The latest headlines across every section, pulled from official and open-access sources.
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry — Blaine Labs Inc · Class II · Ongoing · 5,801 bottles
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry — Blaine Labs Inc · Class II · Ongoing · 1,500 bottles
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp — Blaine Labs Inc · Class I · Ongoing · 1,171 - 1 oz bottles
Failed Impurities/Degradation Specifications — SUN PHARMACEUTICAL INDUSTRIES INC · Class III · Ongoing · 9,048 bottles
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry — Blaine Labs Inc · Class II · Ongoing · 144 bottles
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated — Blaine Labs Inc · Class II · Ongoing · 5,555 bottles and tubes
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry — Blaine Labs Inc · Class II · Ongoing · 26,475 bottles
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated — Blaine Labs Inc · Class II · Ongoing · 519 - 1 oz bottles
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry — Blaine Labs Inc · Class II · Ongoing · 22,143 bottles
undeclared colors (yellow#5) — Le Chef Bakery · Class II · Ongoing · 2595 units
Elevated coliforms — Wells Enterprises, Inc. · Class II · Terminated · 195 cases
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing. — Lupin Pharmaceuticals Inc. · Class II · Ongoing · 64,894 units
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment. — McKesson · Class II · Ongoing · 74 units
Millions of people are facing physical, emotional and financial toll of cancer, a disease that claims more than 26 000 lives every day, according to a report released today by the World Health Organization (WHO). With an estimated 20.6 million new cases and close to 10 million deaths annually, cancer remains the second leading cause of death globally, after cardiovascular disease.
Prime Medicine has come out ahead in its patent dispute with fellow gene-editing biotech Beam Therapeutics, after a panel of adjudicators ruled that the company did not violate its agreement with Beam and can continue developing its lead asset for alpha-1 antitrypsin deficiency.
The Parliamentary Under-Secretary of State writes to the chair of the Food Standards Agency to confirm agreed economic growth goals.
Goals agreed with the Food Standards Agency to clarify how their actions should support economic growth.
Goals agreed with the National Institute for Health and Care Excellence to clarify how their actions should support economic growth.
Goals agreed with the Medicines and Healthcare products Regulatory Agency to clarify how their actions should support economic growth.
The head of the NHS has today issued a stark warning to staff that they face the sack or even prison if they access patient records without a legitimate reason, as part of a new crackdown by the health service. Sir Jim Mackey today said that staff looking at medical records for personal reasons or out of curiosity was “wholly unacceptable, […]
As with any medicinal product, the MHRA will keep the safety and effectiveness of nerandomilast under close review.
For submitting clinical samples to the meningococcal reference unit (MRU).
List of available tests for meningococcal disease, what specimens to send and turnaround times.
Satellos Bioscience has shared evidence that its Duchenne muscular dystrophy drug candidate is active in adults, leading analysts to predict the molecule “could re-imagine the ... therapeutic landscape” if the biotech replicates the data in children.