Abbott Laboratories’ diabetes unit opened the month with a two-cannon salvo – a partnership with Beta Bionics Inc. that will integrate Abbott’s Freestyle Libre 3 Plus continuous glucose monitor with the Ilet Bionic Pancreas system and the roll out of its over-the-counter Lingo CGM in the U.S.
The U.S. Court of Appeals for the Federal Circuit shot down Planmeca’s argument that expert testimony provided by Osseo was disqualified because the expert was not a PHOSITA at the time the patented articles were developed, leaving Planmeca with a negative verdict in excess of $2 million.
The dark matter of long non-coding RNA (lncRNA) is shades brighter, after the signing of two major deals between biotech pioneers and big pharma in the past week. Haya Therapeutics SA announced Sept. 4 that it has sealed a multiyear agreement with Eli Lilly and Co. to apply its lncRNA platform technology to identify targets in obesity and related metabolic disorders.
Following a bioresearch monitoring inspection, the U.S. FDA slapped Julio Flamini, a clinical investigator at the Research Center of Atlanta, with a warning letter citing a “significant” protocol violation in which a 15-year-old girl was given 10 times the maximum daily dose of an unnamed study drug for a week.
Distinguishing between contract law and patent law, the U.S. Court of Appeals for the Third Circuit ruled against a Merck KGaA subsidiary, saying Ares Trading SA is still on the hook for paying royalties to a research partner through 2027 on sales of its cancer drug Bavencio (avelumab), a PD-L1 inhibitor granted accelerated approval in 2017 as a treatment for metastatic Merkel cell carcinoma.
Athira CEO Mark Litton said the firm is “evaluating all the options” after disclosing top-line results from its phase II/III Lift-AD clinical trial of fosgonimeton (fosgo), a hepatocyte growth factor-positive modulator, in patients with mild to moderate Alzheimer’s disease (AD). Javier San Martin, chief medical officer, said the company will schedule “a conversation at the right time” with the U.S. FDA.
The dark matter of long non-coding RNA (lncRNA) is shades brighter, after the signing of two major deals between biotech pioneers and big pharma in the past week. Haya Therapeutics SA announced Sept. 4 that it has sealed a multiyear agreement with Eli Lilly and Co. to apply its lncRNA platform technology to identify targets in obesity and related metabolic disorders.
CMR Surgical Ltd. recently submitted its application to the U.S. FDA for approval for its Versius surgical system as it seeks to get more surgeons using the small, portable, robotic tool in laparoscopic procedures.
Litigation between companies in the med-tech space often revolves around patents, but the ongoing series of lawsuits between Philips Respironics Inc. and Soclean Inc. are directed toward the interaction between CPAP machines and CPAP cleaning systems.
The U.S. FDA is accused of dragging its feet on making public the devices for which it granted market access under the de novo program, and the agency recently been scrambling to bring these decision summaries to light.
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