Biologics
Public Citizen says the HHS Office for Human Research Protections and the Department of Veterans Affairs should immediately suspend the Myocardia Ischemia and Transfusion (MINT) trial that is expected to involve thousands of heart attack patients in the U.S. and Canada, citing alleged serious ethical violations. In an 8/
Drugs
A 9/28/15-10/13/15 FDA inspection at Medical Center Pharmacy, Cleveland, TN, found serious deficiencies in the firm’s practices for producing sterile drug products, which put patients at risk, according to a 7/21 Warning Letter from the agency’s Office of Pharmaceutical Quality post in
Drugs
Sen. Bernie Sanders (I-VT) and Rep. Peter DeFazio (D-OR) are proposing to amend the Federal Food, Drug, and Cosmetic Act with a rule requiring federal agencies and federally funded nonprofits to secure reasonable pricing agreements from drug manufacturers before they grant the manufacturers exclusive rights to make drugs,
Drugs
Four stakeholder organizations are praising the FDA program for enhanced review transparency and communication statement of work that was negotiated as part of the Biosimilars User Fee Agreement. The Association for Accessible Medicines (formerly the Generic Pharmaceutical Association) and its Biosimilars Council say the need to provide adequate agency resources
Drugs
FDA has granted Bristol-Myers Squibb accelerated approval for Opdivo (nivolumab) for treating patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. Approval was based on data from the CHECKMATE
Drugs
FDA has approved Celgene’s Idhifa (enasidenib) for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, Abbott’s RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2
FDA Policy/General
[Analysis by Jim Dickinson] “It seems every two or three years we have another controversy in women’s health,” a 7/30 Washington Post Magazine article quotes Northwestern University health policy researcher Steven Xu as saying, about the ongoing controversy over Bayer’s permanent contraceptive device Essure. Xu co-authored
Drugs
FDA has granted AstraZeneca and MedImmune a breakthrough therapy designation for Imfinzi (durvalumab) for treating patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The designation was granted based on interim results from the Phase III PACIFIC trial,
Drugs
Amgen has submitted a supplemental BLA for Prolia (denosumab) for treating patients with glucocorticoid-induced osteoporosis. The submission is based on a Phase 3 study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment. The data showed that treatment with Prolia for 12 months
FDA Policy/General
Federal Register notice: FDA has classified as a Class 2 (special controls) medical device the oral removable palatal space occupying device for weight management or weight loss. FDA’s decision was based on a 7/2015 request for classification from Scientific Intake of its Sensor Monitored Alimentary Restriction Therapy (SMART)
FDA Policy/General
Federal Register notice: FDA has classified as a Class 2 (special controls) medical device the cranial motion measurement device. FDA’s decision is based on a 12/2014 Jan Medical request for classification of the BrainPulse Model 1100. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 9/13 public workshop on “Developing a Framework for Regulatory Use of Real-World Evidence.” Convened by the Duke-Robert J. Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the workshop is intended to bring
FDA Policy/General
Federal Register notice: FDA has announced an 11/28 public workshop entitled “Cardiac Troponin Assays” to discuss developing the innovative assays which are designed to aid in diagnosing myocardial infarction and additional clinical uses. The workshop is intended to discuss scientific and regulatory challenges associated with the analytical and clinical
Drugs
FDA safety reviewers have raised some concern with a Janssen Biotech BLA for Plivensia (sirukumab) injection going before the agency’s Arthritis Advisory Committee 8/2. The major safety findings with sirukumab were related to immunosuppression (XXX DELETE XXX)consistent with other disease-modifying anti-rheumatic drugs DMARDs, but the
Drugs
FDA’s Vaccines and Related Biological Products Advisory Committee has voted 12 to 1 to recommend approval of a Dynavax Technologies BLA for Heplisav-B [hepatitis b vaccine, recombinant (adjuvanted)] for immunization against hepatitis B infection in adults 18 years of age and older. The positive vote came despite safety
Drugs
President Trump should declare a national emergency in order to deal with the ongoing opioid crisis, according to a just-released White House commissioned interim report. A final report will be issued in this fall. Declaring a national emergency would help the administration get a handle on the crisis, according
Drugs
ICU Medical has recalled one lot of 0.9% sodium chloride injection, USP 1,000 mL due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container. “Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local
Devices
FDA has cleared an Immunalysis 510(k) for the Sefria Fentanyl Urine Enzyme Immunoassay for the qualitative detection of fentanyl in urine. The device is the first analyte utilizing Immunalysis’ proprietary Sefria technology. Previously, fentanyl immunoassay tests were only available for forensic testing, according to the company. With the clearance,
Drugs
Adjunctive Cardiovascular Status Indicator Into Class 2 Federal Register notice: FDA classifies as Class 2 the adjunctive cardiovascular status indicator (special controls). 07/28/2017 List of Difficult Drugs for Compounding Federal Register notice: FDA develops a list of drug products and categories of drug products that are difficult to
Drugs
Apace Packaging has recalled one lot of cyclobenzaprine HCl tablets, USP 5 mg 50ct unit dose, and one lot of amantadine HCl capsules, USP 100 mg 50ct unit dose. The actions were taken due to a potential mislabeling error. A small number of cartons containing cyclobenzaprine HCl may be mislabeled
Devices
FDA has approved a Bracco Diagnostics PMA for Aribar Nectar (barium sulfate) oral suspension for use in modified barium swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients with known or suspected swallowing disorders. The product is designed to provide “adequate visibility
FDA Policy/General
Federal Register notice: FDA has classified as Class 2 the adjunctive cardiovascular status indicator (special controls). The classification was based on a 5/2016 request from Flashback Technologies submitted for its CipherOx CRI Tablet. To view the notice, click here.