Janssen Research & Development LLC, of Titusville, N.J., a unit of Johnson & Johnson, said its San Diego-based Janssen Labs added a Concept Lab, a shared laboratory to offer entrepreneurs access to bench spaces for early stage research, and an Open Collaboration Space, an open-plan office setting designed to provide companies and individuals with desk space...Those additions allow Janssen Labs to accommodate more than double the number of companies as when it launched in late 2011 as a 30,000
Aduro previously had licensed rights to two GVAX vaccines – GVAX Pancreas and GVAX Prostate – for use in combination with its Listeria-based vaccines...Under the terms, Aduro paid BioSante $1 million up front and has committed to additional milestone and royalty payments. (See BioWorld Today, July 1, 2009...BGI-Shenzhen, of Shenzhen, China, said it extended its all-cash tender offer to purchase all outstanding shares of Complete Genomics Inc., of Mountain View, Calif
The transaction is subject to approval by Covidien's board, and the separation is expected to be complete at the end of the second quarter of 2013...The FDA granted orphan drug designation to the product for retinitis pigmentosa
The restricted stock units vest over three years, and each is subject to terms of the company's 2012 equity incentive plan...Seattle Genetics Inc., of Bothell, Wash., reported that Health Canada has approved for marketing Adcetris (brentuximab vedotin), to treat: Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates...No data demonstrated increased survival with Adcetris
Shire plc, of Dublin, Ireland, said it reached agreement in principle to resolve the previously disclosed civil investigation into Shire's U.S...sales and marketing practices relating to Adderall XR (mixed amphetamine salts), Vyvanse (lisdexamfetamine dimesylate) and Daytrana (methylphenidate transdermal system
The company brought patent infringement action in April 2010 against generic firm Watson Laboratories Inc., of Parsippany, N.Y., (now known as Actavis) after Watson applied to the FDA to market a generic version of Rapamune
Spectrum Pharmaceuticals Inc., of Henderson, Nev., said it reacquired development and commercialization rights for apaziquone in the U.S., Europe and other territories pursuant to an agreed-upon restructuring of the firm's collaboration with Allergan Inc., of Irvine, Calif...Spectrum also agreed to conduct one additional Phase III study following its FDA consultation. (See BioWorld Today, Oct. 30, 2008, and April 6, 2012...Teva said it intends to book a noncash net charge of $109 million as a result
Endocyte expects to file an investigational new drug application by the end of 2013...The new facility will enable the firm to supply PLX cells to conduct additional trials in parallel with ongoing trials if it chooses
Boehringer Ingelheim GmbH, of Ingelheim, Germany, said the FDA's Pulmonary-Allergy Drugs Advisory Committee recommended that clinical data included in a new drug application provide substantial and convincing evidence to support the approval of olodaterol as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema
SOHO Industri Pharmasi for the registration and commercialization of Caldolor (ibuprofen) injection, which is used to treat pain and fever in the hospital setting...Merck Serono, of Geneva, a division of Merck KGaA, and the Feinstein Institute for Medical Research, the research division of the North Shore-Long Island Jewish Health System in New York, said they will collaborate to develop antibodies for the treatment of systemic lupus erythematosus (SLE...The program will focus on the use of antibodies
to test AXL1717, an oral small-molecule insulin-like growth factor 1 receptor inhibitor, in patients with malignant astrocytomas, a type of brain tumor...In other news, Novartis said the FDA approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia
BioWorld International | Wednesday, January 30, 2013
Ltd., of South Kora, for exclusive distribution rights to Hanmi's new drug application, currently under FDA review, for esomeprazole strontium delayed-release capsules...Hanmi filed the application pursuant to the 505(b)(2) pathway with data showing comparative bioequivalence of its drug to Nexium (esomeprazole magnesium delayed-release capsules, AstraZeneca plc
The FDA is expected to act on the application in the second half of 2013...The terms of the agreement call for the companies to work together for one year to combine the Plant Factory System with Medicago's protein production technology
Through a two-year collaboration, AstraZeneca will add 250,000 high-quality compounds to LDC's internal screening collection to pursue projects in the areas of oncology, neuroscience, respiratory and inflammation, cardiovascular, gastrointestinal and infection research...AstraZeneca then will have a preferred right to obtain a license for preclinical and clinical development and commercialization
Under the deal, Orexo granted AstraZeneca rights to conduct further preclinical research and evaluate compounds in the OX-CLI program, and AstraZeneca holds an option to acquire the compounds subject to a full asset transfer agreement under which Orexo would be entitled to development milestones and royalties
According to a prospectus filed by Auxilium Pharmaceuticals Inc., of Malvern, Pa., the FDA will not review its supplemental biologics license application for Xiaflex in Peyronie's disease in an advisory committee meeting...Cellceutix now intends to pursue further collaborations with BIDMC to develop combination treatments using Kevetrin and multikinase VEGF receptor antagonists such as sunitinib...to review and assist with the company's strategic and financial alternatives, which may include a
Results will be used to determine the recommended human starting dose and treatment regimen in the clinic...TRV130 is designed to stimulate the mu-opioid G protein coupling to produce analgesia, without stimulating the beta-arrestin pathway, thus minimizing many opioid side effects
Novartis AG, of Basel, Switzerland, said the FDA expanded the approved use of Exjade (deferasirox) to treat patients ages 10 and older who have chronic iron overload resulting from nontransfusion-dependent thalassemia, a genetic blood disorder...The FDA also is authorizing the marketing of FerriScan as an imaging companion diagnostic for Exjade to select patients for therapy and to manage therapy...Exjade previously gained approval for chronic iron overload due to blood transfusions in patients 2 and
The design of the trial later will be adapted, enabling it to separate into three separate personalized arms to test AZD0424 in different combinations alongside standard or other experimental treatments in specific patient populations...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 201335), a next-wave once-daily protease inhibitor, and BI 207127
BioWorld International | Wednesday, January 23, 2013
Janssen Research & Development LLC, of Titusville, N.J., a unit of Johnson & Johnson, said its San Diego-based Janssen Labs added a Concept Lab, a shared laboratory to offer entrepreneurs access to bench spaces for early stage research, and an Open Collaboration Space, an open-plan office setting designed to provide companies and individuals with desk space...Those additions allow Janssen Labs to accommodate more than double the number of companies as when it launched in late 2011 as a 30,000