PHARMACY MARKET
Antares Pharma, Inc. | February 04, 2022
Antares Pharma, Inc. a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration has accepted its New Drug Application resubmission for TLANDO®, an oral treatment for testosterone replacement therapy. The FDA designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022, under the Prescription Drug User Fee Act.
TLANDO® was granted tentative approval from the FDA as a twice-daily oral formulation of testosterone for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. In granting tentative approval, the FDA concluded that TLANDO® met all required efficacy, quality and safety standards necessary for approval and will be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. for JATENZO® on March 27, 2022.
“As we take this final step moving from tentative approval to potential final approval in late March, we will continue to prepare for the commercial launch of TLANDO. Our National Sales Meeting is set for the end of April and will serve as the venue to train and ready our sales professionals to start promoting TLANDO to the medical professionals who treat testosterone deficiency. We are excited to be able to complement our current offering of XYOSTED with an oral formulation to patients and physicians. We will leverage our strong physician relationships which we believe will accelerate the adoption of TLANDO, support our future revenue growth and drive our market share gains in the testosterone market,”
Robert F. Apple, President and Chief Executive Officer of Antares Pharma
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED® (testosterone enanthate) injection and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA® in the U.S. and expects to commercially launch TLANDO® in the U.S. pending final FDA approval.
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PHARMA TECH
LEO Pharma | September 30, 2021
LEO Pharma , a global leader in medical dermatology, and Veeva Systems announced a strategic technology partnership to enable scalable digital trials, paperless and patient-centered.
Building on its success with the Veeva Clinical Operations suite, LEO Pharma will complete its standardization on existing Veeva clinical technology, be an early adopter of future Veeva solutions, and help shape the Veeva digital trials roadmap. By adopting technology and optimized business processes, LEO Pharma plans to achieve the following goals while maintaining the highest standards in data accuracy, regulatory compliance and patient safety:
Significant improvement in the patient experience
Increased patient diversity through decentralized trials
Greater precision of clinical data
25% reduction in the cost of clinical trials
25% reduction in clinical trial time
LEO Pharma will use the integrated suite of Veeva clinical products, including eTMF, CTMS, CDMS, Site Connect, eConsent, ePRO, Virtual Visits and eSource.
We were exploring ways to transform clinical trials, but COVID-19 has accelerated this process. By responding quickly to changing market dynamics, we allowed our testing to continue without delay. The partnership with Veeva supports our 2030 strategy because it will help us deliver innovative treatments to patients faster while supporting a more sustainable business. Veeva's results in terms of product excellence make it the ideal long-term partner to help us achieve this goal, which allows us to help patients better and faster.
- Jörg Möller, Executive Vice President and Head of R&D at LEO Pharma.
We are excited and honored to extend our long-standing partnership with LEO Pharma to be an early adopter of our comprehensive digital testing platform, We intend to help the industry move forward with a scalable digital trials platform that dramatically improves the clinical trial process for patients, sites and sponsors.
- Peter Gassner , Founder and CEO of Veeva
About Veeva Systems
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence and customer success, Veeva has more than 1,000 customers, from the world's largest pharmaceutical companies to emerging biotechnology companies. As a public benefit company, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders and the industries it serves.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. The company is a leader in the field of medical dermatology, with a strong R&D portfolio, a wide range of therapies and a pioneering spirit. Founded in 1908 and majority-owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advancing the science of dermatology, setting new standards of care for people with skin diseases. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company achieved net sales of 1,359 million euros.
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BUSINESS INSIGHTS
Torreya Capital, Virpax Pharmaceuticals | April 23, 2021
Virpax® Pharmaceuticals, Inc. reported today that it has appointed Torreya Capital, LLC as the Company's sole financial adviser for its partnering and licensing activities in strategic global markets.
Torreya is a leading investment bank that has supported more than $100 billion in life sciences transactions since its establishment in 2007.
“We are thrilled to be collaborating with Torreya to extend our partnerships in key markets,” said Anthony Mack, Chairman, and CEO of Virpax Pharmaceuticals. "There is an increasing worldwide need for non-opioid, non-addictive pain treatments, and we agree that our product candidates, EpoladermTM, ProbudurTM, and EnveltaTM, will provide a competitive advantage in their target markets," Mr. Mack concluded.
"We look forward to assisting Virpax Pharmaceuticals in identifying strong regional partners for their innovative acute and chronic pain product candidate pipeline,” said Torreya Partner Tom Bird. "Virpax's product candidates include proprietary technologies that can enable the product candidates to provide enhanced benefits while providing non-addictive pain relief.”
About Torreya
Torreya is a global investment banking boutique that works with life sciences industries. Since its inception in 2007, the company has closed over $100 billion in transactions spanning branded pharmaceutical, biotechnology, generic pharmaceutical, and life sciences firms in nearly 250 assignments. Their associates are senior bankers and executives with extensive industry expertise, insights, and networks. They are a preferred advisor for businesses seeking secure, conflict-free, and knowledgeable advice on M&A, capital markets, licensing, and asset sale transactions. The breadth of Torreya's global footprint separates it from any other life sciences advisory practices.
About Virpax Pharmaceuticals
Virpax is developing branded, non-addictive pain management product candidates by optimizing and enhancing drug delivery using its proprietary technologies. Virpax is seeking FDA approval for its three proprietary drug delivery systems. EpoladermTM is a metered-dose topical diclofenac spray film formulation being used to treat acute musculoskeletal pain and osteoarthritis. ProbudurTM is a liposomal bupivacaine formulation for a single injection that is being used to treat post-operative pain. EnveltaTM is an intranasal molecular-envelope enkephalin formulation that is being developed to treat acute and chronic pain, particularly cancer-related pain. Virpax is also developing its PES200 product candidate to treat post-traumatic stress disorder (PTSD) and its MMS019 product candidate to prevent viral replication caused by influenza or SARS-CoV-2 using its intranasal Molecular Envelope Technology (MET).
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