Devices
FDA has given Staar Surgical IDE approval to begin a clinical trial for the EVO/EVO+ VISIAN Implantable Collamer Lens for myopia, and EVO/EVO+ VISIAN Toric Implantable Collamer Lens for myopia with astigmatism. Under the IDE, FDA recommended study design modifications, which Staar says it plans to incorporate into
Drugs
A 211-2/16 FDA inspection at CTX Lifesciences, Surat, Gujarat, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). A just-released 7/12 Warning Letter says specific deviations were: * failing to ensure that water used in the redacted manufacturing steps of a
Drugs
FDA has approved a Kyowa Kirin NDA for Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “off” episodes, the period when patients’ medications are not working well, which cause an increase in PD symptoms (tremors and difficulty walking)
Drugs
FDA has released the FDA-483 issued following a 5/31 and 6/3-6/7 inspection at First Pharma Associates, Spokane, WA, a producer of sterile and non-sterile drug products. The 10 inspection observations were: * non-microbial contamination was observed in the production area; * personnel were observed manually
Drugs
A 2/25-2/28 FDA inspection at Ningbo Pulisi Daily Chemical Products Co., Ltd., Yuyao City, Zhejiang Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other violations. An 8/13 Warning Letter says specific violations were: * failing to perform, for each
Drugs
FDA has approved Eli Lilly’s Taltz (ixekizumab) injection 80 mg/mL for treating adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis. The drug was initially approved 3/2016 for treating moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or
FDA Policy/General
Federal Register notice: FDA has announced a 10/9 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to hear an overview of the research programs from CBER’s Laboratory of Hepatitis Viruses and the Laboratory of Vector-Borne Viral Diseases. They will also discuss and make
Drugs
FDA commissioner Ned Sharpless says that it plans to release a final guidance on developing amyotrophic lateral sclerosis (ALS) drugs and biologics products by the end of September. “Patients are at the forefront of everything we do, and FDA remains deeply committed to supporting the (ALS) community in its efforts
Drugs
A new report from FDA says that from 4/1/1999 to 8/31/2018 there were 548 orphan indications approved. Of these, FDA identified 200 orphan indications that did not warrant pediatric labeling (adult only indications or indications for which pediatric studies were impossible or highly impracticable). “Of the
FDA Policy/General
A just-released FDA Warning Letter cites Metuchen Pharmaceuticals over its promotional activities related to erectile dysfunction drug Stendra (avanafil) tablets. CDER Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer print ad and display banners make false or misleading claims about the risks associated with the drug.
Drugs
FDA wants to start seeing more males included in breast cancer drug trials and using real world data can help. A draft guidance, Male Breast Cancer: Developing Drugs for Treatment, has been released that provides recommendations on how additional data to support efficacy and safety for male patients with breast
Drugs
FDA has approved an Akorn ANDA for azelastine hydrochloride nasal spray, 0.15%, indicated for relieving symptoms of seasonal allergic rhinitis and perennial allergic rhinitis in patients six years of age and older. U.S. annual sales of azelastine hydrochloride nasal spray are about $18 million. The product will be
Devices
FDA has cleared a Vyaire Medical 510(k) for two of its latest pulmonary function testing (PFT) technologies: Vyntus ONE and Vyntus BODY with SentrySuite Software. Vyntus ONE is designed to be a convenient PFT station available in a fixed or mobile configuration, the company says, and Vyntus BODY is
Drugs
Oklahoma county judge Thad Balkman ruled 8/26 against Johnson & Johnson in the state’s opioid trial, saying the company must pay $572 million in the first ruling in the U.S. holding a drugmaker responsible for helping fuel the opioid epidemic. The judge called the opioid crisis an
FDA Policy/General
Panel to Discuss Chikungunya Vaccine Development Federal Register notice: FDA announces an 11/8 Vaccines and Related Biological Products Advisory Committee meeting to discuss chikungunya vaccine development. 08/23/2019 Correction on Opioids Hearing Federal Register notice correction: FDA corrects a 6/21 notice entitled “Standards for Future Opioid Analgesic
FDA Policy/General
Janssen R&D Ireland has entered into a collaboration with ViiV Healthcare to develop and commercialize a new single tablet regimen containing Janssen’s non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) and ViiV’s integrase inhibitor Tivicay (dolutegravir) as the sole active ingredients for the maintenance treatment of patients
FDA Policy/General
DEVICES FDA has cleared a CorMatrix Cardiovascular 510(k) for the CorMatrix CanGaroo ECM Envelope for use with cardiac implantable electronic devices including pacemakers and implantable cardioverter defibrillators. The device acts as a pouch to securely hold a cardiac implantable electronic device to create a stable environment when implanted in
Devices
FDA has granted Miracor Medical a breakthrough device designation for its PiCSO Impulse System for treating ST-elevated myocardial infarction patients. PiCSO therapy is intended to be provided by interventional cardiologists during percutaneous coronary intervention in patients experiencing ST-elevated myocardial infarction. It works by clearing the coronary microcirculation by
Devices
FDA has cleared a Drawbridge Health 510(k) for the OneDraw A1C Test System, which comprises the OneDraw Blood Collection Device and the OneDraw A1C Test. The device is intended for collecting and stabilizing blood and measurement of HbA1c levels for monitoring long-term blood sugar control in people with
Drugs
Medline has recalled its Primary Warmer Pack because it contains the recalled Vyaire Medical enFlow Disposable Cartridge, “which may elute aluminum into infused fluids during use, potentially exposing patients to unsafe aluminum levels,” according to a recall notice. “Continued use of these products may result in prolonged, undetected aluminum exposure
FDA Policy/General
Federal Register notice: FDA has announced an 11/8 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on developing chikungunya vaccines. Chikungunya is an infection caused by the chikungunya virus, which is spread by mosquitos. To view the notice, click here.
Drugs
Former FDA commissioner Robert Califf says the current concern over the inclusion of faulty data in Novartis’ BLA for Zolgensma (onasemnogene abeparvovec-xioi), a novel gene therapy indicated to treat spinal muscular atrophy in children at a cost of $2.1 million for a single, one-time dose, raises questions