Drugs
A 3/9-3/12 FDA inspection at the Calvin Scott and Company drug manufacturing facility in Albuquerque, NM, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/25 Warning Letter says specific violations were: * failing to assure that the drug product bore an
Drugs
FDA has made availabile a revised draft guidance on Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing. The document is intended to assist sponsors in designing and analyzing drug studies that assess the influence of impaired renal function on pharmacokinetics and pharmacodynamics, and
Drugs
Duke University School of Medicine dermatology professor Meenal Kheterpal is asking FDA to resolve inconsistencies in labeling through class labeling for all currently approved anticancer hedgehog inhibitors. The petition says that all approved hedgehog inhibitors have the same method of action and have comparable safety data supporting their approvals. “As
Drugs
FDA has approved an Athena Bioscience NDA for Qdolo (tramadol hydrochloride) oral solution 5mg/1ml, an opioid agonist indicated in adults for managing pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Tramadol in solid oral dosage forms has been marketed widely for over
Drugs
Natco Pharma says it opposes a 4/28 petition filed by Taiho Oncology asking that FDA take specified actions on an ANDA for a generic version of Lonsurf (trifluridine/tipiracil) tablets. The Taiho petition asked that the agency: * refrain from filing or approving an ANDA for Lonsurf tablets that does
Drugs
FDA says that a clinical study shows that Genentech’s Tecentriq (atezolizumab) in combination with paclitaxel does not work to treat patients with previously untreated inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC). An agency statement says Tecentriq in combination with Abraxane is not approved for use in
Drugs
FDA has approved a Genentech NDA for Gavreto (pralsetinib) for treating adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and
Drugs
FDA has granted Project ALS an orphan drug designation for prosetin and its use in treating amyotrophic lateral sclerosis (ALS). The organization describes prosetin as an oral, brain penetrant MAP4 kinase inhibitor developed by scientists at Columbia University. Project ALS says it funded prosetin’s preclinical development and is sponsoring
Drugs
Amylyx Pharmaceuticals announces clinical trial results published in the New England Journal of Medicine (NEJM) for amyotrophic lateral sclerosis (ALS) investigational drug AMX0035 showed a “clinically meaningful and statistically significant treatment benefit on the Revised ALS Functional Rating Scale (ALSFRS-R), the most commonly used scale in clinics worldwide to
Drugs
FDA says CDER’s use of multiple sophisticated testing methods enabled it to determine that only eight of 16 metformin products that were reported by a private laboratory as containing levels of N-nitrosodimethylamine (NDMA) above allowable intake levels contained higher levels of NDMA. The Center then ordered the recall
Drugs
FDA has issued a draft guidance, Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing, to assist sponsors in the design and analysis of studies assessing the influence of impaired renal function on pharmacokinetics and/or pharmacodynamics of an investigational drug. The document also
Drugs
Some 20 senators, led by Ted Cruz (R-TX), are asking FDA to classify the “abortion pill” Mifeprex (mifepristone) and its generic as an “imminent hazard to the public health” that “poses a significant threat of danger” and remove it from the U.S. market. In a 9/1 letter
Drugs
FDA has accepted for priority review an Athenex NDA for oral paclitaxel and encequidar for treating metastatic breast cancer. The submission is supported by data from a single pivotal Phase 3 study. The company previously reported that the study achieved its primary endpoint by showing statistically significant improvement in overall
Drugs
FDA has granted Alphamab Oncology an orphan drug designation for KN046, a recombinant humanized antibody for treating thymic epithelial tumors. The thoracic tumors, mostly thymomas and thymic carcinoma, are inoperable and the metastatic ones have very poor prognoses, according to the company. Thymic epithelial tumor cells highly express PD-L1,
Drugs
Aerospace engineer Robert Zubrin says FDA is a “federal bureaucracy gone mad” that stifles drug innovations and should face significant cutbacks in its regulatory authority. In a National Review article that was picked up by Yahoo News, Zubrin says he started looking into the agency because FDA was blocking businesses
Drugs
FDA commissioner Stephen Hahn has ousted associate commissioner for external affairs John Wagner, a political appointee in his post for about two months, as part of the purge to right the ship in the wake of Hahn’s missteps in exaggerating convalescent plasma’s Covid-19 use (see earlier story)
Drugs
An NIH Covid-19 treatment guideline panel has refuted FDA’s recent decision to grant an Emergency Use Authorization (EUA) for convalescent plasma for treating of hospitalized patients with Covid-19. The panel 9/1 reviewed available evidence from published and unpublished data on convalescent plasma, including the FDA analyses
Drugs
Mylan has recalled four lots of amiodarone HCl injection, USP 450 mg/9 mL, and tranexamic acid injection, USP 1000 mg/10 mL due to potential labeling mix-ups between the lots. The individual vials contained within the cartons are accurately labeled as amiodarone HCl or tranexamic acid, a recall
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should clarify that patents claiming the device constituent of a drug-device combination product approved in an NDA or a component thereof are drug product patents subject to Orange Book listing requirements. PhRMA states its position in its response to an
Drugs
FDA has denied two of three issues raised in a 1/14/2013 petition filed by the law firm of Kleinfeld, Kaplan and Becker. The petition asked that the agency (1) reconsider and rescind the 5/16/2012 510(k) clearance for the GeNOsyl MV-1000; (2) require NDA approval
Drugs
President Donald J. Trump said 9/1 he would be meeting later this week with drug company representatives to discuss his recent executive order that would, among other things, require Medicare to tie prices it pays for drugs to those paid by other countries. Reuters reports that a spokesperson for
Drugs
A 2/24-2/28 FDA inspection at the Mylan drug manufacturing facility in Sangareddy District, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). An 8/20 Warning Letter says specific deviations were: * failing to have adequate cleaning procedures to prevent contamination or