The FDA and the NIH now have 21st Century Cures expectations to deal with, a task that may be easier to manage thanks to a joint framework the two agencies recently published regarding the evidentiary criteria for biomarker qualification. The document notes that its provisions apply to "all categories of biomarkers and contexts of use," and that the document will be used by FDA to develop guidances relating to biomarker qualification. Read More

Brief treatment that combined suppression of the immunoproteasome with CTLA-immunoglobulin was able to prevent graft rejection for an extended period of time – up to half the lifespan of the mice in which the treatment was tested. The findings suggest that it may be possible to develop treatment regimens that reduce or even eliminate the need for constant immunosuppression in transplantees. Read More

Third Rock Ventures LLC has invested $55 million in a series A financing of Goldfinch Bio, a new Cambridge, Mass.-based company founded to discover and develop precision kidney disease therapies for conditions including focal segmental glomerulosclerosis (FSGS) and polycystic kidney disease. Using a patient registry to collect and integrate genomic and phenotypic data, it will focus on helping molecularly defined patient groups. Read More

DUBLIN – Johnson & Johnson has decided to fold, but Actelion Ltd. is still at the table, engaged in "discussions with another party regarding a possible strategic transaction." Read More

HONG KONG – Celltrion Inc. has much to look forward to in the European market, where perception on biosimilars is shifting for the better. The Congress of the European Crohn's and Colitis Organisation announced its support for switching from reference Remicade (infliximab, Janssen Biotech Inc.), the blockbuster anti-inflammatory drug, to biosimilar infliximab. Read More

Wednesday's FDA approval of topical PDE4 inhibitor crisaborole in atopic dermatitis could give Pfizer Inc. a few months head start over much-heralded breakthrough-designated systemic candidate dupilumab in what's expected to be a blockbuster market, even as other potential competitors advance in the clinic. Read More

Genocea Biosciences Inc., of Cambridge, Mass., announced a research collaboration with Checkmate Pharmaceuticals Inc., also of Cambridge, to characterize the T cell responses of patients in the ongoing Checkmate phase Ib clinical trial and to identify antigens associated with protective T cell responses. Atlas, Genocea's rapid antigen identification screening system, will be used to profile the T cell responses of approximately 20 patients enrolled in Checkmate's ongoing phase Ib clinical trial of CMP-001 in combination with the checkpoint inhibitor pembrolizumab to a library of tumor-associated antigens common to patients with advanced melanoma. Read More

The Patient-Centered Outcomes Research Institute board of governors approved nearly $42 million to fund 19 studies comparing a variety of health care approaches, including a $3 million project to determine the impact of different health plans on medication use and outcomes among adults and children with asthma and a $2.3 million project to determine whether established treatment or a newer drug is more effective against treatment-resistant cases of Kawasaki disease. Other projects include assessments of the quality of communications between health care providers and patients and preservation of patient privacy when linking data sets that include medical information. Read More

Sihuan Pharmaceutical Holdings Group Ltd., of Hong Kong, said that it received approval from the CFDA to run phase II/III trials of its oral hypoglycemic agent, imigliptin dihydrochloride. The candidate, a DPP-4 inhibitor, is a potential treatment for type II diabetes. Read More

Blueprint Medicines Corp., of Cambridge, Mass., said it closed its underwritten public offering of 5.75 million shares of its common stock at $25 each, including the exercise in full by the underwriters of their option to purchase additional shares of common stock. The company estimates net proceeds from the offering will be approximately $134.5 million, after deducting underwriting discounts and commissions and estimated offering expenses. Goldman, Sachs & Co., Morgan Stanley and Cowen and Co. acted as joint book-running managers for the offering and JMP Securities and Wedbush Pacgrow acted as co-managers. Read More