North America

SHERIDAN, WYOMING - December 10, 2025 - Koelnmesse Inc. is initiating a carefully planned leadership transition in North America, with long-time President and Managing Director Mette Petersen set to retire on June 30, 2026, and 22-year company veteran Darrin Stern taking over the top role on January 1, 2026. The structured handover is designed to safeguard continuity while positioning the U.S. subsidiary for its next decade of portfolio growth and international expansion.

Structured transition protects continuity and relationships

From 1 January 2026, Stern will assume the role of President and Managing Director, while Petersen will continue through the first half of the year in an advisory capacity. During this period she will mentor key team members and support strategic initiatives with Koelnmesse's headquarters in Cologne, Germany.

SHERIDAN, WYOMING - December 8, 2025 - Canada is moving to tighten the link between immigration policy and health system capacity, with the federal government announcing new measures to accelerate the arrival and integration of internationally trained physicians-and the Canadian Medical Association (CMA) signalling that the real prize will be pairing these policies with faster, more predictable credential recognition.

New Federal Pathways Aim to Bring Doctors into Practice Faster

In Ottawa, Immigration, Refugees and Citizenship Minister Lena Diab unveiled a package of measures to make it easier for international doctors to settle and work in Canada. The initiative includes a new fast-track entry program for foreign physicians currently working in the country on a temporary basis, as well as additional slots dedicated to doctors under the Provincial Nominee Program.

SHERIDAN, WYOMING - December 8, 2025 - Investors in Perrigo Company plc (NYSE: PRGO) are weighing next steps after The Schall Law Firm announced a putative securities class action alleging the consumer healthcare company misled the market about the condition and turnaround costs of the baby formula business it acquired from Nestlé. The case highlights ongoing governance and disclosure risk around carved-out assets in regulated consumer categories.

Allegations Center on Underinvestment in Nestlé Baby Formula Business

SHERIDAN, WYOMING - December 8, 2025 - Canadian fintech Tuhk Inc. is stepping out of stealth with a US$6 million seed round to turn fragmented fraud data into a real-time collaboration fabric between merchants, banks and service providers, as the payments industry wrestles with a cybercrime threat measured in the trillions of dollars.

Fintech Veterans Target a US$10.5 Trillion Cybercrime Problem

Founded in 2025 by veterans from Ethoca and NuData Security, Toronto-based Tuhk is positioning itself as a "real-time data collaboration platform" at the intersection of fraud prevention and payments optimization. The seed financing is led by FINTOP, with strategic participation from Lloyds Banking Group and Capital One Ventures, signalling early alignment from major issuers and card partners.

SHERIDAN, WYOMING - December 8, 2025 - After a year of mixed signals from U.S. regulators, rare disease executives and policy experts are urging the FDA to match its pro-innovation rhetoric with clearer, more consistent rules for approvals, arguing that uncertainty around evidence standards is starting to chill investment and slow the next wave of therapies.

Mixed Messages from an Activist, Rare-Disease-Friendly FDA

Under Commissioner Marty Makary and CBER director Vinay Prasad, the FDA has made high-profile statements in favor of easing market access for rare disease treatments and even floated a "plausible mechanism" pathway for ultrarare conditions. Yet in practice, sponsor experience has been uneven.

SHERIDAN, WYOMING - December 8, 2025 - The U.S. Food and Drug Administration is preparing a fundamental shift in its evidentiary standards for new drugs, with Commissioner Marty Makary signaling that a single pivotal trial could soon be sufficient for approval-a move that has roiled internal leadership, unsettled some regulators and analysts, and triggered immediate recalculations in biopharma portfolio models.

From Two Pivotal Trials to One: A Structural Break

SHERIDAN, WYOMING - December 8, 2025 - Denali Therapeutics is facing another regulatory setback after the U.S. Food and Drug Administration (FDA) placed a clinical hold on DNL952, its enzyme replacement candidate for Pompe disease, citing preclinical hypersensitivity signals and demanding protocol changes before the company can start Phase I studies.

FDA Flags Hypersensitivity Risk Before First Human Dosing

The clinical hold, disclosed in an SEC filing, stems from "hypersensitivity reactions" observed in mouse models. While the agency has not required additional non-clinical studies, it is insisting on a more conservative first-in-human plan. Denali has been asked to lower the proposed starting dose for DNL952 and implement "revised inclusion criteria, adjusted stopping rules and unspecified safety monitoring commitments" before the program can proceed.

SHERIDAN, WYOMING - December 8, 2025 - Praxis Precision Medicines has doubled down on its neurology strategy with back-to-back updates: a Phase II win for its sodium current blocker relutrigine in rare developmental and epileptic encephalopathies (DEE) and a "successful" pre-NDA meeting for its essential tremor candidate ulixacaltamide, positioning the Boston biotech as a potential new commercial player in both ultra-rare epilepsy and movement disorders.

Relutrigine Study Stopped Early for Efficacy in DEE

Praxis has halted its mid-stage EMBOLD trial of relutrigine early, after an independent data monitoring board recommended the study "stop the study early for efficacy." The Phase II EMBOLD study is evaluating relutrigine in patients with DEE linked to SCN8A and SCN2A mutations, a small but highly underserved genetic epilepsy population with limited therapeutic options and high unmet medical need.

SHERIDAN, WYOMING - December 8, 2025 - The CDC's Advisory Committee on Immunization Practices (ACIP) has triggered a major shift in U.S. newborn immunization policy, voting 8-3 to delay the hepatitis B vaccine for infants born to hepatitis B-negative mothers from the traditional birth dose to two months of age, despite decades of evidence and CDC messaging that the shot is safe, effective and critical for long-term protection.

A Narrow Vote to Delay the Birth Dose for Some Newborns

Under the new recommendation, only babies born to mothers who test positive for hepatitis B-or whose status is unknown-would still receive the birth dose. For infants of mothers who test negative, the vaccine can be delayed until two months, effectively dismantling the universal birth-dose strategy that has been in place for about 30 years.

SHERIDAN, WYOMING - December 8, 2025 - As more practices adopt chairside 3D printing, many clinicians worry quietly about what it means for long-standing dental lab relationships-but rather than replacing labs, in-house production is reshaping them into higher-value, more strategic partnerships built around clearly defined roles and shared digital workflows.

From Full Lab Dependency to Hybrid Production

For years, the dominant model in restorative and appliance production has been full lab dependency: every crown, bridge, model, surgical guide, night guard or retainer went out the door to a third-party provider. In that setup, "Lab controls your timeline. Lab controls your cost per case. Lab capacity limits your capacity. Emergency cases wait on lab availability."