United States

SHERIDAN, WYOMING - December 19, 2025 - Voyager Therapeutics is laying off 30 employees after partner Novartis discontinued two undisclosed discovery-stage programs under the companies' gene therapy collaboration, underscoring how quickly platform-driven R&D bets can be reprioritized even inside marquee pharma partnerships.

Commercial partnerships can shift overnight
Voyager disclosed last month that Novartis had stepped away from two early programs tied to their ongoing relationship, without naming the assets or detailing the rationale. The biotech framed the change as manageable, stating that Novartis' decision will "not impact Voyager's cash runway guidance." Still, the workforce reduction signals that operational resets often follow partnership scope changes-especially when programs are preclinical and the near-term value is concentrated in a smaller set of advancing assets.

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.

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.

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.

SHERIDAN, WYOMING - December 19, 2025 - Henry Schein One says adoption of its cloud-native Dentrix Ascend platform is accelerating as dental groups and DSOs move away from legacy practice management systems to standardize operations, reduce administrative friction, and embed AI into everyday workflows.

Cloud migration becomes a scaling decision, not an IT project
Across U.S. dentistry, consolidation and multi-location growth are forcing operators to treat practice management software as core infrastructure. Henry Schein One reported that nearly 600 practices migrated from alternative systems to Ascend over the past 12 months, adding to the broader Dentrix customer base of more than 48,000 practices using Dentrix technology for clinical, operational, and financial workflows. The company also said monthly Ascend installations more than doubled year over year as practices transitioned away from legacy setups.

SHERIDAN, WYOMING - December 16, 2025 - Advita Ortho has been recognized with an Innovation award in the 2025 Medical Device Network Excellence Awards for its Newton® Balancing Technology, highlighting the growing clinical and commercial demand for more data-driven, reproducible approaches to soft-tissue management in total knee replacement surgery.

Award recognition spotlights soft-tissue balancing as a key outcomes lever
While implant design and alignment remain central to knee arthroplasty performance, soft-tissue balancing is increasingly viewed as a differentiator in patient satisfaction and functional outcomes. Advita Ortho is positioning Newton as a method to bring greater consistency to what has often been a highly surgeon-dependent step-an area the company notes has historically contributed to dissatisfaction in a meaningful share of procedures.

SHERIDAN, WYOMING - December 15, 2025 - HoldCo Asset Management says Comerica shareholders should vote against the proposed merger with Fifth Third at a special meeting scheduled for January 6, 2026, arguing the transaction undervalues Comerica and that rejecting the deal could improve shareholder outcomes with limited downside.

Activist investor challenges deal process and governance safeguards
HoldCo Asset Management, a Florida-based investment firm managing approximately $2.6 billion in regulatory assets under management, said it holds beneficial ownership of approximately 1.6% of Comerica's outstanding common stock and released a presentation titled "Why We Recommend Voting AGAINST The Proposed Merger and Our Litigation Update." The firm's case centers on how the transaction was negotiated and whether the board's process delivered maximum value for shareholders.

SHERIDAN, WYOMING - December 15, 2025 - TuHURA Biosciences (NASDAQ: HURA) has provided a corporate update following a recent $15.6 million equity financing, detailing near-term milestones across its Phase 3 IFx-2.0 program in Merkel cell carcinoma, its VISTA-inhibiting antibody TBS-2025 in AML, and its Delta Opioid Receptor (DOR)-focused conjugate platform aimed at overcoming resistance to cancer immunotherapy.

SHERIDAN, WYOMING - December 15, 2025 - TuHURA Biosciences, Inc. (NASDAQ:HURA) announced that Kintara's REM-001 clinical trial in ten metastatic cutaneous breast cancer patients met its primary endpoint demonstrating safety, a contractual milestone that is expected to trigger distribution of TuHURA common stock to eligible contingent value right (CVR) holders.

SHERIDAN, WYOMING - December 11, 2025 - The FDA's first use of its new Commissioner's National Priority Voucher (CNPV) has gone not to a cutting-edge biologic, but to a decades-old extended-release antibiotic, Augmentin XR-sending a clear signal that domestic manufacturing and supply resilience are now front-and-center regulatory priorities for the U.S. pharmaceutical industry.

A New Fast-Track Tool Aimed at Supply Chain Security

Launched in June, the CNPV program promises to compress review timelines from the usual 10-12 months to as little as 1-2 months for drugs that align with U.S. "national priorities," such as strengthening domestic production or addressing systemic shortages. The first approval under this framework went to USAntibiotics' Augmentin XR after the FDA completed its review in "just two months," focusing heavily on quality, manufacturing and facility assessments rather than new clinical data.