STAT

OCTOBER 23, 2024

Amgen will launch its biosimilar version of a blockbuster Regeneron Pharmaceutical drug for an eye disease following a U.S. regulators in 2011. The FDA still has to make a decision on whether to officially place semaglutide on the lists. appeals court ruling in its favor , Reuters writes. Last year, the drug generated $5.89

Compounding 260

Compounding Compounding Pharmacies Biosimilars Documentation 260

FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Documentation 64

Documentation 64

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. For example: Reduced stay. Revised section 8 damages.

Biosimilars 52

Biosimilars Dosage Documentation 52

FDA Law Blog: Biosimilars

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. In contrast , the two previous withdrawals, Makena in 2023 and Avastin in 2011, took 30 months and 11 months, respectively. All in all, the new expedited procedures took about 7 months from proposal to withdrawal.

Documentation 59

Documentation Labelling Drug Development 59

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

FDA Law Blog: Biosimilars

MAY 11, 2023

No reasonable jury could have concluded that the carved-out labeling for petitioner’s generic carvedilol from 2007-2011 was itself evidence of intent to induce infringement.” Plainly, the Government brief states “The decision below is incorrect. GSK filed a supplemental brief in response to the Government’s brief.

Labelling 72

Labelling Documentation Communication 72