BUSINESS INSIGHTS, PHARMA TECH
CONTINUUS Pharmaceuticals | March 15, 2023
On March 14, 2023, ValGenesis, Inc., a leading enterprise validation lifecycle management solutions provider, announced that CONTINUUS Pharmaceuticals has successfully implemented the ValGenesis Validation Lifecycle Management System (VLMS) for efficient management of validation processes across the company in a 100% digital format.
CONTINUUS Pharmaceuticals is a rapidly growing small business specializing in end-to-end integrated continuous manufacturing (ICM) of pharmaceuticals. As a spin-out company resulting from a long-term collaboration between MIT and Novartis, CONTINUUS Pharmaceuticals is committed to enhancing the accessibility and affordability of pharmaceutical products worldwide by exploring advanced manufacturing paradigms that expedite the development of raw materials and APIs to final dosage forms.
Due to the immense validation requirements involved in the production of different drug products, CONTINUUS Pharmaceuticals needed an electronic solution that determines the disposition of their assets while switching amongst product lines. By leveraging the ValGenesis VLMS, CONTINUUS Pharmaceuticals has successfully implemented facilities, equipment validation, computer system and utility validation.
The ValGenesis VLMS is the system of record for CONTINUUS Pharmaceuticals' engineering team and will be expanded to other teams in the future. The highly automated, real-time, and compliant system provided by ValGenesis minimizes the potential for Good Manufacturing Practice (GMP) non-compliance while accelerating time to market.
About CONTINUUS Pharmaceuticals
CONTINUUS Pharmaceuticals is an end-to-end integrated continuous manufacturing (ICM) company specializing in pharmaceutical production. The company is committed to enhancing the accessibility and affordability of pharmaceutical products worldwide by exploring advanced manufacturing paradigms that expedite the development of APIs and raw materials to final dosage forms. It leverages a novel continuous manufacturing platform called Integrated Continuous Manufacturing (ICM), initially developed through a $65 million joint research project between Novartis and MIT. With ICM, it aims to transform and streamline the supply chain of pharmaceuticals by delivering high-quality, lower-cost drugs "on-demand."
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BUSINESS INSIGHTS, PHARMACY MARKET
Shields Health Solutions | January 12, 2023
Shields Health Solutions (ShieldsRx), one of the leading specialty pharmacy accelerators, informed that the company has now collaborated with more than 850 hospitals at over 75 health systems after adding four more health systems.
ShieldsRx health system partners are well-positioned to improve therapy management and care coordination for critical patients, improving outcomes through high-quality care. Its health systems serve 1 million patients in 44 states.
Matt Conway, Chief Commercial Growth Officer of ShieldsRx stated, "As the foremost expert in health system specialty pharmacy, Shields has proven successful in partnering with health system leaders to develop integrated programs that deliver superior experiences and outcomes for complex patients." He further stated, "Not only do these programs deliver measurable clinical results but integrating specialty pharmacy within the health system also creates the net operating income health systems need to succeed. These proven clinical and financial results are why so many leading health systems trust Shields to elevate access, outcomes and growth within specialty pharmacy."
(Source- PRNewswire)
ShieldsRx's expansion with new health system partnerships includes
MyMichigan Health: Midland-based MyMichigan Health serves 25 counties. Its urgent care, home health, virtual care, and medical offices offer a broad spectrum of care in over 30 specialties and subspecialties.
Nemours Children's Health: Nemours Children's Health, the nation's most extensive multistate pediatric health system, has two free-standing children's hospitals and over 70 general and specialized care practices.
Solution Health: Phoenix Children's Care Network, Arizona's leading children's hospital, offers over 1,175 pediatric primary care professionals and specialists in over 75 subspecialties.
Traditional specialty pharmacy patients had to tackle administrative difficulties like prior authorization and expensive medical bills alone. Shields' expansion facilitated value-based reimbursement.
About Shields Health Solutions
Shields Health Solutions is a leading specialized pharmacy accelerator. Its Performance Platform is designed to improve payer and drug access for specialty pharmacies, improve health outcomes for complex patients, and promote growth across the entire health system. The company has access to over 80% of limited distribution medications (LDDs) and major health insurance payers in the U.S. along with a clinical strategy that lowers the total cost of treatment by 13%. ShieldsRx has collaborated with more than 70 health systems to deliver measurable clinical and financial benefits.
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BUSINESS INSIGHTS, PHARMA TECH
Indivior | March 06, 2023
Indivior PLC, a global pharmaceutical company, recently announced its successful acquisition of Opiant Pharmaceuticals, Inc. The acquisition strengthens Indivior's addiction treatment and science portfolio by adding Opiant's late-stage assets. In particular, OPNT003, an investigational opioid overdose treatment, aims to provide an effective treatment option to address the current wave of opioid overdose caused by powerful synthetic opioids such as fentanyl.
Indivior acquired Opiant for an upfront consideration of $20.00 per share in cash, summing to approximately $145 million and up to $8.00 per share in contingent value rights (CVRs). The CVRs will become payable if OPNT003 meets certain net revenue milestones within seven years after approval and launch. The acquisition was completed after meeting customary conditions, and Indivior funded the upfront consideration with its existing cash. It expects OPNT003 to generate net revenue of 150 million to 250 million dollars and the acquisition to be earnings accretive after the second year of launch. The company plans to provide updated guidance for FY 2023 with its Q1 results announcement on April 27, 2023.
OPNT003 is a patent-protected intranasal formulation of nalmefene. It employs an absorption-enhancing technology to improve its pharmacokinetic and pharmacodynamic profile, resulting in a fast-acting and long-lasting duration of action that helps OPNT003 as a possible new treatment option for opioid overdose. On December 22, 2022, Opiant completed its rolling NDA for OPNT003. OPNT003's FDA PDUFA date is May 22, 2023. One formulation patent (expiry 2038) and five other patent applications cover various aspects of OPNT003, including treatment methods. National Institutes of Health, National Institute on Drug Abuse (NIDA) is funding the development of the program, as well as an agreement from Biological Advanced Research and Development Authority (BARDA).
About Indivior
A global pharmaceutical company, Indivior, is working to support patients in changing their lives by developing medicines that help in coming out of addiction and severe mental illnesses. The company aims to provide access to evidence-based treatment to all patients globally for chronic conditions and co-occurring disorders of substance use disorder (SUD). It is committed to transforming substance use disorder from a worldwide human crisis to a recognized and treated chronic illness. In addition, it has a pipeline of product candidates designed to build on its global portfolio of OUD treatments and potentially address other chronic conditions and co-occurring disorders of SUD, such as alcohol use disorder and cannabis use disorder.
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