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Embracing digitalization in the pharmaceutical supply chain

Pharmaceutical Technology

Digital technologies will be utilized throughout drug development, production, packaging and delivery for increased process efficiency and improved product quality. According to GlobalData, the number of mentions of ‘Artificial Intelligence’ in the company filings of pharmaceutical organizations increased 105% between 2016 and 2021.

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Intellia, Regeneron ace first trial with ‘in vivo’ CRISPR drug

pharmaphorum

Intellia and Regeneron’s in vivo approach involves administration of a gene-editing drug – in the form of a CRISPR mRNA and guide RNA packaged in a lipid nanoparticle – directly into the body. Regeneron has partnered the company since 2016. . — Eric Topol (@EricTopol) June 26, 2021.

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Hikma shares rally after US launch of Advair generic resumes

pharmaphorum

Advair lost US patent protection in 2010 and exclusivity on the Diskus inhaler went in 2016 – but it took until February 2019 for the FDA to approve a generic from Mylan, now part of Viatris. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

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EMA upgrades drug development innovation scheme to PRIME time

Pharmaceutical Technology

The European Medicines Agency (EMA) has announced plans to expedite scientific advice and support the preparation of regulatory packages under its PRIority Medicines (PRIME) scheme. The PRIME scheme, launched in March 2016, gives applicants a number of exclusive benefits to help reach regulatory approval.

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Warnings for Japanese pharmaceutical market may lead to more lenient price controls

Pharmaceutical Technology

According to the report, five member companies decided to decrease their investment in Japan between 2016 and 2017, four companies changed their investment targets between 2018 and 2020, and one company lowered the priority given to Japan after 2021.

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Benefits of chlorophyll for lung health and more

The Checkup by Singlecare

According to a study published in 2016 in the journal Environmental Toxicology and Pharmacology , chlorophyllin showed some promise in targeting non-small cell lung cancer cells in mice. Another study published in 2016 also found that chlorophyll may be helpful for people with anemia. Pharmacopeia , UL Solutions , and Consumer Lab.

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FDA Issues Long-Awaited QMSR Final Rule

The FDA Law Blog

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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