BUSINESS INSIGHTS, PHARMA TECH
Prnewswire | April 13, 2023
Flexan LLC announced that it is expanding its services to include custom manufacturing of sterile liquids and custom formulated solutions for a variety of medical device applications. Flexan is partnering with its parent company, ILC Dover, and its KSE Scientific division to expand offerings to its medical device customers. KSE Scientific provides standard and custom formulations and packaging while following the most stringent quality standards. The company is FDA registered for medical devices and 510(k) for sterile water and saline. With over 50,000L of Water for Injection (WFI) production capacity per day and more than 113,000 square feet of manufacturing, controlled storage, and laboratory space, KSE Scientific is ready to solve customers' challenges for sterile liquids.
Recently, both Flexan and KSE Scientific partnered to deliver a custom solution and packaging service to Clyra Medical Technologies.
"Clyra is pleased to find a high-quality partner under one roof in KSE Scientific and Flexan, to support manufacturing for our best-in-class wound management and surgical product 'Bioclynse'. Bioclynse is 510(k) cleared by the FDA, and is an efficacious, safe, long-acting wound irrigation solution that can be used during wound management, during surgery and for post-surgical wounds, with no need to rinse out throughout the entire procedure," said Steve Harrison, CEO of Clyra Medical Technologies. "We look forward to working with KSE Scientific and Flexan to support solution manufacturing and developing customized packaging and components to ensure we meet the market demand and customer requirements for delivering our solutions."
"Flexan serves a broad range customers in the medical device market and we are excited to expand our services to include custom sterile fluids for various clinical applications. In addition to adding sterile fluids, we are also excited to share that we are now offering platinum-cured silicone tubing, tubing assemblies and molded components to better serve ILC's biopharmaceutical customers worldwide," said Tony Gonzalez, President of Flexan.
About ILC Dover
ILC Dover is a world-leader in the innovative design and production of solutions for biopharmaceutical, pharmaceutical, medical device markets as well as a leading supplier for the (aero)space industries. Our customers will attest to our relentless dedication to high value products, advanced technology, and responsive service, as our visionary solutions have improved efficiency while safeguarding people, product, and infrastructure in hazardous conditions through flexible protective solutions since 1947.
VIEWS AND ANALYSIS, PHARMACY MARKET
prnewswire | May 08, 2023
Telix Pharmaceuticals Limited announces that it has entered into an agreement with Bayer AG to supply Illuccix® kit for the preparation of gallium Ga 68 gozetotide injection) for the Phase III ARASTEP study (ClinicalTrials.gov Identifier: NCT05794906). This global study is investigating the efficacy of Bayer's androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence who have no evidence of metastatic disease by conventional imaging and a positive PSMA-PET/CT at baseline.
The study will enrol up to 750 patients across various sites such as in Europe, Japan and the United States. The more sensitive PSMA imaging may identify prostate cancer lesions not detectable by conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans.
Telix Chief Medical Officer, Dr Colin Hayward stated, "We are pleased to supply Bayer and a number of clinical sites in this important study, reflective of Telix's unique commitment to delivering advanced prostate cancer imaging globally. The use of PSMA-PET/CT in this setting is illustrative of the potential for this imaging modality to move beyond diagnosis to a disease management tool."
022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.
VIEWS AND ANALYSIS
Businesswire | May 05, 2023
Harrow a leading U.S. eyecare pharmaceutical company, announced the completion of the transfer to Harrow of the New Drug Applications (NDAs) for ILEVRO® (nepafenac ophthalmic suspension) 0.3%, NEVANAC® (nepafenac ophthalmic suspension) 0.1%, and MAXIDEX® (dexamethasone ophthalmic suspension) 0.1%. These three FDA-approved ophthalmic medicines, which are now commercially available under the Harrow umbrella, were among the five products that Harrow purchased in January of 2023 and for which Harrow has been receiving net profits from unit sales during the NDA transfer process. Harrow expects to complete the transfer of the NDAs for the two remaining products, VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5% and TRIESENCE® 40 mg/ml, by year-end.
“We are delighted to have completed the NDA transfer process for ILEVRO, NEVANAC, and MAXIDEX earlier than our originally estimated six-month period,” said Mark L. Baum, Chief Executive Officer of Harrow. “We can now implement our market access, marketing, inventory management, and national sales detailing strategies for each of these three products, and we expect to extend those efforts when the NDAs for the remaining two products, VIGAMOX and TRIESENCE, are transferred later this year.
“Our market research has shown that the market need for all five of these products continues to increase with U.S. demographic growth and that there are few, if any, new competitive threats, particularly in the NSAID market. These products are used during procedures and within markets in which Harrow already has a strong foothold, and we look forward to making these well-known and valuable ophthalmic medicines available to the eyecare professionals that we serve nationwide as we continue to execute our branded ophthalmic pharmaceuticals market strategy.”
Product orders for ILEVRO, NEVANAC, and MAXIDEX 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.
Harrow is a leading U.S. eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic prescription therapies that are accessible and affordable. Harrow owns U.S. commercial rights to ten FDA-approved ophthalmic pharmaceutical products. Harrow also owns and operates ImprimisRx, the leading U.S. ophthalmic‑focused pharmaceutical compounding business, which also serves as a mail-order pharmacy licensed to ship prescription medications in all 50 states. Harrow has non-controlling equity positions in Surface Ophthalmics, Inc. and Melt Pharmaceuticals, Inc., companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in four late-stage drug candidates being developed by Surface and Melt.