Drugs
An FDA advisory committee briefing document on Amylyx Pharmaceuticals’ experimental amyotrophic lateral sclerosis (ALS) therapy AMX0035 provides no ringing endorsement from agency reviewers. Although the therapy is not under consideration for accelerated approval, many FDA watchers are painting another Biogen Aduhelm-type scenario due to patient advocacy group pressure urging
FDA Policy/General
Federal Register final rule: FDA is amending the medical device regulations to update mailing address information and to reduce (from three to one) the number of copies of certain documents that need to be submitted to FDA. The rule does not impose any new regulatory requirements as it is editorial
FDA Policy/General
Federal Register final rule: FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during 10/2021, 11/2021 and 12/2021. FDA is also making available the basis of approval and environmental review documents, where applicable.
FDA Policy/General
Senator Rick Scott (R-FL) is urging FDA to fill vacant management posts at CDER and CBER because, he says, “FDA is too important an agency, and too large and complex an organization, for it to operate under temporary leadership.” In a 3/22 letter to FDA commissioner Robert Califf,
FDA Policy/General
FDA is requesting a $2.1 billion (34%) boost in its fiscal year (FY) 2023 proposed spending plan as part of President Biden’s just-released budget request. The proposed budget total would amount to $8.4 billion, which includes $3.7 billion in budget authority – an almost 10% increase
FDA Policy/General
Senate Homeland Security and Governmental Affairs Committee chairman Gary Peters (D-MI), has introduced legislation to help prevent conflicts of interest, such as the one Congress has been investigating — FDA’s consulting contracts with McKinsey & Co. on regulatory actions involving opioids while the company was also advising opioid maker
Devices
FDA has approved a Staar Surgical PMA for the EVO/EVO+ Visian Implantable Collamer Lens (ICL) for correcting myopia and myopia with astigmatism. “The EVO lens is additive, provides excellent quality of vision day and night, does not cause dry eye syndrome and is removable by a doctor,” the company
FDA Policy/General
Drug User Fee Notice Correction 3/25/2022 Federal Register notice: FDA is correcting an 8/16/2021 notice entitled “Prescription Drug User Fee Rates for Fiscal Year 2022.” The notice was published with errors, which do not have an impact on the previously published user fee rates but are
FDA Policy/General
Thermo Fisher Scientific has agreed to acquire Patheon, a pharmaceutical contract development and manufacturing organization, for $7.2 billion, which includes the assumption of about $2.0 billion in debt. WuXi AppTec has completed its acquisition of HD Biosciences, a leading biology-focused preclinical drug discovery contract research organization. HD
FDA Policy/General
DEVICES Becton, Dickinson and Co. has received FDA 510(k) clearance for a new insulin infusion set with BD FlowSmart technology, which features a unique side-ported catheter, which has been developed to improve the insulin flow and reduce the number of flow disruptions, according to the company. It adds
Drugs
FDA has amended a GlaxoSmithKline and Vir Biotechnology Emergency Use Authorization for sotrovimab, an investigational monoclonal antibody used in Covid-19 patients, because the 500mg therapy is unlikely to be effective against the Omicron BA.2 variant. The agency based its decision on the “totality of available evidence, including new
FDA Policy/General
Federal Register notice: FDA is correcting an 8/16/2021 notice entitled “Prescription Drug User Fee Rates for Fiscal Year 2022.” The notice was published with errors, which do not have an impact on the previously published user fee rates but are corrected in this notice for clarity. To view
Biologics
FDA has extended by three months its review of a Bristol-Myers Squibb supplemental BLA for Reblozyl (luspatercept-aamt) for treating anemia in adults with non-transfusion-dependent beta thalassemia. The submission was based on safety and efficacy results from the pivotal Phase 2 BEYOND study. The company says it
Drugs
Bristol-Myers Squibb (BMS) says it has resolved manufacturing constraints that led to “global supply challenges” for Abraxane (paciltaxel protein bound particles for injectable suspension). In a just-posted letter on steps it took to resolve the drug shortage, BMS says the drug product manufacturing site has now returned to
Devices
FDA has cleared a Cutera 510(k) for AviClear, a laser treatment for mild, moderate, and severe acne. “In addition to reducing existing acne, clinical trials show that future breakout episodes are shorter, less intense, and more infrequent following the AviClear procedure,” according to the company. Further, it says acne
Drugs
FDA has discouraged MEI Pharma and Kyowa Kirin from seeking accelerated approval of a BLA for zandelisib, a phosphatidylinositol-3-kinase (PI3K) inhibitor drug candidate for treating patients with B-cell malignancies, based on data from their single-arm Phase 2 TIDAL study. In a recent meeting, FDA told the
Devices
The House Oversight and Reform committee is seeking answers to what FDA regulatory enforcement actions have been sought against Medtronic’s troubled HeartWare Ventricular Assist Device (HVAD) System — a heart pump device associated with more than 20,000 patient injuries and 3,000 deaths before it was recalled 6/2021
FDA Policy/General
The Senate 3/24 passed the “Cannabidiol and Marijuana Research Expansion Act” that is intended to ensure that research on cannabidiol (CBD) and other potentially beneficial marijuana-derived substances is based on sound science while simultaneously reducing the regulatory barriers associated with conducting related research. Introduced by Sens. Chuck Grassley
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) is proposing to conduct a study entitled “Accelerated Approval Disclosures on Direct-to-Consumer (DTC) Prescription Drug Websites.” A recent OPDP analysis of DTC Web sites for accelerated approval products found that 21% contained disclosures about the accelerated approval that used language
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Secura Bio NDA for Farydak (panobinostat) capsules after the company requested the action. The company said the accelerated-approval drug, which is used in treating multiple myeloma, was not shown to be effective in a confirmatory postmarketing study because it was
Devices
CDRH director Jeffrey Shuren says he would like to see legislative changes that would give the Center greater regulatory flexibility in dealing with artificial intelligence/machine learning (AI/ML)-driven medical devices. Speaking to a 3/22 Duke Margolis Center for Health Policy Webinar on regulation, development, and real-world
Biologics
Former CBER Office of Vaccines Research and Review (OVRR) deputy director Philip Krause has joined Mesoblast’s board of directors. Mesoblast says Krause’s “biologics development and regulatory expertise that he brings will be invaluable in our ongoing FDA interactions on our lead and follow-on product candidates.” In 2020,