BUSINESS INSIGHTS, PHARMACY MARKET
Harrow | February 16, 2023
On February 15, 2023, Harrow, a renowned pharmaceutical firm specializing in eyecare in the United States, announced the launch of its next-generation, patent-pending compounded Atropine formulations. These formulations are now accessible through ImprimisRx, a mail-order pharmacy subsidiary wholly owned by Harrow.
The following are the key features of ImprimisRx's next-generation Atropine formulations
Thoroughly validated analytical tests are conducted to ensure potency, consistency, and stability.
The formulations are free of preservatives and boric acid.
They possess a physiologic pH of 5.5.
They can be stored at room temperature for up to 180 days.
Eyecare professionals can purchase these compounded Atropine formulations for as less as $39 per 5mL bottle through various channels, such as online via atropine.com or by contacting ImprimisRx Customer Service at 615-437-4690 via call or text.
Compounded formulations are recommended for patients with clinical requirements that are not met by FDA-approved medications. It is essential to note that compounded medications are not reviewed by FDA for their safety and effectiveness. ImprimisRx does not manufacture copies of products that are already available in the market.
Harrow's Chairman and Chief Executive Officer, Mark L. Baum, commented, "Our mission has always been to help our eyecare professionals address their patients' unmet needs and to make ophthalmic medications both accessible and affordable. The availability of these innovative compounded atropine formulations is in keeping with our mission. We believe ophthalmologists, optometrists, and the millions of Americans who may benefit from topical atropine therapy, will appreciate the tremendous value these patent-pending formulations offer."
(Source – Business Wire)
Founded in 2012, Harrow is a leading ophthalmic pharmaceutical firm in the United States focused on discovering, developing, and introducing accessible, innovative, and affordable prescription therapies. It holds commercial rights for ten FDA-approved eyecare pharmaceutical products. In addition, the company also operates ImprimisRx, a leading U.S. compounding business that specializes in ophthalmic medications and is licensed to ship prescription drugs in all 50 states. The success of its efforts is reflected in its remarkable financial performance, with a 72% compound annual growth rate achieved during our first eight years in operation. This phenomenal growth rate has established Harrow as one of the fastest-growing ophthalmic pharmaceutical companies in the United States.
BUSINESS INSIGHTS, PHARMA TECH
ADC Therapeutics | January 03, 2023
Sobi® and ADC Therapeutics SA informed that Zynlonta® (loncastuximab tesirine) has recently received conditional marketing authorization from the European Commission (EC) for the treatment of diffuse large B-cell lymphoma ((DLBCL) that has relapsed or become resistant. The approval comes after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a favorable opinion in September.
Sobi has said that it wants to give Zynlonta, a new treatment for diffuse large B-cell lymphoma, to people in the European Union who have this debilitating blood cancer.
The approval was granted based on the findings from LOTIS-2, which was a large (n=145), phase 2 multinational, single-arm clinical study of Zynlonta for treating adult patients who had relapsed or refractory DLBCL following two or more prior lines of systemic therapy. Zynlonta was granted accelerated approval by the United States Food and Drug Administration in April 2021. This approval made it the first CD19-targeted antibody-drug conjugate to be used as a single-agent treatment for adult patients who had relapsed or been resistant to two or more lines of systemic therapy for their DLBCL.
Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialize Zynlonta in Europe and other international markets. The license aims to boost Sobi's presence in hematology, one of its two main disease areas. Besides, Zynlonta will be sold with other Sobi hematology drugs.
ADC Therapeutics added that this approval expands Zynlonta's global reach. Zynlonta will fill a critical unmet need for DLBCL patients in Europe. The EU decision applies to Iceland, Norway, and Liechtenstein.
According to the terms of the license agreement and as previously communicated, Sobi will pay ADC Therapeutics USD 50 million as a result of the EU's approval of DLBCL. Sobi's clinical development and product supply are handled by ADC Therapeutics.
About ADC Therapeutics
ADC Therapeutics next-generation, targeted antibody-drug conjugates help cancer patients. With a deep understanding of oncology and an ADC platform that the FDA's approval of Zynlonta has proven, the company is working to meet unmet medical needs and improve outcomes for people with hard-to-treat hematological cancers and solid tumors. ADC Therapeutics' highly skilled global team is committed to fighting cancer with science, bringing targeted therapies and hope to patients and their families.
BUSINESS INSIGHTS, PHARMA TECH
Dalton Pharma Services | February 17, 2023
On February 16, 2023, Dalton Pharma Services, a leading cGMP pharmaceutical firm, announced a significant strategic expansion of its sterile filling and pharmaceutical manufacturing capabilities. The capital expansion plan includes a brand-new, state-of-the-art, and fully automated cGMP sterile filling line that can fill syringes, vials and cartridges under isolator technology. The sterile fill line is integrated with a new cGMP lyophilizer to provide customers with complete sterile finished dosage form manufacturing capabilities.
In compliance with cGMP aseptic filling regulations, the newly launched sterile filling line supports small-scale commercial production to cater to the global market. Additionally, the capital expansion plan comprises further cGMP non-sterile powder filling capacity, enhanced multi-kilogram API manufacturing capabilities, and a better infrastructure for handling and storing organic solvents.
The company's capital expansion plan supports the goal of establishing it as a leading Contract Development and Manufacturing Organization (CDMO). As part of the Seikagaku Group, Dalton's long-term strategy is to provide pharmaceutical and biotechnology customers with high-quality integrated drug discovery, development, and manufacturing services through its North American facility.
Dalton Pharma Services CEO Peter Pekos commented, "This major investment in the expansion of our sterile manufacturing capabilities enables us to meet the needs of our customers as their critical products advance to commercialization." He added, "It also represents a leap forward in both scale and technology for us, placing Dalton at the leading edge of sterile manufacturing capabilities."
(Source – PR Newswire)
About Dalton Pharma Services
Founded in 1986, Dalton is a leading contract pharmaceutical manufacturer that offers integrated chemistry, development, and manufacturing services to biotechnology and pharmaceutical clients worldwide. The company operates from a 42,000 sq. ft. facility where they provide cGMP manufacturing of APIs, sterile injectables, finished drug products, and solid oral dosage forms. It has the capability to produce APIs in gram-to-kilogram quantities, including sterile APIs, and supports clients at any stage of the regulatory process. Dalton's development services include analytical method development, formulation, and polymorphism screening, among others. Additionally, the company offers over 2,500 reference standards, building blocks, metabolites, and impurities via its Dalton Research Molecules business to support the industry's pharmaceutical research programs.