Drugs
Sen. Bernie Sanders (I-VT) and Rep. Elijah E. Cummings (D-MD) are urging the Justice Department to investigate 20 generic drug manufacturers for allegedly engaging in a price-fixing scheme. “It is sick and disgraceful that generic pharmaceutical executives, who should be making medicines affordable for the American people,
Drugs
FDA has granted NuCana an orphan drug designation for its investigational drug, Acelarin (NUC-1031), and its use in treating biliary tract cancer. The company describes the new chemical entity as its “ProTide transformation of gemcitabine... Our Phase 1b study of Acelarin combined with cisplatin showed an approximate doubling of
Drugs
FDA has approved an expanded use for Novo Nordisk’s Victoza (liraglutide) for improving blood sugar control in pediatric patients with Type 2 diabetes. “Victoza improves blood sugar levels by creating the same effects in the body as the glucagon-like peptide (GLP-1) receptor protein in the pancreas,” an
Drugs
FDA has revised its guidance on “ANDA Submissions — Content and Format.” The document is intended to assist applicants in preparing ANDAs and it details the information that should be provided in each section of the common technical document (CTD) format. The CTD collects quality, safety, and efficacy information into a
Drugs
Merck, Eli Lilly and Amgen have filed suit in DC federal court seeking to stop an HHS rule to include drug prices in direct-to-consumer ads. Joined by the Association of National Advertisers, the complaint contends that the rule violates the companies’ First Amendment rights, and it would mislead
Drugs
At FDA’s request, U.S. marshals have seized more than 300,000 dietary supplement containers, including tablets, capsules, and teas from Life Rising Corp. The seized goods comprised more than 500 products bearing brand names Life Rising, Holicare, or HopeStream. Northern Illinois federal court determined there was probable cause
Drugs
FDA has selected IBM, KPMG, Merck, and Walmart to participate in a pilot program to assist drug supply chain stakeholders in developing an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S. The pilot will use IBM blockchain technology that will
Drugs
As ordered by a Georgia federal court, FDA has returned to Hi-Tech Pharmaceuticals over $19 million worth of DMAA (1,3-dimethylamylamine), a food additive that FDA has said is illegal to use. The product was seized over 18 months ago as part of agency enforcement action against companies
Drugs
A Federal Circuit Appeals Court ruling in Amarin v. ITC has reaffirmed the Supreme Court’s Buckman decision that only the federal government, and not private litigants, can bring suit for noncompliance with medical device requirements. Attorneys James Beck (ReedSmith) writes online in the Drug & Device Law blog the
Drugs
Certara says its Simcyp physiologically-based pharmacokinetic (PBPK) modeling and simulation technology was used to demonstrate bioequivalence (BE) in an undisclosed complex generic drug ANDA that was approved recently. “This drug approval represents a breakthrough for the industry and will help usher in a new era in which complex generic
Drugs
A 12/17-12/22/18 FDA inspection at Glint Cosmetics, Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/31 Warning Letter. The letter also says the firm manufactures two unapproved new drugs and 12 products that are misbranded.
Drugs
FDA says Teva is expanding a recall to include seven additional lots of losartan potassium tablets, including three lots of 50 mg strength and four lots of 100 mg strength. An agency notice says the recall is due to unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)
Drugs
The European Medicines Agency (EMA) says that Luxembourg and the Netherlands have been added to the list of states in the FDA-European Union (EU) mutual recognition agreement. An EMA announcement says FDA has confirmed the ability of regulators in the two countries to carry out current good manufacturing practice
Drugs
CDER Office of Biotechnology Products director Steven Kozlowski says FDA supports United States Pharmacopeia monograph standards for small molecule drugs, but believes that a mandatory monograph for biologics “would impede innovative technologies, as well as place unnecessary burdens on industry and on FDA reviewers.” Writing in an online CDER Conversation,
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FDA has accepted for priority review a Genentech supplemental BLA for Rituxan (rituximab) for combination use with glucocorticoids for treating granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children two years of age and older. GPA and MPA are rare, potentially life-threatening diseases affecting small and medium sized
Drugs
The HHS Inspector General (IG) says that most hospitals that use non-patient-specific compounded drugs obtain them from an outsourcing facility that is registered with FDA. In fact, an IG report says, 89% of hospitals that obtained non-patient-specific compounded drugs did so from outsourcing facilities, 9% obtained
Drugs
Catalyst Pharmaceuticals is suing FDA in a Florida federal court, challenging the agency’s recent approval of Jacobus Pharmaceuticals’ Rezurgi for treating Lambert-Eaton Myasthenic Syndrome in pediatric patients. The company says its suit alleges that the approval violates multiple FDA labeling regulations, resulting in Rezurgi being misbranded. The suit
Drugs
Bloomberg News reports that a letter from a U.S. attorney describing settlement discussions with Novartis to resolve a six-year-old whistleblower suit alleging the company made illegal kickbacks to doctors to promote and use several of its drugs was accidentally made public for a short time before it
Drugs
An 11/8-11/16/18 FDA inspection at Spectrum Laboratory Products, Gardena, CA, found CGMP and other violations in the firm’s manufacturing of active pharmaceutical ingredients (API). A 6/4 Warning Letter says the CGMP violations were: * failing to transfer all quality or regulatory information received from the
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports involvement of patients, their caregivers, and advocates in the rare disease drug development process and it commends FDA for the format and construct of a 4/29 public meeting it held on the subject. The association’s letter says
Drugs
CDER Office of Medical Policy health science policy analyst Lauren Milner says a new agency draft guidance on submitting documents using real-world data (RWD) and real-world evidence (RWE) to FDA for drugs and biologics is needed because the availability of such data and evidence has created interest within
Drugs
Eli Lilly says data from its REWIND study, a cardiovascular (CV) outcomes trial involving diabetes drug Trulicity (dulaglutide), showed a significant 12% reduction in major cardiovascular events (MACE), a composite endpoint of non-fatal myocardial infarction (heart attack), non-fatal stroke or CV death. “REWIND data showed a consistent MACE