Biologics
Pfizer says results from a Phase 3 trial of older adults for its respiratory syncytial virus (RSV) prefusion F vaccine candidate showed efficacy of 85.7% in participants with more severe disease primary endpoint of lower respiratory tract illness. A company statement says the vaccine was well-tolerated with no
Drugs
Last month, the U.S. Court of Appeals for the Second Circuit affirmed a lower court’s decision that a Pfizer-planned copay subsidy program for Tafamidis, indicated for treating a rare heart condition, violated the anti-kickback statute. The program would have offered financial assistance to qualifying patients (including
Devices
FDA has approved Abbott’s Proclaim Plus spinal cord stimulation system that the company says builds on its proprietary BurstDR stimulation. A company statement says the system features FlexBurst360 therapy that offers pain coverage across up to six areas of the trunk and/or limbs and enables programming that can
Biologics
BioMarin Pharmaceutical says it will resubmit by the end of September its BLA for hemophilia A gene therapy Roctavian (valoctocogene roxaparvovec) gene therapy after announcing the European Commission just granted conditional marketing authorization for the treatment. “Typically, BLA resubmissions are followed by a six-month review procedure,” BioMarin says. “However,
Biologics
FDA commissioner Robert Califf says there will not be any advisory committee meeting to review recent submissions from Pfizer/BioNTech and Moderna that seek emergency use authorizations for new Covid-19 booster vaccines. In an 8/25 Twitter post, Califf said an “extensive discussion” was held in June by the
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on FDA to identify the legal authority for rescinding breakthrough therapy designations (BTDs) as described in a draft guidance. Its comment letter also says the agency should (1) explicitly incorporate procedural details from relevant SOPPs (standard operating policies and procedures) and
Drugs
FDA has approved a Pharmacyclics supplemental NDA for Imbruvica (ibrutinib) for pediatric patients over one year of age with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. Approval was based on data from the 47-patient iMAGINE trial that measured overall response
Drugs
Attorneys Joanna Hawana and Benjamin Zegarelli (Mintz) say a recent FDA Warning Letter to Amazon.com “signals that the agency may be adding new tools to its arsenal in the perpetual fight to protect U.S. consumers from adulterated, misbranded, and potentially unsafe products. It also highlights the fact that
Biologics
The Informed Consent Action Network (ICAN) is petitioning FDA to withdraw or suspend approval for the polio vaccine IPOL for infants, toddlers, and children “until a properly controlled and properly powered double-blind trial of sufficient duration is conducted to assess the safety of this product.” The petition says the
Drugs
FDA has denied a citizen petition seeking a “freeze” on all regulatory requests from pharmaceutical and medical device companies headquartered in Russia or with majority Russian ownership due to the country’s invasion of, and war against, Ukraine. The February petition was filed by former FDA Office of Orphan Product
Devices
FDA has cleared a Surgalign Holdings 510(k) for its Cortera Spinal Fixation System. The device features a 5.5/6.0mm rod pedicle screw system that “maintains a comparatively low profile and a newly designed locking mechanism,” according to the company. Surgalign says the Cortera system will be integrated
Drugs
FDA has published three drug safety-related labeling changes affecting two drugs. Changes were approved for Novartis’ Gleevec (imatinib) in the Adverse Reactions section and Pfizer’s Rapamune (sirolimus) in the Drug Interactions and Warnings and Precautions sections.
Biologics
The House Select Subcommittee on the Coronavirus Crisis has issued its second report, documenting three instances in which Trump White House officials “executed coordinated pressure campaigns that sought to bend FDA’s coronavirus decision making to the White House’s political will.” The report documents evidence it says committee staff
FDA Policy/General
Federal Register notice: FDA is making available a revised draft guidance for industry entitled “Charging for Investigational Drugs Under an IND: Questions and Answers.” Since issuing a final guidance in 2016, FDA has received questions from stakeholders through the docket and in the form of communications with review divisions. The
FDA Policy/General
Federal Register notice: FDA has announced an 11/2-3 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. On 11/2, panel members will review and discuss CDER’s Quality Management Maturity program and its proposed rating system that will help incentivize drug manufacturers to adopt more mature quality management
Drugs
GlaxoSmithKline is asking the Supreme Court not to hear Teva’s appeal of a “skinny label” case involving the heart drug Coreg (carvedilol). In its appeal, Teva framed the question for the high court as: If a generic drug’s FDA-approved label carves out all of the language that
Drugs
Bristol Myers Squibb (BMS) says that while it appreciates the framework in an FDA draft guidance on risk management plans to mitigate the potential for drug shortages, there are some aspects of the draft that are not clear concerning execution, FDA expectations, and overall processes used to mitigate drug shortages.
Drugs
The Northern District of Illinois federal court has approved a consent decree of permanent injunction that orders Morton Grove Pharmaceuticals to stop making and distributing drugs alleged to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Under the decree, the firm decided for commercial reasons
Drugs
Woodfield Pharmaceutical (Boca Raton, FL) president Adam P. Runsdorf has pleaded guilty to drug trafficking violations in the Eastern District of Texas federal court. According to the government, Runsdorf conspired with drug traffickers in Houston, TX to distribute misbranded and counterfeit cough syrup. The company also pleaded guilty to the
FDA Policy/General
Three Harvard Medical School researchers say there are steps FDA could take to become more consistent in its use of advisory committees to increase public confidence in the agency’s regulatory processes. Writing in the New England Journal of Medicine, the researchers say advisory committees can do more than provide
Devices
FDA has updated its Web page listing enhancements to CDRH’s Electronic Medical Device Reporting (eMDR) system. The page says the agency recognizes the importance of providing early notice and predictability about potential eMDR system changes. It is adopting a yearly schedule for announcing and implementing enhancements to the eMDR
Devices
The Medical Device Information Consortium (MDIC) has launched its somatic reference samples (SRS) initiative with a pilot project to improve the validation and regulatory review process for cancer diagnostics based on next-generation sequencing (NGS). An MDIC release says the group is collaborating with FDA, the National Institute of Standards