Pharmacy Market
PRNewswire | August 08, 2023
Palatin Technologies, Inc. a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced that it has entered a strategic partnership with UpScriptHealth, a leading direct-to-consumer telemedicine company providing telemedicine services to pharmaceutical and medical technology companies. Under terms of the agreement, UpScriptHealth will make Vyleesi available to the hundreds of thousands of patients in its proprietary Women's Telehealth Platform. Vyleesi is the first and only as-needed treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).
"We are excited to partner with UpScriptHealth, a pioneer in telehealth," stated Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "This partnership fortifies our existing telehealth programs and provides a platform to create greater awareness of HSDD and access to Vyleesi through UpScriptHealth's patient base of hundreds of thousands of women."
"UpScriptHealth's Women's Telehealth Platform was launched in 2015 to provide women with a convenient way to consult healthcare providers and obtain therapies to improve the quality of their lives," stated Peter Ax, Founder and Chief Executive Officer of UpScriptHealth. "The addition of Vyleesi furthers our female health strategy and provides our patient base with education surrounding HSDD as a significant and common condition, and importantly, access to a meaningful treatment option."
About Vyleesi® (bremelanotide injection) for Hypoactive Sexual Desire Disorder (HSDD)
Vyleesi is the first and only as-needed treatment approved by the FDA for premenopausal women with acquired, generalized HSDD.
Palatin is actively seeking Vyleesi collaborations for the United States and for territories outside the currently licensed territories of China and South Korea. Vyleesi is licensed to Fosun Pharma in China and Kwangdong Pharmaceuticals in South Korea.
About Palatin
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential.
About UpScriptHealth
UpScriptHealth™ is the leading comprehensive, direct-to-consumer telehealth and virtual prescribing platform that has been innovating the way customers receive care and obtain medications for more than two decades. UpScriptHealth is committed to improving the lives of consumers by providing immediate and long-term convenient access to medical therapies. UpScriptHealth's philosophy of providing extraordinary care is strengthened through their core values of transparency, integrity and the relentless pursuit of excellence.
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Pharmacy Market
PRNewswire | July 13, 2023
Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, today announced the completion of the pilot phase of their previously announced partnership with Novo Nordisk, a leading global healthcare company, to develop expression systems for pharmaceutical products. With the pilot phase completed and the first milestone achieved, the two companies will now move into the development phase to work towards making a more effective production process. Achievement of the first milestone included extensive modification and testing of a microbial expression system to understand the impact of the modifications on key performance parameters.
"Ginkgo's achievement of the first milestone has both excited and inspired us, giving us the confidence to move into the next phase of this ambitious project," said Brian Vandahl, Senior Vice President, Global Research Technologies at Novo Nordisk. "This progress is a strong indicator of the potential we have to engineer biological systems that will expand the chemical space of biological medicines."
"We're excited to continue our work with Novo Nordisk to help provide innovative treatment options for patients with diabetes, obesity, and other serious chronic diseases," said Jason Kelly, CEO and co-founder, Ginkgo Bioworks. "The next phase of this project will build on our existing microbial design, engineering, and phenotyping expertise while expanding Ginkgo's capabilities in genome-scale design and engineering. We believe this work will enable us to support even more pharmaceutical products, helping to achieve better outcomes for patients."
About Ginkgo Bioworks.
Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect, and respond to a wide variety of biological threats.
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Pharmacy Market
PRNewswire | July 18, 2023
Karyopharm Therapeutics Inc. a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to the development program of selinexor for the treatment of patients with myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis.
"Fast Track Designation for selinexor highlights its potential to address the unmet medical need in myelofibrosis, an important acknowledgement as we continue our pivotal Phase 3 study," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "Selinexor's unique mechanism of action, XPO1 inhibition, is a novel and potentially fundamental mechanism in myelofibrosis. We have been highly encouraged by the efficacy and safety data observed to date [in our Phase 1 study] with selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis and believe selinexor has the potential to shift the treatment paradigm. We look forward to continued interaction with the FDA as we advance the development of this promising treatment for patients in need."
In June 2023, Karyopharm initiated a pivotal Phase 3 clinical trial to assess the efficacy and safety of once-weekly selinexor 60 mg in combination with ruxolitinib in JAKi-naïve patients with myelofibrosis. Updated data from the Phase 1 study were presented at the American Association for Cancer Research Annual Meeting 2023, American Society of Clinical Oncology 2023 and European Hematology Association 2023, which showed rapid, deep and sustained spleen responses and robust symptom improvement in patients treated with selinexor 60 mg in combination with ruxolitinib as of the April 10, 2023 cut-off date. Top-line data from the Phase 3 study is expected in 2025. The Company plans to expand its clinical development program in myelofibrosis by investigating selinexor in other JAKi-naïve settings, such as novel combinations, to benefit the greatest number of patients.
Fast Track Designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. Features of Fast Track Designation include frequent interactions with the FDA review team, and if relevant criteria are met, eligibility for Priority Review and Rolling Review.
About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. is a commercial-stage pharmaceutical company pioneering novel cancer therapies. Since its founding, Karyopharm has been an industry leader in oral Selective Inhibitor of Nuclear Export (SINE) compound technology, which was developed to address a fundamental mechanism of oncogenesis: nuclear export dysregulation. Karyopharm's lead SINE compound and first-in-class, oral exportin 1 (XPO1) inhibitor, XPOVIO® (selinexor), is approved in the U.S. and marketed by the Company in three oncology indications and has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including Europe and the United Kingdom (as NEXPOVIO®) and China. Karyopharm has a focused pipeline targeting multiple high unmet need cancer indications, including in multiple myeloma, endometrial cancer, myelodysplastic neoplasms and myelofibrosis.
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