AIT Therapeutics Inc., of New York, said investigators at the National Heart, Lung and Blood Institute completed treatment of a patient with treatment-refractory Mycobacterium abscessus lung disease with the AIT Nitric Oxide generator system under the FDA compassionate use program. Read More

Mallinckrodt plc, of Staines-upon-Thames, U.K., said it is acquiring Ocera Therapeutics Inc., of Redwood City, Calif., a clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutics for orphan and liver diseases. Read More

Ironwood Pharmaceuticals Inc., of Cambridge, Mass., reported U.S. net sales of constipation drug Linzess (linaclotide), as reported by partner Allergan plc, of Dublin, totaling $190.9 million for the third quarter, up 16 percent over the third quarter in 2016. Read More

Spero Therapeutics Inc., of Cambridge, Mass., priced its IPO of 5.5 million shares at $14 per share, the low end of its previously proposed range, for gross proceeds of $77 million. The company granted underwriters a 30-day option to purchase up to 825,000 additional common shares, which could add up to $11.6 million to the proceeds. Read More

If it stands up against promised challenges, a new payment rule that would let the Centers for Medicare & Medicaid Services (CMS) cash in on some of the outpatient drug savings U.S. hospitals get through the 340B discount program could deepen the pricing rift between hospital groups and the biopharma industry. Read More

A lot of effort has been expended on understanding what determines the efficacy of checkpoint blockade. Much of that effort has been focused on the tumor and the immune system – reasonably enough, since those are the direct combatants in the tumor-immune face-off. Read More

LONDON – Further uncertainty has been added to the stew of Brexit imponderables after the British government confirmed that the long-awaited Clinical Trials Regulation will not be transposed into U.K. law when the country leaves the EU in March 2019. Read More

DUBLIN – Advicenne SA set out its stall this week with plans to raise up to €35 million (US$41 million) in an IPO on the Euronext in Paris, in order to continue clinical development of its lead therapy, ADV-7103, and to initiate the commercial rollout of the product in Europe. Read More

Boehringer Ingelheim GmbH is enlisting early stage RNAi specialist Dicerna Pharmaceuticals Inc. to discover and develop new therapies for chronic liver diseases, starting with nonalcoholic steatohepatitis (NASH). Read More

The FDA released a draft guidance on controlled correspondence regarding generic drug development. A revision of a draft guidance issued in 2015, the new draft discusses how sponsors can submit controlled correspondence requesting information related to generic drug development and how the agency responds to such requests. Read More