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STAT+: FDA cites Dr. Reddy’s for quality control problems at a biologics plant

STAT

Reddy’s Laboratories, one of the world’s largest generic drugmakers, was cited by the U.S. Food and Drug Administration for a host of manufacturing violations at one of its plants in India, the latest instance in which the company was tagged by the regulator for quality-control problems.

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PharmaShots Weekly Snapshots (March 20 - 24, 2023)

PharmaShots

PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)

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PharmaShots Weekly Snapshots (March 20 - 24, 2023)

PharmaShots

PTC Therapeutics’ Upstaza (eladocagene exuparvovec) Receives NICE Recommendation for the Treatment of AADC Deficiency Date: Mar 24, 2023 | Tags: PTC Therapeutics, Upstaza, eladocagene exuparvovec, AADC Deficiency, Regulatory, NICE Onconova Therapeutics Entered into a Research Collaboration with Pangea Biomed to Identify Biomarkers for Cancer (..)

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Cannabinoids receptors: popular preclinical target but banned in 137 countries

Pharmaceutical Technology

The two types of cannabinoids targeting cannabinoid receptors are endocannabinoids, which are naturally occurring endogenous ligands and synthetic cannabinoids, which are designed in a laboratory. Cannabinoid receptors fall into two categories: CB1 and CB2 receptors. This is closely followed by CB2 receptors in second place.

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Predicting pandemics with unconventional digital tools

pharmaphorum

People get sick, the data goes into health records, the laboratory confirmations end up in Centers for Disease Control (CDC) and the ministries of health, and eventually with world bodies. At this moment, people recognise that monitoring infectious diseases, in the US or globally, is challenging because data takes time.

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Equipment cleaning procedure in pharmaceutical, Do’s and Don’ts

GMPSOP

Also, laboratory testing for potential contaminants after every use of a piece of equipment is generally not practical, economical, or reliable. Cleaning is usually followed first by visual inspection, and then by laboratory testing to verify that the cleaning continues to be effective. Additional documents included each month.

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Pharmaceutical sampling procedures for non-sterile products

GMPSOP

Apply Red Dot in Compression/Encapsulation area in place of “Sampled By” tag or label. The samples are delivered to the Quality Control Laboratory for testing. The sample is then covered with aluminium foil (as the suspension is light sensitive) and transferred to the QC Laboratory as soon as possible.