The FDA approved Tarceva (erlotinib) tablets for first-line treatment of metastatic non-small-cell lung cancer characterized by tumors with epidermal growth factor receptor-activating mutations...The product is marketed by Genentech Inc., a member of the Basel, Switzerland-based Roche Group, and Astellas Pharma Inc., of Tokyo

Avilex Pharma ApS, of Copenhagen, Denmark, said it has received seed funding from Novo Seeds, the early stage financing arm of Novo A/S, which will be used to support the development of dimeric ligands targeting PDZ domains...In other news, GSK experienced manufacturing delays for manufacture and supply of Horizant (gabapentin enacarbil), partnered with XenoPort Inc., of Santa Clara, Calif., resulting in a stockout of the drug...The firms will aim to offer pharma and biotech companies a set of fully

BioAlliance Pharma SA, of Paris, said it received marketing authorization from the FDA for Sitavig (acyclovir Lauriad) in the treatment of recurring herpes labialis, marking the successful conclusion to the assessment procedure carried out by the American authorities...According to Epivax Inc., of Providence, R.I., the new H7N9 flu virus has serious potential for rapid expansion on a global scale...To date, 60 people have been confirmed infected with H7N9 in China, with 13 deaths

Covis Pharma Sarl, of Zug, Switzerland, inked a deal with affiliates of Paris-based Sanofi SA to acquire full commercial rights to Nilandron (nilutamide), Plaquenil (hydroxychloroquine), Rilutek (riluzole), Uroxatral (alfuzosin hydrochloride) and Kayexalate (sodium polystyrene sulfate) in the U.S. Sanofi will retain rights to the products outside of the U.S. Financial terms were not disclosed...In other news, Prana reported that it received a A$2.5 million (US$2.6 million) cash refund under the R&D

Sorrento Therapeutics Inc., of San Diego, signed an exclusive option to acquire Igdrasol Inc., of Fountain Valley, Calif., a private company focused on the development of oncologic agents for the treatment of metastatic breast cancer (MBC), non-small-cell lung cancer (NSCLC) and other cancers

Antisense Pharma GmbH, of Regensburg, Germany, revised its business objectives related to the advancement of its next-generation TGF-beta inhibitor oligonucleotide program...BioAlliance Pharma SA, of Paris, said it inked a collaboration with an undisclosed vaccine company to develop a vaccine application of its Lauriad mucoadhesive technology...In other news, Biotie and partner H. Lundbeck A/S, of Copenhagen, Denmark, said they received marketing authorization from the European Commission for Selincro

At all doses tested, ALX-0061 was well tolerated and the safety profile compared favorably to data reported for other biological DMARDs...To date, almost 50 percent of planned patients have been enrolled in about 30 European centers...In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents age 2 months to younger than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases

OSE Pharma SA, of Paris, said the FDA granted orphan drug status to its lead candidate, OSE 2101, to treat non-small-cell lung cancer (NSCLC) in patients expressing HLA-A2

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...Valeant Pharmaceuticals International Inc., of Montreal

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

Astellas Pharma Inc., of Tokyo, said the FDA accepted for filing a supplemental new drug application for Tarceva (erlotinib) for first-line use in patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have epidermal growth factor receptor (EGFR)-activating mutations...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

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

Astellas Pharma Inc., of Tokyo, said the FDA accepted for filing a supplemental new drug application for Tarceva (erlotinib) for first-line use in patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have epidermal growth factor receptor (EGFR)-activating mutations

Afatinib is under review for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer with an epidermal growth factor receptor mutation as detected by an FDA-approved test...Lilly acquired Avid in 2010 for $300 million up front, with another potential $500 million tied to regulatory and commercial milestones associated with Amyvid. (See BioWorld Today, Nov. 9, 2010, and April 10, 2012

The Merck expansion grants the big pharma further access to Adimab's technology to discover and optimize fully human antibody candidates, including potentially bispecific antibody candidates, across all disease areas...to-BBB Technologies BV, of Leiden, the Netherlands, entered a collaboration with the ALS Therapy Development Institute (ALS TDI) in Cambridge, Mass., to investigate potential treatments for amyotrophic lateral sclerosis

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.

Astellas Pharma Inc., of Tokyo, said it submitted a supplemental new drug application seeking approval of Tarceva (erlotinib) in first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have EGFR-activating mutations as detected by an approved test...LEO Pharma A/S, of Ballerup, Denmark, said the European Commission granted marketing authorization for Picato (ingenol mebutate) gel as a treatment for actinic keratosis, a skin condition that can

Astellas Pharma Inc., of Tokyo, said it submitted a supplemental new drug application seeking approval of Tarceva (erlotinib) in first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer whose tumors have EGFR-activating mutations as detected by an approved test...LEO Pharma A/S, of Ballerup, Denmark, said the European Commission granted marketing authorization for Picato (ingenol mebutate) gel as a treatment for actinic keratosis, a skin condition that can

Ironwood plans to initiate Phase I studies in healthy volunteers to assess the pharmacokinetics of IW-2143...CellAct Pharma GmbH, of Dortmund, Germany, said its topoisomerase inhibitor CAP7.1 showed promising safety and tolerability in heavily pretreated solid tumors...Immune Pharmaceuticals Ltd., of Herzlyia-Pituach, Israel, and EpiCept Corp., of Tarrytown, N.Y., entered a merger agreement, anticipated to close in the first quarter of 2013, that will create a combined company – Immune Pharmaceuticals