DRC to administer second vaccination to tackle Ebola outbreak

Pharmaceutical Technology | September 23, 2019

The World Health Organization (WHO) has announced that the health authorities of the Democratic Republic of Congo (DRC), which is currently tackling a serious Ebola epidemic, will be providing vaccination to at-risk populations with a second product in addition to the current use of Merck’s rVSV-ZEBOV-GP. The vaccine chosen for the second vaccination is manufactured by Johnson & Johnson (J&J) and will be provided in two doses 56 days apart. It will administered to at-risk people in areas yet to see active Ebola transmission. WHO director-general Dr Tedros Adhanom Ghebreyesus said: “The DRC authorities, in deciding to deploy the second experimental vaccine to extend protection against this deadly virus, have once again shown leadership and their determination to end this outbreak as soon as possible.” The organisation’s regional director for Africa Dr Matshidiso Moeti commented: “The evaluation of the second Ebola vaccine will help ensure that we have potentially an additional tool to prevent the expansion of the outbreak and also a potential tool to protect populations before outbreaks hit areas at risk.”

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A well-stocked prepper home pharmacy ensures that you will not need to run out to the store to purchase a medication when you are feeling under the weather or when it may not be safe to venture out.

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BUSINESS INSIGHTS

ARS Pharmaceuticals Expands Executive Leadership Team with Addition of Pharmaceutical Commercialization Veterans

ARS Pharmaceuticals, Inc. | February 10, 2022

ARS Pharmaceuticals, Inc., a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced the expansion of its executive leadership team with the appointments of Harris Kaplan as executive vice president, commercial strategy and Daniel Relovsky as senior vice president, sales and marketing. Mr. Kaplan and Mr. Relovsky, accomplished industry veterans with proven track records of commercial strategy and launch execution, will be responsible for preparing for and leading the commercialization of neffy™, once approved. neffy, a proprietary composition of epinephrine, is a small, reliable, easy-to-use option that allows for needle-free intranasal delivery of epinephrine, the only drug approved for the emergency treatment of Type I allergic reactions, including anaphylaxis. "The appointments of both Harris and Dan to the ARS team represent another building block in our ongoing commercialization preparations for neffy. We believe neffy's 'no needle, no pain' delivery, small size for convenient portability, and ease of use can provide a patient-friendly solution for individuals and caregivers to more easily and reliably administer epinephrine sooner, achieving more rapid symptom relief and preventing the allergic reaction from becoming severe or life-threatening. I'm excited to welcome Harris and Dan, both of whom bring decades of product launch and commercial leadership experience to our leadership team, and look forward to benefiting from their expertise as we progress toward our mission of being an innovative pharmaceutical leader in the treatment of severe allergy." Richard Lowenthal, founder, chief executive officer and president of ARS Harris Kaplan, MBA, executive vice president, commercial strategy, will join the ARS commercial team as lead for commercial strategy and oversee launch preparations for neffy. He brings more than 40 years of global experience across the pharmaceutical, biotechnology and healthcare consulting industries and most recently served as managing partner of Red Team Associates. Throughout his career, Mr. Kaplan has worked on the development, launch and commercialization of over 125 new products across more than 40 therapeutic categories, including LIPITOR®, Nexium, VIAGRA®, HUMIRA®, ALLEGRA®, HERCEPTIN® and Trikafta, and Yescarta. He has extensive experience in establishing and building new product planning initiatives, leadership and development programs and managing global strategic operations. Mr. Kaplan earned an MBA in marketing and operations research from Temple University where he also taught in the MBA program for several years. Daniel Relovsky, senior vice president, sales & marketing, will be responsible for leading the U.S. sales and marketing organization for neffy. He brings more than 30 years of commercial and operational experience, including product launch leadership in highly competitive markets and in establishing new standard-of-care therapies. Mr. Relovsky specializes in commercial planning and efficient team building to address complex executions, and brings a diverse background and success record in specialty, orphan, and major therapeutic markets. Prior to joining ARS, Mr. Relovsky held various senior commercial and operational leadership positions at MAIA Biotechnology, Inc., Clarity Global Solutions, LLC., Puma Biotechnology, Inc., Somaxon Pharmaceuticals, Inc., Cephalon, Inc. (now Teva Pharmaceuticals, Inc.), Salmedix, Inc., Maxim Pharmaceuticals, Inc., Agouron Pharmaceuticals, Inc. (now Pfizer, Inc.), Women First Healthcare, Inc., and IQVIA. Mr. Relovsky earned his B.S. in business administration, finance from Drexel University. About ARS Pharmaceuticals, Inc. ARS Pharmaceuticals is dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The company is developing neffy™, an intranasal epinephrine spray with a unique absorption technology that could be easy-to-use, convenient, and more reliable for patients and loved ones at-risk of severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis.

