Akela Pharma Inc., of Vancouver, British Columbia, said its wholly owned subsidiary, Formulation Technologies LLC, received a notice of default and that on Feb. 13 the subsidiary also received a notice of disposition of collateral on default from a secured creditor...In connection, it entered into a loan and security agreement with Biotech Investment Group LLC, relating to the funding of certain tenant improvements, relocation costs, security deposit, portions of rents related to the leased San

Isotechnika Pharma Inc., of Edmonton, Alberta, and privately held Aurinia Pharmaceuticals Inc., of Victoria, British Columbia, said they signed a binding term sheet for a merger to create a clinical-stage firm focused on the global nephrology market

Cerulean Pharma Inc., of Cambridge, Mass., said preclinical data showed that CRLX101 in combination with Avastin (bevacizumab, Roche AG) inhibited tumor growth and improved survival vs

Astellas Pharma Inc., of Tokyo, said the FDA accepted for filing a supplemental new drug application for Tarceva (erlotinib) for first-line use in patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have epidermal growth factor receptor (EGFR)-activating mutations...In other news, Boehringer Ingelheim said it enrolled the first patients in its Phase III interferon-free (IFN-free) program, HCVerso, testing its IFN-free polymodal regimen combining faldaprevir (BI

Astellas Pharma Inc., of Tokyo, said the FDA accepted for filing a supplemental new drug application for Tarceva (erlotinib) for first-line use in patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have epidermal growth factor receptor (EGFR)-activating mutations

Astellas Pharma Inc., of Tokyo, said it received European approval for Betmiga (mirabegron) for treating overactive bladder symptoms in adults...In other news, Evotec said a compound identified and optimized in a research collaboration with Osaka, Japan-based Ono Pharmaceutical Co

It also licensed rights to an oral calcitonin tablet to Tarsa Therapeutics Inc., of Philadelphia, which is developing it for postmenopausal osteoporosis...Research and further development will be funded and carried out through a special purpose development company, Spitfire Pharma Inc., of South San Francisco

Astellas Pharma Inc., of Tokyo, said it received European approval for Betmiga (mirabegron) for treating overactive bladder symptoms in adults...In separate news, Janssen reported that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 10-5 late Thursday to recommend approval of canaglifozin, a selective sodium glucose co-transporter 2 inhibitor, to treat Type II diabetes in adults

In other news, Evotec said it expanded its collaboration with MedImmune, part of London-based AstraZeneca plc, after hitting a key milestone...Under the agreement, Pepscan will use its CLIPS platform and other protein mimicry technologies to help discover new antibodies

PharmaIN Corp., of Bothell, Wash., and LAT Pharma LLC, of Chicago, said the FDA granted orphan designation for terlipressin for the treatment of ascites due to all etiologies except for cancer...Tranzyme Pharma Inc., of Research Triangle Park, N.C., reported the successful completion of its chemistry-based drug discovery collaboration with New York-based Bristol-Myers Squibb Co., which will now further develop the transferred active macrocycles across multiple drug targets

Victory Pharma Inc., of San Diego, will pay $11,420,743 to resolve liabilities resulting from marking of Naprelan, Xodol, Fexmid and Dolgic, according to the Justice Department

NovaDel Pharma Inc., of Bridgewater, N.J., said it signed a preliminary agreement to sell its NovaMist technology to Australian public pharmaceutical company Suda Ltd

for the sale of the non-Colcrys (colchicine, USP), generic business of URL Pharma Inc...and Canada to Probuphine, a subdermal implant and a long-acting product designed to deliver six months of buprenorphine hydrochloride following a single treatment

UMN Pharma Inc., of Akita, Japan, and Catalent Pharma Solutions, of Somerset, N.J., signed a deal in which Catalent will provide UMN a broad range of biosimilar cells lines using its GPEx technology

Astellas Pharma Inc., of Tokyo, said the FDA accepted for review its new drug application for tacrolimus extended-release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients...Galderma Pharma SA, of Lausanne, Switzerland, and Valeant Pharmaceuticals International Inc., of Montreal, reached agreement on terms of a revised North American aesthetics arrangement, resolving Galderma's pending litigation related to Valeant's

Akela Pharma Inc., of Vancouver, British Columbia, said its voluntary delisting from the Toronto Stock Exchange occurred at the close of trading Dec. 7...Payments to Isis could total $200 million, including license fees and regulatory milestones per program, plus additional double-digit royalties

Isotechnika Pharma Inc., of Edmonton, Alberta, reported positive anti-hepatitis C virus (HCV) results from the second round of in vitro testing of its cyclophilin antagonist molecules (NICAMs...Valeant Pharmaceuticals International Inc., of Montreal, and Galderma Pharma SA, of Lausanne, Switzerland, reached agreement on terms of a revised North American aesthetics arrangement, resolving Galderma's pending litigation related to Valeant's acquisition of Medicis Pharmaceuticals International Inc., of

Astellas Pharma Inc., of Tokyo, said the FDA accepted for review its new drug application for tacrolimus extended-release capsules for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients

Akela Pharma Inc., of Vancouver, British Columbia, said it applied for voluntary delisting from the Toronto Stock Exchange, citing an inability to maintain the continuous listing requirements