Devices
Medtronic says FDA granted an emergency use authorization for its Puritan Bennett 560 ventilator that will soon be available in the U.S. A company statement says it expects the units, currently sold in 35 countries, to be available in the U.S. in May. Also, Medtronic says it has
Drugs
FDA says it is concerned about some firms falsely claiming that their serological tests are FDA approved/authorized or that they can diagnose Covid-19. In a 4/8 notice, the agency says it will take “appropriate action” against firms making such false claims or marketing tests that are not
Drugs
FDA has granted EicOsis a Fast Track designation for its lead drug candidate, EC5026, for treating neuropathic pain. C5026 is described by the company as a first-in-class, orally administered, potent small molecule that inhibits sEH, a key regulatory enzyme involved in the metabolism of endogenous anti-inflammatory lipid
Drugs
A Hyman, Phelps & McNamara 4/6 memo summarizes the OTC Monograph Drug Review Reform provisions that were included in the Coronavirus Aid, Relief, and Economic Security Act of 2020. The memo says OTC monograph reform legislation that has been stalled in Congress for more than two years found its
Devices
Just how accurate are the Covid-19 diagnostic tests? That’s a question two House lawmakers are asking FDA to provide information on in the wake of testing failures earlier this year involving Centers for Disease Control test kits. A 4/9 letter from U.S. reps. Lloyd Doggett (D-
Devices
FDA has just released a 3/20 petition submitted by the Judge Rotenberg Educational Center, Canton, MA, asking that the agency immediately and indefinitely stay the two effective dates for its final regulation banning electrical stimulation devices used to treat self-injurious or aggressive behavior. The petition, which asked for
Biologics
Pfizer and its German partner BioNTech say they could start joint clinical trials of BioNTech’s mRNA Covid-19 vaccine program at the end of this month, assuming regulatory clearance. The trials would be held at multiple sites in the U.S. and Europe. In a statement, the companies say
Drugs
Seneca Biopharma says that discussion and feedback during a 3/10 meeting with the FDA Office of Tissues and Advanced Therapies led the company to believe that the Phase 1 and 2 trial results of its NSI-566 neural stem therapy candidate to treat patients with amyotrophic lateral sclerosis (ALS)
Drugs
Janssen says it supports policies for biologics and biosimilars that are guided by patient safety and clinical considerations and are consistent with the protection of intellectual property. In a comment on an FDA draft guidance with questions and answers on promotional labeling and advertising considerations for prescription biological reference and
Drugs
FDA has posted online updated guidance on drug compounding activities during the Covid-19 pandemic. The document explains four policy clarifications: * agency guidance for hospitals and health systems including the “one-mile radius” provision is still in draft and FDA will issue a revision; * FDA does not plan to enforce
Drugs
FDA has posted online a question-and-answer document with information on how to implement drug manufacturing and site changes as well as reporting to the application during the Covid-19 pandemic. Questions answered in the document involve: * adding or changing a facility in an application due to pandemic-related
Drugs
FDA has granted Acceleron Pharma a breakthrough therapy designation for sotatercept and its use in treating patients with pulmonary arterial hypertension (PAH). Last year, the agency granted an orphan drug designation for the therapy. Sotatercept is being developed under a licensing agreement with Bristol Myers Squibb. Acceleron says sotatercept was
Drugs
The CBER Office of Compliance and Biologics Quality says Dynamic Stem Cell Therapy, Henderson, NV, is marketing cellular products derived from adipose tissue and human umbilical cord as a treatment for many diseases and conditions, including Covid-19. A 4/1 letter says the products are regulated as drugs and
Drugs
Lannett says FDA has granted it a 6/9 Biosimilar Biological Product Development Type 2 meeting to plan “next steps“ for the clinical development of its biosimilar insulin glargine product candidate for use in treating adults with Type 2 diabetes, as well as adults and pediatric patients with Type 1
Drugs
FDA has extended by three months its review of a Roche NDA for risdiplam and its use in treating spinal muscular atrophy (SMA). The review extension was triggered by the company’s recent submission of additional data, including data from the pivotal SUNFISH Part 2 study. The new user fee
Drugs
Several former FDA executives are voicing concerns about the wisdom of the agency issuing an emergency use authorization (EUA) for the malaria drugs chloroquine phosphate and hydroxychloroquine sulfate to treat Covid-19. In a lengthy ScienceInsider post, former FDA commissioner Magaret Hamburg said she fears the agency has taken “a
Devices
The Justice Department says Pentax Medical Company will pay $43 million to resolve criminal charges based on the company’s shipment of four types of endoscopes for 18 months without FDA-cleared instructions for use and the company’s failure to file timely reports of two infractions associated with its
Drugs
FDA has approved Cipla Limited’s generic form of Merck’s Proventil HFA (albuterol sulfate) metered-dose inhaler 90 mcg/inhalation for treating or preventing bronchospasm in patients age four years and older who have reversible obstructive airway disease and for preventing exercise-induced bronchospasm in the same age group.
Devices
The development of serology tests for Covid-19 detection is of “growing importance” in CDRH’s response to the ongoing coronavirus health emergency, Center Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel said during a 4/8 virtual town hall teleconference on diagnostic tests. The tests will
Biologics
FDA says it has determined that additional safety protections are needed for any investigational use of fecal microbiota for transplantation (FMT), whether under an IND on file with the agency or FDA’s enforcement discretion policy. A 4/6 announcement about the recommended new safety steps follows a 3/12
Drugs
FDA has accepted for review a Liquidia Technologies 505(b)(2) NDA for LIQ861 (treprostinil) for treating pulmonary arterial hypertension. The inhaled dry powder formulation was designed to enhance deep-lung delivery of treprostinil through a palm-sized dry powder inhaler. The drug was developed with the company’s PRINT
Drugs
A Society of Corporate Compliance and Ethics (SCCE) online white paper points to the lack of drug and medical device supply chain resiliency as a major problem in worldwide efforts to combat the novel coronavirus. “If the nations of the world all had access to accurate and swift testing, ventilators,