Archive for November 2023

The lot size doesn’t really matter when it comes to choosing a sample size for a pharmaceutical or medical device, says sampling expert Steven Walfish. Source: Drug Industry Daily

Upcoming events in the coming weeks and months include three FDA advisory committee meetings; MAGI 2024: The Clinical Research Conference; and webinars on medical device cybersecurity, overcoming common clinical trial challenges, supplier quality agreements and FDA inspections. Source: Drug Industry Daily

Continued efforts to obtain approval for a drug to treat a rare neuromuscular disorder appear in this month’s Research Roundup along with an oral anticoagulant, and treatments for peanut allergy in children and migraine. Source: Drug Industry Daily

This edition of Quick Notes highlights a major supplier’s data breach, good news for wearable defibrillator and renal denervation devices, and labeling to remind surgeons about nonapproved mesh products. Source: Drug Industry Daily

Nearly half of rare oncology drug approvals include postmarketing requirements (PMR) for drug-drug interactions (DDI), a particular concern for cancer patients who are frequently being treated for co-morbidities and palliative care. Source: Drug Industry Daily

In this edition of Quick Notes, we review recent FDA drug approvals of combination drug Truqap/Faslodex for breast cancer, DefenCath for hemodialysis patients, non-small cell lung cancer treatment Augtyro, a 38th approval for Keytruda, and an approval for Xtandi for prostate cancer. Source: Drug Industry Daily

The FTC has filed an amicus brief amid the ongoing dispute between Viatris’ Mylan and Sanofi over the latter’s patents for Lantus insulin, assailing the use of improperly listed Orange Book patents to delay generic competition. Source: Drug Industry Daily

The first systematic review using statistical methods to look at the risk of switching patients from reference biologics to a biosimilar, or the other way around, found no difference in the safety profiles or immunogenicity rates in patients who were switched and those who remained on a reference biologic or a biosimilar. Source: Drug Industry…

Reorganization of two of the FDA’s larger offices in 2024 will bring about changes in how the agency handles inspections and drug assessments. Source: Drug Industry Daily

While the FDA has a longstanding requirement that risk information must be included in television and radio prescription drug ads, the final rule the FDA just issued focuses on ways to help consumers notice, attend to, and understand the drug’s risks. Source: Drug Industry Daily