Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy as monotherapy for treating patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or
Drugs
FDA’s Office of New Drugs has denied a Lexicon Pharmaceuticals appeal of a March Complete Response Letter on its NDA for Zynquista (sotagliflozin), a dual SGLT1 and SGLT2 inhibitor for adults with Type 1 diabetes in combination with insulin. Without disclosing FDA’s concerns, the company says the agency
Drugs
FDA has posted a final guidance entitled “Adaptive Designs for Clinical Trials of Drugs and Biologics.” The document provides recommendations on the appropriate use of adaptive designs for clinical trials to provide evidence of a drug or biologic’s effectiveness and safety. It describes principles for designing, conducting, and reporting
Drugs
FDA says that most recent, interim post-approval study (PAS) results for the Impella RP System continue to show the survival rate for the subgroup of PAS patients who would have met the enrollment criteria for the premarket clinical studies (72.7%, 16 out of 22 patients) is similar to
Drugs
Attorney Joanna Hawana (Mintz) says in an online post that three FDA 11/15 public announcements give the first definitive statements about how the agency intends to apply its existing authorities to cannabidiol and other unapproved cannabis-derived ingredients. The announcements were: * a media statement on Warning Letters issued to
Drugs
FDA has denied without comment a 7/1 US WorldMeds petition asking that the agency: * require any ANDA referencing the company’s Apokyn (apomorphine hydrochloride) injection to seek approval of both the drug and medical device constituent parts of Apokyn; and * establish a policy framework clarifying the circumstances, if any,
Drugs
Evofem Biosciences has resubmitted its NDA for Amphora (L-lactic acid, citric acid and potassium bitartrate), a multipurpose vaginal pH regulator for preventing pregnancy. The submission includes full results from the Phase 3 AMPOWER study, a confirmatory single-arm, open-label Phase 3 trial evaluating the safety and efficacy of
Drugs
The Justice Department says that Heather Alfonso, who worked as an advanced practice registered nurse in a Connecticut pain management center, has been sentenced by a Connecticut federal judge to three years of probation for engaging in a kickback scheme related to fentanyl spray prescriptions. A department statement says that
Drugs
A 3/12-3/22 FDA inspection at the Lohxa drug manufacturing facility in Worcester, MA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 9/10 Warning Letter says specific violations were: * failing to establish and follow an adequate written testing program
Drugs
CymaBay Therapeutics has terminated a Phase 2b study of seladelpar in subjects with non-alcoholic steatohepatitis and its recently initiated Phase 2 study of seladelpar in subjects with primary sclerosing cholangitis due to safety concerns. In addition, the company is putting on hold all studies of seladelpar in subjects with
Drugs
Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) have released their ideas for Cures 2.0 legislation to update the 21st Century Cures Act. Upton and DeGette say (contains link to Cures 2.0 document) they are looking for feedback on their proposal and new ideas to consider
Drugs
University of Tokyo researchers say the quality of adverse event reports submitted to FDA seems to depend on information costs accrued to potential reporters. They found that the completeness of reports from consumers was generally greater than that of reports from healthcare professionals. “Completeness of specific items varied among different
Drugs
Teva and other generic drug companies have held talks with the federal government over the last six months in an attempt to resolve a long-running criminal antitrust investigation into alleged price-fixing. Bloomberg News reports it has learned from sources familiar with the matter that among the possible outcomes
Drugs
Spherix Global Insights says that approval of a new indication for Janssen’s Invokana, a sodium-glucose co-transporter 2 inhibitor, could lead to a paradigm shift in the way patients with Type 2 diabetes and chronic kidney disease are treated in the future. Invokana was approved to treat Type
Drugs
FDA has issued a draft guidance on “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” The document is intended to clarify what data and information may or may not be needed to support a biosimilarity or interchangeability demonstration for a proposed insulin product. The draft also reflects input from
Drugs
FDA has issued Adamis Pharmaceuticals a complete response letter on its NDA for Adamis’ ZimHi (naloxone) high-dose injection for treating opioid overdose. The letter cited Chemistry, Manufacturing and Controls (CMC) information, the company says, adding that it plans to expand on CMC testing that has already been provided to
Drugs
CDER Office of Prescription Drug Promotion (OPDP) has sent Rockwell Medical an untitled letter after reviewing the company’s Triferic Web page and finding false and misleading information. The page is violative because it presents information about Triferic’s benefits but fails to include any risk information about the drug,
Drugs
FDA has accepted for priority review an Intercept Pharmaceuticals NDA for obeticholic acid (OCA) seeking accelerated approval for treating fibrosis due to nonalcoholic steatohepatitis (NASH). “If approved, OCA would be the first available therapy for patients with fibrosis due to NASH, a condition that is expected to become the leading
Drugs
U.S. Justice Department has announced that a foundation based in Orlando, FL has agreed to pay $4 million to resolve allegations that it violated the False Claims Act by enabling certain pharmaceutical companies to pay kickbacks to Medicare patients taking the companies’ drugs. The Assistance Fund (TAF) conspired with
Drugs
FDA has accepted for review an Endo International BLA for collagenase clostridium histolyticum (CCH) for treating cellulite in the buttocks. The submission is based on data from two identical Phase 3 RELEASE studies that demonstrated a greater percentage of the 843 women treated during the studies met the primary endpoint
Drugs
President Trump has signed a short-term continuing resolution that funds FDA and other agencies at FY 2019 funding rates through 12/20. For now, a government shutdown was averted and more time is available to advance pending spending bills. As previously discussed, the Alliance for a Stronger FDA has
Drugs
FDA has approved a SK Life Science NDA for Xcopri (cenobamate tablets) for treating partial-onset seizures in adults. Approval was based on data from two randomized, double-blind, placebo-controlled studies that enrolled 655 adults. “In these studies, patients had partial-onset seizures with or without secondary generalization for