Drugs
FDA has released the FDA-483s issued following two 3/22-4/2/21 inspections at WuXi Biologics Co., a WuXi, Jiangsu, China, drug substance and drug product manufacturer. The first FDA-483 has these five observations: * failing to exercise appropriate controls over computer or related systems to prevent changes
Drugs
A California federal judge has sentenced the former CEO and COO of JHL Biotech for their roles in conspiring to commit trade secret theft and wire fraud. Former CEO Racho Jordanov was sentenced to 12 months and one day in prison and 36 months of supervised release, including nine months
Devices
FDA says a Celltrion USA 2/28 recall of its Celltrion DiaTrust Covid-19 Ag Rapid Test is Class 1. Some 45,500 units that were distributed between 6/2 and 12/21/21 were recalled due to a high number of false-positive reports for some tests, an agency
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Device Accessories” (OMB Control Number 0910-0823). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB and information collection revision entitled “MedWatch: The FDA Safety Information and Adverse Event Reporting Program” (OMB Control Number 0910-0291). The agency is revising the collection to include electronic submission of adverse event reports. To view the notice, click here.
Drugs
Five men have been charged by the federal government with conspiring to smuggle prescription drugs into the U.S. illegally. Two of the defendants also were charged with money laundering conspiracy and one with a single count of money laundering. A Department of Justice statement says the defendants operated two
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Considerations for the Development of Chimeric Antigen Receptor T Cell Products.” The document includes CAR T cell-specific recommendations regarding chemistry, manufacturing, and control, pharmacology and toxicology, and clinical study design. To view the notice, click here.
Drugs
FDA has lifted clinical holds on Aprea Therapeutics’ clinical trials involving eprenetapopt in combination with azacitidine in myeloid malignancy programs. In 8/2021, FDA placed holds on the company’s Phase 3 frontline Myelodysplastic Syndrome (MDS) clinical trial, a Phase 2 MDS/acute myeloid leukemia post-transplant clinical trial, and
Devices
FDA has cleared a Niramai Health Analytix 510(k) for its SMILE-100 System, a breast thermography device that is intended to help healthcare professionals review, measure and analyze thermally significant areas in the breast region. The device, which is designed to be used in the hospital, acute care settings,
Drugs
Biogen says new data show that after 128 weeks of Aduhelm (aducanumab-awwa) treatment, patients in the long-term extension phase of Phase 3 trials “continued to experience reductions in two key Alzheimer’s disease pathologies….” A company statement said the data were “meaningful findings, which further our understanding of
Drugs
Several senators and representatives say Pharmaceutical Research and Manufacturers of America (PhRMA) provided misleading information to them in response to their letter asking about high drug prices. In a statement (contains links to letters to and from PhRMA), the members of Congress say their 3/1 letter to PhRMA expressed
FDA Policy/General
Federal Register notice: FDA is announcing the fee rates under the over-the-counter (OTC) monograph drug user fee program (OMUFA) for fiscal year 2022. The fees are as follows: * OTC monograph order request Tier 1 fee: $507,021 * OTC monograph order request Tier 2 fee: $101,404 * OTC monograph
Drugs
FDA has approved an AbbVie supplemental NDA for Rinvoq (upadacitinib) for treating adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. The company says the approval marks the first indication for Rinvoq in gastroenterology and
Drugs
An 8/24-8/31/21 FDA inspection at Accu Bio-Chem Laboratories, a Glendale, CA, contract testing laboratory, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/24 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure
FDA Policy/General
Federal Register notice: FDA has issued an order to permanently debar Nayade Varona from providing services to anyone having an approved or pending drug product application. FDA bases this order on a finding that Varona was convicted of a felony (guilty plea) while employed as an assistant study coordinator at
Devices
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Agreement for Shipment of Devices for Sterilization — 21 CFR 801.150” (OMB Control Number 0910-0131). Under FDA regulations, nonsterile devices that are labeled as sterile but are in interstate transit to a facility to be sterilized
Devices
A 9/28-10/6/21 FDA inspection at the NeuroField medical device operation in Bishop, CA, found multiple violations in the firm’s manufacturing of neurostimulation and electroencephalogram signal processing devices and software products. A 2/28 Warning Letter says the firm’s devices are adulterated because the company
Biologics
FDA has published a draft guidance, Human Gene Therapy Products Incorporating Human Genome Editing, with recommendations for sponsors developing human gene therapy products incorporating genome editing of human somatic cells. Specifically, the document provides recommendations about the information that should be provided in an IND application to assess the safety
Drugs
Due to disappointing overall survival data, Merck has stopped its Phase 3 KEYLYNK-010 trial evaluating Keytruda, an anti-PD-1 therapy, in combination with Lynparza, a PARP inhibitor, for treating patients with metastatic castration-resistant prostate cancer who progressed after treatment with chemotherapy and either abiraterone acetate or enzalutamide.
Devices
FDA has classified as Class 1 a LuSys Laboratories recall of its Covid-19 antigen tests (nasal/saliva) and Covid-19 IgG/IgM antibody tests because they do not have an Emergency Use Authorization, 510(k), or PMA and therefore cannot be legally marketed and distributed in the U.S.
Drugs
FDA has published a draft guidance, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, to assist industry and academic sponsors in developing such products. The document provides CAR T cell-specific recommendations about chemistry, manufacturing, and control; pharmacology and toxicology; and clinical study design. Recommendations specific
Drugs
FDA has approved Mylan’s generic of AstraZeneca’s Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol for treating asthma in patients age 6 and older and maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. An