Oncobiologics Inc. allied with Zhejiang Huahai Pharmaceutical Co. Ltd. to develop, manufacture and commercialize biosimilar monoclonal antibody products equivalent to Humira, Rituxan, Avastin and Herceptin in a rapidly expanding subsector which has reached $2.4 billion – a 20 percent increase from 2012. The products will be commercialized by Huahai and manufactured in China at a Huahai biologics facility for the China market. The companies will also establish a co-development and

Cardio3 BioSciences (C3BS) closed a €19 million ($25 million) investment round to fund an ongoing European Phase III trial of its stem cell therapy for ischemic heart failure, C-Cure. Just €7 million of the total represents new money, however. The remainder comprises an equity conversion of existing loans. The new cash comes from the company's existing investors. C3BS, of Mont-Saint-Guibert, Belgium, is developing a therapy that originated at the Mayo Clinic, in Rochester, Minn. C-Cure (formerly

Cell Medica Ltd., of London, treated its first patient in the ASPIRE Phase I/II trial of Cytovir ADV for adenovirus infection in immunosuppressed pediatric patients following bone marrow transplantation. The project is a collaboration between Cell Medica, UCL Institute of Child Health, and Great Ormond Street Hospital for Children, funded in part by a grant from the Technology Strategy Board, the UK's innovation agency. The trial will enroll up to 15 patients and is scheduled for completion in

Merck & Co. Inc., of Whitehouse Station, N.J., said the biologics license application (BLA) for its investigational ragweed pollen (Ambrosia artemisiifolia) sublingual allergy immunotherapy tablet was accepted for review by the FDA. Merck expects the review for this BLA, as well as a BLA for its Timothy grass pollen (Phleum pretense) sublingual allergy immunotherapy tablet, to be completed in the first half of 2014. The latest application is supported by five studies evaluating the efficacy and

Cellmid Ltd., of Sydney, Australia, is acquiring Japan's Advangen Inc. in a deal that includes purchase of the company's shares for JPY120M (AU$1.2M) in cash and the issuance of 55.7 million Cellmid shares (AX:CDY) at AU5 cents each. The shares will be subject to voluntary escrow agreements for up to 12 months. Advangen owns FGF-5 inhibitor hair growth technology, including natural extracts and novel compounds. Cellmid already markets évolis hair products, derived from the FGF-5 inhibitor

Ablynx NV, of Ghent, Belgium, initiated preclinical development of next-generation anti-IgE Nanobody ALX-0962 in severe allergic asthma. ALX-0962 consists of a potent anti-IgE Nanobody with a dual mode of action – the ability to bind with high affinity to IgE while also displacing receptor-bound IgE – together with a serum albumin binding Nanobody for in vivo plasma half-life extension. AmorChem, of Montreal, and InflammatorRx Inc., of Quebec City, said they launched a research collaboration

Aileron Therapeutics Inc., of Cambridge, Mass., completed the first-in-human study of its lead stapled peptide drug, ALRN-5281. The long-acting growth hormone-releasing hormone agonist is in development for orphan endocrine disorders such as adult growth hormone deficiency and HIV lipodystrophy and broader indications in metabolic and endocrine disease. The initial Phase I evaluated the safety and tolerability of single ascending doses of ALRN-5281 administered by subcutaneous injection in

Baxter International Inc., of Deerfield, Ill., said a Phase III study testing immunoglobulin did not meet the co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease. Results, however, showed a positive, numerical difference in the change from baseline vs. placebo in cognition in a subgroup analysis, though the study was not powered to show statistical significance among subgroups. Based on those data, Baxter

Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancer. The product previously received orphan status in the U.S. and Japan. Lenvatinib is in Phase III testing in several indications, including thyroid cancer. In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting

Array BioPharma Inc.'s Phase III trial planned for this summer in recurrent low-grade serous ovarian cancer (LGSOC) with its Novartis AG-partnered MEK inhibitor is one of a handful of late-stage studies expected to roll out this year. "We're looking at five pivotal trials, all starting this year, across our two MEKs," said Ron Squarer, Array's CEO. "There could be more, based on data that's emerging at [the American Society of Clinical Oncology (ASCO) meeting] this year." Called MILO (MEK

Ariad Pharmaceuticals Inc., of Cambridge, Mass., reported its first revenue from cancer drug Iclusig (ponatinib), which was approved in December for use in adults with chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia that is resistant or intolerant to prior tyrosine kinase inhibitor therapy. Net sales totaled $6.4 million for the quarter ending March 31. Ariad posted a net loss for the quarter of $64.7 million, or 36 cents per share, a narrower loss

Astellas Pharma Inc., of Tokyo, and Drais Pharmaceuticals Inc., of Bridgewater, N.J., will repeat for the third time a spinout maneuver that has been successful with two other programs in the past. The companies partnered to develop and commercialize Astellas's compound ASP7035, a vasopressin V2 receptor selective agonist in development for nocturia, by means of a licensing arrangement to a new virtual company, Tacurion Pharma Inc., to be managed by the Drais executive team. InterWest Partners

Success rates doubled for cancer drugs that entered clinical trials in the early 1990s and those that entered the clinic a decade later, even as the number of such compounds increased by 50 percent over the period, according to a new analysis by the Tufts Center for the Study of Drug Development (CSDD). Clinical success rates – the percentage of investigational compounds that eventually obtain FDA approval – for cancer therapeutics rose from 9.9 percent for drugs that entered the clinic in the

Generic drugmakers appear to be winning in the showdown with biologics makers over state legislation that would limit the automatic substitution of future biosimilars. Colorado, Florida and Indiana are the latest states to shoot down a bill that would require notification and recordkeeping if a pharmacy substitutes a biosimilar for the prescribed biologic. The legislation was modeled on principles the Biotechnology Industry Organization (BIO) has identified as core safeguards for patients

The immune system is able to kick out many viral invaders after a few days to weeks. But others, from herpes to hepatitis C, can come to be in a permanent standoff with the immune system, controlled but not eliminated altogether. In chronic viral infection, CD8 "killer" T cells enter a state that has been called "exhausted." Such cells no longer produce cytokines to any appreciable effect, and many scientists thought they were incapable of dividing. But a team from the Swiss Vaccine Research

After voting 17-1 that data from a National Institutes of Health (NIH)-sponsored animal study were sufficient to approve Amgen Inc.'s Neupogen as a treatment for radiation sickness, two FDA advisory committees told the agency that the data should be applied to all drugs in the same class. With the Biomedical Advanced Research and Development Authority (BARDA) looking to procure a hefty supply of a granulocyte colony-stimulating factor (G-CSF) such as Neupogen for emergency use in case of a

Cel-Sci Corp., of Vienna, Va., reported findings from an efficacy study in a second animal model of rheumatoid arthritis (RA) using its LEAPS technology. The study evaluated the LEAPS vaccine's effect in the Proteoglycan-induced arthritis (PGIA) model of RA with a dominant T helper 1 (Th1) cytokine profile. Disease severity, measured on the basis of the Arthritis Index and histopathology, was significantly suppressed in mice treated with the LEAPS vaccine compared to controls. The reduction in