Devices
GE HealthCare subsidiary Datex-Ohmeda is recalling (Class 1) its Giraffe OmniBed and Giraffe OmniBed CareStation to update their use instructions after receiving reports about the warmer heater doors becoming loose. “If doors become loose, a high-priority alarm goes off and canopy movement stops,” a recall notice says. “If
Drugs
UCB says its investigational Alzheimer’s drug bepranemab failed to meet its primary endpoint in the full population in the Phase 2a TOGETHER study, but slowed cognitive decline and the rate of tau accumulation in key secondary endpoints. The company says the study is investigating the safety, efficacy, and tolerability
Drugs
Verastem Oncology has completed a rolling NDA for the potential first-in-class combination of avutometinib, an oral RAF/MEK clamp, and defactinib, an oral selective FAK inhibitor, for adults with recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy. The company
Drugs
FDA has published the International Council for Harmonization’s M13A guidance, Bioequivalence for Immediate-Release Solid Oral Dosage Forms, with recommendations on conducting bioequivalence studies during both development and post-approval phases for orally administered immediate-release solid dosage forms designed to deliver drugs to the systemic circulation. The document
Drugs
Sage Therapeutics and Biogen say they will not seek an expanded use (major depressive disorder (MDD)) for postpartum depression (PPD) drug Zurzuvae (zuranolone). In 2023, FDA issued a complete response letter on an NDA seeking approval for zuranolone in the treatment of adults with MDD. “Sage and Biogen will not
Drugs
Rep. Abigail Spanberger (D-VA) is asking FDA and the Drug Enforcement Administration (DEA) to provide additional information on their work to end shortages of attention deficit hyperactivity disorder (ADHD) medications, including Adderall. A media statement says that while DEA has adjusted production quotas for certain ADHD medications and encouraged
Drugs
FDA has just posted the establishment inspection report issued following a 5/29-6/9/2023 inspection at the Boehringer Ingelheim drug manufacturing facility in Shanghai, China. The report says it covered the initial inspection of the facility and was limited to the manufacturing of a redacted drug substance and
Devices
FDA has approved the removal of an imaging contraindication on Abbott’s FreeStyle Libre 2 and 3 continuous glucose monitoring systems, and they can now be worn during common imaging procedures, such as X-rays, CT scans and MRIs. “Previously, patients had to remove their sensors during these procedures, resulting
FDA Policy/General
Federal Register notice: FDA is making available additional revised draft product-specific guidances that provide product-specific recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here.
Drugs
In advance of the 10/31 meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the Lexicon Pharmaceuticals resubmitted NDA for sotagliflozin (Zynquista), the agency released a briefing document with questions for the committee to consider. The document says Lexicon is proposing an indication for Zynquista
Devices
FDA is partnering with the Department of Veterans Affairs to test healthcare-related artificial intelligence (AI) tools. A Nextgov/FCW report says the AI testing lab “will be an asset for federal agencies and the private sector to be able to test applications of AI in a virtual lab environment
Drugs
FDA has accepted for review a PTC Therapeutics NDA resubmission for Translarna (ataluren) and its use in treating nonsense mutation Duchenne muscular dystrophy. In 2017, the agency issued a complete response letter on the original NDA, which called for effectiveness evidence from an additional adequate and well-controlled clinical trial.
Drugs
FDA has granted Prolong Pharmaceuticals a fast-track designation for PP-007 (PEGylated carboxyhemoglobin, bovine) and its use for treating acute ischemic stroke. The company says the drug has been shown to open collateral vessels, selectively deliver oxygen to hypoxic neurons, and reduce inflammation in stroke victims. PP-007 is
Drugs
FDA has accepted for review a Shanghai Henlius Biotech and Organon BLA for HLX14, an investigational biosimilar of Amgen’s Prolia/Xgeva (denosumab). The submission is based on data from head-to-head studies, including comparative quality analytical studies and two clinical studies, the companies say. In 2022, Henlius entered
Drugs
A 5/6-5/10 FDA inspection at the MedOffice Saglik Endustri Anonim Sirketi drug manufacturing facility in Torbah/Izmir, Turkey, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/23 Warning Letter says the specific violations were: * failure to have, for each batch
Drugs
FDA has released the form FDA-483 issued following a 3/15-3/25 inspection at a Novo Nordisk drug substance manufacturing site in Kalundborg Sjalland, Denmark. The eight inspection observations were: * the routine sample volume that is used to test for appropriate standards of quality and purity of the
Drugs
FDA has published a guidance, Emerging Scientific and Technical Information on Ritonavir, that sets an acceptable intake (AI) limit of 26.5 ng/day for a nitrosamine drug substance-related impurity known as NITMA (N-((2-isopropylthiazol-4-yl)methyl)-N-methylnitrous amide that may be present in some finished
Drugs
FDA has approved a Grifols BLA supplement for its plasma-protein based fibrin sealant Vistaseal for controlling surgical bleeding in pediatric patients. The product combines two plasma proteins — fibrinogen and thrombin — and is applied with Johnson & Johnson MedTech’s airless spray technology to rapidly form clots. J&J
Biologics
Abeona Therapeutics has resubmitted a BLA for prademagene zamikeracel (pz-cel), an autologous cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB). The resubmission follows an April complete response letter that requested additional information to satisfy chemistry manufacturing and controls requirements (see earlier story). “We have incorporated
Devices
FDA says the restrictions on GE Healthcare EVair compressor use that were announced in response to a company 12/29/2023 urgent medical device correction noting a potential for elevated levels of formaldehyde, based on preliminary testing, no longer apply. A 10/29 agency notice says GE determined that the
Drugs
FDA has approved Protega Pharmaceuticals’ Roxybond (oxycodone hydrochloride), an abuse-deterrent, immediate-release (IR) 10 mg tablet for managing pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The company says Roxybond is the only abuse-deterrent IR 10 mg oxycodone formulation that is
Drugs
A Canadian Health Policy Institute (CHPI) study says the U.S. won’t be able to manage healthcare costs by importing prescription drugs from Canada. CHPI CEO Brett Skinner looked at 2023 Canadian and American sales volumes for the 27 prescription drugs listed for importation in proposals submitted by Colorado