Biologics
Biogen says its Phase 2/3 XIRIUS study of cotoretigene toliparvovec (BIIB112), a gene therapy being investigated as a one-time therapy for patients with X-linked retinitis pigmentosa (XLRP), did not meet its primary endpoint. XLRP is a rare, inherited retinal disease that is associated with progressive vision loss
Drugs
Idaho attorney general Lawrence Wasden has announced that an agreement was reached between all 50 states and Indivior that requires it to pay $300 million to settle allegations that the company falsely and aggressively marketed/promoted Suboxone (buprenorphine), which resulted in improper Medicaid expenditures. Last year, Indivior pleaded guilty to
Devices
FDA has approved a Zoll Medical IDE for a randomized prospective study evaluating the use of TherOx SuperSaturated Oxygen Therapy in patients presenting with ST Elevation Myocardial Infarction (STEMI) and cardiogenic shock and treated concurrently with a mechanical circulatory support device. Patients presenting with STEMI and cardiogenic shock typically have
Drugs
The International Council for Harmonization is challenging the usefulness of two-year rat studies in a just-released Addendum to the Guideline on Testing for Carcinogenicity of Pharmaceuticals S1B(R1). The document expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled M9 Biopharmaceutics Classification System-Based Biowaivers. The document provides recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of the in vivo bioequivalence (BE) study requirement for certain drug products. It is
FDA Policy/General
Federal Register notice: FDA has announced its intent to prepare an environmental impact statement (EIS) to evaluate the potential environmental effects of revised conditions for marketing certain sunscreen products for over-the-counter use without prior approval of a new drug application. The EIS is also open to public comments,
Drugs
FDA has released its summaries from five GDUFA 3 reauthorization meetings. The summaries with discussion topics were: * March 25 – Continued clarifying discussions around shared proposals related to drug master files; FDA proposals to streamline annual reporting commitments; the role of inspections in meeting the requirements for a complete review; and
Devices
The House Energy and Commerce Committee leadership has written to HHS secretary Xavier Becerra urging that he reverse the Trump administration HHS decision to remove FDA authority to require premarket review of Covid-19 laboratory-developed tests (LDTs). The 5/11 letter says that at the time former HHS secretary
Biologics
The House Select Subcommittee on the Coronavirus Crisis will hold a hearing 5/19 that will take testimony from two Emergent BioSolutions top executives on how the company got into FDA trouble over its manufacturing of Covid-19 vaccines at its Baltimore plant. Company president Robert Kramer and executive chairman
Drugs
A Baltimore Sun op-ed column written by two students at the NYU School of Law and a Yale University physician calls on whoever is named as FDA’s new commissioner to commit to enforcing clinical trial transparency. “Doing so is simple, requires no congressional action, and will meaningfully protect
Devices
FDA is advising pacemaker and other electronic implant device wearers to keep their cell phones, smart watches and other electronic devices at least six inches away from their implants due to magnetic interference concerns. The safety advisory notes that some consumer electronic devices (cell phones, smart watches) may contain high
Drugs
FDA has approved a Heron Therapeutics NDA for Zynrelef (bupivacaine and meloxicam) extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. HTX-011is described as a dual-acting,
Devices
FDA says an Abbott (St. Jude Medical) 3/15 recall of a subset of Assurity and Endurity pacemakers is Class 1. An agency notice says Assurity and Endurity are implantable bradycardia pacemakers. The notice says the company recalled a subset of the pacemakers distributed from 4/2015 to 2/2019
Drugs
University of Connecticut Department of Pharmacy Practice head C. Michael White says FDA may have become too dependent on industry user fees and is not sufficiently funded for work not covered by those fees. In an online column at The Conversation, White traces the history of FDA funding from full
Drugs
FDA has accepted for review a Strongbridge Biopharma NDA for Recorlev (levoketoconazole) for treating endogenous Cushing's syndrome. The agency has set a user fee review action target date of 1/1/2022. The submission is based on data from the Phase 3 SONICS and LOGICS studies, which the
Drugs
The CDER Office of Surveillance and Epidemiology (OSE) 2020 annual report covers activities in the four core functions assigned to OSE — pharmacovigilance, pharmacoepidemiology, medication error prevention, and risk management. The report notes the Covid-19 pandemic poses particular challenges to OSE and it is using its full array of tools
Devices
CDRH director Jeff Shuren believes FDA will likely favor a “hybrid” inspection program going forward in the post-Covid-19 world, relying both on in-person and interactive online assessments. Speaking last week at an FDA/Xavier MedCon conference, Shuren acknowledged the pandemic’s disruption on inspecting manufacturing facilities. “We
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials. The guidance was prepared under the auspices of the International Council for Harmonization to clarify, update, and extend a 1998 guidance entitled E9 Statistical
Drugs
The Department of Justice (DoJ) says a Miami, FL, federal grand jury has indicted Jessica Palacio, Miami, on charges of conspiring to falsify clinical trial data for an asthma medication. A DoJ statement says Palacio worked as a study coordinator for Unlimited Medical Research, a Miami clinical trial firm. The
Drugs
The 2nd Circuit Court of Appeals has upheld a New York federal court’s determination that a suit accusing Pfizer of failing to adequately warn that its cholesterol drug Lipitor could cause diabetes was preempted by federal law. The appeals court summary order says the decision was based on “substantially
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled S11 Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceuticals. The document provides a “weight of evidence” approach to determine when nonclinical toxicity studies may be recommended in juvenile animals. If such studies are recommended, the guidance provides
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals. The document provides key considerations for developing a testing strategy to identify hazard and characterize reproductive risk for human pharmaceuticals. To view the notice, click here.