prnewswire | August 29, 2023
Halozyme Therapeutics, Inc. announced the approval of Roche's Tecentriq® SC (atezolizumab), using Halozyme's ENHANZE® drug delivery technology, by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain. Tecentriq® subcutaneous (SC) is co-formulated with Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, allowing for subcutaneous delivery, which takes approximately seven minutes, compared with 30-60 minutes for intravenous (IV) infusion. Tecentriq® SC will be available to patients in Great Britain for certain types of lung, bladder, breast, and liver cancer.7
Multiple oncology studies suggest that most cancer patients prefer to receive their treatments via subcutaneous delivery, instead of intravenous infusion because of reduced discomfort, ease of administration, and shorter duration of treatment.2,4,11
"We are delighted that Roche has received approval of Tecentriq SC in Great Britain. Subcutaneous delivery of Tecentriq provides cancer patients a faster and more flexible treatment option and may alleviate pressure on healthcare system resources," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to additional regulatory approvals of our partner products utilizing ENHANZE."
Tecentriq® SC is the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain and is Roche's fourth subcutaneous cancer therapy using Halozyme's ENHANZE® drug delivery technology.8-10 The approval is based on clinical data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq® in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.12 While the IMscin001 trial was conducted within the hospital setting, the SC formulation may be suitable for out-of-hospital administration by a healthcare professional.
The U.S. Food and Drug Administration (FDA) is currently evaluating Tecentriq® SC for regulatory approval.
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 700,000 patient lives in post-marketing use in six commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including XYOSTED®, TLANDO® and NOCDURNA® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.
Businesswire | August 16, 2023
Advanced Infusion Care (AIC), a division of AIS Healthcare, today announced the opening of a new pharmacy location in Cockeysville, Maryland. This continued expansion to the Northeast provides a platform for the company to serve more patients and physicians in the region. The Maryland pharmacy is AIC’s sixth location from which the company dispenses essential medications and personalized care to patients across the United States with complex medical conditions like immune deficiency diseases.
The newly opened pharmacy is strategically positioned and designed to cater to the unique needs of patients and providers in the Mid-Atlantic. With a firm commitment to elevating the patient experience, AIC aims to make medications and home infusion services more accessible to those in need of care solutions.
"We are thrilled to open a pharmacy location in Maryland. This expansion is a testament to AIC’s unwavering dedication to our patients and our vision of providing best-in-class healthcare services with a personal touch. By opening this location, we aim to streamline the medication fulfillment process, enhance convenience, and ultimately improve the lives of our patients,” said Jud Hall, President at AIC.
With a focus on efficiency and compassion, AIC is committed to addressing the unique medication needs of each patient and fostering strong relationships with healthcare providers in the area. The fully operational pharmacy in Maryland has started dispensing its extensive inventory of prescription medications, over-the-counter products, and specialty medications to patients. The location utilizes cutting-edge technology and a team of highly skilled pharmacists and healthcare professionals to serve patients. The facility also features a state-of-the-art USP797-compliant cleanroom, which is critical to ensuring sterility and quality in the medications.
In recent months, AIC announced further expansion into the New England market and the grand reopening of a newly designed pharmacy in Valdosta, Georgia. AIC also made medications like GAMMAKED™ and LEQEMBI™ available to patients through its locations in Valdosta, Georgia; Birmingham, Alabama; Clinton, Mississippi; Panama City, Florida; and Dallas, Texas.
About AIS Healthcare
As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do.
Businesswire | August 01, 2023
Harrow a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Application (NDA) for VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eye drop for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms. The U.S. commercial rights to VIGAMOX werepurchasedby Harrow in January of 2023, and VIGAMOX is the fourth FDA-approved ophthalmic product from that acquisition to have completed the NDA transfer process and become commercially available under the Harrow name.
“Having now completed the NDA transfer of VIGAMOX, we are excited to begin the implementation of the market access, marketing, inventory management, national sales detailing, and other brand‑leveraging strategies that we have developed during this transfer period,” said Mark L. Baum, Chief Executive Officer of Harrow. “With an exceptional record of safety and efficacy, VIGAMOX is a well-known, reliable, and trusted product by U.S. eyecare professionals, many of whom regard VIGAMOX as the preferred broad-spectrum topical antibiotic to treat patients for bacterial conjunctivitis (sometimes referred to as 'pink eye') as well as many other common bacterial-based infections.”
Product orders for VIGAMOX 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.
About VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%:
INDICATIONS AND USAGE
VIGAMOX® is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, and Chlamydia trachomatis.
Efficacy for this organism was studied in fewer than 10 infections.
IMPORTANT SAFETY INFORMATION
VIGAMOX® is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.
Warnings and Precautions
Hypersensitivity Reactions –Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin.
Prolonged Use –May result in overgrowth of non-susceptible organisms, including fungi.
Avoid Contact Lens Wear –Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1%-6% of patients.
Nonocular adverse events reported at a rate of 1%-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.
Harrow Health, Inc. is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the U.S. market. Harrow helps U.S. eyecare professionals preserve the gift of sight by making its comprehensive portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of Americans each year.