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BUSINESS INSIGHTS

NovaBay Pharmaceuticals Collaborates with Harrow Health’s ImprimisRx to Promote Prescription Avenova

NovaBay Pharmaceuticals | July 20, 2021

NovaBay Pharmaceuticals, Inc., a pharmaceutical firm focused on commercializing Avenova for the eye care market, has announced a collaboration with ImprimisRx, one of the nation's top ophthalmology-focused pharmaceutical companies, to promote prescription Avenova. ImprimisRx, a wholly-owned subsidiary of Harrow Health, Inc., will offer national sales, marketing, and distribution support for NovaBay's FDA-cleared 0.01% hypochlorous acid Avenova in 40 ml bottles. Avenova is a clinically approved antimicrobial lid and lash solution used to treat various chronic eye conditions. Avenova serves a large and rapidly growing dry eye market, with 30 million Americans suffering from chronic eye diseases such as blepharitis and meibomian gland dysfunction. It is the only lid and lash spray made with NovaBay's patented pure hypochlorous acid and is suitable for daily usage. In addition, Avenova is usually prescribed by ophthalmologists and optometrists before and after cataract and Lasik procedures, making it a complementary therapy for many ImprimisRx's existing products. About ImprimisRx ImprimisRx is one of the nation's top ophthalmology-focused pharmaceutical companies, with 40 proprietary ophthalmic formulations serving thousands of ophthalmologists and optometrists throughout all 50 states. About Harrow Health Harrow Health, Inc. is a healthcare company specializing in ophthalmology. ImprimisRx, the leading ophthalmology-focused pharmaceutical company, and Visionology, a direct-to-consumer eye care subsidiary focusing on chronic eye disease, are owned and operated by the company. Harrow Health also owns stakes in Eton Pharmaceuticals, Surface Ophthalmics, and Melt Pharmaceuticals, all of which began as Harrow Health subsidiaries. Harrow Health also has royalty rights to four clinical-stage drug candidates developed by Surface Ophthalmics and Melt Pharmaceuticals. About NovaBay Pharmaceuticals, Inc. NovaBay Pharmaceuticals, Inc. is a biopharmaceutical company focused on high-quality, differentiated anti-infective consumer products such as Avenova, the top antimicrobial lid and lash spray, CelleRx Clinical Reset, a game-changing product in the beauty category, and NeutroPhase Skin and Wound Cleanser for wound healing. NovaBay products include its patented, pure, stable, pharmaceutical-grade hypochlorous acid, replicating the antimicrobial chemicals used by white blood cells to combat infection. NovaBay's hypochlorous acid products cause no stinging or irritation, are nontoxic, and are non-sensitizing, making them entirely safe for daily usage. In addition, Avenova is the first commercial hypochlorous acid lid and lash spray product that has clinically proven to reduce bacterial load on ocular skin surfaces, effectively addressing the underlying cause of bacterial dry eye.

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PHARMA TECH

Hovione and Zerion Pharma announce a strategic partnership to market the Dispersome® technology platform

Hovione | February 23, 2022

Hovione, the leader in spray drying and particle engineering, announced a strategic partnership with Zerion Pharma to market and commercialize Dispersome®, Zerion´s proprietary solubility enhancement technology platform. Zerion´s innovative Dispersome® technology builds on a new concept of increasing drug solubility by using natural protein-based excipients to formulate APIs into amorphous solid dispersions (ASDs) by spray drying. By combining Dispersome® technology with Hovione's unique spray drying capabilities, experience in development, scale-up and GMP manufacturing, Hovione further strengthens its leadership in amorphous solid dispersions and shows its commitment to innovative solutions to overcome one of the most prevalent challenges faced by the industry: low drug solubility. "We are extremely pleased to have entered into this partnership with Zerion whom we recognize as a very innovative company in the field of oral drug formulations. By joining forces, Zerion and Hovione will be able to bring Dispersome® to the market faster. We look forward to applying the technology in collaboration with our customers and partners in our effort to develop novel drugs with strong benefits to patients. Hovione will continue to pursue opportunities to enhance its offering around core areas of expertise such as particle engineering and inhalation by partnering with companies and research institutions developing innovative drug formulation technologies, like Dispersome®". Jean-Luc Herbeaux, Hovione´s Chief Operating Officer Zerion´s CEO, Ole Wiborg, sees a strong synergy in the partnership and expects it to generate new pharma partnerships. "We consider Hovione the global leader in the field of producing amorphous solid dispersions by spray-drying. More importantly for us, this leadership has resulted in Hovione being, over the last 5 years, the main commercial manufacturer of novel FDA-approved drugs formulated as amorphous solid dispersions. Incorporating these competencies in our offering to the pharma industry both validates the strength of our Dispersome® platform and provides us and our pharma partners immediate access to the highest quality in upscaling and commercial GMP manufacturing." says Ole Wiborg. The announcement of this partnership follows Hovione's communication on a further expansion with an expected investment of $170 million in assets worldwide and shows the company's commitment to also expand its technology platforms. Hovione is investing both in new assets and innovative technologies to meet customer demand for integrated and differentiated services in drug substance manufacturing, particle engineering and most recently drug product manufacturing. About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solution across the entire drug life cycle. In the inhalation area, Hovione is the only independent company offering a complete range of services, from API, formulation development and devices. Hovione is a company with a culture based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards. About Zerion Pharma ApS Zerion has pioneered the Dispersome® technology that greatly enhances the solubility of poorly soluble, oral drugs and improves bioavailability and therapeutic outcomes for the patients. The Dispersome® technology is based on preparing stable amorphous formulations by mixing high loads of the drug compound with beta-lactoglobulin, a sustainable and biodegradable by-product from cheese production. Zerion develops proprietary drug formulations and offers the Dispersome® technology to established pharma companies as a means to solve their most challenging drug solubility problems.

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