Drugs
FDA is recommending placing 7-hydroxymitragynine (7-OH) —a highly concentrated, synthetic byproduct of the kratom plant — under the Controlled Substances Act. The move marks a strategic crackdown on products the agency says are potent, addictive, and increasingly available in unregulated forms. Unlike natural kratom leaf, which is not currently
Drugs
A 1/20-1/24 FDA inspection at the Shiva Analyticals Private Limited contract testing laboratory in Hoskote, Bangaluru, Karnataka, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/23 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained
Drugs
The CDER Office of Pharmaceutical Quality has published a white paper, “Quality Management Initiatives in the Pharmaceutical Industry: An Economic Perspective,” that concludes the costs of investing in quality management initiatives are outweighed by the far-reaching economic and societal benefits. The paper says the growing momentum toward mature quality
Drugs
FDA has published a guidance, Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases — Questions and Answers, to assist sponsors in the clinical development of new antibacterial drugs to treat serious bacterial diseases, particularly those caused by antimicrobial drug-resistant organisms, in patients
Drugs
FDA has approved a PTC Therapeutics NDA for Sephience (sepiapterin), indicated for treating adult and pediatric patients with phenylketonuria (PKU), a rare inherited metabolic disorder. “The approval includes broad labeling for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients one month of age and older with sepiapterin-responsive
Drugs
Recognify Life Sciences says its Phase 2b trial of inidascamine, a drug candidate for treating cognitive impairment associated with schizophrenia (CIAS), did not meet its primary efficacy endpoint, though it did show encouraging signals of cognitive benefit and reaffirmed the drug's strong safety profile. The six-week, placebo-
Drugs
Under mounting criticism of FDA commissioner Marty Makary bypassing the agency’s advisory committee processes to address health issues under an “expert panel” process, the agency 7/28 announced an open docket to collect public input on a 7/17 panel that addressed warnings associated with hormone replacement therapies (HRT)
Drugs
FDA has issued a revised draft guidance entitled Small Volume Parenteral (SVP) Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations. The document reiterates the agency’s position on the importance of minimizing aluminum contamination and provides the rationale for setting an aluminum limit for
Drugs
Roche is reporting new data on its Alzheimer’s therapy trontinemab and its plans to begin two Phase 3 clinical trials by the end of the year. Trontinemab, delivered via Roche’s proprietary Brainshuttle technology, continues to show promising results in an ongoing Phase 1b/2a study, according to the
Drugs
FDA has extended by three months its review of a Bayer NDA for elinzanetant, a neurokinin 1 and neurokinin 3 receptor antagonist for treating moderate to severe vasomotor symptoms (hot flashes) due to menopause. The agency told the company that additional time is needed for a full review of the
Drugs
FDA and American Society of Clinical Oncology (ASCO) researchers are urging drug makers to abandon outdated drug dosing strategies that are potentially putting cancer patients at risk. Their just-posted article in the Journal of Clinical Oncology lays out a new scientific framework aimed at ensuring patients receive cancer treatments
Drugs
Edwards Lifesciences has recalled (Class 1) its OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula after receiving reports in which a 3mm to 4mm section of wire, from the wire-reinforcement coil at the cannula tip, was found to be exposed (released from the cannula body). “Since some Femoral
Drugs
FDA has issued an alert based on its ongoing investigation into the root causes of benzene contamination, calling on drug makers to evaluate their manufacturing processes, particularly where ingredients derived from hydrocarbons are used. The agency identified several components of concern, including carbomers (thickening agents), isobutane (a spray propellant), and
Drugs
FDA will give priority review to Sprout Pharmaceuticals’ sNDA for an expanded indication for its Addyi (flibanserin) to treat low sexual desire in post-menopausal women. A company statement says Addyi is currently the only FDA-approved pill to treat low sexual desire in women. Sprout says Addyi works on
Drugs
Abivax is announcing favorable topline results from two pivotal Phase 3 induction trials of its investigational oral therapy obefazimod (ABX464) in moderately to severely active ulcerative colitis (UC) patients. Both trials met their primary endpoint, demonstrating statistically significant rates of clinical remission at eight weeks with the once-daily 50
Drugs
Pennsylvania attorney general Dave Sunday says his state is expected to receive $1.28 million as its share of a $202 million settlement that 49 attorneys general reached with Gilead Sciences for running an illegal kickback scheme to promote its HIV medication. In a statement, Sunday says, “Gilead violated federal
Drugs
As FDA moves forward with efforts to reauthorize the Prescription Drug User Fee Act, the Center for Science in the Public Interest (CSPI) asks the agency to consider that congressional appropriations should be the primary source of its funding. In its 7/17 comment letter, CSPI says it supports an
Drugs
FDA says up to five drug and biologic developers will be selected in the first year to participate in the Commissioner’s National Priority Voucher pilot program. An agency statement solicits statements of interest in the pilot that will offer these benefits: * faster review times (1-2 months rather than
Drugs
Researchers from the University of Pennsylvania and the University of Southern California say that members of the FDA Oncology Drugs Advisory Committee (ODAC) reported that very few questions posed by the agency for committee votes were difficult to answer. Writing in JAMA Network Open, the researchers say there has been
Drugs
The CDER Center for Clinical Trial Innovation has published a white paper, “Selective Safety Data Collection,” which is defined as the planned reduction in the collection of certain types of data in a clinical investigation for drugs with a well-characterized safety profile. The document describes the FDA 2016 guidance
Drugs
Apnimed is announcing positive topline results from its second pivotal Phase 3 trial of AD109 (aroxybutynin and atomoxetine), a once-daily oral pill for treating obstructive sleep apnea (OSA). The company says the LunAIRo study met its primary endpoint, reinforcing earlier findings from the SynAIRgy trial, moving it one step
Drugs
The Congressional Budget Office (CBO) says a nine-month increase in FDA review times for NDAs would reduce the number of FDA-approved drugs in the first year following the increase. The CBO analysis was in response to a request from Democratic leaders of four House and Senate committees with