Pharmacy Market
Businesswire | August 01, 2023
Harrow a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Application (NDA) for VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eye drop for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms. The U.S. commercial rights to VIGAMOX werepurchasedby Harrow in January of 2023, and VIGAMOX is the fourth FDA-approved ophthalmic product from that acquisition to have completed the NDA transfer process and become commercially available under the Harrow name.
“Having now completed the NDA transfer of VIGAMOX, we are excited to begin the implementation of the market access, marketing, inventory management, national sales detailing, and other brand‑leveraging strategies that we have developed during this transfer period,” said Mark L. Baum, Chief Executive Officer of Harrow. “With an exceptional record of safety and efficacy, VIGAMOX is a well-known, reliable, and trusted product by U.S. eyecare professionals, many of whom regard VIGAMOX as the preferred broad-spectrum topical antibiotic to treat patients for bacterial conjunctivitis (sometimes referred to as 'pink eye') as well as many other common bacterial-based infections.”
Product orders for VIGAMOX can be made directly through Harrow’s dedicated customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen.
About VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%:
INDICATIONS AND USAGE
VIGAMOX® is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, and Chlamydia trachomatis.
Efficacy for this organism was studied in fewer than 10 infections.
IMPORTANT SAFETY INFORMATION
Contraindications
VIGAMOX® is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.
Warnings and Precautions
Hypersensitivity Reactions –Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin.
Prolonged Use –May result in overgrowth of non-susceptible organisms, including fungi.
Avoid Contact Lens Wear –Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1%-6% of patients.
Nonocular adverse events reported at a rate of 1%-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.
About Harrow
Harrow Health, Inc. is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the U.S. market. Harrow helps U.S. eyecare professionals preserve the gift of sight by making its comprehensive portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of Americans each year.
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Pharmacy Market
PRNewswire | August 11, 2023
Capital Rx, the health technology company changing the way prescription drugs are priced and patients are cared for in America, has received a strategic investment from Memorial Hermann Health System, a non-profit health system committed to creating healthier Houston communities. Memorial Hermann joins Capital Rx's existing investors in supporting the development of JUDI®, the new standard for backend claims processing platforms in the pharmacy benefit management (PBM) industry, and the overall growth of Capital Rx's full-service PBM and pharmacy benefit administration (PBA) platform as a service (PaaS) solution.
"We're thrilled to have the investment support of Memorial Hermann as we work to modernize this country's claims processing infrastructure and deploy our aligned customer model to more employers, unions, municipalities, and other payers to create enduring change," said AJ Loiacono, Co-Founder & CEO of Capital Rx. "It's especially rewarding because we share the same values and prioritize community, compassion, credibility, and having the courage to be innovative in everything we do."
Capital Rx's JUDI brings exponential operational efficiency and control to Medicare, Medicaid, and commercial plans and prescription claims processing. A modern, open, and scalable platform, JUDI allows for seamless communication and data integration between vendors and across the continuum of care. Importantly, its intuitive design and workflows save time, allowing health systems and other payers to allocate resources more efficiently and toward what matters most: caring for patients and members in the communities and populations they serve.
"As we assessed the health care ecosystem for innovative capabilities to help accelerate the evolution of the pharmacy service model and prescription claims processing, Capital Rx's vision for a framework that prioritizes efficiency and allows for exceptional patient care set the company apart for investment consideration," said Feby Abraham, Ph.D., Executive Vice President and Chief Strategy Officer at Memorial Hermann. "Capital Rx's platform is focused on bringing clarity and consistency to drug prices, broadening access to medication, and helping its clients control pharmacy costs, all without sacrificing member service and patient outcomes."
The Health Management Academy's Strategic Partnership Alliance, which explores new venture and investment opportunities on behalf of a group of the country's largest health systems, identified Capital Rx as a mission-aligned disruptor with next-generation technology for its members, including Memorial Hermann.
