Biotech’s New Edge: 5 Companies Mastering "How" We Dose

ISSUED ON BEHALF OF DOSEOLOGY SCIENCES INC.
VANCOUVER – Baystreet.ca News Commentary – Pharmaceutical markets are witnessing drug delivery devices surge toward $862.16 billion by 2034 as industry focus shifts from discovering new molecules to engineering how existing drugs reach their targets[1]. Meanwhile, biologics manufacturers invest $27 billion in production capacity to secure advanced delivery infrastructure, signaling that proprietary platforms now command valuation premiums once reserved for the therapeutics themselves[2]. This convergence positions several biotechnology companies to capitalize on delivery-first innovation, including Doseology Sciences Inc. (CSE: MOOD) (OTCPK:DOSEF) (FSE: VU70), Insulet Corporation (NASDAQ: PODD), Lipocine Inc. (NASDAQ: LPCN), Daré Bioscience, Inc. (NASDAQ: DARE), and West Pharmaceutical Services, Inc. (NYSE: WST).
Industry analysts project platform drug delivery devices will accelerate regulatory approvals through modular, reusable device data that pharmaceutical manufacturers can deploy across multiple combination products[3]. Recent clinical data demonstrate enhanced oral bioavailability platforms achieving 38-45% absorption improvements over conventional formulations, creating timing advantages for companies controlling precision delivery technologies before major adoption cycles intensify[4].
Doseology Sciences Inc. (CSE: MOOD) (OTCPK:DOSEF) (FSE: VU70) is a biotechnology-driven company developing oral delivery platforms for modern stimulants, positioning itself within a consumer shift away from traditional energy drinks, vapes, and cigarettes toward formats designed for precision, control, and convenience.
"Our strategy is clear: to lead innovation in the oral stimulant category with a sharp focus on speed to market and operational excellence," said Chris Jackson, CEO of Doseology.
In early December 2025, the Kelowna, British Columbia-based company launched a formal Investor Communications Initiative to strengthen disclosure practices and capital markets readiness.
The communications push follows a November 2025 announcement in which Doseology secured a strategic manufacturing agreement through Doseology USA Inc., its Florida-based wholly owned subsidiary established in March 2025. The move came after extensive due diligence across North American manufacturing partners and positions the company to begin commercial production of caffeine, nicotine, and functional ingredient pouches.
The company's commercial execution is being led by Patrick Sills, Head of Commercialization, who previously managed the joint venture between Swedish Match AB and Philip Morris International Inc.—known then as JV SMPM International.
With a national Canadian retail footprint already established through its functional mushroom tincture business in over 500 locations, Doseology is leveraging existing distribution infrastructure to support expansion into the oral stimulant category.
"In my experience under the JV SMPM International, I witnessed how quickly oral formats reshaped modern consumption and created a new ritual," said Sills. "With the global pouch market expected to exceed US$69.46 billion by 2032 and functional stimulant formats outpacing traditional energy categories, Doseology's next-generation stimulant platform is directly aligned with these high-growth trends and strategically positioned within this rapidly evolving category."
In August 2025, Doseology acquired Feed That Brain, a Toronto health supplements brand specializing in cognitive performance, for $400,000 in securities. The transaction brought established brand equity in functional wellness and a strategic advisor: Joseph Mimran, the retail visionary behind Club Monaco and Joe Fresh.
"Doseology is building something both innovative and timely," said Mimran. "I'm excited to work alongside the team in shaping a brand that redefines how energy and performance can be delivered."
Mimran's three-year advisory agreement, valued at $400,000 in restricted share units, reflects his commitment to supporting Doseology's roadmap as the company develops pouch-based products for professionals, students, and wellness consumers seeking clean, functional stimulation without pills, sugar, or smoke.
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Insulet Corporation (NASDAQ: PODD) has received FDA 510(k) clearance for significant enhancements to the Omnipod 5 Automated Insulin Delivery System, introducing a lower 100 mg/dL Target Glucose option that expands customization to six settings between 100-150 mg/dL in 10 mg/dL increments. The upgraded algorithm helps users remain in Automated Mode with fewer interruptions, even during prolonged high glucose events, addressing the two most requested features since the system's 2022 launch.
"This is the most significant algorithm advancement to our Omnipod 5 System since its launch in 2022," said Eric Benjamin, Executive Vice President and COO of Insulet. "These new features address the two most requested enhancements and reflect our relentless commitment to delivering meaningful innovation for those living with diabetes and the healthcare providers who support them."
The enhanced system is anticipated to launch in the United States in the first half of 2026, where Omnipod 5 is cleared for people aged 2 and older with type 1 and aged 18 and older with type 2 diabetes. Healthcare providers will be able to seamlessly integrate the updates into their workstreams by prescribing and configuring the system using Dexcom Clarity, with efforts underway to bring the enhancements to international markets in the future.
Lipocine Inc. (NASDAQ: LPCN) has reached 80% enrollment in its pivotal Phase 3 clinical trial evaluating LPCN 1154, an oral formulation of brexanolone designed to provide rapid relief for postpartum depression, with 66 of the 80 planned participants now randomized. The trial is being conducted entirely in an outpatient setting without medical monitoring requirements, and a second independent Data Safety Monitoring Board review is scheduled for early January 2026, with topline results expected in the second quarter of 2026.
