Drugs

FDA Approves GSK’s Hibsago for Chronic Hepatitis B

FDA has approved GlaxoSmithKline’s Hibsago (bepirovirsen) to treat chronic hepatitis B virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI therapy for at least six months, who have suppressed HBV deoxyribonucleic acid (DNA), and with hepatitis B virus (HBV) surface antigen (HBsAg) levels ≤3000 IU/ml, as determined by an FDA-authorized test. A company statement says the approval is based on Phase 3 data showing “unprecedented functional cure rates compared to standard of care.”

The application received FDA Priority Review and Breakthrough Therapy designation.

Bepirovirsen is described as an antisense oligonucleotide designed to recognize and inhibit the production of the genetic components of the hepatitis B virus that can lead to chronic disease.

FDA Warns Baxter Over GMP Issues at Injectable Drug Plant

FDA has issued a warning letter to Baxter International citing significant GMP deficiencies at its Round Lake, IL, manufacturing facility, including recurring cross-contamination involving cephalosporin antibiotics, inadequate sterile manufacturing controls, particulate contamination and failures to properly investigate sterility test results. The just-posted 9/29 Warning Letter, which followed

Senators Urge FDA to Crack Down on ‘Research Use Only’ Drugs

Sen. Jim Banks (R-IN) is leading a group of senators urging FDA to ramp up enforcement against online vendors using “for research use only” labeling to market unapproved drugs and active pharmaceutical ingredients (APIs) to consumers, citing growing concerns about counterfeit versions of Eli Lilly’s investigational weight-loss

FDA Guidance on Drug-Related Software, Labeling Requirements

FDA has finalized a guidance entitled Regulatory Considerations for Prescription Drug Use-Related Software that outlines how prescription drug manufacturers should address software applications used with their products, including when claims about the clinical benefits of such software can be included in FDA-approved drug labeling. The guidance addresses mobile

Device QMSR Fears Easing: Panel

Industry executives and FDA officials who participated in a 10/19 panel at The MedTech Conference say initial industry concerns about the new Quality Management System Regulation (QMSR) and its implementation by FDA are easing as companies get more experience with inspections under the new protocol. A Regulatory Affairs Professionals

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FDA Warns Baxter Over GMP Issues at Injectable Drug Plant

Senators Urge FDA to Crack Down on ‘Research Use Only’ Drugs

FDA Guidance on Drug-Related Software, Labeling Requirements

Device QMSR Fears Easing: Panel