About Memorial Hermann Health System
Charting a better future. A future that's built upon the HEALTH of our community. This is the driving force for Memorial Hermann, redefining health care for the individuals and many diverse populations we serve. Our 6,700 affiliated physicians and 32,000 employees practice the highest standards of safe, evidence-based, quality care to provide a personalized and outcome-oriented experience across our more than 260 care delivery sites. As one of the largest not-for-profit health systems in Southeast Texas, Memorial Hermann has an award-winning and nationally acclaimed Accountable Care Organization, 17* hospitals, and numerous specialty programs and services conveniently located throughout the Greater Houston area. Memorial Hermann-Texas Medical Center is one of the nation's busiest Level I trauma centers and serves as the primary teaching hospital for McGovern Medical School at UTHealth. For more than 115 years, our focus has been the best interest of our community, contributing nearly $500 million annually through school-based health centers and other community benefit programs. Now and for generations to come, the health of our community will be at the center of what we do – charting a better future for all.
Memorial Hermann Health System owns and operates 14 hospitals and has joint ventures with three other hospital facilities, including Memorial Hermann Surgical Hospital First Colony, Memorial Hermann Surgical Hospital Kingwood, and Memorial Hermann Rehabilitation Hospital-Katy.
About Capital Rx
Capital Rx is a healthcare technology company changing the way prescription drugs are priced and patients are cared for in America. As a Certified B Corp™, Capital Rx is executing its mission through an efficient Single-Ledger Model™ that increases visibility and reduces variability in drug prices. The company's cloud-native enterprise pharmacy platform, JUDI®, connects every aspect of the pharmacy ecosystem, servicing over 2.4 million members for Medicare, Medicaid, and commercial plans.
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PHARMACY MARKET
businesswire | September 26, 2023
Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain, addiction and neurological disorders, today announced that Health Canada has authorized the use of Quillivant® ER (extended release) for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 12. Quillivant ER will be available as both an oral suspension and chewable tablet (known in the United States as Quillivant XR® and QuilliChew ER®, respectively). Quillivant ER is the first once-daily, long-acting, chewable and oral suspension formulations of methylphenidate to be approved for the treatment of ADHD in Canada.
“Children with ADHD around the world need medications that provide fast-acting and long-lasting relief in a range of formulations that are easy for them to take. Since the launch of our Quillivant XR product in the United States, we have been approached by potential partners to make our portfolio of ADHD products available around the world,” said Ketan Mehta, founder and chief executive officer at Tris Pharma. “We are truly delighted by this milestone, which will make this important medication available to millions of patients in Canada.”
Ontario-based KYE Pharmaceuticals, Inc. will make Quillivant ER Oral Suspension and Quillivant ER Chewable Tablets available to patients in Canada beginning in Q1 2024. Tris will manufacture Quillivant ER in the United States and export to KYE Pharmaceuticals for Canadian patients.
ADHD is one of the most common neurodevelopmental disorders diagnosed among children. Many therapies approved to treat ADHD have well-established and significant drawbacks, including early symptom rebound, limited duration of release and efficacy, delayed onset, inability to customize or control titration, and patient difficulty taking the medications (e.g., children unable to swallow a tablet).
In Canada, Quillivant ER is authorized for administration to children aged 6 to 12 diagnosed with ADHD as a once-daily liquid suspension or as a chewable tablet to overcome the difficulty of swallowing pills while still achieving the duration needed to control ADHD symptoms for the desired timeframe. Quillivant ER has demonstrated onset of action as soon as 45 minutes through 12 hours post-dose, providing consistent, continuous delivery throughout the day. Quillivant ER Oral Suspension allows for personalized dosing with ease of titration and the Quillivant ER chewable tablets are scored tablets, which are ideal for pediatric patients, providing additional flexibility in dose administration with the most dosing options available in an extended-release methylphenidate tablet. Tris developed both formulations using the company’s proprietary LiquiXR® technology.
“Quillivant ER has the potential to address a significant unmet market need in the treatment of ADHD by overcoming drawbacks associated with many other ADHD medications, particularly among children,” said John McKendry, president at KYE Pharmaceuticals. “Our strategic partnership with Tris allows us to apply our extensive regulatory and commercial expertise to ensure this unique ADHD medication is made available to patients in Canada.”
About Tris Pharma
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.
About KYE Pharmaceuticals
Kye Pharmaceuticals Inc. is a private company headquartered in Mississauga, Canada focused on bringing medications to the Canadian market which fulfill clinically significant and unmet needs. KYE has licensed many innovative products and was founded on an entrepreneurial spirit that optimizes our team’s strengths and brings unique value to our partners, Canadian healthcare professionals, and most importantly, patients across Canada.
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