The COVID-19 pandemic shone an unsparing light on counterfeit devices, but the FDA has previously enjoyed only limited authority to deal with those products. Thanks to legislation passed in January 2021, the agency now has authority to destroy imported counterfeit devices, including those combined with counterfeit drugs. The agency has had authority to destroy counterfeit drugs for a number of years, but that authority did not extend to counterfeit devices until passage of the Safeguarding Therapeutics Act of 2020, which was signed into law in January 2021.
PERTH, Australia – The FDA has given the green light to Telix Pharmaceuticals Ltd.’s lead radiopharmaceutical imaging agent, Illuccix, for prostate cancer. Illuccix is a kit for the preparation of gallium-68 (68Ga) prostate-specific membrane antigen (PSMA) 11 for imaging prostate cancer with positron emission tomography (PET). It targets PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells.
The FDA granted 510(k) clearance to Sky Medical Technology Ltd.’s Geko device for patients with venous insufficiency and/or ischemia. The neurostimulation device is worn at the knee and increases blood flow in lower limb soft tissue of patients. The company said it will initiate a controlled market release in partnership with U.S. clinicians in a bid to reshape venous insufficiency treatment.
China is making some advances in approving and reimbursing drugs to treat or prevent rare diseases. More than 60 rare disease drugs have been approved for marketing in China, with more than 40 of those included in the national medical insurance system, according to figures released at a national conference on rare diseases held in Beijing Dec. 18.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Edwards Lifesciences, Neuronetics, Organox.
A lead clinical trial investigator for Five Prime Therapeutics Inc.’s flagship cancer drug, bemarituzumab, is facing SEC and criminal charges related to insider trading.
Following extensive discussions with their British counterparts, the European Commission (EC) advanced proposals to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address supply concerns in Cyprus, Ireland and Malta, which historically have been dependent on drugs from the U.K.
The U.K.’s National Institute for Health and Care Excellence (NICE) will welcome a new chief executive in February. Samantha Roberts was named to succeed Gillian Leng, who is retiring after 20 years at the agency. With extensive experience in health care delivery and as a clinician, Roberts currently serves as managing director for health and care at NHS England.
The European Council reached an agreement Dec. 20 that will allow the European Health Emergency Preparedness and Response Authority to respond much more quickly to public health emergencies such as the COVID-19 pandemic by activating urgent and targeted medical countermeasures (MCMs) across the EU.
The FDA has approved Astrazeneca plc and Amgen Inc.’s first-in-class biologic, tezepelumab, for the add-on maintenance treatment of adults and children ages 12 and older with severe asthma, adding further competition to a hotly contested market. An injection marketed under the brand name Tezspire, tezepelumab inhibits the action of thymic stromal lymphopoietin (anti-TLSP). This is a signaling molecule at the top of several cascades influencing allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.
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