Jazz Pharmaceuticals plc, of Dublin, said the initial purchasers of its private offering of $500 million aggregate principal amount of 1.5 percent exchangeable senior notes due 2024 by Jazz Investments I Ltd., its wholly owned subsidiary, have exercised in full their option to purchase an additional $75 million aggregate principal amount of notes.

Iovance Biotherapeutics Inc., of San Carlos, Calif., said the FDA granted fast track designation for LN-144, its adoptive cell therapy using its tumor-infiltrating lymphocyte technology, for the treatment of advanced melanoma.

Sosei Group Corp.’s wholly owned subsidiary Heptares Therapeutics, of London, dosed the first healthy subject in its phase I trial testing HTL-0016878, a muscarinic M4 receptor agonist.

As far as adult regeneration goes, the lung and liver are far better than most human tissues. Even those organs, however, can become unable to repair themselves in the face of persistent injuries, such as those caused by smoking or excessive drinking. Experimentally, regenerative capacity can be restored by stem cell transplants.

As the dust settled following the FDA’s precedent-setting approval of Kymriah (tisagenlecleucel, previously CTL-019), the chimeric antigen receptor T-cell (CAR T) immunotherapy developed by Novartis AG, analysts and observers began to parse the long-term impact to the players and broader implications for the field.

Kymriah (tisagenlecleucel, CTL-019, Novartis AG) and other chimeric antigen receptor (CAR) T cells have been making their way through clinical trials as cell therapies. So the FDA’s Aug. 30 announcement that its approval of Kymriah was “a historic action today making the first gene therapy available in the United States” initially led to some head-scratching.