Healthcare & Biotech

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 - SprintRay's acquisition of the EnvisionTEC dental product portfolio marks a strategic step in the consolidation of the dental 3D printing market, expanding its materials ecosystem, reinforcing supply resilience and giving both SprintRay and EnvisionTEC users clearer long-term pathways in digital production.

What Changes for SprintRay Customers: More Materials, Same Workflow

For existing SprintRay practices and labs, the immediate impact is about breadth rather than disruption. The EnvisionTEC dental portfolio brings additional validated resin formulations that SprintRay is adapting for its own printers, which means customers gain more material options without having to invest in new hardware.

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."

SHERIDAN, WYOMING - December 8, 2025 - Chairside 3D printing has moved from conference buzzword to everyday reality in U.S. dental practices, and SprintRay is positioning its ecosystem as a way for clinics to bring production in-house, compress treatment timelines, and turn same-day crowns into a strategic differentiator rather than a marketing slogan.

From Lab Dependency to In-Practice Production

At its core, "chairside" simply means producing the restoration in your own practice while the patient is still in your care, instead of sending cases to an external lab and waiting one to two weeks. Clinically, the workflow is familiar-examination, preparation, design and cementation remain the same-but the fabrication step moves from a third party you can't control to equipment in your operatory that you can.

SHERIDAN, WYOMING - December 4, 2025 - Life sciences dealmaking is regaining momentum after a period of macroeconomic caution, but new research from West Monroe shows that transaction volume alone will not determine who comes out ahead. Instead, success in the next wave of M&A will hinge on execution speed, AI and digital maturity, and the ability to integrate people and cultures without losing focus on the deal thesis.

Dealmaking Rebounds, but the Rules Have Changed

West Monroe's report, The Next Wave of Life Sciences M&A: Navigating Policy, Power, and Progress, combines practitioner insight with a survey of 250 private equity firms and strategic acquirers in life sciences. The findings point to a clear rebound in activity: 68% of respondents expect more acquisitions in the next two years, while only 7% plan no deals at all.

SHERIDAN, WYOMING - December 3, 2025 - AGC Biologics is expanding its Cell Line Development Center of Excellence through a new partnership with ATUM, integrating the Leap-In Transposase® expression platform to help biopharma developers move monoclonal antibodies and complex next-generation biologics into the clinic faster and more cost-effectively.

New options for faster, more flexible cell line development

As pressure grows to launch high-value biologics at lower cost, drug sponsors are looking for cell line development (CLD) solutions that combine speed, robustness and scalability. AGC Biologics' collaboration with ATUM adds a modern transposase-based expression platform to its CLD toolkit, creating a menu of fit-for-purpose options for standard monoclonals, multi-specific antibodies and other complex molecules.

SHERIDAN, WYOMING - December 3, 2025 - AGC Biologics has signed a new manufacturing agreement with AAVantgarde Bio to produce dual-vector AAV gene therapies for Stargardt disease and retinitis pigmentosa, positioning its BravoAAV™ platform at the center of next-generation treatments for inherited retinal disorders with no approved therapies.

Dual-vector AAV platform targets previously "untreatable" retinal genes

Under the deal, AGC Biologics will provide GMP manufacturing for AAVantgarde's two clinical-stage candidates: AAVB-039 for Stargardt disease, the most common inherited form of macular degeneration in children and young adults, and AAVB-081 for retinitis pigmentosa caused by Usher syndrome type 1B. Both programs are in Phase 1/2 trials, with AAVB-039 being tested in the U.S., UK and Europe, and AAVB-081 representing the first-ever dual AAV gene therapy in an ocular indication.

SHERIDAN, WYOMING - December 3, 2025 - AGC Biologics has signed a strategic development and manufacturing agreement with Repair Biotechnologies to advance a novel mRNA therapeutic aimed at rapidly stabilizing and shrinking atherosclerotic plaques, addressing what both partners describe as the leading single cause of human mortality worldwide.

Targeting plaque biology in a high-burden cardiovascular market

The collaboration focuses on an mRNA-based therapy designed to stabilize and reduce atherosclerotic plaques in major blood vessels, directly tackling the root pathology behind heart attacks and strokes. Rupture of unstable plaque and subsequent thrombotic events account for an estimated 27% of all human deaths, underscoring the strategic importance of any technology capable of reversing or halting plaque progression.

SHERIDAN, WYOMING - December 3, 2025 - AGC Biologics is partnering with public benefit company Rarity PBC to bring a potentially life-saving gene therapy for Adenosine Deaminase Severe Combined Immunodeficiency (ADA-SCID) through commercial manufacturing and toward FDA approval, underscoring how CDMO collaborations are becoming central to translating academic breakthroughs into scalable rare disease treatments.

From transformational trials to a U.S. commercial pathway

Under the new agreement, AGC Biologics will provide end-to-end development and GMP manufacturing for Rarity's ex vivo autologous gene therapy RDP-101. If approved, RDP-101 would become the first gene therapy commercially available in the United States to reverse ADA-SCID, a rare inherited immunodeficiency that leaves infants dangerously exposed to severe, recurrent infections.

SHERIDAN, WYOMING - December 2, 2025 - Roche has secured FDA 510(k) clearance with a CLIA waiver and CE IVDR certification for its first point-of-care test to diagnose Bordetella infections, providing primary care and emergency clinicians with PCR-accurate results in just 15 minutes to help control whooping cough and related diseases.

Fast, PCR-accurate diagnosis at the point of care

Running on the cobas® liat system, Roche's new assay delivers lab-quality PCR results in GP offices and emergency rooms within a standard consultation. The 15-minute turnaround allows physicians to move from suspicion to definitive diagnosis immediately, supporting timely antibiotic prescribing that can prevent severe complications and reduce onward transmission.