regulatory_update

Berlin – September 07, 2026 -- Germany's largest pharmaceutical trade association, Pharma Deutschland, has warned that new cost-containment measures under the GKV-BStabG threaten drug supply, innovation, and investment in the country, even as it welcomes a fresh round of government dialogue on AMNOG reform.

Federal Ministry convenes stakeholders for September 3 dialogue

The Federal Ministry of Health has invited industry representatives to an in-depth discussion on Thursday, September 3, 2026, focused on harmonizing Germany's drug pricing and assessment framework. Pharma Deutschland, which represents roughly 400 member companies employing about 80,000 people in Germany, said it backs the continuation of the Pharma- und Medizintechnik Dialog but insists selective bureaucratic fixes cannot offset broader damage from recent legislation.

Berlin – September 07, 2026 -- The German Fire Brigade Association (DFV) has published new technical guidance on grounding live overhead lines in rail zones, following DB InfraGO's decision to revoke existing voluntary agreements with fire departments nationwide.

DB InfraGO Cancels Prior Grounding Agreements With Fire Departments

Previous contractual arrangements allowing fire brigades to perform emergency grounding, known as "Bahnerdung," on Deutsche Bahn AG infrastructure have been withdrawn by the rail operator's emergency management unit. Fire department carriers and DB InfraGO, the infrastructure operator, must now negotiate new agreements based on updated regulations and revised training requirements.

New York – September 07, 2026 -- Bayesian Health has secured a New Technology Add-on Payment (NTAP) from the Centers for Medicare and Medicaid Services, making it the first continuous sepsis monitoring technology to hold both FDA clearance and a dedicated Medicare reimbursement pathway.

The approval, issued under CMS's FY 2027 Inpatient Prospective Payment System Final Rule, takes effect October 1, 2026, and allows hospitals using Bayesian's FDA-cleared sepsis flagging device to bill Medicare an add-on payment of up to $61.84 per eligible inpatient case.

Tysons Corner, Virginia – September 7, 2026 -- Cellebrite Federal Solutions, Inc. (CFSI), a subsidiary of Cellebrite (Nasdaq: CLBT), has achieved Cybersecurity Maturity Model Certification (CMMC) Level 2, placing the company among the top 3% of organizations to meet the standard following an independent assessment by a certified third-party assessor organization (C3PAO).

CFSI implements 110 security controls across 14 domains to secure defense contract data

CMMC Level 2 is an advanced cybersecurity tier under the U.S. Department of War framework, required for contractors handling Controlled Unclassified Information (CUI). CFSI documented and deployed 110 security practices spanning 14 control families, including access control, incident response, risk management, system and communications protection, and audit accountability.

Gothenburg – August 31, 2026 -- AB SKF confirmed a total of 455,351,068 shares outstanding following a conversion of Series A shares into Series B shares under the company's Articles of Association.

Series B shares now dominate SKF's capital structure

As of August 31, 2026, SKF's share base comprises 28,918,310 Series A shares and 426,432,758 Series B shares. The total number of votes in the company stands at 71,561,585.8.

SKF holds no treasury shares

The Gothenburg-based bearings and seals manufacturer stated it does not hold any of its own shares. The disclosure was made public in compliance with the Financial Instruments Trading Act, submitted for publication at 08:00 CEST on August 31, 2026.

Belmont, W.Va. – September 07, 2026 -- Six separate objections have been filed in the Chapter 11 case of Omnis Pleasants, LLC, owner of the 1,278-megawatt Pleasants Power Station, ahead of a September 3 hearing before U.S. Bankruptcy Judge Karen B. Owens in Wilmington, Delaware.

Four objections come from Omnis and Quantum entities challenging lender protections

Omnis Fuel Technologies, LLC (doing business as Omnis Energy) and Quantum Pleasants, LLC filed four objections disputing whether obligations claimed by lenders TRAG LLC and RG Energy LLC are properly secured by Omnis Pleasants assets. The filings also challenge the proposed sale timetable and the retention of Herbert Smith Freehills Kramer (US) LLP as bankruptcy counsel, citing the firm's disclosed prior representation of TRAG and RG Energy. The debtor, lenders and HSF Kramer dispute these positions.

Uppsala, Sweden – September 04, 2026 -- Orexo AB has reached a non-binding agreement in principle with the US Department of Justice to pay USD 4 million in installments over several years, closing a federal investigation that began in 2020.

Orexo agrees to capped contingent payment tied to 2030-2031 sales thresholds

Beyond the fixed USD 4 million payment, Orexo would accept a capped contingent payment equal to five percent of net sales, triggered only if certain sales-related thresholds are met in 2030 and 2031 and Orexo's commercial products perform successfully in the market. The company is in the final stages of negotiating the settlement but cautions there is no assurance the deal will be finalized on these terms.

Uppsala, Sweden – September 04, 2026 -- Orexo AB has struck a non-binding agreement in principle with the US Department of Justice to settle a federal investigation that has run since 2020, the Swedish pharmaceutical company said.

Orexo to pay $4 million in installments over several years

Under the tentative terms, Orexo would pay USD 4 million in installments spread across multiple years. The company would also accept a capped contingent payment equal to five percent of net sales, triggered only if certain sales thresholds are met in 2030-2031 and contingent on Orexo's commercial products performing well in the market.

Minneapolis – September 04, 2026 -- The American Academy of Neurology (AAN) and American Headache Society (AHS) have issued a joint update to their 2012 clinical practice guideline on migraine prevention medications for adults, published simultaneously in Neurology and Headache journals on August 31, 2026.

Guideline sets clear treatment threshold for clinicians

The update recommends preventive treatment for patients experiencing four or more migraine days per month, four or more moderate-to-severe headache days per month, or migraine that impairs their ability to work or complete daily tasks. It distinguishes between chronic migraine, defined as 15 or more headache days a month with at least eight showing migraine features, and episodic migraine, which occurs on fewer days per month.

STOCKHOLM – September 04, 2026 -- Canada's Drug Agency (CDA-AMC) has issued a final recommendation supporting public reimbursement of Leqembi (lecanemab) for patients with mild cognitive impairment or mild dementia due to early Alzheimer's disease, BioArctic AB's partner Eisai announced.

Final recommendation follows agency reconsideration process

The decision comes after CDA-AMC reconsidered its position on the drug, marking a step toward broader patient access in Canada. Negotiations will now proceed through the pan-Canadian Pharmaceutical Alliance, followed by individual reimbursement decisions from public drug plans across Canada's provinces and territories.