FDA Policy/General
Federal Register notice: FDA has determined that Cephalon’s Trisenox (arsenic trioxide) injection, 1mg/mL, was not withdrawn for safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Trisenox is indicated in
Devices
FDA has published a draft guidance, Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions, that, when finalized, will provide detailed recommendations for manufacturers on the information that should be included in PMA, HDE, and 510(k) submissions, IDE applications, and de novo requests for medical devices that include
Drugs
FDA has issued a draft guidance, Bispecific Antibody Development Program, to assist industry and other parties involved in the development of bispecific antibodies. The document covers general considerations and recommendations for bispecific antibody development programs, as well as regulatory, quality, nonclinical, and clinical considerations in the context of bispecific antibody
Devices
FDA has published a draft guidance, Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol, to give the agency’s current thinking on technical considerations specific to devices using nitinol, a commonly used material in the medical device industry. The document says that medical device manufacturers have used
Drugs
Friends of Cancer Research chairperson Ellen Sigal says a recent White House memo requiring Office of Management and Budget (OMB) review of all non-binding guidance documents from all federal agencies “potentially threatens the future of many scientific innovations that could save patients’ lives.” Writing in an op-ed in
Drugs
Mustang Bio has reported positive data from a Phase 1/2 clinical trial of a lentiviral gene therapy for treating newly diagnosed infants under two years old with XSCID, also referred to as SCID-X1 and commonly known as “bubble boy disease.” Under a licensing agreement with St. Jude Children’
Devices
FDA has cleared a RMS Medical Products 510(k) for its High-Flo Super26 Subcutaneous Needle Sets, indicated for subcutaneous infusion of medications in home, hospital, or ambulatory settings to facilitate high flow rates, including human plasma-derived immunoglobulins. The product will be offered as a single-needle set, as
Drugs
FDA researchers have reported for the first time a link between the abnormal chemical environment of sickle cell disease red blood cells and destruction of a highly reactive form of sickle cell hemoglobin by a cellular structure called the proteasome. Writing in JCI Insight, the researchers say they also have
Drugs
FDA has granted Viela Bio a breakthrough therapy designation for the company’s anti-CD19 monoclonal antibody inebilizumab, an investigational monotherapy for neuromyelitis optica spectrum disorder (NMOSD), a rare, life-threatening autoimmune disease affecting the central nervous system. The designation is based on data from the N-MOmentum study that
Drugs
Corbus Pharmaceuticals says that after a meeting with FDA staff, it will change the primary efficacy endpoint of the ongoing RESOLVE-1 Phase 3 trial of its investigational drug lenabasum for systemic sclerosis in the U.S. The company says the primary endpoint is being changed from change in modified
Drugs
The Supreme Court may decide at a 4/26 conference whether to hear arguments in a case involving adequacy of warnings of adult suicidality for a generic form of GlaxoSmithKline’s Paxil (paroxetine). The Cook County Reporter says the case was brought by the widow of a Chicago attorney who
Drugs
FDA has approved an Akorn ANDA for an over-the-counter version of GlaxoSmithKline’s Flonase (fluticasone propionate) nasal spray USP, 50 mcg per spray, indicated for the temporary relief of hay fever and other upper respiratory allergies in adult and pediatric patients four years of age and older. Akorn
FDA Policy/General
FDA has launched a new tool to alert the public when it becomes aware of ingredients that appear to be unlawfully marketed in dietary supplements — the online Dietary Supplement Ingredient Advisory List. The listing is intended to tell industry to avoid making or selling dietary supplements containing ingredients on the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for its “Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926” (OMB Control Number 0910-0814). To view the notice, click here.
Drugs
Federal Register notice: FDA has announced a 6/12 public workshop entitled “Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities.” Mandated by the current user fee agreement, the workshop is intended to discuss challenges and opportunities (XXX DELETE XXX)in drug development and regulatory review.
Drugs
National Institutes of Health (NIH) director Francis Collins says a study funded by NIH that gathered survey data from over 27,000 people over a six-year period found that individuals who reported taking dietary supplements had about the same risk of dying as those who got their nutrients through
Biologics
CBER director Peter Marks says one of the highlights for FY 2018 was approval of two gene therapies and three vaccines. The Center’s annual report from the director says the gene therapies were Luxturna, the first directly-administered gene therapy for a specific genetic disorder (an inherited retinal disease)
Drugs
With immunotherapeutics accounting for 21% of FDA’s oncology drug approvals in 2018, Oncology Center of Excellence director Richard Pazdur convened executives from six drug companies at an American Association for Cancer Research (AACR) annual meeting panel to discuss whether there are too many such drugs on the market. An
Devices
FDA has granted Advanced Prenatal Therapeutics a breakthrough device designation for its Targeted Apheresis Column for Preeclampsia (TAC-PE). The device is being designed to remove disease-causing factors from a mother’s blood. The company says it is intended to treat preeclampsia, a leading cause of prematurity and maternal/
Drugs
FDA has granted Intensity Therapeutics a fast track designation for INT230-6 and its use treating patients with relapsed or metastatic triple negative breast cancer (TNBC) who have failed at least two prior lines of therapy. The company says TNBC is considered to be more aggressive and have a poorer
Drugs
Federal Register notice: FDA has announced it is withdrawing approval of 31 ANDAs from multiple applicants. The applicants notified the agency in writing that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
Drugs
Hi-Tech Pharmaceuticals, Norcross, GA, says a 4/10 FDA Warning Letter dealing with four of the company’s dietary supplements containing DMHA represents agency “bullying” attempts to “quasi ban a product by Warning Letter rather than rulemaking” and “is not the law.” The Warning Letter questions whether DMHA is