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Regulatory & Policy Updates

CGTN Highlights China's 2025 Policy Priorities as the Country Prepares for the Next Five-Year Plan

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CGTN Highlights China’s 2025 Policy Priorities as the Country Prepares for the Next Five-Year Plan

SHERIDAN, WYOMING - January 1, 2026 - CGTN published a year-end review of China's 2025 national agenda, drawing on President Xi Jinping's inspection tours and key leadership meetings to outline the priorities shaping the country's next phase of modernization.

Policy Signal as China Moves Between Five-Year Plans

According to CGTN, China ended 2025 at a transition point: the 14th Five-Year Plan nearing completion and the 15th about to begin. The article frames inspection visits and central meetings led by Xi as a practical window into governance priorities and the direction of the next planning cycle. For businesses and institutional stakeholders, this kind of messaging matters less as a headline and more as a signal of what policy levers and administrative attention are likely to concentrate on.

PSEG Long Island Secures LIPA Operating Contract Extension as New Leadership Takes Charge

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PSEG Long Island Secures LIPA Operating Contract Extension as New Leadership Takes Charge

SHERIDAN, WYOMING - December 30, 2025 - Public Service Enterprise Group (PSEG) says New York State's comptroller has granted final approval for an extension of PSEG Long Island's operations services agreement with the Long Island Power Authority (LIPA), locking in continued grid-operations responsibilities through the end of 2030.

Contract extension now fully cleared

PSEG said the LIPA Board of Trustees awarded PSEG Long Island a five-year extension of the existing contract on September 25, followed by approval from the New York State attorney general in October and final approval from the comptroller this week. The extension begins January 1, 2026, and runs through December 31, 2030. PSEG Long Island has operated the electric grid on behalf of LIPA since 2014, covering Long Island and the Rockaways.

Lilly's Oral Obesity Candidate Orforglipron Shows "Maintenance" Potential as FDA Review Clock Tightens

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Lilly’s Orforglipron Posts Phase III Maintenance Data as Oral Obesity Race Tightens

SHERIDAN, WYOMING - December 19, 2025 - Eli Lilly's experimental daily oral obesity medicine orforglipron posted Phase III data suggesting it can help patients maintain weight loss after long-term treatment with injectable GLP-1 therapies-an outcome with direct implications for adherence, payer strategy, and competition with Novo Nordisk's coming oral semaglutide filing.

Merck Secures Positive CHMP Opinion to Expand WINREVAIR Use in PAH, Potentially Extending Treatment to WHO FC IV in Europe

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Merck Secures Positive CHMP Opinion to Expand WINREVAIR Use in PAH, Potentially Extending Treatment to WHO FC IV in Europe

SHERIDAN, WYOMING - December 19, 2025 - Merck said the EMA's CHMP has recommended approval of an expanded European indication for WINREVAIR (sotatercept) in adults with pulmonary arterial hypertension (PAH), a move that-if confirmed by the European Commission-could broaden use to include WHO Functional Class (FC) IV patients and strengthen the product's positioning around morbidity and mortality benefit.

EXZOLT CATTLE-CA1 Wins FDA Conditional Approval, Expanding Options to Prevent and Treat New World Screwworm in Cattle

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FDA Conditionally Approves Merck Animal Health’s EXZOLT CATTLE-CA1 to Address New World Screwworm Risk in U.S. Beef and Heifer Herds

SHERIDAN, WYOMING - December 19, 2025 - Merck Animal Health says the U.S. Food and Drug Administration (FDA) has granted conditional approval for EXZOLT™ CATTLE-CA1 (fluralaner topical solution), positioning the pour-on as a new systemic parasiticide option for U.S. beef operations and replacement dairy heifers facing New World screwworm (Cochliomyia hominivorax) larvae (myiasis) risk and cattle fever tick (Rhipicephalus microplus) pressure.

FDA Weighs National Priority Vouchers for Merck's Enlicitide and Sacituzumab Tirumotecan, Potentially Compressing Review Timelines

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FDA Weighs National Priority Vouchers for Merck’s Enlicitide and Sacituzumab Tirumotecan, Potentially Compressing Review Timelines

SHERIDAN, WYOMING - December 19, 2025 - The FDA is considering awarding Commissioner's National Priority Vouchers to two investigational Merck programs-PCSK9 pill enlicitide decanoate and antibody-drug conjugate sacituzumab tirumotecan-an early signal that the agency may be willing to accelerate reviews for high-impact products even before formal filings, according to a Reuters report.

