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

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

Watson Pharmaceuticals Inc., of Parsippany, N.J., changed its name to Actavis Inc

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

Toxicity experiments conducted to date revealed best-in-class potential with a greatly improved therapeutic index compared to other armed antibodies, due to an impressive safety profile, according to the company, which has opened a manufacturing facility in Nijmegen for the production of ADCs up to Phase III trials and early launches

Allergan Inc., of Irvine, Calif., said the FDA approved Botox (onabotulinumtoxinA) for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency in adults who have had an inadequate response to or are intolerant of an anticholinergic medication

The drug is expected to launch in Canada in the second quarter

ACT agreed to pay $12.5 million to the investors, plus legal expenses, comprised of $2 million in cash, $4.5 million in restricted common stock and $6 million through the issuance of an 8 percent amortizing redeemable convertible debenture maturing in June 2015...The firms agreed to the deal – valued at about $510 million – last month

Ltd., of Osaka, Japan, inked a licensing deal to develop and market in Japan an oral formulation of a pediatric beta-blocker for the treatment of infantile hemangioma requiring a systemic therapy

Amgen Inc., of Thousand Oaks, Calif., said it plans to build a new manufacturing facility in the Tuas Biomedical Park area of Singapore...Construction is slated to start in the next few months...The vaccine is the first to be made in a 100 percent egg-free system without growing influenza viruses

The drug is indicated in combination with other antiretrovirals in HIV-1-infected patients with no darunavir resistance-associated mutations