The U.S. FDA’s reissued draft guidance for pre-submission activity addresses the circumstances in which a manufacturer’s questions can be handled informally, but industry has a few misgivings about the draft. One of these is that a preformatted template proposed by the FDA would limit the number of topics that can be handled in an informal manner, which the Advanced Medical Technology Association said might drive more utilization of formal pre-submission programs, an outcome that would thwart the intent of these informal interactions.

The U.S FDA approved Camaps FX for use in pregnant women with type 1 diabetes. This first, hybrid, closed-loop app was developed by Camdiab Ltd., a spinout from Cambridge University, allows individuals aged two years and older with type 1 diabetes to manage their glucose levels.

Anaveon AG has received FDA approval of its IND application to conduct a phase I/II study of ANV-600.

JJP Biologics Sp. z o.o. has received clearance from the EMA to conduct a first-in-human study of its CD89 antagonist, JJP-1212, for IgA-mediated autoimmune and fibrotic diseases. A phase I study in healthy participants will be conducted in Poland.

South Korea’s Celltrion Inc. secured May 22 the European Commission’s go-ahead for Omlyclo (CT-P39) to be the first biosimilar to Genentech Inc./Novartis AG’s Xolair (omalizumab) in Europe for three of its major indications.

A recent hearing in the U.S. House of Representatives highlighted some of the issues Congress has with the agency’s performance, but there were questions as well about the FDA’s statutory authorities. One of these is the lack of statutory authority to require a recall for prescription drugs as well as the deadline for notifying the agency of device recalls, both of which are areas of legislative interest on the part of Congress.

Vyaire Medical Inc., of Mettawa, Ill., reported a class I recall of its Twin Tubes devices, which are used in the collection of air samples during cardiopulmonary exercise testing. The recall was prompted by the risk that the device nozzle will separate during patient use and potentially result in choking, although the FDA said there have been no reports of adverse events in connection with the problem.

The U.S. FDA has granted orphan drug status to HM-15421 (GC-1134A, LA-GLA) for the treatment of Fabry disease.

Be Biopharma Inc. has announced the FDA’s clearance of its IND for BE-101, an autologous potentially first-in-class B-cell medicine in development for the treatment of hemophilia B.

Novo Nordisk A/S’s once-weekly human insulin analogue for adults with type 1 diabetes mellitus could be a useful tool for patients and physicians, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee said May 24, but it also agreed that the risks outweighed the benefits for improving glycemic control.