"We are encouraged by the recruiting rate in our Phase 3 study for postpartum depression, which may be indicative of this population's unmet medical need," said Mahesh Patel, CEO of Lipocine. "We extend our deepest gratitude to the patients, their families, and the dedicated clinical teams at the trial sites whose commitment has made this progress possible."
LPCN 1154 represents the first topical sildenafil formulation manufactured in accordance with cGMP requirements and supported by clinical data that will be accessible to women, addressing a significant gap as an estimated 20 million women in the United States experience challenges related to genital arousal yet there are no FDA-approved therapeutics for this indication. The Company plans to use data from this Phase 3 trial to support a 505(b)(2) NDA submission in 2026.
Daré Bioscience, Inc. (NASDAQ: DARE) has announced that providers in select states can now begin prescribing DARE to PLAY Sildenafil Cream, representing the first and only evidence-backed sildenafil cream formulation developed specifically for women and manufactured in accordance with cGMP requirements through a 503B outsourcing facility. The proprietary topical arousal cream has been shown in clinical studies to increase genital blood flow in 10-15 minutes and improve arousal sensations, and is now available for pre-order in CT, FL, IN, MO, NH, NJ, OR, PA, RI, and UT, with prescriptions shipping within 45 days during the pre-order phase and availability expanding to other states throughout December and early 2026.
"When Viagra was approved in 1998, it revolutionized sexual medicine for men. But for women, comparable progress on enhancing the natural arousal sensations has stalled for nearly three decades," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "We believe DARE to PLAY represents a long overdue correction, giving women an option to reconnect with their own bodies, their pleasure, and their confidence, using science that finally recognizes their needs."
The cream represents a significant market opportunity as an estimated 20 million women in the United States experience challenges related to genital arousal, yet there are no FDA-approved therapeutics to address this need, with existing products relying primarily on marketing language and consumer reviews without clinical evidence. While continuing activities necessary to seek FDA approval of its proprietary sildenafil cream formulation, Daré is making the product available through multiple clinical trials and published, peer-reviewed research in medical journals including The Green Journal and the Journal of Sexual Medicine, with prescriptions being accepted through the DARE Health Hub managed by Medvantx.
West Pharmaceutical Services, Inc. (NYSE: WST) has launched its West Synchrony™ Prefillable Syringe System at CPHI Worldwide in Frankfurt, marking a significant shift in drug delivery by offering a fully verified platform from a single supplier that will be commercially available in January 2026. The system is designed specifically for biologics and vaccines, delivering comprehensive performance and regulatory data packages that streamline syringe selection.
"Leaders in drug development face pressures to meet milestones efficiently amid complex challenges, amongst them, selecting prefillable syringes," said Andy Polywacz, President of Integrated Systems at West. "With West Synchrony prefillable syringe system, it enables pharmaceutical companies to streamline design, accelerate regulatory submission, and secures a reliable supply chain for combination products that meets quality and volume needs."
The system provides single design verification ensuring form, fit and function, streamlined regulatory submission with one system-level drug master file, and single-source supply offering both make-to-stock and make-to-order options with low minimum order quantities. West generated $2.89 billion in net sales in fiscal 2024 and delivers over 41 billion components and devices annually.
West Pharmaceutical Services, Inc. (NYSE: WST) has launched its West Synchrony™ Prefillable Syringe System at CPHI Worldwide in Frankfurt, marking a significant shift in drug delivery by offering a fully verified platform from a single supplier that will be commercially available in January 2026. The system is designed specifically for biologics and vaccines, delivering comprehensive performance and regulatory data packages that streamline syringe selection.
"Leaders in drug development face pressures to meet milestones efficiently amid complex challenges, amongst them, selecting prefillable syringes," said Andy Polywacz, President of Integrated Systems at West. "With West Synchrony prefillable syringe system, it enables pharmaceutical companies to streamline design, accelerate regulatory submission, and secures a reliable supply chain for combination products that meets quality and volume needs."
The system provides single design verification ensuring form, fit and function, streamlined regulatory submission with one system-level drug master file, and single-source supply offering both make-to-stock and make-to-order options with low minimum order quantities. West generated $2.89 billion in net sales in fiscal 2024 and delivers over 41 billion components and devices annually.
Article Source: https://usanewsgroup.com/2025/12/19/what-comes-after-cigarettes-vapes-and-energy-drinks/


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SOURCES CITED: 1. https://media.market.us/global-drug-delivery-devices-market-news/
2. https://www.globenewswire.com/news-release/2025/12/17/3207167/0/en/Drug-Delivery-Devices-Market-Set-to-Exceed-US-450-7-Billion-by-2035-as-Biologic-Revenue-Surges-Drive-Urgent-Expansion-of-Device-Manufacturing-Capacity-Says-Astute-Analytica.html
3. https://ispe.org/pharmaceutical-engineering/november-december-2025/platform-drug-delivery-devices-regulatory
4. https://www.globenewswire.com/news-release/2025/11/24/3193490/0/en/Gelteq-Announces-Positive-Preclinical-Results-Demonstrating-Enhanced-Bioavailability-Using-Its-Proprietary-Gel-Based-Drug-Delivery-Platform.html

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