Regulatory & Policy Updates

SHERIDAN, WYOMING - December 10, 2025 - Germany's service economy is facing its sharpest increase in corporate insolvencies in more than a decade, with hospitality, tourism and leisure businesses bearing a disproportionate share of the pain. In response to new 2025 insolvency figures from Creditreform, the Denkfabrik Zukunft der Gastwelt (DZG) is urging the Bundesrat to pass the Tax Amendment Act unchanged, including the reintroduction of the reduced 7% VAT rate on food, to stabilise one of the country's largest employment sectors.

Insolvency spike exposes deeper structural stress in services

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 - 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 - 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 4, 2025 - Butler National Corporation's Avcon Industries has secured European Union Aviation Safety Agency (EASA) and UK Civil Aviation Authority (CAA) approvals for its non-halon portable fire extinguisher retrofit on Learjet cabins, giving operators a certified, drop-in path to meet the looming December 31, 2025 halon phase-out deadline. The new approvals extend an earlier FAA Supplemental Type Certificate (STC) and position Avcon as a one-stop regulatory solution provider for Learjet fleets operating across North America, the UK and Europe.

Halon Phase-Out Drives Urgent Retrofit Decisions

SHERIDAN, WYOMING - December 2, 2025 - A leaked memo from FDA vaccine chief Vinay Prasad alleging that COVID-19 vaccines caused the deaths of 10 children has triggered a sharp backlash from scientific experts and investors, underscoring deep tensions inside U.S. vaccine regulation and adding fresh volatility for mRNA players Moderna and BioNTech.

An internal memo with external market consequences

In a six-page document titled "Deaths in children due to COVID-19 vaccines and CBER's path forward," Center for Biologics Evaluation and Research head Vinay Prasad claimed that an internal investigation had identified 10 child deaths "linked" to COVID-19 vaccination, based on reports in the Vaccine Adverse Events Reporting System (VAERS). The memo, published by The Washington Post, did not provide specific data, case details or manufacturer names.

SHERIDAN, WYOMING - December 2, 2025 - Imvax is moving its autologous glioblastoma immunotherapy IGV-001 toward the FDA, despite a missed primary endpoint in Phase IIb, betting that a six-month overall survival benefit and a novel "synergistic" treatment concept will resonate in a setting where outcomes have barely budged in two decades.

Phase IIb data highlight survival benefit despite PFS miss

In a mid-stage trial of 99 patients with newly diagnosed glioblastoma, Imvax evaluated IGV-001, a biologic-device combination, against placebo. While the study did not achieve its primary endpoint of improving progression-free survival, the company reported a median overall survival of 20.3 months in the treatment arm-around six months longer than in the control group.