Drugs
FDA has approved a Circassia Pharmaceuticals supplemental NDA to add new data to Tudorza Pressair’s (aclidinium bromide inhalation powder) prescribing information that includes data from the ASCENT trial showing that the therapy reduces exacerbations in chronic obstructive pulmonary disease (COPD) and does not increase major adverse cardiovascular events in
Drugs
The Federal Trade Commission (FTC) has released an opinion and final order against generic company Impax Laboratories, finding that it engaged in an illegal pay-for-delay, or “reverse payment,” settlement to block consumers’ access to a lower-cost generic version of Endo Pharmaceuticals’s branded extended-release opioid pain
FDA Policy/General
Federal Register notice: FDA is proposing to amend and repeal parts of its radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The
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
FDA Policy/General
DEVICES FDA has cleared a Deerfield Imaging 510(k) to market its SYMBIS stereotactic brain biopsy system in the U.S. The device allows for a biopsy to be performed while a patient is inside an MRI scanner that is intended to improve targeting and procedure times. EDAP TMS has
FDA Policy/General
Pfizer Inc. and Allergan say they are not going forward with their $160 billion merger, in part because of new U.S. Treasury rules aimed at thwarting tax inversions. Pfizer has agreed to pay Allergan $150 million for reimbursement of expenses associated with the transaction. The National Institutes of Health
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
Devices
FDA is proposing to amend and repeal parts of the radiological health regulations on recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. A Federal Register 4/
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
FDA Policy/General
Just as he leaves the agency, FDA commissioner Scott Gottlieb has received the go-ahead for his proposed reorganization of the Office of the Commissioner and several changes to other agency elements. The Regulatory Affairs Professionals Society (RAPS) says Gottlieb told staff the reorganization plan “elevates the role of the
FDA Policy/General
Federal Register notice: FDA has awarded Vertex Pharmaceutical a priority review voucher after it determined that a qualified rare pediatric disease product gained approval. The agency recently approved the company’s Symdeko (tezacaftor/ivacaftor), indicated for treating patients with cystic fibrosis aged 12 years and older who are homozygous for
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
FDA Policy/General
Federal Register proposed rule: FDA has proposed to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 and the Federal Food, Drug, and Cosmetic Act to modernize the regulations by incorporating current science and mammography best practices. The updates are intended to improve the
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the Cellular, Tissue and Gene Therapies Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/28/2020. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling.” The document is intended to assist applicants in determining the appropriate placement and content of pediatric information in human prescription drug and biological product labeling as described in
Devices
FDA Commissioner Scott Gottlieb has reversed course on certain device summary reporting about adverse events that are hidden to the public and researchers, and now says the agency will make such reports received prior to 2017 more easily accessible. “I think that the imperative of the agency is to make
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