Drugs
FDA has granted Pfizer a breakthrough therapy designation for tafamidis for treating patients with transthyretin cardiomyopathy, a rare and fatal condition associated with progressive heart failure. The designation was based on data from the tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study, in which the drug demonstrated a statistically significant
Drugs
FDA has accepted for review an AcelRx Pharmaceuticals NDA resubmission for Dsuvia (sufentanil sublingual tablet, 30 micrograms) for treating moderate-to-severe acute pain for adult patients in medically supervised settings. FDA has assigned a user fee review action target date of 11/3. In 10/2017, the agency issued
Biologics
FDA has accepted for review a Bio Products Laboratory supplemental BLA for Coagadex (coagulation factor X, human) for prophylactic treatment of hereditary factor X deficiency. The submission is based on data from TEN02, a Phase 3 prospective study. The primary endpoint was the investigator’s assessment of overall efficacy, “which
Drugs
The Supreme Court is refusing to hear an appeal of a 5th Circuit Court of Appeals decision to uphold summary judgment and award costs in favor of Solvay Pharmaceuticals in a False Claims Act case. Attorneys Jennifer Thomas and Andrew Hull (Hyman, Phelps & McNamara) write in their firm’s
Drugs
FDA has issued a complete response letter to Recro Pharma for the NDA on its IV meloxicam. The company reports that FDA said that although the pivotal Phase 3 trials demonstrated statistically significant outcomes on the primary endpoint, the agency is unable to approve the NDA in its current form.
Drugs
Pfizer will pay $23.85 million to resolve claims that it used a foundation to pay copays of Medicare patients taking three company drugs. A Justice Department news release on the settlement identifies the Pfizer drugs as Sutent and Inlyta, which both treat renal carcinoma, and Tikosyn, which treats arrhythmia
Drugs
A Senate Appropriations Committee 5/24 mark-up for FY 2019 has approved $2.97 billion in discretionary funding for FDA, which is $159 million (5%) over the FY 2018 enacted level, but about $150 million less than the House has approved (see earlier story). Both measures are now awaiting
Devices
FDA has cleared a Mauna Kea Technologies 510(k) for the Cellvizio 100 series F400 and F800 multidisciplinary confocal laser endomicroscopy platform for use during neurosurgical procedures. The device features CranioFlex that provides imaging of tissue internal microstructures and allows the identification of cells and vessels and their organization within
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled ‘‘Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.’’ The document is intended to assist sponsors in developing new drugs for the prophylaxis of inhalational anthrax. It finalizes a draft guidance issued on 3/2016. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments as it evaluates current thinking about the design of studies intended to generate data to support investigational new animal drugs intended for preventing heartworm disease in dogs. Specifically, public input is sought on possible alternative approaches for evaluating such products or information to
FDA Policy/General
Federal Register notice: FDA has submitted to OMB for approval an information collection extension for “Prescription Drug Marketing Act of 1987 — Administrative Procedures, Policies, and Requirements” (OMB Control Number 0910–0435). This information collection supports FDA regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA). The PDMA is intended
Drugs
FDA has cleared a protocol amendment for Cotinga Pharmaceuticals’ ongoing clinical Phase 1b/2a trial of COTI-2. The amendment expands the trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers, the company says. Cotinga says it will initially evaluate COTI-2 combined with
Drugs
FDA has released the FDA-483 issued following a 4/11-4/26 inspection at Pine Pharmaceuticals, a Tonawanda, NY, outsourcing facility. The three observations listed on the form were: * employees engaged in the processing of a drug product lack the training required to perform their assigned functions; * procedures designed
Drugs
CDER director of nonprescription drug products Theresa Michele says that a new draft guidance on maximal usage trials (MUsT studies) will help industry design and conduct MUsT studies for topical active ingredients that are under consideration for inclusion in an OTC monograph. Writing in an FDA Voice blog post, Michele
Drugs
FDA is asking manufacturers to voluntarily withdraw from the market over-the-counter (OTC) oral health products containing the pain reliever benzocaine indicated for the temporary relief of sore gums due to teething in infants or children. If companies do not comply, the agency says in a statement, it will
Drugs
FDA has published a guidance, Anthrax: Developing Drugs for Prophylaxios of Inhalational Anthrax, to assist sponsors in developing drugs with an indication of prophylaxis to inhalational anthrax in persons who have or may have inhaled aerosolized Bacillus anthracis spores but who have not yet manifested clinical evidence of disease. The
Drugs
The U.S. Solicitor General says the Supreme Court should hear Merck’s appeal of an appeals court ruling in a failure-to-warn case involving its Fosamax. In an amicus brief, the government says the 3rd Circuit Court of Appeals erred in holding that a jury must determine whether
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Enforcement Policy — OTC Sunscreen Drug Products Marketed Without an Approved Application.” The document describes FDA’s approach to enforcement for over-the-counter (OTC) sunscreen products marketed without approved applications before a final OTC sunscreen drug monograph becomes effective. To
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance for industry entitled “Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” The document addresses FDA’s current thinking on the conduct of in vivo absorption trials for
Drugs
FDA has approved an Eli Lilly supplemental NDA for a label update for Taltz (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area. The product was first approved 3/2016 for treating adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic
Drugs
FDA has issued a complete response letter (CRL) for Cosmo Pharmaceuticals’ NDA for Methylene Blue MMX, intended as a visualization aid to increase detection of colon lesions. The company says the CRL is consistent with preliminary feedback it announced 5/9 that FDA had identified unspecified deficiencies that preclude continuation
Drugs
FDA has accepted for review a Sanofi NDA for Zynquista (sotagliflozin), an oral treatment added to insulin therapy to improve blood sugar control in adults with Type 1 diabetes. The oral dual inhibitor of SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys absorb and eliminate