BUSINESS INSIGHTS, PHARMACY MARKET
Framework Solutions, LLC | March 02, 2023
On March 1, 2023, Framework Solutions, a leading clinical to commercial solutions provider, announced that it has acquired ONIX Life Sciences, a consultancy focused on regulatory operations services for the life sciences industry. The acquisition will enable both firms to expand their global reach and strengthen their service capabilities by providing clients with a broader range of critical services. ONIX's expertise in eCTD Submissions, Publishing, and eCTD Lifecycle Management has helped clients submit their regulatory documents to health authorities worldwide, including the FDA and EMA.
ONIX, based in the United Kingdom, has successfully completed eCTD submissions for over 100 clients globally across North America, Europe, South America, the Middle East, and Asia Pacific regions. In addition, ONIX is proud of its accomplishment of never having an eCTD technical rejection and never missing a deadline since its inception in 2010.
Frameworks, headquartered in Connecticut, received a growth investment from WestView Capital Partners in 2021 to develop end-to-end solutions for clinical and commercial-stage organizations in the life sciences industry. WestView Capital Partners, a Boston-based growth equity firm, focuses on investing in middle-market companies with a longstanding dedication to the life sciences services industry.
The transaction terms between Framework Solutions and ONIX Life Sciences were not disclosed.
Frameworks CEO Joe Walsh commented, "We are thrilled to welcome Jasbir and the ONIX team to Frameworks." He further emphasized, "ONIX has built an impeccable reputation in the industry and we are excited to bring Regulatory Operations services to our customers. We look forward to working with Jas as we continue to expand our suite of service offerings to best serve the clinical to commercial-stage needs of life sciences clients."
(Source – PR Newswire)
About Framework Solutions, LLC
Framework Solutions is a leading clinical to commercial solutions provider to pharmaceutical and biotechnology companies with the aim of promoting customer success. The company provides both strategic and tactical solutions in various fields, including Regulatory Affairs, Medical Affairs, MLR, and Commercialization. These services are reinforced by the Technology Group, which delivers tech-enabled solutions and integrated enterprise help desk and infrastructure support. Over 100 clients, from emerging biotech to large pharma, have utilized its services. Its operation centers are located in Europe, North America, and Asia, allowing us to provide these services globally.
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BUSINESS INSIGHTS, PHARMA TECH
Innate Pharma | January 17, 2023
On January 16, 2023, Innate Pharma SA announced the publication of preclinical findings demonstrating the control of acute myeloid leukemia (AML) cells by a trifunctional NKp46-CD16a-NK cell engager (NKCE) targeting CD123 in the scientific journal Nature Biotechnology. Innate and Sanofi conducted the experiments, which were published in Nature Biotechnology on January 12, 2023.
This study demonstrates that CD64 expression on AML blasts imparts resistance to anti-CD123 antibody-dependent cell cytotoxicity (ADCC) and that redirecting NK cells against cancer targets by binding to CD16a and NKp46 circumvents this resistance. Moreover, through their binding to NKp46, CD123-NKCE primarily target NK cells and have substantial antitumor activity against primary AML blasts; they stimulate NK cell activation and cytokine secretion exclusively in AML cells' presence.
In vivo, its antitumor activity observed in a mouse tumor model surpasses that of the anti-CD123 antibody used as the comparator. Furthermore, in vitro in human peripheral blood mononuclear cells and in vivo in nonhuman primates, the efficacy of CD123-NKCE was associated with the induction of low pro-inflammatory cytokine release and the absence of toxicity.
These results support CD123-NKCE clinical development. IPH6101/SAR'579 (SAR443579), the first NKp46/CD16-based CD123-targeted ANKETTM NK cell engager, is currently being evaluated in a Phase 1/2 clinical trial by Sanofi in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL), or high-risk myelodysplastic syndrome (HR-MDS).
About Innate Pharma
Headquartered in Marseille (France), Innate Pharma SA is a global, clinical-stage oncology-focused biotech firm dedicated to enhancing patient treatment and clinical outcomes using therapeutic antibodies that employ the immune system to combat cancer. Its extensive antibody pipeline has numerous potentially first-in-class clinical and preclinical candidates for cancers with a high unmet medical need. In addition, Innate has been a pioneer in the study of natural killer cell (NK cell) biology and developed its expertise in tumor antigens, tumor microenvironment, and antibody engineering. This innovative strategy has resulted in a varied proprietary portfolio and substantial alliances with biopharmaceutical industry leaders, including Sanofi, Bristol-Myers Squibb, Novo Nordisk A/S, and a multi-product collaboration with AstraZeneca.
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BUSINESS INSIGHTS, PHARMA TECH
Cambrex | January 24, 2023
Cambrex, a renowned global contract development and manufacturing organization (CDMO) offering drug substance, product, and analytical services throughout the drug lifecycle, recently announced the completion of its acquisition of Snapdragon Chemistry, a US-based provider of chemical process development services to a diverse range of emerging and established biopharma customers.
Snapdragon Chemistry specializes in the development of active pharmaceutical ingredient (API) batch and continuous flow processes, employing cutting-edge automated technology and proprietary equipment to address complicated process and analytical development challenges. With its headquarters for R&D and manufacturing in Waltham, Massachusetts, Snapdragon's 70+ employees, including 31 Ph.D. scientists, have strong ties to the local scientific community.
Cambrex's CEO Tom Loewald commented, "Today, we welcome our new colleagues from Snapdragon to Cambrex." He added, "With Snapdragon's depth of scientific expertise in API process development, I'm certain our customers will see the benefits of this combination and be delighted to work with Snapdragon's team."
(Source – PR Newswire)
Cambrex's portfolio of specialized pharmaceutical development and manufacturing solutions continues to grow, with Snapdragon reinforcing its experience in continuous flow production in addition to augmenting the recent investments in continuous flow process development capabilities at its North Carolina facility in High Point.
Snapdragon's CEO Matt Bio said, "I am extremely proud of what our team at Snapdragon has built over the years." He further added, "With Cambrex, we have found an ideal home for our customers and employees, and I look forward to continued success as part of Cambrex."
(Source – PR Newswire)
About Cambrex
Founded in 1981, Cambrex is a contract development and manufacturing organization (CDMO) that offers drug substances, products, and analytical services throughout the drug lifecycle. It provides a variety of specialized medicinal substance technologies and capabilities, such as controlled substances, biocatalysis, continuous flow, material characterization, solid-state science, stability storage and testing, and potent APIs. Cambrex is a trusted partner in the branded and generic markets for the development and manufacturing of API and finished dosage forms. With over 40 years of experience, it has a growing workforce of over 2,300 specialists serving global clients from North America and Europe.
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