The matter of how adhesion of its Viaskin Peanut allergy patch relates to efficacy became a major problem for DBV Technologies SA, which drew a complete response letter (CRL) for the once-daily epicutaneous (EPIT) product. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Aug. 4 at $2.34, down $1.76, or 43%, in reaction to the CRL for the patch, designed to protect children ages 4 to 11. The FDA wants DBV to modify the patch, which means a new human-factor study; officials also are requiring clinical data for the modified patch.

LONDON – Morphosys AG finally has some heft to put behind its U.S. commercialization ambitions following FDA approval for its long-nurtured anti-CD19 antibody, Monjuvi (tafasitamab-cxix) in relapsed or refractory diffuse large B-cell lymphoma (r/rDLBCL).

In a time when the FDA needs its best and brightest people onboard, nearly half the senior leadership at the agency will be eligible for retirement by Sept. 30.

The FDA approved Kite Pharma Inc.’s Tecartus (brexucabtagene autoleucel, KTE-X19), the first cell-based gene therapy for adults with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment.

Since the stock-jolting phase III blowup in March of Milestone Pharmaceuticals Inc.’s etripamil for paroxysmal supraventricular tachycardia (PSVT), questions have lingered regarding the short-acting channel blocker’s regulatory path forward – but no longer. Shares of Montreal-based Milestone (NASDAQ:MIST), which in the spring plummeted to an all-time low of $1.70, made up for the loss and then some, closing at $8.91, up $5.57, or 167%, on word that the FDA has agreed to terms whereby an NDA for the nasal spray may be submitted without launching another phase III study.

Although PDUFA VI still has two years of life left to it, PDUFA VII is already in the birthing process, with the use of real-world data (RWD), AI, and a coming surge of novel cell and gene therapies looking to be prominent features of the next five-year user fee agreement. Politics likely will play a role as well.

Interludes of classical music. Little kids talking in the background. Unmuted mics as panelists multitask. Gurgles of “underwater” sound. Periods of silence as speakers forget to unmute. And then the technical problems – lots of them. Such are the challenges of addressing a virtual FDA advisory committee in the time of COVID-19.  

With an Aug. 22 PDUFA date set, Tricida Inc. said it received an FDA notification regarding the NDA for veverimer (TRC-101) for treating metabolic acidosis in chronic kidney disease (CKD) patients, noting that it had identified deficiencies precluding discussion of labeling and postmarketing requirements/commitments.