The FDA has released final guidance on determining requirements for changes to medical device manufacturing sites. Requirements include a 180-day premarket approval application supplement for use of a different site that has an impact to a product's safety or effectiveness and either a PMA annual report or a 30-day notice for process changes that are not directly tied to the facility change.
Amgen's Nplate, or romiplostim, has been approved by the FDA as a treatment for patients age 1 and older with immune thrombocytopenia for six months or longer who do not respond adequately to immunoglobulins, corticosteroids or splenectomy. The drug was previously approved to treat adult patients with chronic ITP.
The NIH is being urged by advocacy groups to keep the cost of an FLT 3-targeting chimeric antigen receptor T-cell therapy affordable should ElevateBio, whose managers are former or current members of health care investment firm MPM Capital, be granted an exclusive license. The groups expressed their concern through a letter sent last week to the NIH.
The UK Intellectual Property Office has awarded Co-Diagnostics a patent for its RapidProbe probe design technology. The patent is associated with tests for nucleic acid detection that boost reaction kinetics and maintain a simple continuous sequence probe design.
Spokane Produce is recalling Northwest Cuisine Creations and Fresh & Local sandwiches because they contain green leaf lettuce and foodservice lettuce filets that could be contaminated with E. coli O157:H7 bacteria. The Spokane Produce recall follows a recall by Adam Bros. Farming.
The rates of 12th-, 10th- and eighth-grade students who used e-cigarettes in the previous month rose by 10 percentage points, 7.9 percentage points and 2.6 percentage points, respectively, between 2017 and 2018, resulting in nearly 1.3 million additional teens who vaped tobacco products this year, according to a study in The New England Journal of Medicine. Researchers also found that the prevalence of marijuana vaping increased by up to 50% across all students from 2017 to 2018, but cigarette use and binge drinking among 12th-graders declined during the same period.
Novartis has withdrawn the European marketing application seeking approval for a cardiovascular risk reduction claim for ACZ885, or canakinumab. The company said it would not be able to respond to concerns in the agreed timeframe.
Supernus Pharmaceuticals received approval from the FDA to market its Oxtellar XR, or oxcarbazepine, extended-release tablets as a monotherapy for patients age 6 and older who have partial-onset seizures. The drug was previously approved as adjunctive treatment for the same indication.
A marketing application for Xarelto, or rivaroxaban, intended for use in patients who are medically ill to prevent blood clots, has been submitted to the FDA by Johnson & Johnson unit Janssen Pharmaceutical. The drug is approved by the FDA for five clotting indications.
The European Medicines Agency's Committee for Medicinal Products for Human Use has backed the approval of two of Shionogi's medications: lusutrombopag, a drug to treat severe thrombocytopenia in adult patients with chronic liver disease who require invasive operations, and Rizmoic, or naldemedine, indicated for treatment of opioid-induced constipation. The European Commission is expected to release its final decision in approximately 60 days.
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