Generic manufacturer Impax Laboratories agreed to pay $35 million to settle pay-for-delay lawsuits brought by a class of direct purchasers of the acne medication Solodyn (minocycline), sold by Medicis Pharmaceutical,…
The FDA’s approvals of generic drugs picked up slightly in February after January’s steep dropoff, while overall ANDA submissions dropped sharply, according to the agency’s latest monthly report. Source: Drug…
A Louisiana federal judge managing the tide of lawsuits against the blood thinner Xarelto (rivaroxaban) ordered them to be prepared for trial in individual federal courts nationwide, with selection and…
The FDA issued Nan San Pharmaceutical a warning letter for significant violations of CGMPs, including a failure to test product batches and inadequately labeling of product expiration dates. Source: Drug…
The FDA should revise its draft guidance on ANDA submissions to clarify sponsors’ responsibility for reviewing existing guidances on generics, stakeholders said in comments to the agency. Source: Drug Industry…
The EMA’s Pharmacovigilance Risk Assessment Committee recommended contraindicating the use of Zytiga (abiraterone acetate) with Xofigo (radium-223 dichloride) and prednisone/prednisolone, after preliminary clinical trial results showed the combination posed an…
Most oncology treatments that received the FDA’s accelerated approval pathway in the past 25 years have demonstrated a clinical benefit, according to a review by agency officials published in the…
A Gastrointestinal Drugs Advisory Committee panel voted unanimously in favor of including a 16-week induction dosing regimen of 10mg Xeljanz (tofacitinib) twice daily in patients who have not reached “adequate…
Switching from a reference medicine to a biosimilar does not affect patient safety, according to a data review by a research team that looked at 90 studies involving 14,225 subjects…
The FDA plans to make tools available to provide incentives for doctors or physician groups to collaborate on stem-cell and regenerative medicine products, eventually leading to a biologics license for…