If the U.S. FDA has its way, biosimilars and interchangeable biosimilars would no longer be a difference with a distinction – at least when it comes to labeling. Instead of distinguishing between the two, the agency is recommending that the labeling for both follow-ons include a “biosimilarity statement.”
Five years after Gilead Sciences Inc. gave up on momelotinib in the wake of two phase III failures in myelofibrosis, the JAK1/2 and ACVR1 inhibitor has found its way to the market in the hands of GSK plc. Branded Ojjaara, the drug gained U.S. FDA approval for use in intermediate- or high-risk myelofibrosis patients with anemia regardless of prior administration with JAK inhibitors such as Jakafi (ruxolitinib, Incyte Corp.).
Apple Inc., of Cupertino, Calif., has prevailed over Masimo Corp., in a ruling at the U.S. Court of Appeals for the Federal Circuit, an outcome that invalidated several Masimo patents for physiological monitoring. However, the two companies are not finished with each other yet as the International Trade Commission has yet to rule on a similar case that could foreclose importation of Apple devices on grounds of patent infringement.
A fluorescent imaging agent developed by Vergent Bioscience Inc. enables visualization of elusive and previously undetected tumors, a phase II study presented last week at the 2023 World Conference on Lung Cancer (WCL23) demonstrated. The ability of the tumor-targeting agent, Vgt-309, to illuminate tumors could help surgeons more precisely locate tumors, better ensure clean margins and guide care decisions. In 10% of cases, the agent revealed unknown tumors in lymph nodes, which could affect which nodes are biopsied as well as when or whether a systemic therapy is recommended.
Stimvia s.r.o. (previously Tesla Medical s.r.o.) is in the process of securing $10 million in investment in a series A financing round that will allow the company to conduct a pivotal clinical study addressing overactive bladder, using Uris, its neuromodulation system, CEO Lukas Doskocil told BioWorld.
The U.S. FDA has broken out of the summer guidance doldrums in fine form, inking a series of nine draft and final guidances in the first half of September alone. The latest bolus includes a revised version of a guidance for the breakthrough devices program and two draft guidances for devices for weight loss, giving industry plenty to mull over as the final days of fiscal year 2023 trickle away.
The U.S. FTC put brand drug companies on notice Sept. 14 when the commissioners unanimously voted, 3-0, to issue a policy statement recognizing that improperly listed patents in the FDA’s Orange Book “may constitute an unfair method of competition.”
A U.S. FDA advisory committee’s backing keeps Alnylam Pharmaceuticals Inc.’s Onpattro (patisiran) on the road to a supplemental approval in treating a rare heart disease, but it couldn’t stop the company stock from sliding. Shares (NASDAQ:ALNY) closed Sept. 14 down 8.8% at $193.06, the day after the Cardiovascular and Renal Drugs Advisory Committee voted 9-3 that patisiran’s benefits outweigh the risks in treating cardiomyopathy of transthyretin-mediated amyloidosis.
Authors of a multi-center study welcomed results from a device that works with a smartphone or tablet to capture medical images for a more detailed understanding of infected wounds. By capturing heat produced by a wound and using bacterial fluorescence, the Swift Ray 1 developed by Swift Medical Inc., may help clinicians tell the difference between inflammation and a potentially dangerous infection.
Awak Technologies Pte Ltd. raised more than $20 million in a series B round that will position the company to potentially transform the management of chronic kidney disease with its wearable and portable peritoneal dialysis (PD) device designed to enable patients with end-stage kidney disease to have dialysis on the go.
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