Drugs
FDA has granted Bracco Imaging a fast-track designation for its BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection, which is being developed for detecting areas of active bowel inflammation in patients with Crohn’s disease. BR55 is described as a novel molecular imaging ultrasound contrast agent designed to specifically target
Drugs
An FDA review of the records it requested on 3/4/2024 from Imperial Palace Commodity—Dongguan—Co., Ltd., in Dongguang, Guangdong, China, a manufacturer of over-the-counter drugs, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/27 Warning Letter says the
Drugs
New York is the latest state to publicly express interest in developing a program to import drugs from Canada. That’s the word in a Bloomberg Law “Deep Dive” into the issue of drug importation. “State leaders are reviving talk of importing prescription drugs from Canada, even as U.S.
Drugs
Kura Oncology and Kyowa Kurin say they are on track to submit a second-quarter NDA for ziftomenib, described as a highly selective once-daily oral investigational menin inhibitor indicated to treat patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). A Kura statement reports positive results from the
Drugs
Novo Nordisk says a recent Phase 2 trial of monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist, in diabetic kidney disease patients failed to meet its primary endpoint. The trial evaluated the therapy’s efficacy and safety of once-daily 10 mg and 25 mg dosing compared
Drugs
A 7/29-8/2/2024 FDA inspection at the Global Calcium drug manufacturing facility in Tamil Nadu, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 1/16 Warning Letter says the specific deviations were: * failure of the firm’s quality
Drugs
A 9/18-9/20/2024 FDA inspection of the contract testing laboratory at the Center for Instrumental Analysis of China Pharmaceutical University in Jiangsu Sheng, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 1/23 Warning Letter says specific deviations
Drugs
FDA has approved a Supernus Pharmaceuticals NDA for Onapgo (apomorphine hydrochloride) injection as the first subcutaneous apomorphine infusion device for treating motor fluctuations in adults with advanced Parkinson’s disease. The approval follows two previous complete response letters seeking additional information from the company. In 4/2024, FDA issued its
FDA Policy/General
Doctors for America, a health justice organization representing 27,000 doctors and medical students nationwide, is suing FDA, CDC, HHS, and the federal Office of Personnel Management over the removal of a broad range of health-related data and other information used by health professionals and researchers from publicly accessible
Drugs
Despite his many years of advancing vaccine skepticism, Robert F. Kennedy Jr.’s nomination to be the next HHS secretary moves one step closer to completion after the Senate Finance Committee voted 2/4 to advance it to a floor vote. The 14-13 vote followed party lines. The committee’
Drugs
Olympus is recalling (Class 1) its MAJ-891 endoscope accessory due to infection risks that may result from improper device reprocessing. Due to the risks, the company says alternatives to the MAJ-891 should be used. A recall notice says patient infections could result from exposure to a contaminated device
Drugs
A final guidance released earlier this month on communicating scientific information to healthcare professionals (HCPs) about unapproved uses of medical products emphasizes the importance of selecting appropriate source publications to share, and companies should select those that “describe scientifically sound studies and analyze and use generally accepted design and methodological
Drugs
Pfizer says it will seek full approval for current accelerated-approved Braftovi (encorafenib) in combination with cetuximab (Erbitux) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) in patients with metastatic colorectal cancer harboring a BRAF V600E mutation. The decision to seek full approval is based on positive data from the confirmatory Phase
Drugs
FDA has approved a Vertex Pharmaceuticals NDA for Journavx (suzetrigine), a groundbreaking move away from opioid pain drugs for treating moderate to severe acute pain in adults. The first-in-class drug offers a novel approach to pain relief by targeting sodium channels in the peripheral nervous system, preventing pain
Drugs
An FDA alert is advising healthcare providers about Fresenius Kabi’s Ivenix large-volume pumps and their increased chance of issuing a non-recoverable pump problem alarm. The company has identified a subset of pneumatic valves installed in some Ivenix pumps that could experience the alarm issue. The alert says
Drugs
Mercury Medical is recalling (Class 1) its Neo-Tee T-Piece resuscitator due to a small spring in the controller that may prevent the device from delivering the required pressure levels needed for effective ventilation. A malfunctioning device could reduce positive pressure, affecting a patient’s breathing support, a recall
Drugs
Senators Chuck Grassley (R-IA) and Dick Durbin (D-IL) are urging the Pharmaceutical Research and Manufacturers of America (PhRMA) to support their bipartisan Drug-price Transparency for Consumers (DTC) Act that would require price disclosures on prescription drug advertisements to “empower consumer choice and reduce patients’ bloated spending on
Drugs
Inhibikase Therapeutics says it is pausing further development of risvodetinib, a selective inhibitor of the non-receptor Abelson Tyrosine Kinases and its use in untreated Parkinson’s disease. The company says that recent data from its Phase 2 201 trial did not demonstrate an “improvement in the top hierarchical efficacy
Drugs
FDA has cleared a Roche 510(k) clearance for its cobas liat sexually transmitted infection (STI) multiplex assay panels. The company says the panels include tests for chlamydia and gonorrhea and chlamydia, gonorrhea and Mycoplasma genitalium. They enable clinicians to diagnose and differentiate between multiple STIs with a single sample.
Drugs
Three Hyman, Phelps & McNamara attorneys say the publication of FDA guidances on its new accelerated approval authorities in 12/2024 and 1/2025 provide a framework for how it plans to enforce its requirements that confirmatory trials for products receiving accelerated approval be “underway” and “conducted with due diligence.
Drugs
Merck says it is stopping early the Phase 3 HYPERION study evaluating Winrevair (sotatercept-csrk) versus placebo in recently diagnosed adults with pulmonary arterial hypertension (PAH) due to robust results already seen in other studies and a review of the Winrevair clinical program. “The decision to stop the HYPERION study
Drugs
A 7/15-8/2/2024 FDA inspection at the ProRx outsourcing facility in Exton, PA, found evidence that drug products the company produced failed to meet regulatory conditions necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the Federal Food, Drug, and