Mylan Pharmaceuticals' Semglee has gained FDA approval as the first interchangeable insulin, allowing the product to be substituted for glargine at pharmacies without a change in prescription. Semglee is classified as an "interchangeable biosimilar," and it is indicated for improved glycemic control in children and adults with type 1 diabetes and for adults with type 2 diabetes.
An AgencyIQ analysis found generic drug applications dropped to a monthly average of 66 submissions in the first half of this year from a high of 94 submissions per month in 2017. The number of generic drugs that received the FDA's full or tentative approval also declined to 343 and 72, respectively, in the first half of this year, compared with 361 full approvals and 92 tentative approvals in the same period last year.
The CDC's opioid prescribing guideline for chronic pain were intended to improve patient outcomes and reduce public health risks, but the guideline affected pain management in oncology and palliative care, Roger Chriss writes. "Patients and providers are hopeful the upcoming revision of the guideline will address these outcomes and improve pain care," Chriss writes.
A public alert has been issued by the FDA to warn health care professionals and patients that Oncopeptides' Pepaxto, or melphalan flufenamide, may cause early death in myeloma patients, citing data from a confirmatory trial. The agency has halted patient enrollment in all Pepaxto clinical studies and may convene a public meeting to "explore the continued marketing of Pepaxto," which received accelerated approval in February for the treatment of relapsed or refractory multiple myeloma.
Eli Lilly's baricitinib was granted expanded emergency use authorization by the FDA as a COVID-19 drug that can be administered separately from Gilead's remdesivir. The expanded authorization was based on results from a trial involving 1,525 hospitalized COVID-19 patients that showed those treated with baricitinib had a lower risk of progressing to ventilator use or death compared with patients given standard of care.
Tesomet, or tesofensine with metoprolol, was granted orphan drug status by the FDA to treat hypothalamic obesity. The designation was granted based on data from a midstage trial that showed the treatment resulted in statistically significant body weight reductions and improvements in glycemic control and waist circumference.
The supplemental biologics license application for Merck's immunotherapy Keytruda, or pembrolizumab, was approved by the FDA as a neoadjuvant therapy for early-stage, high-risk, triple-negative breast cancer in combination with chemotherapy. The drug is now approved in the US as a treatment for 30 types of cancer.
A revised manual of policies and procedures was released by the FDA's Office of Generic Drugs outlining internal procedures for handling labeling changes on generic drugs. The document "clarifies that the agreement to submit revised labeling after approval under the provisions of 505(j)(10) is a statutory requirement, now defined as a Post-Approval Labeling Requirement (PALR). As a result, the templates now reference PALR and the MAPP now includes language for a release from the PALR."
Researchers studied 816 children and found that receiving intravenous magnesium in the emergency department was linked to subsequent hospitalization among children with asthma, compared with not receiving the therapy. The findings were published in JAMA Network Open.
The White House is taking additional steps to boost the number of vaccinated Americans as a new wave of COVID-19 infections threatens areas with low vaccination rates with the mandate to require proof of vaccination from federal workers and contractors and payments of $100 for each newly vaccinated. "With freedom comes responsibility. So please exercise responsible judgment. Get vaccinated for yourself, the people you love, for your country," President Joe Biden said. Presently, the number of fully vaccinated Americans has reached 163.9 million, while the number of administered COVID-19 vaccine doses now totals 344.1 million, according to the CDC.