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...The company said it is now free to commercialize or enter into commercialization agreements for its oral BDP suite of products with other parties without limitation

The FDA acknowledged receipt of a new drug application for Eliquis in September and deemed it a complete response to its June 22 complete response letter requesting additional information on data management and verification from the ARISTOTLE trial

BioAlliance Pharma SA, of Paris, said the European Independent Board of Experts held its first meeting on the ReLive Phase III trial evaluating the efficacy of Livatag (doxorubicin Transdrug) in primary liver cancer and recommended continuing the global, multicenter, randomized study without modification...Gentium expects to receive an opinion from the agency regarding the approval of defibrotide during the first quarter of 2013...It is designed to compare the effects of an optimized background drug

to Firdapse, a drug in development for Lambert-Eaton myasthenic syndrome BioMarin agreed to invest $5M in Catalyst under a promissory note and note purchase agreement 11/1/12 Colby Pharmaceutical Co. (San Jose, Calif.) MannKind Corp. (Valencia, Calif.) $140 Deal for disease-specific antigen compounds and intra-lymph node injection (INLI) technologies from its MKC1106 cancer vaccine program Colby is paying up to $140M in up-front and milestone payments to MannKind, which also will receive tiered

Without admitting or denying allegations, Lilly consented to pay a civil settlement of $29.4 million and agreed to have an independent compliance consultant conduct a 60-day review of the company's internal controls and compliance program related to the FCPA...As part of the settlement, Sanofi agreed to pay $109 million to the settling parties and expects to enter a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services

Allergan Inc., of Irvine, Calif., said it completed the acquisition of SkinMedica Inc., of Carlsbad, Calif., for about $350 million.

Flutemetamol, an investigational positron emission tomography imaging agent, to support Merck's development of MK-8931, an oral, beta-amyloid precursor protein site cleaving enzyme inhibitor in development for Alzheimer's disease...Shire plc, of Dublin, Ireland, reported a positive outcome from the European Decentralised Procedure for Elvanse (to be known as Tyvense in Ireland), indicated as part of a comprehensive treatment program for attention-deficit hyperactivity disorder in children, ages 6

Takeda acquired URL Pharma earlier this year for gout therapy Colcrys...and Canada to Probuphine, a subdermal implant and a long-acting product designed to deliver six months of buprenorphine hydrochloride following a single treatment

The cornerstone of the initiative is the MMRF CoMMpass study, which is designed to follow 1,000 newly diagnosed multiple myeloma patients over five years to understand the molecular changes underpinning the progress of the disease...Vanda said it intends to appeal the opinion and request a re-examination of the CHMP decision

The alliance will involve researchers from both organizations working together to investigate new ways of treating neurological diseases such as Alzheimer's, Parkinson's and other related disorders...The goal will be to identify and validate drug targets, develop new therapeutics and evaluate them in proof-of-concept trials

The company expects to receive about $725,200 after sales commission and other expenses...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

In a flash note, she observed that, with respect to pharmacokinetics, "it's unclear whether PI3K gamma inhibition by IPI-145 has meaningful contribution to anticancer activity...OncoSec plans to use the proceeds to fund clinical trials and research and development and for other corporate purposes...The company plans to use the proceeds to fund research and development, clinical trials and for other corporate purposes.

Galderma Pharma SA, of Lausanne, Switzerland, agreed to acquire Spirig Pharma AG, of Egerkingen, Switzerland

Eisai has a pending new drug application for Aciphex delayed-release sprinkle capsules 5 mg and 10 mg for the proposed indication of gastroesophageal reflux disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children, ages 1 to 11

Distribution of Prothena ordinary shares in the demerger is conditioned upon, among other conditions to the demerger, a registration statement filed with the SEC, having been declared effective by the SEC and the affirmative vote of the Elan shareholders...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

GlaxoSmithKline plc, of London, and the Fred Hutchinson Cancer Research Center entered a partnership to develop therapeutics to treat an inherited form of muscular dystrophy...The goal of the agreement is to develop a small-molecule-based medicine to potentially reverse facioscapulohumeral muscular dystrophy by inhibiting the activity of a protein that is incorrectly expressed by the DUX4 gene in people with the disease

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...Geron agreed to assign to TA Sciences Inc., of New York, those patents previously licensed to Asia Biotech, including intellectual property relating to telomerase activation technology

Reddy's Laboratories Ltd., of Hyderabad, India, acquired exclusive marketing and sales rights to Pamorelin LA (triptorelin) Depot, by Debiopharm Group, of Lausanne, Switzerland, in India for locally advanced or metastatic, hormone-dependent prostate cancer

Janssen Biotech Inc., of Horsham, Pa., and Janssen Biologics B.V., of Leiden, Netherlands, both part of Johnson & Johnson, submitted a supplemental biologics license application (sBLA) to the FDA and a Type II Variation to the European Medicines Agency (EMA) requesting approval of Stelara (ustekinumab) to treat adult patients with active psoriatic arthritis...The FDA gave guidance and permission to Lipocine Inc., of Salt Lake City, for its Phase III study of oral testosterone replacement therapy