and license agreement with Teva Pharmaceutical (NASDAQ: TEVA). The international Phase 3 trial will be conducted at about 50 cancer centers and will [...]

Intellipharmaceutics CEO moulded at Biovail U

Fifteen years ago, Dr. Isa Odidi performed magic as CSO of Biovail (NYSE:BVF; TSX:BVF), developing several blockbuster generics, including hard-to-manufacture copies of Bayer’s Adalat CC, Pfizer’s Procardia XL and Novartis’ Voltaren XR. “We have the same style here at Intellipharmaceutics (NASDAQ:IPCI; TSX:I) as we had at Biovail,” Dr. Odidi says in an exclusive interview with [...]

AEterna to raise $12.1 million in direct offering

AEterna Zentaris (NASDAQ:AEZS; TSX:AEZ) has received commitments from institutional investors to purchase $12.1 million (U.S.) of securities in a registered direct offering under its U.S. shelf registration statement. The offering includes about 8.8 million common shares at a price of $1.3725 each and warrants to acquire about 4.4 million shares at an exercise price of [...]

YM reshuffles the Cytopia deck

YM BioSciences (AMEX:YMI; TSX:YM) got more than it bargained for with its recent acquisition of Australia’s Cytopia. “When we were buying the company, our sole interest was in CYT997, Cytopia’s lead vascular disrupting agent (VDA),” CEO David Allan told biotuesdays.com in an exclusive interview.  VDAs, which can disrupt the blood flow that feed tumours, became [...]

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