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Comments from AstraZeneca, Pfizer, Johnson & Johnson and Certara on the FDA’s draft guidance on developing peptide drugs focused on ways to categorize peptides and the potential for the drugs to cause an immune response. Read More
The FTC announced on Monday its intention to block Sanofi’s proposed acquisition of an exclusive license to Maze Therapeutics’ therapy in development for treatment of Pompe disease and hours later Sanofi announced that it was cancelling the deal. Read More
AdvaMed announced the establishment of a new medical imaging technology division that will advocate on behalf of large and small devicemakers, and is establishing itself as the new home for advocacy, supplanting the Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association. Read More
Getinge’s recall of its Cardiohelp for problems with its emergency drive has been identified by the FDA as a Class I recall — the most serious type of recall as use of these devices may cause serious injuries or death. Read More
Eight of 10 high-cost drugs — with increases that totaled $1.27 billion — had substantial price increases in 2022 that were not supported by new clinical evidence, a new report shows. Read More
Teva Pharmaceuticals has asked a Colorado federal judge to keep alive its lawsuit challenging the state’s epinephrine auto-injector (epi-pen) affordability program as unconstitutional, arguing that suing in state court for compensation is not reasonable under the circumstances. Read More
HHS’s fall unified agenda of proposed rules for the FDA includes a new rule that revokes two old rules that have either been superseded or do not reflect current agency practice, the agenda says. Read More
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
A survey conducted among attendees of Team NB’s second in vitro device regulation (IVDR) training seminar reflected the worrisome trend of foot-dragging among manufacturers in making an application to a Notified Body for approval of devices under the new EU medical device regulations. Read More
Angering drugmakers, the Biden Administration announced Thursday that it’s supporting a previously unused, obscure and controversial regulatory authority called “march-in” rights to achieve lower prices on taxpayer-funded drugs deemed too expensive for consumers. Read More
Over the past week, the FDA issued final guidance on verification systems for certain prescription drugs under the Drug Supply Chain Security Act and draft guidances on the interim policy on compounding using bulk drug substances under Section 503A and 503B of the FD&C Act. Read More
In this edition of Quick Notes, we review recent FDA drug approvals of Jaypirca for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma, Ogsiveo for desmoid tumors who require systemic treatment, Fabhalta an oral monotherapy for the treatment of PNH and a priority review voucher award for Genzyme. Read More