Drugs
A Government Accountability Office (GAO) study of the federal government’s response to drug shortages says HHS should implement a mechanism to coordinate its activities related to shortages since the department says the current coordination function will end in May. The GAO report says that as of 7/31/2024,
Drugs
FDA has approved updated labeling for Idorsia’s Tryvio (aprocitentan) that eliminates the Risk Evaluation and Mitigation Strategy (REMS) requirement. A company statement says Tryvio is a dual endothelin receptor antagonist indicated for treating systemic hypertension in combination with other antihypertensives to lower blood pressure in patients who are not
FDA Policy/General
Rep. Jamie Raskin (D-MD) and other federal lawmakers from the state are asking for a meeting with FDA commissioner Martin Makary to discuss the impact of significant cuts to the agency’s workforce. The Baltimore Sun reports the lawmakers said in a letter that “entire offices were reportedly eliminated,
FDA Policy/General
In striking testimony delivered to a House Committee on Oversight and Government Reform hearing 4/9, former FDA commissioner David Kessler issued a dire warning about the future of the U.S.’s public health and scientific leadership, pointing to recent sweeping FDA staff cuts as “devastating, haphazard, thoughtless, and
Devices
FDA approved nine new or substantially changed high-risk medical devices in the first quarter of 2025, the lowest number of approvals in 10 years. The Minneapolis Star Tribune reports there were 13 such devices approved in the comparable period in 2024 and 14 in 2023. The newspaper says the
Drugs
ZyVersa Therapeutics says it is optimistic about a new regulatory development that could significantly shorten the path to approval for treatments targeting focal segmental glomerulosclerosis (FSGS), a rare and debilitating kidney disorder. FSGS affects about 40,000 people in the U.S. and is one of the leading causes of
FDA Policy/General
Former FDA acting commissioner and CDER director Janet Woodcock says the situation at FDA in the Trump administration is “like the flat earthers taking over NASA.” Speaking on 4/7 at the Biopharma Congress on a panel on “The Future of FDA: Where Do We Go From Here?”, the agency
Drugs
FDA has approved Bristol Myers Squibb’s combination of Opdivo (nivolumab) with Yervoy (ipilimumab) for treating adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The agency says it also converted the
Devices
An 11/12-12/13/2024 FDA inspection at EpiCare Acquisitions in Lawrenceville, NJ, found Quality System Regulation and other violations in the firm’s manufacturing of the EpiCare-Zenith family of laser systems. A just-released 3/21 Warning Letter says the specific violations were: * failure to establish and
Devices
Bausch + Lomb has recalled its enVista intraocular lenses (IOLs) after the company received reports of complications, which it says could not immediately be explained. “The recall is in response to an increased number of reports of toxic anterior segment syndrome, and includes all lots of enVista Aspire, enVista Aspire Toric,
Devices
Six Sidley attorneys say that a Texas federal court’s 3/31 decision throwing out FDA’s final rule on oversight of laboratory-developed tests (LDTs) relied heavily on the Supreme Court’s 2024 Loper Bright decision that eliminated the precedent of courts deferring to agency interpretations of unclear laws.
FDA Policy/General
FDA’s user fee programs — long recognized as the financial backbone of the agency’s medical product reviews and authorizations — could be in jeopardy, according to regulatory experts, as sweeping layoffs and political indifference from the Trump administration threaten their reauthorization. AgencyIQ regulatory intelligence director Alec Gaffney warned last week
Drugs
Physician Douglas R. Smith is asking FDA to severely curtail the use of the indications of opioid addiction and opioid use disorder. His just-released 2/18 petition says the agency should curtail the indications for treatment and for manufacturing. It is the second opioid-related petition Smith has submitted.
FDA Policy/General
Rhythm Pharmaceuticals is reporting “positive topline results” from the pivotal Phase 3 TRANSCEND trial evaluating setmelanotide, a melanocortin-4 receptor agonist, for treating acquired hypothalamic obesity. The company says the trial met its primary of a “statistically significant and highly clinically meaningful reduction in body mass index (BMI)” for setmelanotide
Drugs
FDA has accepted for review a Teva Pharmaceuticals supplemental BLA for Ajovy (fremanezumab-vfrm) to expand the indication to include preventing episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kg or more. The application is based on positive results from the Phase 3 SPACE
Devices
Recent staff cuts at CDRH will likely lead to “longer review times, at least in the near term,” former CDRH director Jeff Shuren said in a 4/3 Webinar on the current challenges facing the MedTech industry, clinical investigators, and regulators. The device user fee program is shaken up by
Biologics
FDA has granted Allogene Therapeutics three fast track designations for ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T cell therapy. The designations are for treating adults with: * active refractory moderate-to-severe systemic lupus erythematous (SLE); * active severe/refractory idiopathic inflammatory myopathy (IIM), specifically dermatomyositis, immune mediated
Drugs
A Senate HELP Committee hearing tentatively planned for 4/10 has been postponed because the focus of interest, HHS secretary Robert F. Kennedy Jr., reportedly could not appear this week. Sens. Bill Cassidy (R-LA) and Bernie Sanders (I-VT), chairman and ranking member of the Senate HELP Committee respectively,
FDA Policy/General
FDA has approved an Amgen supplemental BLA for Uplizna (inebilizumab-cdon) for treating adults living with immunoglobulin G4-related disease (IgG4-RD), which is described as a chronic and debilitating immune-mediated inflammatory condition that can affect and damage multiple organs. The approval is based on data from the MITIGATE
FDA Policy/General
HHS secretary Robert F. Kennedy Jr. admitted 4/3 that many mistakes were made in cuts across HHS health agencies, including FDA, this week. He told the media that in the course of making cuts, “personnel that should have not been cut were cut,” and he said some have been
FDA Policy/General
The U.S. House Committee on Oversight and Government Reform is holding a 4/9 hearing on “Restoring Trust in FDA: Rooting Out Illicit Products.” While no FDA official is invited to attend, the committee says other expert witnesses will testify on the “necessary steps to reduce inefficiencies and bureaucracy
Biologics
One day before his forced resignation took effect 4/5, CBER director Peter Marks alleged in an exclusive interview with the Wall Street Journal that HHS secretary Robert F. Kennedy Jr. not only sought generation of new FDA data to support his antivaccine narratives but also reduction of regulatory safeguards