A new FDA lever that can reshape launch timing
Commissioner's National Priority Vouchers are designed to shorten the FDA's regulatory review window from the typical 10-12 months to 1-2 months. For large pharma, that time compression can meaningfully shift competitive dynamics-pulling forward commercialization, altering payer and guideline sequencing, and increasing the urgency of manufacturing readiness, launch supply, and field execution.

UAV DACH Calls for Europe-Wide Standards to Counter Illegal Drones and Protect Critical Airspace Infrastructure

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UAV DACH Calls for Europe-Wide Standards to Counter Illegal Drones and Protect Critical Airspace Infrastructure

SHERIDAN, WYOMING - December 19, 2025 - As illegal and abusive drone activity increasingly threatens people and critical infrastructure-especially near air traffic assets-industry association UAV DACH is urging European and national policymakers to establish clearer rules, shared visibility, and coordinated capabilities for effective drone detection and defense across Europe.

UAE Grants XPENG AEROHT Special Manned Flight Permit, Advancing "Land Aircraft Carrier" eVTOL Testing in Ras Al Khaimah

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UAE Grants XPENG AEROHT Special Manned Flight Permit, Advancing “Land Aircraft Carrier” eVTOL Testing in Ras Al Khaimah

SHERIDAN, WYOMING - December 15, 2025 - XPENG AEROHT has secured a manned aircraft special flight permit from the UAE's General Civil Aviation Authority (GCAA) for its modular flying car "Land Aircraft Carrier" in Ras Al Khaimah, enabling manned flight tests across the country and marking a notable step in the overseas commercialization of China's low-altitude eVTOL technology.

Aviation permission becomes a market-entry signal for advanced air mobility
The permit, granted in Ras Al Khaimah, is positioned as the first such authorization obtained by a Chinese flying car company overseas. For B2B stakeholders-from mobility operators to public-sector agencies-regulatory access is often the gating factor that turns "future mobility" narratives into measurable pilots, procurement conversations, and infrastructure planning.

Saol Positions Ultrarare PDCD Therapy SL1009 as Test Case for FDA's New Rare Disease Evidence Principles

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Saol Positions Ultrarare PDCD Therapy SL1009 as Test Case for FDA’s New Rare Disease Evidence Principles

SHERIDAN, WYOMING - December 11, 2025 - Saol Therapeutics is turning an FDA rejection into a potential regulatory test case, as the biotech prepares to argue that its pyruvate dehydrogenase complex deficiency (PDCD) drug SL1009 is the ideal "poster child" for the agency's new Rare Disease Evidence Principles (RDEP) framework at a Type A meeting on December 18.

Saol Recasts a Complete Response Letter as a Strategic Opening

On September 8, Saol disclosed that the FDA had issued a complete response letter (CRL) for SL1009, an oral formulation of sodium dichloroacetate for children with PDCD, a genetic disorder affecting fewer than 1,000 people in the U.S. The CRL, according to CEO Dave Penake, "suggested that we would need to do an additional adequate and well controlled clinical trial," and that "and that's not feasible to be done by our company and in this patient population."

Smarter Spectrum Policy Could Unlock Europe's 5G SA Investment Gap, GSMA Warns

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Smarter Spectrum Policy Could Unlock Europe’s 5G SA Investment Gap, GSMA Warns

SHERIDAN, WYOMING - December 10, 2025 - A new GSMA Intelligence report argues that European mobile operators could unlock billions in network investment, accelerate standalone 5G (5G SA) deployments and boost economic output-if policymakers adopt a more disciplined, long-term approach to spectrum pricing and renewals. As more than 500 spectrum licences come up for renewal over the next decade, the study frames spectrum policy as one of the most powerful levers for Europe's digital competitiveness.

Rising spectrum costs squeeze capex for 5G SA and beyond

The report, Spectrum pricing and renewals in Europe, traces how legacy auction and pricing strategies have driven up total spectrum costs over the past ten years. According to GSMA Intelligence, spectrum fees now absorb around 8% of recurring mobile operator revenues, directly limiting financial headroom for 5G roll-out, fibre backhaul and future network upgrades.