Other, sub-Saharan countries are at the very beginning...They wouldn't have to do this in a mature market, or in some of the other emerging markets, whether it's about education, or a secure distribution, or even pharmacovigilance, which they will have to build their own systems for

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

The company plans to use the proceeds for R&D expenses, acceleration of clinical trials acquisitions of new technologies and other corporate purposes...Santen will join other investors, including Mountain Group Capital, Hatteras Venture Partners, Georgia Research Alliance Venture Fund and Kenan Flagler Business School Private Equity Fund to fund an additional $7.9 million for continued development of CSL1001 into pivotal testing and to further Clearside's pipeline in ocular choroidal

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

Other, sub-Saharan countries are at the very beginning...They wouldn't have to do this in a mature market, or in some of the other emerging markets, whether it's about education, or a secure distribution, or even pharmacovigilance, which they will have to build their own systems for

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

Net proceeds are expected to total about $314.5 – about $338.7 million if the underwriters' option is exercised in full – and will be used to pay the cost of note hedge transactions and for general corporate purposes...OPKO Health Inc., of Miami, priced its offering of $175 million aggregate amount of 3 percent convertible senior notes due 2033 in a private offering, OPKO said it intends to use proceeds for general corporate purposes, including R&D, acceleration of clinical trials, acquisitions of

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

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