Proximagen Group plc, of London, partnered three of its developmental central nervous system (CNS) programs with H. Lundbeck A/S, of Valby, Denmark, in exchange for a stock purchase worth £10.3 million (US$16.2 million). The companies will work together to develop the three programs in the areas of epilepsy, pain and inflammatory disorders.

Onyx Pharmaceuticals Inc.'s submission of a new drug application (NDA) for its multiple myeloma drug, carfilzomib, is an audacious move that has investors biting their nails. The strength of the submission rests on study 003-A1, an open-label, single-arm Phase IIb trial in 266 heavily pretreated patients with relapsed and refractory multiple myeloma.

San Diego-based Afraxis will receive crucial early stage funding through a new collaboration with the National Institute of Health's (NIH) Therapeutics for Rare and Neglected Disease Program (TRND), boosting its Fragile X program through the notorious "Valley of Death." If all goes well, that will get a product to the investigational new drug (IND) application stage. Afraxis was one of four companies selected for the TRND program in the current application cycle. The award has no dollar amount associated with it, but is funded out of a $50 million budget through the NIH.

Transcept Pharmaceuticals Inc. and Vivus Inc. each have adjusted the proposed labeling of their respective products in response to FDA concerns, with the hope that more restrictive labels will allow the products to be approved. Transcept's Intermezzo (zolpidem tartrate sublingual tablets) for insomnia will carry a lower recommended dose for women and instructions detailing the safest use of the drug. Likewise, Vivus is adding labeling material for Qnexa (phentermine/topiramate) stating that the drug is contraindicated for women with childbearing potential.

Thrasos Innovation Inc. kicked off a Phase I trial investigating the safety and tolerability of THR-184, an activator of specific receptors in the bone morphogenetic protein (BMP) receptor pathway. The peptides are designed to help protect and repair acutely injured kidneys. Although acute kidney injury (AKI) is a source of significant morbidity and mortality following surgery – and a major frustration for physicians – there is no approved drug therapy for the condition.

Shares in RXi Pharmaceuticals Corp. (NASDAQ:RXII) jumped 14 percent Monday on news that the FDA had cleared a chemistry, manufacturing and controls (CMC) partial clinical hold on its lead cancer vaccine, NeuVax. Now that the Worcester, Mass.-based company has satisfied all of the FDA's requirements, it is on schedule to begin its Phase III (PRESENT) trial in early 2012.

Oxigene Inc. reported a radical restructuring to conserve resources and focus on earlier stage programs. The company will conclude its Phase II trial of Zybrestat in non-small-cell lung cancer (NSCLC), and defer initiation of Phase III registration studies of the drug in anaplastic thyroid cancer due to lack of funding.

OrbiMed Advisors LLC has closed a new fund dedicated to acquiring health care royalty streams and providing minimally dilutive debt capital to companies in the health care sector. The $600 million fund will provide an alternative to financing through the equity markets for companies with approved products or products close to approval. The fund has already made two investments: XOMA Ltd. and Velico Medical Inc.

A growth hormone-stimulating drug by Aeterna Zentaris Inc., of Quebec City, achieved its endpoint as a diagnostic for adult growth hormone deficiency (AGHD) according to top-line results from a Phase III trial reported by the company Tuesday. The drug, AEZS-130 (Solorel), was given to a group of growth hormone-deficient and normal patients, and diagnosis based on response to the drug had sensitivity and specificity greater than 90 percent.

All three of Affinium Pharmaceuticals Inc.'s original Series A investors have returned for a $15 million follow-on financing. SV Life Sciences, Genesis Capital Partners and Forward Ventures are joined by new investor Ontario Emerging Technologies Fund in a financing round that will support completion of a Phase II trial of Affinium's oral antibiotic AFN-1252, and Phase I trials of an I.V. formulation of the same drug.