Drugs
A large-scale population analysis by Skaggs School of Pharmacy and Pharmaceutical Sciences at University of California San Diego has supported anecdotal reports of the effectiveness of ketamine as an antidepressant. The study was published in Scientific Reports. By analyzing the FDA Adverse Effect Reporting System database for depression symptoms
Drugs
Friends of Cancer Research (FOCR) is promoting updated research continuing to show that cancer drugs are approved faster in the U.S. than in the European Union. In summary, it says in an online Data Driven blog post, between 2003 and 2016, 97% of cancer drugs were available in the
Drugs
Updating an FDA 5/12/16 safety communication, the agency says that as part of its ongoing review of fluoroquinolone antibiotics, it has determined that patient cases identified by FDA and findings from published studies currently do not support reports that the drugs may result in retinal detachment or aortic
Drugs
The Tufts Center for the Study of Drug Development says that FDA approved more than 300 biotech products covering 267 indications from 1980 through 2016, or about 35% of all new drug approvals. The center’s latest Impact Report (subscription or purchase required) says that given the historically high Phase
Drugs
A 12/13-22/16 FDA inspection at Huron Pharmaceuticals, Farmington Hills, MI, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a 4/20 Warning Letter from the agency’s Detroit District Office. Specific deviations included: * failing to transfer all quality or
Drugs
FDA has granted accelerated approval to an EMD Serono NDA for Bavencio (avelumab) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Approval was supported by data from an open-
Drugs
CDER Emerging Technology Team chief Sau Lee says the agency is “taking proactive steps to facilitate the drug industry’s implementation of emerging technologies, including continuous manufacturing, to improve product quality and address many of the underlying causes of drug shortages and recalls.” Writing in an online position paper, Lee
Drugs
The Justice Department has opened an investigation into management and advisory services provided by Johnson & Johnson’s Janssen unit to rheumatology and gastroenterology practices that bought its Remicade (infliximab) and Simponi Aria (golimumab) arthritis drugs. Reuters reports that the company also indicated in a quarterly filing that the U.
Drugs
A new study published in JAMA finds that nearly a third of recently approved drugs resulted in adverse events that led to new boxed warnings or safety alerts. Researchers examined more than 222 new drug and biologics approvals from 2001 through 2010. They documented 123 significant postmarket safety events (3
Drugs
C.O. Truxton has expanded an ongoing recall to now include all phenobarbital and amitriptyline tablets that were repackaged into a Truxton label due to the potential for a label mix-up. The company says it has not received any complaints about the additional products recalled, according to a recall
Drugs
The Senate 5/9 voted 57-42 to approve the nomination of Scott Gottlieb as the next FDA commissioner. The nomination now moves to the White House for an official swearing in. Gottlieb previously served as deputy FDA commissioner during the George W. Bush administration. “Dr. Gottlieb is the right
Drugs
U.S. Senators Roger Wicker (R-MS) and Amy Klobuchar (D-MN) have introduced legislation aimed at providing patients and advocates the ability to play a larger role in FDA’s benefit-risk framework for drug approval. The “Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act,” is
Drugs
U.S. Senators Michael Bennet (D-CO), Orrin Hatch (R-UT), Richard Burr (R-NC), and Bob Casey (D-PA) have introduced legislation to improve clinical trials for experimental treatments that have life-saving potential. “The current clinical trial process is outdated, preventing the FDA and drug manufacturers from developing
Drugs
Data from post-approval clinical trials required for certain novel drugs approved on limited evidence (e.g., surrogate endpoints) varied in quality and quantity, “with few controlled studies published after approval that confirmed efficacy using clinical outcomes for the original FDA approved indication,” according to a new study in the
Drugs
FDA has granted Oncolytics Biotech a fast track designation for Reolysin, an immuno-oncology viral agent for treating metastatic breast cancer. Last month, the company reported Phase 2 data from an open-label, randomized study assessing the therapeutic combination of intravenously-administered Reolysin given in combination with paclitaxel versus paclitaxel
Drugs
FDA has sent TherapeuticsMD a complete response letter (CRL) on its NDA for TX-004HR, an investigational applicator-free estradiol vaginal softgel capsule for treating moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy due to menopause. The agency’s letter raised concern
Drugs
FDA has cleared a CurveBeam 510(k) for InReach, a cone beam computed tomography imaging system designed for the hand, wrist, elbow and lower extremities in non-weight bearing position. The device provides high-contrast 3D datasets of bony anatomy, which could potentially replace radiographs as a first line diagnosis,
Drugs
FDA has cleared a Crospon 510(k) for its Endoflip System with Flip Topography Module, which is intended to assess patient motility disorders during endoscopy. The device features imaging software that displays real-time esophageal contractility patterns on a 24-in. touch-screen. “The unique repetitive visual cues of the
Drugs
Growth in U.S. spending on prescription drugs dropped last year as competition between manufacturers heated up and payers stepped up efforts to curb price increases, according to QuintilesIMS Institute’s annual report, Medicines Use and Spending in the U.S. – A Review of 2016 and Outlook to 2021. It
Drugs
FDA has approved a Mitsubishi Tanabe Pharma America NDA for Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis, commonly known as Lou Gehrig’s disease. The intravenous infusion is intended to be administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day
Drugs
FDA has posted a Dr. Reddy’s Laboratories Form 483 from a 4/28 inspection that cited the firm’s Bachupally, Hyderabad, India manufacturing facility on 11 observations. The agency said the firm’s lab controls do not include scientifically sound and appropriate sampling plans. It also found that the
Drugs
The 10th Circuit Court of Appeals has remanded to a Utah federal court portions of a failure-to-warn case brought against Aventis over its fertility drug Clomid (clomiphene citrate). The Utah court had granted summary judgment to Aventis on the failure-to-warn, breach of implied warranty, negligent misrepresentation,