FDA Policy/General
BIOLOGICS Seqirus has received FDA approval of Afluria Quadrivalent (Influenza Vaccine) for use in persons 18 years of age and older. The company says it is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the
Drugs
FDA has issued Immunomedics a complete response letter (CRL) on its BLA for sacituzumab govitecan for treating patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. “The issues related to approvability in the CRL were exclusively focused on chemistry, manufacturing and
FDA Policy/General
FDA commissioner Scott Gottlieb says the agency is curbing “discretionary activities” and looking to order furloughs in areas where the workload has dropped during the partial government shutdown to preserve resources for drug reviews. In a 1/17 interview with the Washington Post, he said “What we are trying to
Drugs
Eli Lilly says results from ANNOUNCE, a Phase 3 study of Lartruvo (olaratumab), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma (STS), did not confirm the therapy’s clinical benefit, which is a requirement for a product to demonstrate post approval under FDA’s accelerated
Devices
FDA has classified as Class 1 a Medtronic recall of its Synergy Cranial Software and Stealth Station S7 Cranial Software due to reports of incorrect information displaying during biopsy procedures that could result in serious or life-threatening patient harm. The software is used with the company’s StealthStation Surgical
Drugs
Prinston Pharmaceutical Inc. (dba Solco Healthcare) has recalled one lot of irbesartan and seven lots of irbesartan hydrochlorothiazide tablets due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient manufactured by Zhejiang Huahai Pharmaceuticals. “Prinston is only recalling lots of irbesartan-containing products
Biologics
FDA has approved Merck’s Ontruzant (trastuzumab-dttb) as a biosimilar to Genentech’s Herceptin (transtuzumab) for patients with HER2-overexpressing breast cancer. The product will be manufactured by Samsung Bioepis. The Ontruzant prescribing information says common expected side effects include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure,
FDA Policy/General
FDA Webview’s newsroom will be closed Monday (1/21) in observance of Martin Luther King day. Nightly emails will resume 1/22.
Devices
FDA has cleared an EBM Technologies 510(k) for its iPad Pro-based Rad System for diagnostic reading of radiological images. The clearance is intended to untether physicians from traditional fixed workstations and paving the way for greater work flexibility and financial efficiencies. Users download images by connecting iPad lightning
Devices
FDA says it is evaluating recent information regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral arterial disease (PAD) in the femoropopliteal artery. “A recent meta-analysis of randomized trials published in the Journal of the American Heart
Drugs
FDA has issued Johnson & Johnson's Actelion Pharmaceuticals a complete response letter for its supplemental NDA for Opsumit (macitentan) for treating adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) to improve pulmonary vascular resistance (PVR) and exercise capacity. The agency said that additional data are needed to evaluate
Drugs
FDA has approved a Nexus Pharmaceuticals ANDA for busulfan injection, the company’s AP-rated therapeutic equivalent to Otsuka’s Busulfex 60 mg/10 mL (6 mg/1 mL). “Busulfan is currently on the American Society of Health System Pharmacists drug shortage list,” Nexus notes. It is indicated for use
Drugs
In an effort to encourage drug companies to enter the over-the-counter market and increase access to the opioid overdose reversing drug naloxone, FDA has developed a model drug facts label (DFL) with easy-to-use pictograms on how to use the drug. A statement from FDA commissioner Scott
Drugs
FDA says it has approved a modification to the Risk Evaluation and Mitigation Strategy (REMS) for clozapine (Novartis’ Clozaril), an antipsychotic drug used to help improve symptoms of schizophrenia in patients who do not respond adequately to standard antipsychotic treatment. The changes take effect 2/28 and include a requirement
Devices
FDA has accepted for review a Genentech supplemental BLA for Tecentriq (atezolizumab) in combination with Celgene’s Abraxane (albumin-bound paclitaxel; nab-paclitaxel) and carboplatin for the first-line treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic
Drugs
Medtronic says it has enrolled the first patient in its Embrace TDD (targeted drug delivery) study to evaluate using the SynchroMed II intrathecal drug delivery system as an alternative to oral opioids for patients with chronic intractable non-malignant primary back pain, with or without leg pain. The company says
Drugs
FDA has granted Bridge Biotherapeutics an orphan drug designation for BBT-877, an autotaxin inhibitor that deregulates ATX, an enzyme found to be associated with inflammation and fibrosis. The early-stage compound of BBT-877 had been originally discovered by LegoChem Biosciences and Bridge Biotherapeutics acquired the worldwide exclusive rights
Drugs
As a result of a meeting with FDA staff, Omeros and the agency have finalized the company’s clinical plan for its OMS721 submission and approval in immunoglobulin A nephropathy (IgAN). The company says OMS721 is its lead human monoclonal antibody targeting MASP-2, the effector enzyme of the complement
Drugs
FDA has released a final guidance, Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices, to assist drug or medical device sponsors who are planning to develop new drugs and test devices and want to coordinate development of the products so that the test device could be cleared either
Drugs
UCLA Anderson School of Management researchers say they have developed a quantitative framework that FDA could use to assess candidate drugs based on severity and prevalence as well as characteristics of the drug development process and existing market. “Such a model could augment the complex decision-making and statistical analyses
Devices
As part of an agreement to resolve all long-standing patent disputes between the two companies, Edwards Lifesciences is making a one-time payment of $180 million to Boston Scientific. The two firms have been involved for several years in litigation over heart valve replacement systems, including transcatheter aortic valves,
Biologics
FDA has approved an expanded use for Sanofi’s Adacel (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine adsorbed) to include repeat vaccination to help protect against tetanus, diphtheria, and pertussis. The company says Adacel is the first and only Tdap vaccine in the U.S. approved for