Devices
FDA has cleared an Aidoc 510(k) for its artificial intelligence (AI) component for flagging large-vessel occlusion in head computed tomography angiography scans. The latest AI module joins a previous cleared module for flagging and prioritizing intracranial hemorrhage to provide a comprehensive AI package for identifying and triaging both
Devices
Galemed has recalled (Class 1) its Babi.Plus Pressure Relief Manifold system due to complaints about the device not holding pressure when initially set up on a patient. This malfunction is traced to a dislodged valve not being properly seated, resulting in loss of pressure in the system, a recall
Drugs
FDA has accepted for review a Chiasma NDA resubmission for Mycapssa (octreotide) capsules for the maintenance treatment of adults with acromegaly. According to Chiasma, acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone, which leads to significant health problems and early death if
Drugs
FDA has accepted for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with bevacizumab (Genentech’s Avastin) for the maintenance treatment of women with advanced ovarian cancer whose disease has shown a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab. The
FDA Policy/General
Meeting on Asbestos in Talc and Cosmetic Products Federal Register notice: FDA announces a 2/4 public meeting entitled “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc.” 01/10/2020 FDA Withdrawing 249 ANDAs Over Annual Reports Federal Register notice: FDA proposes to withdraw approval of 249
Drugs
Evotec has entered into a definitive agreement with Aptuit under which Evotec will acquire all operational business of Aptuit for $ 300 million that will expand Evotec’s role as a leading player in integrated outsourced drug discovery and development solutions. LabCorp has agreed to purchase private contract research organization (CRO)
Devices
FDA has released a draft guidance on “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions.” The document provides draft recommendations, including bench testing and coating characterizations for 510(k) submissions for PTA balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-
Drugs
FDA has issued SCA Pharmaceuticals (Little Rock, AR) a six-observation Form 483 after a November inspection cited GMP issues at the drug outsourcing facility. For example, the agency said that each batch of drug product required to be free of objectionable microorganisms is not subjected to appropriate laboratory testing.
Devices
A year after Bayer stopped selling and distributing Essure, an implantable contraceptive device, CDRH director Jeff Shuren says the company has repossessed 99% of unused devices in the market. “Additionally, postmarket safety monitoring for women who have Essure implanted remains a top priority for the agency, and today we are
FDA Policy/General
Federal Register notice: FDA has announced a 2/4 public meeting entitled “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc.” The meeting is intended to discuss and obtain scientific information on topics related to testing methodologies, terminology, and criteria that can be applied to characterize and measure
Biologics
FDA has granted Meissa Vaccines a fast track designation for MV-012-968, an investigational, live attenuated vaccine for protection against respiratory syncytial virus (RSV) infection. RSV is the most common cause of acute lower respiratory tract infections in young children and infects nearly all children by two years of
Devices
FDA has granted Reflow Medical a breakthrough device designation for the Temporary Spur Stent System, a novel retrievable stent technology intended for treating below-the-knee (BTK) peripheral artery disease. The combination device comprises a “patented retrievable stent system having a series of radially expandable spikes designed to create multiple
Devices
FDA has approved a MicroVention PMA for the FRED (Flow Re-Direction Endoluminal Device) device for treating brain aneurysms. The company says this is the first flow diverter in the U.S. to use a self-expanding braided nitinol mesh to help re-direct blood flow and promote aneurysm occlusion.
Drugs
The Coalition to Preserve Access to Pharmacogenomics (PGx) Information has petitioned FDA urging it to stop enforcement actions against genetic tests that claim to predict a patient’s response to specific medications. Over the past year, the agency has warned several companies about claims made for specific genetic tests. It
Drugs
Alnylam Pharmaceuticals has begun a rolling submission of its NDA for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for treating primary hyperoxaluria Type 1 (PH1). Specifically, the company submitted non-clinical components and it expects to submit the remaining components later this year 2020. Alnylam also says it has
FDA Policy/General
Federal Register notice: FDA is proposing to withdraw approval of 249 ANDAs from multiple companies because they have repeatedly failed to file required annual reports for the applications. The ANDA holders are being offered an opportunity to request a hearing on the withdrawal proposal and they have until 2/10
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Human Tissue Intended for Transplantation — 21 CFR Part 1270” (OMB Control Number 0910-0302). FDA regulations require written procedures to be prepared and followed, and require records to be maintained concurrently with the performance of each significant
Drugs
Researchers from the University of Michigan and Harvard Medical School say that Reckitt Benckiser earned at least $1 billion in extra profits by exploiting various FDA regulatory procedures to impede the entry of generic competitors and maintain elevated prices for its Suboxone (buprenorphine), used to treat opioid use disorder. Writing
FDA Policy/General
FDA, the Department of Agriculture, and the Environmental Protection Agency have launched a unified Web site for biotechnology regulation to streamline information about the three regulatory agencies charged with overseeing agriculture. An FDA statement said the Web site is part of President Donald Trump’s executive order on modernizing the
Devices
CDRH scientists and engineers have developed a new tool to help hospitals determine how clean an endoscope is after it has been reprocessed. The effort is being led by the Center’s Biofilms Research Group and the Office of Science and Engineering Laboratories. Studies at hospitals are underway to confirm
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “General Administrative Practice and Procedures” (OMB Control Number 0910-0191). FDA says it has reviewed its regulations and is revising the collection to include provisions that it believes may be subject to OMB review. To view the
Drugs
A study funded by Pharmaceutical Research and Manufacturers of America says that it is a misconception that manufacturers retain the vast majority of drug spending. In fact, the study says, despite absolute growth in brand medicine spending at the point of sale, which increased from $354 billion in 2015 to