FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) says that a Celator convention exhibit hall panel on its investigational product CPX-351 (cytarabine, daunorubicin) liposome injection suggested that the drug is safe and effective for the purposes for which it is being investigated or otherwise promotes the product. An 8/
Drugs
FDA has granted Sage Therapeutics a breakthrough therapy designation for SAGE-547 for treating postpartum depression (PPD). The company recently reported top-line results from a placebo-controlled Phase 2 trial in women with severe PPD in which SAGE-547 showed a reduction in depression scores compared with placebo. “There
Drugs
A 11/30-12/3/15 FDA inspection at Pan Drugs, Vadodara, India, found significant violations of current good manufacturing practice regulations and data integrity concerns in the firm’s manufacturing of finished pharmaceuticals, according to an 8/25 Warning Letter. Specific violations included: * failing to establish an adequate quality
Devices
BD (Becton, Dickinson) says it has submitted a PMA application to FDA for its Onclarity HPV (human papilloma virus) assay. The company says the PMA is supported by data collected during a two-year multi-center clinical trial enrolling more than 33,000 women. The submission seeks approval to use
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Central Admixture Pharmacy Services, Inc. Allentown, PA (8/19). Inspected Allentown, PA facility 6/4-11/14 and from 2/3/15-2/11/15. Inspected San Diego, CA
FDA Policy/General
BIOLOGICS Panel to Discuss Dynavax Hepatitis B Vaccine Federal Register Notice: FDA will hold a meeting of the Vaccines and Related Biological Products Advisory Committee11/16, from 8:30 a.m. to 2:30 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center,
FDA Policy/General
Danaher is acquiring molecular diagnostics company Cepheid for about $4 billion. including indebtedness and net of acquired cash. Cepheid generated $539 million in annual revenue in 2015. Headquartered in Sunnyvale, CA, Cepheid will become part of Danaher's $5 billion diagnostics segment, joining its Beckman Coulter, Leica Biosystems and
Drugs
FDA has granted Catalyst Pharmaceuticals an orphan drug designation for Firdapse (amifampridine phosphate) for treating myasthenia gravis. The rare disease is caused by antibodies to the muscle-specific kinase (MuSK-MG) and is “characterized by a predominance in females, prominent bulbar involvement, more severe clinical condition and resistance to treatment,
Drugs
Pressure from Capitol Hill is continuing against Mylan and its pricing on Epipen. Senate Finance Committee Ranking Member Ron Wyden (D-OR) and House Energy and Commerce Committee Ranking Member Frank Pallone (D-NJ) have now sent a letter to HHS secretary Sylvia Mathews Burwell requesting additional information regarding EpiPen’
Devices
CDRH has allowed under its de novo review the marketing of Concentric Medical’s two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities. These devices should be used within six hours of symptom onset and
Drugs
FDA has issued a final rule that bans 19 active ingredients — including most commonly triclosan and triclocarban — from use in over-the-counter (OTC) antiseptic wash products. “Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both
Drugs
FDA has granted Biogen fast track status for aducanumab, an investigational treatment for early Alzheimer’s disease. The therapy is currently being evaluated in two global Phase 3 studies, ENGAGE and EMERGE, which are designed to evaluate its safety and efficacy in slowing cognitive impairment and the progression of disability
Drugs
Ariad Pharmaceuticals has completed a rolling NDA submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, for its use treating patients with metastatic ALK-positive non-small cell lung cancer who are resistant or intolerant to crizotinib. The company is seeking accelerated approval and has requested a priority review.
Drugs
FDA and the generic drug manufacturing industry have reached agreement on an extension of the Generic Drug User Fee Amendments of 2012 (GDUFA), which expire in 2017. GDUFA 2 will run from FY 2017 through FY 2022. Generic Pharmaceuticals Association (GPhA) vice president for scientific and regulatory affairs David Gaugh
Drugs
FDA has granted Cynapsus Therapeutics a fast track designation for APL-130277, a product candidate for treating “off episodes” in patients with Parkinson’s disease. Off episodes are thought to occur when brain dopamine levels fall below a critical threshold to sustain relatively normal motor function, the company says. These
Drugs
Scientists in New York and London say there are steps researchers can take when a trial’s primary outcome fails to achieve statistical significance. Writing in the New England Journal of Medicine, they suggest that researchers ask a set of 12 questions to help them clarify whether the new treatment
Devices
FDA says that Baxter has told it about multiple adverse event reports in 2016 associated with its Vascu-Guard peripheral vascular patch during carotid endarterectomy (CEA). An agency statement says that the report includes instances of intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention, and
FDA Policy/General
The Patient, Consumer, and Public Health Coalition took advantage of an FDA request for comment on a proposed direct-to-consumer (DTC) ad survey to raise again concerns about the DTC ads themselves. The 13 organizations in the coalition say they are “very concerned about the impact of DTC ads
Drugs
FDA has moved the drug safety labeling changes program from MedWatch in the Office of the Commissioner to the CDER Office of Communications in an effort to speed publication of labeling changes on the Internet. CDER director Janet Woodcock says that MedWatch posted safety labeling changes monthly. Now, she says,
Devices
CDRH has released a guidance on “Submission of 510(k)s for Solid State X-ray Imaging Devices” that outlines the type of data to establish the substantial equivalence of such devices to a previously cleared conventional radiographic film/screen system, fluoroscopic image intensified imaging system, or similar device. The
Devices
FDA has approved a Medtronic PMA for the Enlite sensor for use with the iPro2 Professional Continuous Glucose Monitoring system. The disposable device can be worn up to six days, and like a holter monitor for cardiovascular care it records a patient’s glucose levels 24 hours a day. “Used
Drugs
FDA has granted Perrigo tentative ANDA approval for a generic version of Gladerma’s Epiduo Gel (adapalene and benzoyl peroxide 0.1%/2.5%), indicated for treating acne vulgaris in patients 12 years of age and older. Annual sales for the brand product are about $379 million. According to FDA’