Drugs
FDA has awarded a three-year $2 million grant to the Long Island University (LIU) Arnold and Marie Schwartz College of Pharmacy and Health Sciences to study variability in marketed drug products. The research initiative, “Building Towards Statistically-Based Pharmaceutical Quality Standards,” will focus on assessing the variability in some
Drugs
Teva Pharmaceuticals has recalled seven lots of amikacin sulfate injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for glass particulate matter to be present in vials. The product is used short-term for treating serious infections caused by
Drugs
FDA has approved a GSK Consumer Healthcare NDA for Flonase Sensimist Allergy Relief (fluticasone furoate, 27.5 mcg spray) as an over-the-counter treatment for symptoms associated with seasonal and perennial allergies. Previously, the product was approved for prescription-only use. Flonase Sensimist provides non-drowsy, 24-hour relief
Drugs
FDA has granted Novartis a breakthrough therapy designation for LEE011 (ribociclib) and its use in combination with letrozole for treating hormone receptor positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. The designation was based primarily on positive results from the Phase 3 MONALEESA-2 trial,
Drugs
The Alliance for Patient Access says it is concerned that biosimilar labeling may not include relevant clinical trials data submitted by the applicant. Commenting on an FDA draft guidance on labeling for biosimilar products, the alliance says that rather than recognizing the difference between a biosimilar drug and its reference
Drugs
A 1/18-20 FDA inspection at Xiamen Origin Biotech, Fujian, China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a 7/19 Warning Letter. Specific deviations noted in the letter include: * failing to establish, document, and implement an effective system for
Drugs
Imarch Research says that FDA issued just five Warning Letters to clinical investigators in FY 2015 as a result of the agency’s Bioresearch Monitoring Inspection Program. An online post says that only two types of violations were cited in the letters. Failing to ensure that the investigation was conducted
Drugs
FDA has denied a 1/10/14 Jame Fine Chemicals (JFC) petition asking the agency to reconsider its decision to close a drug efficacy study implementation docket that left standing a prior determination that certain products identified in the docket were less than effective and could be introduced into interstate
Drugs
FDA has approved in part and denied in part petitions filed by Ken Suprenant, a Michigan man whose wife died from rare adverse effects of chemotherapy, asking that the agency revise prescribing information for fluorouracil injection and Xeloda (capecitabine) to clarify the risk of severe toxic reactions in patients with
Drugs
Pfizer says it has reached a $486 million settlement with shareholders for allegedly concealing safety risks associated with its Celebrex and Bextra pain drugs. The company says the deal is “subject to the negotiation of a final settlement agreement and court approval.” Shareholders accused the company of hiding clinical trial
Drugs
FDA and the HHS Office for Human Research Protections have issued a joint guidance to assist institutional review board (IRB) administrators, chairs, and other officials responsible for preparing and maintaining written procedures for the IRB. The guidance provides an IRB written procedures checklist incorporating the HHS and FDA regulatory requirements
Drugs
Foley & Larder says a recent complaint filed under Section 337 of the Tariff Act at the International Trade Commission (ITC) on behalf of Par Pharmaceutical and related parties will be heard by an administrative law judge. The complaint alleges that potassium chloride powder products are being unlawfully imported into
Drugs
The DC federal court has ruled in FDA’s favor in a lawsuit brought by Otsuka that sought to reverse the agency’s approval of Alkermes’ 505(b)(2) NDA for Aristada (aripiprazole lauroxil) extended-release injectable suspension. The 2015 agency Aristada approval came after it denied an Otsuka petition
Drugs
FDA has approved an Ipsen sBLA for Dysport (abobotulinumtoxinA) for injection for treating pediatric lower limb spasticity in children two years of age and older. Approval was based on data from a Phase 3 pivotal study that showed the majority of patients achieved a response lasting 16 to 22 weeks
Drugs
FDA has issued the University of Michigan an eight-observation Form-483 about pharmacy compounding violations it observed during a June inspection. The document said university investigations into batch failures did not extend to other drug products that may have been associated with the specific discrepancy/failure. The agency also
Drugs
FDA officials say the agency will begin piloting a new inter-Center consult request (ICCR) procedure for proposed combination products. In a new agency blog post, they say that “close inter-Center collaboration and communication are important to facilitate timely, appropriately-tailored and well-informed submission review. A combination product
Drugs
FDA has granted Shire a fast track designation for SHP626 (volixibat), an investigational drug for treating adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis. The company is developing SHP626 as a once daily, orally-administered inhibitor of the apical sodium dependent bile acid transporter, a protein that it says
Drugs
A team of NIH researchers has developed a new software tool called AptaTRACE for drug developers and other scientists who want to identify molecules that bind with high precision to targets of interest. “This research is an excellent example of how the benefits of ‘big data’ critically depend upon the
Drugs
FDA has conditionally accepted an Evoke Pharma proprietary brand name submission to name its product candidate, EVK-001 (metoclopramide nasal spray), “Gimoti.” The full submission will be included in a planned NDA submission. The name Gimoti (pronounced “jye-MOH-tee”) was developed in compliance with the agency’s guidance on
Drugs
FDA has approved a Sanofi-Aventis NDA for Adlyxin (lixisenatide), a once-daily injection to improve glycemic control in adults with Type 2 diabetes. The glucagon-like peptide-1 receptor agonist was approved based on data from 10 clinical trials that enrolled 5,400 patients with Type 2 diabetes. It
Drugs
Four FDA National Center for Toxicological Research staffers say that it is likely that some cancer drugs could be repositioned to treat rare diseases. In an opinion article in the journal Trends in Pharmacological Sciences, the four look at the possible association between cancers and rare diseases across clinical observation,
Drugs
A review of cancer drugs approved by FDA between 1998 and 2014 found that a personalized approach for drug development was associated with faster clinical development, according to an online study report in Impact Journals. Researchers also reported no differences in access to FDA expedited review programs between personalized and