Pfizer Inc., of New York, said the European Commission gave conditional marketing authorization for Xalkori (crizotinib) for the treatment of adults with previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer...The alliance will facilitate research on 13 undisclosed rare disease indications and has the potential to add candidates to Shire's early stage pipeline

BioAlliance Pharma SA, of Paris, said it signed a deal with Shafayab Gostar to distribute Loramyc (miconazole Lauriad mucoadhesive buccal tablet) in Iran for the treatment of oropharygeal candidiasis in immunocompromised patients...Under the agreement, Shafayab will get rights to import, promote and market the product in Iranian territories, though BioAlliance will remain the marketing authorization holder...In other news, Prolor said data from a Phase II trial of its long-acting human growth hormone

BioAlliance Pharma SA, of Paris, said it signed a deal with Shafayab Gostar to distribute Loramyc (miconazole Lauriad mucoadhesive buccal tablet) in Iran for the treatment of oropharygeal candidiasis in immunocompromised patients...Under the agreement, Shafayab will get rights to import, promote and market the product in Iranian territories, though BioAlliance will remain the marketing authorization holder

CellTex was advised to address the violations or risk an injunction or seizure of its facility...Kite Pharma Inc., of Los Angeles, entered a Cooperative Research and Development Agreement with the National Cancer Institute for the development and commercialization of novel engineered peripheral blood autologous T-cell therapeutics for the treatment of multiple cancer indications...Hepalink also agreed to make a $10 million equity investment in ProMetic in exchange for the issuance of about 48.1

In other news, Almirall reported data from the MOVE 2 study supporting the use of Sativex, an endocannabinoid modulator, to reduce symptoms of moderate to severe spasticity due to multiple sclerosis

Bristol-Myers Squibb Co., of New York, said the European Commission granted marketing authorization for the subcutaneous formulation of Orencia (abatacept) in combination with methotrexate for the treatment of adults with moderate to severe active rheumatoid arthritis

Early last year, the European Commission granted marketing authorization for Esbriet in adults for the treatment of mild to moderate IPF in all 27 member states...LEO Pharma A/S, of Ballerup, Denmark, disclosed plans to establish five long-term, strategic research collaborations in Australia, France, Germany and the U.S...Theravance retains full rights to velusetrag in the U.S., Canada, Japan and certain other countries

In other news, BioLineRx said results from the Phase II EAGLE trial of BL-1020, an oral GABA-enhanced antipsychotic, published in the Journal of Clinical Psychiatry, showed that the drug was safe and effective in improving schizophrenia, in addition to improving cognitive impairment associated with the disease...In other news, Evotec and Aspireo Pharmaceuticals Ltd., of Tel Aviv, Israel, said they inked an advisory agreement for support in the development and partnering of Aspireo's Somatoprim

Curadev Pharma Private Ltd., of New Delhi, India, triggered a milestone payment from Endo Health Solutions, of Newark, Del., by advancing its oncology program to the next stage of development...Endocyte said it expects to submit marketing authorization applications to European health authorities in the fourth quarter of 2012

Gentium SpA, of Villa Guardia, Italy, said the European Committee for Medicinal Products for Human Use (CHMP) decided to adopt a second List of Outstanding Issues relating to its marketing authorization application for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing hematopoietic stem cell transplantation therapy...Teijin Pharma Ltd., of Tokyo, and Pulmagen Therapeutics (Asthma) Ltd., of Slough, UK, inked an exclusive licensing deal granting

BioAlliance Pharma SA, of Paris, said it executed a licensing agreement with Vestiq Pharmaceuticals Inc., of Research Triangle Park, N.C., to commercialize Oravig in the U.S...Other partners in the consortium include IBIS Technologies BV, Infors Benelux BV and Wageningen University

In other news, Ablynx said it and partner Merck Serono, a division of Darmstadt, Germany-based Merck KGgA, advanced Nanobody candidate ALX-0751 into preclinical development in cancer...In other news, Boehringer and Eli Lilly and Co., of Indianapolis, said they received a positive opinion from the European Committee for Medicinal Products for Human Use for DPP-4 inhibitor Trajenta (linagliptin) in combination with insulin in adults with Type II diabetes...are soliciting consents from note holders for

Payments to LDC could aggregate to €82.5 million (US$106.8 million) in development milestones and €55 million in sales milestones, plus royalties on any net sales...Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it submitted a marketing authorization application to the European Medicines Agency for approval of afatinib, an irreversible ErbB family blocker, as a treatment for patients with EGFR mutation-positive non-small-cell lung cancer...Lundbeck A/S, of Copenhagen, Denmark, said it

The transaction now returns more cash to Nabi stockholders and provides increased certainty, through the use of a collar mechanism to protect against drops in the price of Biota shares...United Therapeutics Corp., of Silver Spring, Md., said under an exclusive agreement with Ascendis Pharma A/S, of Copenhagen, Denmark, it will apply Ascendis' TransCon technology platform to its treprostinil molecule, the active ingredient in Remodulin (treprostinil) injection for the treatment of pulmonary arterial

In other news, 3SBio said its special committee of independent directors has retained Cleary Gottlieb Steen & Hamilton LLP, of New York, as the committee's legal counsel...In other news, Boehringer said it started an open-label U.S...The objectives are to decrease or stabilize the number of blood-circulating CLL cells and to delay the onset of other signs of progression, such as swelling of lymph nodes, which then requires immunochemotherapy treatment

The agency said the resubmission constituted a complete Class 2 response to its July 26 letter and set a PDUFA date of Feb. 28, 2013...Shire also has applied for European marketing authorization for Vyvanse in the same indication

In other news, BioLineRx said BL-7010, an oral candidate in celiac disease and gluten sensitivity, was found to be safe and well tolerated in preclinical studies presented at the Better Life for Coeliacs 2012 Conference in Helsinki, Finland...The company expects to submit a new drug application in PsA to the FDA in the first quarter of 2013 and a combined marketing authorization application in PsA and moderate-to-severe psoriasis to the European Medicines Agency in the second half of 2013

Pfizer Inc., of New York, said the European Commission granted marketing authorization for Inlyta (axitinib) in adult patients with advanced renal cell carcinoma after failure of prior treatment with Sutent (sunitinib) or a cytokine...A kinase inhibitor, Inlyta is designed to selectively inhibit vascular endothelial growth factor receptors 1, 2 and 3

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency seeking conditional approval for the use of TMC207 (bedaquiline) as part of combination therapy for pulmonary, multidrug-resistant tuberculosis (MDR-TB...Two months ago, Janssen submitted a new drug application for bedaquiline, under priority review, to the FDA