Although last year’s massive U.S. launch of Humira biosimilars captured headlines, the market adoption of those competitors has been nothing to write home about, even with discounts as low as 85% off the innovator price.

Telix Pharmaceuticals Ltd. filed an NDA with the U.S. FDA for its radiopharmaceutical glioma imaging product, TLX-101-CDx (Pixclara, 18F-floretyrosine, 18F-FET), for the characterization of progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients.

During a webinar arranged by Demy-Colton, panelists discussed a wide range of potential outcomes that might occur depending on which political party ends up in power next year. From tweaks to the Inflation Reduction Act to new laws to the Federal Trade Commission's regulation of M&As, there’s potential for the government to have substantial effects on the drug development industry.

The U.S. FDA caught up with four makers of CPAP cleaning machines in the form of warning letters advising the manufacturers that the claims made for their systems fall under the definition of a regulated medical device. In two of these warning letters, the FDA said it had been in touch with the manufacturer for at least two years, indicating that the agency has been steadily working on enforcement activities in this space for some time.

Suven Life Sciences Ltd. has received IND approval from the FDA allowing it to initiate a first-in-human phase I study of SUVN-I6107, a muscarinic M1 receptor positive allosteric modulator (PAM) as a potential new treatment to address the dementia market.

Siemens Healthineers AG made a binding offer to Novartis AG, of Basel, Switzerland, to acquire its Advanced Accelerator Applications Molecular Imaging business which includes the European manufacturing and distribution network of diagnostic radiopharmaceuticals for positron emission tomography scans.

Telix Pharmaceuticals Ltd. filed an NDA with the U.S. FDA for its radiopharmaceutical glioma imaging product, TLX-101-CDx (Pixclara, 18F-floretyrosine, 18F-FET), for the characterization of progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients.

Vitestro Holding BV received CE marking for its automated blood drawing device which uses artificial intelligence, ultrasound-guided imaging and robotics to ensure accurate and secure blood collection. The device is the first of its kind to achieve CE mark and the company believes it will be transformational for health care.

While product liability litigation in the U.S. for medical devices is a matter of state law, a legal theory from 1965 seemed to hint at a uniform national standard on strict liability for medical devices.

Find Therapeutics Inc. has obtained FDA clearance of its IND application for FTX-101, a first-in-class remyelinating agent that aims to restore vision in people with chronic optic neuropathy.