The U.S. FDA’s reissued draft guidance for pre-submission activity addresses the circumstances in which a manufacturer’s questions can be handled informally, but industry has a few misgivings about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.

Insmed Inc.’s phase III study of brensocatib in treating noncystic fibrosis bronchiectasis hit its primary and multiple secondary endpoints, impressing investors with statistically significant results. The positive data could lead to the first drug approval for the treating the deadly lung disease.

Gaining full rights to a bispecific antibody to treat atopic dermatitis, Johnson & Johnson is paying $1.25 billion to acquire Yellow Jersey Therapeutics, a wholly owned subsidiary of Numab Therapeutics AG. The subsidiary houses all assets related to NM-26, which targets IL-4Ra (type I and II receptors) and IL-31, and was designed with Numab’s MATCH (Multispecific Antibody-based Therapeutics by Cognate Heterodimerization) technology platform. It is ready for phase II development for atopic dermatitis, although J&J intends to develop, manufacture and commercialize the drug globally for follow-on indications as well.

Cambridge, U.K.-based Astrazeneca plc is looking to Asia, specifically China and Singapore, to build an innovative cancer-focused pipeline filled with antibody-drug conjugates (ADC), monoclonal antibodies (MAbs) and cell therapies.

Shares of Redwood City, Calif.-based Rezolute Inc., and Korean parent company Handok Inc., rose May 22 on positive results of a phase II proof-of-concept study for its investigative oral diabetic macular edema (DME) drug, RZ-402. RZ-402 is an oral small-molecule plasma kallikrein inhibitor designed to block vascular leakage and inflammation for treating chronic DME.

News out of the Heart Rhythm Society 2024 meeting May 16-19 highlighted the rapid disruption pulsed field ablation (PFA) devices have wrought in cardiac arrhythmia treatment, so it is little surprise to see that PFAs are among the top five technologies with transformative potential identified by Clarivate plc in its Medical Technologies to Watch in 2024 report. The impact of the other four – continuous glucose monitors (CGM) for diabetes, neurostimulation devices, surgical robotics and renal denervation – has been just as revolutionary, if longer in being realized.

Japanese industrial conglomerate Asahi Kasei Corp. has made an offer to acquire Swedish rare diseases specialist Calliditas Therapeutics AB for SEK11.8 billion (US$1.1 billion). The offer, at an 83% premium to the closing share price of SEK113.60 on Monday, May 27, is recommended by the three biggest shareholders and the board of Calliditas, which said the company would benefit from “being part of a larger platform.”

Nordson Corp. said it will buy Atrion Corp. for $460 per share in cash, representing a total equity value of approximately $815 million. The transaction enterprise value reflects a multiple of 20.2 times Atrion's 2023 EBITDA, and the $460 per share price represents a 15% premium to Atrion's 90-day average daily volume-weighted average stock price.