The U.S. FDA inked a Dec. 20, 2022, warning letter to Righteye LLC that handed the company a list of quality system issues in dire need of redress, but the agency was more concerned about off-label promotion of the Righteye vision system as a method for evaluating the patient’s ocular tremors as a sign of Parkinson’s disease.
A lot of biosimilar sponsors and wannabes will be watching as the Humira biosimilar competition unfolds in the U.S. While the competition started Jan. 31 with the launch of Amgen Inc.’s Amjevita, the true test of the strength of the competition will come in five months when other adalimumab biosimilars, including Boehringer Ingelheim GmbH’s interchangeable, hit the market.
The ruling Communist Party of China increasingly views intellectual property (IP) through a national security lens, and generally accepted concepts of IP as a private right and respect for the rule of law don’t always apply as China prioritizes its pursuit of global technology dominance.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Modulight.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, Arugula, Ascletis, Deka, Fennec, Help, Idorsia, Loxo, Jazz, Reneo, Rise.
Computational modeling and simulation (CM&S) isn’t the new flavor of the month in the medical device industry, but it hasn’t exactly achieved the status of a buzzword, either. However, the Medical Device Innovation Consortium (MDIC) has published a report which makes clear that these software tools are continuing to open new frontiers in device development, a trend that seems certain to continue to expand in the decades ahead as to-market costs continue to grow.
Neither the courts nor the Department of Health and Human Services (HHS) get to fill in the gaps in the law that created the 340B prescription drug discount program, the U.S. Court of Appeals for the Third Circuit said, as it struck down HHS’ interpretation that requires drug companies to provide the drug discounts to an unlimited number of contract pharmacies.
With at least six others behind it, Amgen Inc.’s Amjevita is leading a 2023 U.S. biosimilars charge to challenge the all-time biggest-selling drug, Humira (adalimumab), from Abbvie Inc. Amjevita hit the U.S. market Jan. 31, and Amgen has the biosimilar priced at two levels, both lower than Humira’s. One is a list price 55% below Humira’s list price of about $115,000 annually and the second is 5% below Humira’s list price. Boehringer Ingelheim GmbH, Sandoz Inc., Samsung Bioepis Co. Ltd./Organon & Co., Pfizer Inc., Viatris Inc. and Coherus Biosciences Inc. all have biosimilar challengers to Humira that are set to launch in July 2023, all likely to come with a lower price tag than Humira’s.
It is a “landmark moment” in the long-awaited upgrade of the management of clinical research in Europe, but the industry has given a lukewarm welcome to a mandate to submit all clinical trial applications via the EMA’s clinical trials information system, as of Jan. 31.
Alpha Biopharma Ltd. submitted an NDA in China for zorifertinib, a next-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) to treat advanced EGFR-mutated non-small-cell lung cancer with central nervous system metastases. Zorifertinib is the first EGFR-TKI to be tested in a clinical study for this patient population, according to the company.
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