Instead of inter partes review (IPR) being a streamlined alternative to costly patent litigation as intended, a precedential decision by the U.S. Circuit Court of Appeals for the Federal Circuit could make appeals of IPR decisions, regardless of their merits, another way to delay competition.
A China-based manufacturer of active pharmaceutical ingredients (API) suspended producing API for the U.S. market following an FDA inspection that found “significant deviations” from good manufacturing practices at the facility.
After more than a decade of industry pleading for guidance on Orange Book patent listings, the U.S. FDA is finally planning on answering that request this year. If the guidance that’s produced reflects the FTC’s position that device patents can’t be listed for combination products, it could overturn years of accepted practice and possibly hinder the development of new, more advanced drug administration technologies.
Unless there’s a last-minute meeting of the minds, it looks like any extension of the World Trade Organization’s (WTO) five-year intellectual property waiver for COVID-19 vaccines will be shelved, at least for now.
The U.S. FDA has accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan (dato-dxd) to treat adults with locally advanced or metastatic nonsquamous non-small-cell lung cancer who have received prior systemic therapy.
Roughly 35 years after early patient data suggested the potential of tumor-infiltrating lymphocytes (TIL) in cancer, Iovance Biotherapeutics Inc. received U.S. FDA approval for lifileucel, marking both the first autologous TIL cell therapy for commercial use and the first one-time cell therapy for a solid tumor cancer. Branded Amtagvi, lifileucel is cleared for use in patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor
The U.S. FDA approved eight drugs in January 2024, down from 10 approvals the previous January and also down from December’s 21 FDA greenlights. Approvals of new molecular entities also continued to decline, going from six in November to three in December, to one in the first month of 2024.
Citing national security and intellectual property (IP) concerns, a bipartisan group of U.S. lawmakers is calling on three federal departments to investigate China’s Wuxi Apptec’s ties, and that of its subsidiary, Wuxi Biologics, to the Chinese Communist Party and the country’s People’s Liberation Army.
Seeking the root causes and possible solutions to the chronic drug shortages plaguing the U.S. health care system, the FTC and Health and Human Services jointly issued a request for information regarding how group purchasing organizations and drug wholesalers may be contributing to the shortages of generic drugs.
The U.S. Court of Appeals for the Sixth Circuit made it clear that it’s the court’s purview, not a jury’s, to determine whether an expert’s testimony is “relevant and reliable” when it comes to issues such as causation. It gave that lesson Feb. 13 when it affirmed a lower court’s dismissal of multi-district litigation in which the plaintiffs claimed that Onglyza (saxagliptin) and Kombiglyze (saxagliptin/metformin hydrochloride), developed by Astrazeneca plc and Bristol Myers Squibb Co., caused their heart failure.
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