Drugs
FDA has posted Warning Letters to four companies who produce homeopathic drug products, citing them for significant GMP violations. One letter was sent to King Bio (Asheville, NC), a firm the agency issued a safety alert about 8/2018. The Warning Letter to King Bio cites flaws in manufacturing operations
Drugs
Vertex Gains Priority Review Voucher Federal Register notice: FDA awards Vertex Pharmaceutical a priority review voucher after it determined that a qualified rare pediatric disease product gained approval. 03/29/2019 Proposed Rule Seeks Improved Mammography Services Federal Register proposed rule: FDA proposes to update the mammography regulations that were
Drugs
Daiichi Sankyo says it is accelerating filing a BLA for [fam-] trastuzumab deruxtecan, an investigational HER2 targeting antibody drug conjugate in patients with HER2 positive metastatic breast cancer previously treated with ado trastuzumab emtansine (Genentech’s Kadcyla). The company says submission had been scheduled for 2020 but is now set
Drugs
FDA commissioner Scott Gottlieb, CDER director Janet Woodcock, and CBER director Peter Marks are urging drug companies to offer expanded access to patients who have been in a clinical trial after the trial ends. In a statement, the three say that sometimes drugs that have not shown benefit across the
Drugs
The Institute for Safe Medication Practices (ISMP) says an FDA safety evaluation of Acadia Pharmaceuticals’ Parkinson’s drug Nuplazid (pimavanserin) that found no “new or unexpected” risks not covered in the labeling still leaves questions about the drug’s safety and efficacy unanswered. A CNN report says ISMP does not
Drugs
FDA commissioner Scott Gottlieb believes that the most “enduring” accomplishment at the agency during his almost two-year stint is CDER’s ongoing new drug approval process reform and changing the nature of the application process to move away from a paper-based submissions. In a 3/29 sit-down
Drugs
Amarin has submitted a supplemental NDA seeking an expanded indication for Vascepa (icosapent ethyl) capsules based on data from the REDUCE-IT cardiovascular (CV) outcomes study. “The REDUCE-IT results support that approximately one fewer major cardiovascular adverse event would occur on average for every six patients treated with Vascepa
Drugs
FDA is proposing new rules as part of a multi-year effort to change the way drugs are manufactured in an attempt to improve the safety of the nation’s drug supply. Bloomberg News reports that currently FDA mostly relies on the drug industry to police itself. “That approach has
Drugs
Attorneys Lucas Przymusinski and Matt Holian (DLA Piper) say a 2nd Circuit Court of Appeals decision upholding lower court actions in multi-district litigation against Bristol-Myers Squibb and Pfizer over their anticoagulant Eliquis significantly strengthens preemption law. In an online analysis, they say the appeals court upheld lower court
Drugs
FDA has approved UCB’s Cimzia (certolizumab pegol) injection for treating adults with non-radiographic axial spondyloarthritis, with objective signs of inflammation. An agency news release says this is the first approved treatment for this condition. Cimzia’s efficacy was studied in a trial of 317 adult patients with objective
Drugs
New York attorney general Letitia James has filed what she says is the nation’s most expansive lawsuit against the manufacturers, Sackler family, and distributors of opioids for their role in the nation’s opioid epidemic. The suit, which expands an earlier complaint against Purdue Pharma, alleges that through years
Drugs
FDA commissioner Scott Gottlieb told a Senate Appropriations Committee subcommittee 3/28 that a new comparative standard is needed for approving new opioid drugs. Gottlieb made the comment during a hearing into the FDA FY 20 budget request that includes a 5.5% increase over FY 19, one of the
Drugs
FDA has granted Imbrium Therapeutics an orphan drug designation for its investigational drug EDO-S101 (tinostamustine), a potentially first-in-class alkylating deacetylase inhibiting molecule being studied in early phase clinical trials for treating T-cell prolymphocytic leukemia (T-PLL). The extremely rare and aggressive T-cell leukemia is characterized
Drugs
FDA has approved a Novartis NDA for Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Approval is based on data from a 1,651-patient clinical trial that compared Mayzent to placebo in patients
Drugs
FDA has issued a guidance, Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling, to help applicants determine the appropriate placement and content of pediatric information in human prescription drug and biological product labeling. The document says its goal is to provide recommendations to help ensure that information
Drugs
The FDA Oncology Center of Excellence (OCE) 2018 annual report describes steps taken to get the Center up and running since its 1/2017 establishment as authorized by the 21st Century Cures Act. Director Richard Pazdur writes that OCE “has collaborated with FDA’s medical products Centers to expedite many
Drugs
A Washington Post article reports that Gilead Sciences is fighting to prevent the U.S. government from reaping any financial benefit for discovering a use for an HIV drug on which the company makes $3 billion annually. Federal grants from the Centers for Disease Control funded research that proved Gilead’
FDA Policy/General
FDA says the iMedDo Web site takes orders for NeuSilver Colloidal Silver and NeuKids lower dose silver for pets and children. A just-released 2/19 Warning Letter gives examples of Web site claims that provide evidence that the products are intended for use as drugs. Since the products are
Drugs
FDA has approved a Clarus Therapeutics NDA for Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. An FDA release says that the product is intended for men having low testosterone levels due to specific medical conditions, and should not be used to treat
Drugs
A 3/6-3/15/18 FDA inspection at Thibiant International, Newbury Park, CA, found significant violations of current good manufacturing practice (CGMP) regulations in its production of finished pharmaceuticals. A 3/6 Warning Letter says the specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
FDA has cleared an InControl Medical 510(k) for the Attain, described by the company as the first over-the-counter non-implantable muscle stimulator designed for at-home use to help treat women suffering with stress, urge, mixed urinary incontinence or bowel incontinence. The device provides a guided exercise
Drugs
Stakeholders are praising FDA for its draft guidance on developing and submitting proposed draft guidance relating to patient experience data. The Biotechnology Innovation Organization (BIO) says it believes that “strong trilateral communication between FDA, patients and patient organizations, and sponsors around patient experience will result in incorporation of patient experience