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Citrate-free HCF of adalimumab biosimilar gets positive opinion

European Pharmaceutical Review

Upon approval, the adalimumab citrate-free high concentration (100mg/ml) formulation will have the same auto-injector, the currently offered drug delivery option. The study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the two concentrations.

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EMA validates first regulatory submission for CRISPR-based medicine

European Pharmaceutical Review

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively.

Medicine 111
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MicroPort Navibot Receives 510(K) Clearance for its SkyWalker™ Robot-Assisted Platform for Orthopedic Applications

Legacy MEDSearch

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. was established in China in 2015 and is a subsidiary of MicroPort Scientific Corporation.

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Senju Pharmaceutical and Novaliq close agreement for dry eye disease therapy

Pharmaceutical Technology

The therapy has shown efficacy and safety in trials for patients with a history of dry eye disease and clinical Meibomian gland dysfunction. Its safety and efficacy have been demonstrated in numerous studies in Europe, the United States and China. to treat dry eye disease.

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Article Reviews the Evolution of Arthroscopy from its Invention in 1912 to the Dawn of the Wireless ArthroFree™ Era

Legacy MEDSearch

Developed by Cleveland-based Lazurite Holdings LLC, ArthroFree recently became the first wireless camera for arthroscopy and general endoscopy to receive market clearance from the Food and Drug Administration. 2015) designs devices to set new operating-room standards for efficiency and patient safety.

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Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects. New hope for stomach cancer patients.

Patients 104
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Automation to guide technology shift in aseptic environments

European Pharmaceutical Review

Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015. Another 563 new nanomedicines were under clinical trial or in other stages of drug development. Yet in 2021, 100 nanomedicines had been marketed.