BUSINESS INSIGHTS, PHARMACY MARKET
Cellworks Group | January 13, 2023
Cellworks Group Inc., a pioneer in personalized therapy biosimulation, announced the introduction of its precision drug development business units.
These units will use predictive biosimulation to shorten drug development time-to-market and revive previously researched but disapproved pharmaceutical assets.
The two new business units will use Cellworks' computational biology model (CBM) and biosimulation platform to predict responses to pharmaceutical interventions in silico, streamlining the clinical trial by identifying suitable patients more quickly, thereby reducing the time and cost of developing successful pharmaceutical agents.
Cellworks precision drug development: Pre-clinical stage
Companion molecule development: The Cellworks platform can augment a drug's usability by finding companion molecules that improve performance when combined with the investigational agent.
Biomarker development: Cellworks utilizes cell lines and historical patient data to uncover novel biomarkers for investigational agents. This may increase drug success rates by proactively identifying individuals who will respond to an agent.
Indication expansion: By utilizing the Cellworks patient database of 100,000+ omics patient profiles and 1,800 oncology cell lines to examine the agent's effectiveness in different indications, the Cellworks platform can identify additional indications where an experimental treatment may be successful.
Cellworks precision drug development: Clinical stage
Drug revival and repurposing: The platform seeks to anticipate whether certain drugs cause a response, which may be used to identify whether shelved assets can be resurrected via suitable patient selection or the discovery of non-obvious reasons.
Clinical trial biosimulation: Through biosimulation clinical trials, the Cellworks platform may anticipate humans' clinical response to pharmaceutical agents in weeks, yielding critical insight years ahead of a traditional clinical practice.
Cellworks Platform and Computational Biology Model (CBM)
The Cellworks platform biosimulates the impact of specific pharmacological molecules on a given patient or class of patients using the patient's genetic profile. To generate a customized or cohort-specific disease model, multi-omic data from a cohort or patient is fed into the Cellworks computational biology model (CBM).
About Cellworks Group
Cellworks is one of the leaders in precision medicine. The organization assists physicians and payers in navigating the most efficacious, cost-effective therapies for patients. Its primary therapeutic areas are oncology, immunology, dermatology, and infectious diseases. Its one-of-a-kind biosimulation platform is a unified representation of biological information gathered from disparate databases and used to find cures. The company has the world's strongest trans-disciplinary team of molecular biologists, cellular pathway modelers, and internet software technologists working towards a common goal, i.e., taking on significant diseases to improve patients' lives.
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CPD AND LEARNING
Miravo Healthcare | March 16, 2023
Nuvo Pharmaceuticals Inc., which operates as Miravo Healthcare (Miravo), and Searchlight Pharma Inc., a Canadian specialty firm, have recently announced the closing of the previously announced plan of arrangement of Miravo with Searchlight. As per the arrangement terms, Searchlight acquired all the outstanding common shares of Miravo in exchange for $1.35 per share in cash, and the Miravo common shares will be removed from the Toronto Stock Exchange. Miravo will also apply to cease being a reporting issuer in each of the Canadian provinces.
The registered shareholders of Miravo must complete, sign and return the letter of transmittal and share certificate(s) to TSX Trust Company, the depositary, to receive their compensation under the arrangement. Non-registered shareholders will receive their compensation through their intermediary.
Before the Arrangement, Searchlight did not possess any Company Shares. Searchlight bought 11,388,282 Company Shares, representing 100% of the issued and outstanding Company Shares, for $1.35 per Company Share in conjunction with the arrangement.
Searchlight Pharma Inc., President and CEO, Mark Nawacki, commented, "Today marks the beginning of a new chapter for Miravo as it officially combines with Searchlight and continues as a private company." He further emphasized, "Searchlight plus Miravo will be a diversified, large and strong company – based on IQVIA CDH sales data, we will rank in the top three of Canadian specialty pharma companies – and this positions us well to continue to execute our successful business model and to deliver on our leadership objective in the sector. On behalf of the Searchlight team, I express our thanks to all Miravo stakeholders for their cooperation throughout this acquisition process, and I warmly welcome our new Miravo colleagues to the Searchlight family."
(Source – Business Wire)
About Miravo Healthcare
Miravo Healthcare, formerly known as Nuvo Pharmaceuticals Inc., is a Canadian specialty pharmaceutical company that focuses on developing and commercializing innovative therapies. Its mission is to improve patient's quality of life by providing them with safe and effective treatments for chronic conditions such as pain, inflammation, and addiction. Miravo Healthcare's portfolio includes a range of prescription drugs, over-the-counter products, and medical devices used in various therapeutic areas, including pain management, dermatology, and women's health. The company's flagship product is Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID) used to treat knee osteoarthritis. It is committed to sustainability and social responsibility, and the company's initiatives include reducing its environmental footprint, supporting local communities, and promoting diversity and inclusion. With a focus on innovation and patient care, it continues making significant contributions to the pharmaceutical industry in Canada and beyond.
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PHARMA TECH
BioMarin Pharmaceutical Inc. | March 08, 2023
On March 7, 2023, BioMarin Pharmaceutical Inc., a global biotech company focused on improving lives via genetic discovery, announced that the US FDA has accepted its supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) for injection to expand the treatment of achondroplasia in children under the age of 5.
Achondroplasia is a common form of disproportionate short stature. The FDA has set an action date of October 21, 2023, for the sNDA. The sNDA is supported by data from a Phase 2 double-blind, randomized, placebo-controlled clinical trial, which showed similar safety and efficacy profiles in children under five years of age compared to those aged five years and older.
The European Medicines Agency (EMA) also validated BioMarin's application for VOXZOGO in January to treat children under the age of 2. If approved, VOXZOGO could be prescribed for over 1,000 additional children from birth for achondroplasia.
VOXZOGO is the first EMA and FDA-approved treatment for achondroplasia with open bone growth plates. The treatment uses a new class of therapy, C-type natriuretic peptide (CNP) analog, which promotes bone growth by acting as a positive regulator of the signaling pathway downstream of the fibroblast growth factor receptor 3 gene (FGFR3).
The drug is approved in the EU, Brazil, and Australia for children aged two years and above with epiphyses (bone growth plates) and in Japan for children from birth who have achondroplasia with open growth plates. BioMarin has enrolled 250 children with achondroplasia in seven clinical studies in eight countries to evaluate the safety and efficacy of VOXZOGO.
About BioMarin Pharmaceutical Inc.
BioMarin is a leading biotechnology firm established in 1997 with a mission to transform people's lives by using genetic discovery. The company creates targeted therapies that address the underlying cause of genetic disorders to improve the quality of life for individuals with rare genetic diseases. It has developed eight first or best-in-class treatments and has a range of product candidates to address various genetic disorders using the same science-based approach. As BioMarin continues to create new and innovative solutions, it has the potential to impact the lives of even more people. The company is committed to prioritizing patients and their needs in its approach to drug development.
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