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    Digital Content for pentyl N-[1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-methyloxolan-2-yl]-5-fluoro-2-oxopyrimidin-4-yl]carbamate

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    pentyl N-[1-[(2R,3R,4S,5R)-3,4-dihydroxy-5-methyloxolan-2-yl]-5-fluoro-2-oxopyrimidin-4-yl]carbamate

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    Divi’s Labs on FDA’s Import Alert List; but did it refuse an inspection?

    Divi’s Labs on FDA’s Import Alert List; but did it refuse an inspection?

    Divi's Laboratories — an Indian active pharmaceutical ingredient (API) manufacturer and until recently the darling of the Indian bourses — received another setback this week.  The US Food and Drug Administration (FDA) placed its Unit II, located in Visakhapatnam, on its import alert list for “refusing FDA foreign establishment inspection” as also for “not meeting drug GMPs” (good manufacturing practices). According to the FDA website “the refusal to permit inspection of a foreign facility or provide reasonable access to FDA’s inspectional personnel, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions.” The firm is considered to have refused the FDA inspection. This news comes as a surprise, as it adds an additional dimension to the problems that the FDA encountered at Divi’s facilities.  PharmaCompass had previously shared news that Health Canada had placed the company on its inspection tracker after data integrity and general GMP observations were reported by its “regulatory partner(s)”.  According to media reports, the firm was inspected by the US FDA from November 29 to December 6, 2016, and the regulators had issued an 18-page long Form 483 with five observations. Second Divi’s group firm to refuse inspection   The news comes a few months after its affiliate – Divi’s Pharmaceutical Private Ltd was placed on FDA’s Import Alert List for refusing an inspection by the US FDA. The two facilities of Divi’s Pharmaceutical  that were placed on the FDA’s Red List were Divi Towers in Hyderabad, and a facility in Medak district, Telangana. Divi Towers is also the corporate headquarters of Divi’s Laboratories. Divi’s Laboratories’ Unit-II is a major producer of APIs and a key supplier to leading companies around the world. The FDA has excluded some intermediates and the following APIs from the import alerts – Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen sodium , Raltegravir potassium and Atovaquone.  The exemptions did not help as far as the stock market was concerned. Divi’s stock price, which has already been under significant pressure after news of the inspection initially broke out in December, tanked another 20 percent on Tuesday. Our view   While the details are yet to emerge on the exact nature of problems which the US FDA inspectors uncovered and encountered at Divi’s Laboratories Unit II, it is clear that Divi’s has a long road ahead insofar as regulatory compliance is concerned.
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    https://www.pharmacompass.com/radio-compass-blog/divi-s-labs-on-fda-s-import-alert-list-but-did-it-refuse-an-inspection

    #Phispers by PHARMACOMPASS
    23 Mar 2017
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    Akeso's Cadonilimab Plus Chemotherapy for Gastric Cancer Presented at 2024 AACR
    Akeso's Cadonilimab Plus Chemotherapy for Gastric Cancer Presented at 2024 AACR

    08 Apr 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/oral-report--the-positive-interim-analysis-results-from-the-phase-iii-clinical-study-of-akesos--cadonilimab-pd-1ctla-4-bsab-plus-chemotherapy-as-first-line-treatment-for-advanced-gastric-cancer-presented-at-2024-aacr-302110917.html

    PR NEWSWIRE
    08 Apr 2024
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    Processa Provides Interim Analysis from Ongoing Phase 1b Trial of Capecitabine
    Processa Provides Interim Analysis from Ongoing Phase 1b Trial of Capecitabine

    19 Dec 2023

    // GLOBENEWSWIRE

    https://www.globenewswire.com//news-release/2023/12/19/2798574/0/en/Processa-Pharmaceuticals-Provides-Interim-Analysis-from-Ongoing-Phase-1b-Trial-of-Next-Generation-Capecitabine-Showing-Improved-Safety-Over-Capecitabine.html

    GLOBENEWSWIRE
    19 Dec 2023
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    Akeso's bispecific notches ph. 3 victory against gastric cancer
    Akeso's bispecific notches ph. 3 victory against gastric cancer

    08 Nov 2023

    // FIERCE BIOTECH

    https://www.fiercebiotech.com/biotech/akeso-claims-overall-survival-win-its-bispecific-patients-severe-gastric-cancer

    FIERCE BIOTECH
    08 Nov 2023
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    Ongoing Results From a Dose Expansion Cohort of CYT-0851
    Ongoing Results From a Dose Expansion Cohort of CYT-0851

    12 Oct 2023

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20231012887827/en

    BUSINESSWIRE
    12 Oct 2023
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    Trifluridine/Tipiracil Plus Bevacizumab Provides Potential 1st-Line Alternative
    Trifluridine/Tipiracil Plus Bevacizumab Provides Potential 1st-Line Alternative

    30 Aug 2023

    // ONCLIVE

    https://www.onclive.com/view/trifluridine-tipiracil-plus-bevacizumab-provides-potential-first-line-alternative-to-bevacizumab-capecitabine-in-mcrc

    ONCLIVE
    30 Aug 2023
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    Adjuvant Ibandronate Plus Capecitabine Does Not Significantly Improve OS
    Adjuvant Ibandronate Plus Capecitabine Does Not Significantly Improve OS

    07 Jul 2023

    // ONCLIVE

    https://www.onclive.com/view/adjuvant-ibandronate-plus-capecitabine-does-not-significantly-improve-os-in-elderly-patients-with-early-breast-cancer

    ONCLIVE
    07 Jul 2023
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