Drugs
President Biden has signed into law two FDA-related bills that are intended to help lower drug/biologic prices. The Advancing Education on Biosimilars Act of 2021 (S 164) requires FDA to advance education and awareness programs for health care providers on biological/biosimilar products, including by developing or improving
Biologics
FDA has removed a clinical hold against UniQure’s hemophilia B gene therapy program after determining it satisfactorily addressed all issues identified by the agency concerning a single patient diagnosed with hepatocellular carcinoma (HCC) in the HOPE-B pivotal trial, according to the company. “Our comprehensive investigation showed that AMT-
Devices
Becton, Dickinson has submitted a 510(k) for the BD Alaris System that updates the infusion pump to address FDA regulatory issues (see earlier story) raised last year. The device, which the company says is used on about 70% of patients undergoing infusion therapy, has been hampered by a recent
Drugs
The House Energy and Commerce Health Subcommittee has announced a 5/4 hearing to discuss legislative proposals to lower prescription drug costs. Focal point of the hearing will be the Elijah E. Cummings Lower Drug Costs Now Act, a bill to require HHS to negotiate maximum prices for: (1) insulin
Drugs
FDA has announced a 6/9 workshop entitled “The Nonprescription Drug Facts Label in a Changing Consumer Marketplace 2021” that will evaluate data and information currently available on consumer comprehension of the nonprescription Drug Facts Label (DFL) and discuss areas where improvements could be made to its format and content.
Drugs
FDA says it supports increasing use of pharmacometric models in drug development because once validated against independent empirical data they allow it to better understand drug effects in individuals and populations who were not part of the clinical trials and to explore additional real-world scenarios. “For example, a model
FDA Policy/General
Covid-19 Guidance Documents Listing 4/23/2021 Federal Register notice: FDA is updating the availability of guidance documents related to the Covid-19 public health emergency. The listing is periodically being updated as part of the agency’s transparency efforts during the health emergency. The documents have been implemented
FDA Policy/General
Pfizer has agreed to sell its global infusion therapy business to ICU Medical for $1 billion in cash and stock. Pfizer had acquired the hospital infusion system business, which has annual sales of about $1.2 billion, through its $15 billion purchase of Hospira in 2015. Boston Scientific has launched
Drugs
The International Conference for Harmonization (ICH) has released for adoption a revised guideline entitled ICH Q3C(R8) Guideline on Impurities: Guideline for Residual Solvents. The document was revised to include the permitted daily exposure levels for three solvents — 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tertiary butyl alcohol. Additionally, an introductory
Devices
FDA has approved a Roche PMA for its Ventana MMR RxDx Panel, a companion diagnostic for qualifying patients for treatment with GlaxoSmithKline’s just-approved Jemperli (dostarlimab-gxly) for advanced or recurrent endometrial cancer patients. The qualitative immunohistochemistry test is intended for use in assessing mismatch repair (MMR) proteins in
Drugs
The FTC says it will advocate for Congress to act quickly and advance legislation to strengthen its powers in the wake of a 4/22 Supreme Court decision that curtails its authority to seek monetary restitution from companies engaged in deceptive practices, such as pharmaceutical company anticompetive measures. The unanimous
Biologics
A CDC advisory committee 4/23 voted (10 to 4) to recommend that the U.S. resume vaccinations with Johnson & Johnson’s Covid-19 vaccine. Its use was paused earlier this month (see earlier story) to review safety data in the wake of rare blood clot reports. Panel members
FDA Policy/General
Federal Register notice: FDA is updating the availability of guidance documents related to the Covid-19 public health emergency. The listing is periodically being updated as part of the agency’s transparency efforts during the health emergency. The documents have been implemented without prior comment, but they remain subject to
Drugs
Federal Register notice: FDA has determined that Hospira’s sodium chloride 14.6% solution for injection (50 milliequivalent/20 milliliters) in plastic containers was not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory
Devices
FDA has granted a de novo marketing authorization for Neurolutions’ IpsiHand Upper Extremity Rehabilitation System for use in adult patients undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. The brain-computer-interface device is intended to assist in rehabilitatimg stroke patients with
Devices
Cordis has recalled (Class 1) its Precise PRO Rx Carotid System because of the potential for the distal tip to become separated from the lumen wire in specific lots. FDA says about 7,300 devices are affected, and so far seven reported complaints about the defect have been received, including
Drugs
A Texas state senator has introduced the “Truth in Medicine Act” to allow drug companies, doctors, and patients to freely discuss medical options, including potentially life-saving medications that have not been approved by FDA. Sen. Paul Bettencourt (R) told State of Reform that while providers are legally permitted to
Drugs
At an FDA/Untragenyx end-of-Phase-2 meeting for the DTX301 ornithine transcarbamylase (OTC) deficiency gene therapy program, the parties reached an agreement on the design and endpoints for a Phase 3 study. The company says the study will include a 64-week primary efficacy analysis period and enroll
FDA Policy/General
Federal Register notice: FDA is announcing a 6/9 public workshop entitled “Model Informed Drug Development Approaches for Immunogenicity Assessments.” The workshop will discuss the best practices and future directions of quantitative methods for predicting biological product immunogenicity. It is also being conducted to satisfy one of FDA’s performance
FDA Policy/General
Federal Register notice: FDA has published an updated listing of Emergency Use Authorizations (EUAs) for molecular diagnostic and antigen tests for Covid-19, excluding multi-analyte tests. The EUAs contain, among other things, conditions for their emergency use. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim — 21 CFR 101.82” (OMB Control Number 0910-0428). To view the notice, click here.
Devices
FDA has cleared a Soundbite 510(k) for the SoundBite Crossing System — Peripheral with an 0.014” Active Wire. The company says the recanalization tool is designed to help physicians’ placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions in patients suffering from heavily