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
globenewswire | August 28, 2023
Tarsus Pharmaceuticals, Inc. whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, announced that XDEMVY™ (lotilaner ophthalmic solution) 0.25% is now available at pharmacies nationwide for prescription. The U.S. Food and Drug Administration (FDA) approved XDEMVY on July 24, 2023, for the treatment of Demodex blepharitis.
“We are delighted that within weeks of FDA approval, XDEMVY is now available to millions of patients with Demodex blepharitis,” said Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus. “The efforts of our team have created incredible interest in XDEMVY, the first and only approved solution for this highly prevalent disease. I’m so appreciative of our team and our partners who’ve worked diligently to bring this product to eye care providers and patients quickly and seamlessly following regulatory approval. We are proud to introduce XDEMVY to the eye care community and look forward to its potential to significantly change the way this disease is treated.”
XDEMVY is the only FDA approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis. Demodex blepharitis is characterized by redness, inflammation, missing or misdirected eyelashes, itching along the eyelid base, and the presence of collarettes. XDEMVY is a prescription eye drop that is administered with one drop in each eye twice daily (approximately 12 hours apart) for 6 weeks.
Tarsus is committed to ensuring that patients have affordable and broad access to XDEMVY and developed Tarsus Connect, a suite of assistance programs that provide financial support for eligible patients. More information about Tarsus Connect can be found on xdemvy.com or by calling: 1-866-846-3092.
About Demodex Blepharitis
Blepharitis is a common lid margin disease that is characterized by eyelid margin inflammation, redness and ocular irritation. Demodex blepharitis is caused by an infestation of Demodex mites, the most common ectoparasite found on humans and accounts for over two-thirds of all blepharitis cases. Demodex blepharitis may affect as many as 25 million Americans based on an extrapolation from the Titan study indicating 58% of patients presenting to U.S. eye care clinics have collarettes, a pathognomonic sign of Demodex mite infestation, and that at least 45 million people annually visit an eye care clinic. Demodex blepharitis can have a significant clinical burden and negative impact on patients’ daily lives. The Titan study also showed that current management tools, such as tea tree oil and lid wipes, are ineffective at targeting the root cause of Demodex blepharitis.
About XDEMVY™
XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop for the treatment of Demodex blepharitis and is designed to target and eradicate the root cause of the disease – Demodex mite infestation. The active ingredient in XDEMVY is lotilaner, a well-characterized agent that eradicates Demodex mites by selectively inhibiting the GABA-Cl channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eyelash follicles where the mites reside. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found XDEMVY to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis.
About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. Tarsus is studying three investigational medicines in clinical trials. In addition to XDEMVY (lotilaner ophthalmic solution) 0.25%, which is FDA approved in the United States for the treatment of Demodex blepharitis, Tarsus is also investigating TP-03 for the treatment of Meibomian Gland Disease, which is currently being studied in a Phase 2a clinical trial. In addition, Tarsus is developing TP-04 for the potential treatment of Rosacea and TP-05, an oral tablet for the prevention of Lyme disease. TP-04 and TP-05 are both currently being studied in Phase 2a clinical trials to evaluate safety, tolerability, and proof-of activity.
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Pharmacy Market
Businesswire | June 30, 2023
NanoTemper Technologies, creator of biophysical tools for drug discovery, today, proudly announced the launch of their highly anticipated Biotinylated Target Labeling Kit, expanding the molecular interaction analysis toolkit for scientists working with complex or undruggable targets, filling a vital gap in screening and hit validation workflows in the pharma industry.
This new kit combined with NanoTemper’s exclusive Spectral Shift technology is the preferred orthogonal method for scientists utilizing surface plasmon resonance (SPR), who predominantly use biotinylated proteins for affinity screening or binding affinity assays. “Now, direct comparison of binding affinities from an immobilized method to the in-solution, immobilization-free technique of Spectral Shift is possible,” says Regina Borovac, Consumables Product Manager at NanoTemper Technologies. “And, not only that, it enables those who already use Spectral Shift to analyze a broader range of interactions, tackling even more projects involving complex targets.”
Spectral Shift is a growing power in molecular affinity measurements
Because of Spectral Shift’s early success in removing roadblocks for scientists who have found difficulty finding candidates for their complex targets, NanoTemper is continuing to invest in creating products that empower scientists to do more with Spectral Shift technology.
"We’ve put Spectral Shift technology into Dianthus, our affinity screening instrumentation, and Monolith X, our instrumentation for molecular interactions, and they’ve now become a necessity for anyone tackling challenging disease targets,” comments Jocelyn Davé, Chief Product Officer at NanoTemper Technologies. “When it comes to addressing difficult and undruggable targets, there is no other company with the ability to outperform SPR in this category."
About NanoTemper Technologies
Our mission at NanoTemper Technologies is to create biophysical tools for scientists in drug discovery and development who need to tackle challenging characterizations. Working with scientists striving to make a difference in the world gets us excited. If you’re facing challenges with affinity screening, molecular interactions, or protein stability, let’s talk.
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