Building on its partnership with the World Health Organization (WHO) to improve access in Sub-Saharan Africa to vaccines, drugs and medical technologies, the EU committed at least €24.5 million (nearly US$27 million) to fund projects aimed at tackling some of the barriers to that access.
Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA. The pair sought approval of a BLA for sintilimab plus pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small-cell lung cancer (NSCLC) but found near-unanimous opposition from FDA advisers dissatisfied with China-only trial data submitted in support of the application. The medicine is already approved for multiple indications in China, where it’s marketed as Tyvyt.
The U.S. FDA has approved Novartis AG’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) for treating adults with metastatic prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. The treatment is the indication’s first FDA-approved targeted radioligand therapy that contains a radioisotope.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Emmaus, Moberg, Morphosys, Novavax, Phanes, Secura, Silence, TC, Xcovery.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Artio Medical, Cerus Endovascular, SIS Medical.
The FDA cleared a peripheral vascular occlusion product developed by Artio Medical Inc. The Solus Gold embolization device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
Patent law cases are known for lengthy, intricate arguments and explanations, but a recent decision by the U.S. Court of Appeals for the Federal Circuit flew against this trend.
Broncus Holding Corp.’s thermal vapor treatment system Intervapor has won approval from China’s NMPA. The system is used for the treatment of chronic obstructive pulmonary disease (COPD), lung cancer and other pulmonary diseases.
Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated.
The U.S. FDA has finally unveiled the fifth edition of the device user fee program (MDUFA V), and some of the performance measures remain unchanged from MDUFA IV, such as that the FDA will process 95% of 510(k) filings within 90 days.
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