Drugs
Attorney Kurt Karst (Hyman, Phelps & McNamara) says that while the GDUFA 2 reauthorization negotiations are likely to yield only small changes and refinements, one thing he would like to see included is a deadline for FDA to rule on a citizen petition asking the agency to designate a drug
Drugs
The 2016 first quarter Stericycle Recall Index says that the number of recalled drug and medical device units dropped significantly in the quarter. The analysis shows that while the number of drug recalls remained consistent with the historical average, the number of units affected dropped to the second lowest quarter
Drugs
Healthcare Supply Chain Association president Todd Ebert says that the backlog of generic drug applications at FDA is contributing to the problem of drug price increases. Writing in a letter to the New York Times, Ebert says that his association supports legislation (S. 2615, the Increasing Competition in Pharmaceuticals Act)
Drugs
FDA has again postponed its final rule on generic drug post-approval labeling changes, this time until 4/2017. Public Citizen previously criticized the agency for delaying the rule’s issuance until 7/2016. The group has long complained (see earlier news release) that brand name drug manufacturers currently are
Drugs
FDA has issued a drug safety alert that warns healthcare professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets for unapproved uses to treat skin and nail fungal infections. “Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines
Drugs
Celator Pharmaceuticals says it plans to file an NDA in the third quarter of this year for Vyxeos (also known as CPX-351), an investigational drug in development for treating acute myeloid leukemia (AML) and other blood cancers. The agency recently granted the therapy a breakthrough designation based on positive
Drugs
FDA has approved a Boston Scientific PMA for its Precision Montage MRI Spinal Cord Stimulator (SCS) System which is intended to help relieve chronic pain while also enabling safe access to full body magnetic resonance imaging in a 1.5 Tesla environment. The device uses the company’s MultiWave technology
Drugs
The CDER Office of Pharmaceutical Quality has issued a Manual of Policies and Procedures (MAPP) on applying three International Council on Harmonization (ICH) principles to chemistry, manufacturing, and controls review of drug applications. The MAPP says the ICH Q8(R2) document published 11/20/09 provides information on how to
Drugs
A Rhode Island federal judge has ordered FDA to allow experimental cancer trial treatments to resume for a 20-year-old man while a full hearing on the case is scheduled. The Providence Journal reports that FDA had shut down a clinical trial at the Burzynski Research Institute in Texas
Drugs
Several stakeholders are asking FDA to make substantive changes to a draft guidance on implementing the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council say that although they agree with many aspects
Drugs
FDA has granted Genentech accelerated approval for Tecentriq (atezolizumab) for treating people with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months after receiving chemotherapy. Urothelial carcinoma accounts for 90% of all bladder cancer. Approval
Drugs
FDA has issued a drug safety alert on Janssen’s diabetes medicines containing canagliflozin (Invokana and Invokamet) after data from an ongoing clinical trial showed an increase in leg and foot amputations, mostly affecting the toes. The ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) identified amputations that occurred about twice as
Drugs
Oramed Pharmaceuticals has announced “positive top-line results” from its Phase 2b study that was designed to evaluate the safety and efficacy of its oral insulin capsule (ORMD-0801) in patients with Type 2 diabetes. The study’s primary endpoint, a significant reduction in weighted mean night-time glucose, was
Drugs
A 6/1-6/12/15 FDA inspection at Lincare Holdings (United Medical Home Infusion), Little Rock, AR, found “serious deficiencies” in the firm’s practices for producing sterile drug products, putting patients at risk, according to a 4/25 Warning Letter from the agency’s Dallas District Office. The
Drugs
FDA’s New York District Office says that Super Power Khan, distributed as a dietary supplement by Economax, Flushing, NY, through a Web site, is an unapproved new drug that also is misbranded. A 5/6 Warning Letter says that the agency confirmed through laboratory analysis that a sample of
Drugs
Deputy attorney general Sally Yates, who drafted the Individual Accountability Policy that has become known as the “Yates Memo,” says that implementation of the policy has already had the desired effect of changing corporate behavior. Speaking to the 5/10 New York City Bar Association White Collar Crime conference, Yates
Drugs
The study involved 365 patients, who were randomized 1:1 to treatment with up to six cycles of of atumumab in combination with fludarabine and cyclophosphamide or up to six cycles with fludarabine and cyclophosphamide alone. The study met the primary endpoint with a median progression free survival in patients
Drugs
FDA has granted accelerated approval to Bristol-Myers Squibb for its NDA for Opdivo (nivolumab) and its use in treating patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin (Adcetris). The approval was granted three and a
Drugs
An Alabama federal court has dismissed a case charging that Wyeth failed to update labeling for its generic metoclopramide. Writing in an online blog post, attorney James Beck says that the plaintiff alleged that for a period of several months in 2004-05, the company did not include the latest
Drugs
The FDA-endorsed Clinical Trials Transformation Initiative has released new recommendations on best practices for using Data Monitoring Committees (DMCs) to ensure the validity and integrity of a clinical trial when there is a need to periodically review accumulating safety and efficacy data and advise on whether to continue, modify,
Drugs
FDA has approved an Eisai NDA for Lenvima (lenvatinib) capsules for combination use with everolimus for treating advanced renal cell carcinoma following one prior anti-angiogenic therapy. Lenvatinib was first approved in 2015 for treating locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. The expanded approval was
Drugs
DEVICES Bone Index Ltd. has received 510(k) clearance from FDA for the Bindex point-of-care instrument to help in osteoporosis diagnosis. According to the company, Bindex measures the cortical bone thickness of the tibia and the algorithm calculates the Density Index, a parameter which estimates bone mineral density