Drugs
The only letter relevant to our readership can be accessed by clicking on the link below. Interquim Barcelona, Spain (11/22): FDA inspected the firm’s manufacturing facility in May and cited significant GMP deviations involving its active pharmaceutical ingredients (APIs). For example, the firm failed to have adequate cleaning
Drugs
The Foundation for the National Institutes of Health 12/6 released its Framework for Defining Evidentiary Criteria for Biomarker Qualification, developed in collaboration with FDA, NIH, the Critical Path Institute, PhRMA and numerous drug companies, including Genentech, Merck, Pfizer and Takeda. The 44-page document incorporates input from nearly 200
Drugs
FDA has approved Genentech’s Avastin (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for treating patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Platinum-sensitive form of the disease is when a
Drugs
After almost 25 years at FDA, and nearly 32 years of federal government service, CDER Office on New Drugs (OND) director John Jenkins will retire effective 1/6/2017. Jenkins joined FDA in 1992 as a medical officer in CDER’s former Division of Oncology and Pulmonary Drug Products. He
Drugs
Federal Register Notice: FDA is seeking comments on an information collection extension request related to a guidance on “Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.” The guidance suggests that applicants who submit certain medical device applications include, if
Drugs
FDA has approved a new indication for Eli Lilly’s Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with Type 2 diabetes mellitus and cardiovascular disease. The approval is based on a postmarketing study required by the agency when it approved Jardiance in 2014 as an
Drugs
FDA has stepped up its focus on combination products and plans to finalize its guidance on human factors and GMPs this coming year. In an update on its combination products program, the agency also says it will issue a final rule on postmarket safety reporting, and it will update a
Drugs
FDA has released a guidance on the “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format” that offers recommendations on preparing this section in prescription drug labeling. “Not all of the information identified in this guidance for inclusion in the Clinical Pharmacology section of
Drugs
FDA has granted Biostage an orphan drug designation for Cellspan Esophageal Implant to restore the structure and function of the esophagus after esophageal damage from cancer, injury or congenital abnormalities. “Based on preclinical, large-animal studies conducted to date, we believe our Cellspan esophageal implants may have the potential to
Drugs
FDA has released a draft guidance on “Physiologically Based Pharmacokinetic Analyses — Format and Content” that outlines the recommended format and content for a sponsor to submit physiologically based pharmacokinetic (PBPK) analyses to support applications. To enable efficient and consistent review, the document recommends including the following five sections in a
Drugs
FDA has granted Arsanis fast track status for ASN100 for preventing Staphylococcus aureus pneumonia in mechanically ventilated patients who are at high risk for the condition. “Despite current antibiotic treatments, S. aureus pneumonia has a mortality rate as high as 30% in this patient population, according to the company. ASN100
Drugs
FDA could see a $500 million funding boost over the next 10 years after the House passed the 21st Century Cures Act in a 392-26 vote Wednesday (11/30) night. The bill now heads to the Senate and could be voted on as early as next week. The White
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FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with refractory classical Hodgkin lymphoma (cHL) or for patients who have relapsed after three or more prior lines of therapy. The user fee review target action date is 3/
Drugs
FDA says changes have been made to the list of approved REMS (Risk Evaluation and Mitigation Strategies). The updates include: * Ariad’s Iclusig REMS modified to update data on incidence of arterial occlusive and venous thromboembolic events; * Endo’s Xiaflex REMS modified to remove the communications plan and make other
Drugs
Two lengthy, detailed reports from the Project on Government Oversight (POGO) “document the extent to which FDA depends upon funding from the pharmaceutical industry — money that comes with extraordinary strings attached.” The group calls on Congress to reject the latest reauthorization of the Prescription Drug User Fee Act (PDUFA) and
Drugs
Egalet Corp. has filed a supplemental NDA for Oxaydo (oxycodone HCl) tablets for an abuse-deterrent label claim for the intravenous route of abuse. The sNDA includes Category 1 in vitro data that demonstrate Oxaydo resists extraction of oxycodone and, based on its gelling properties, is more difficult to draw
Drugs
CDER has issued its latest quarterly report on the work of its Data Standards Program Board, which is the governing body for data standards initiatives. A data standards program action plan calls for quarterly updates to internal and external stakeholders with an overview and progress update of current data standards
Drugs
FDA has denied petitions filed by Sun Pharmaceutical and Emcure Pharmaceuticals asking it to determine that Wyeth’s original Protonix IV for injection was not withdrawn for reasons of safety or efficacy and thus an ANDA could be filed citing the Wyeth formulation. The denial letter says that based on
Drugs
Pfizer says its pivotal REFLECTIONS B3271002 study, a comparative safety and efficacy study of biosimilar candidate PF-05280014 versus Genentech’s Herceptin (trastuzumab), met its primary endpoint. “The trial demonstrated equivalence in the primary endpoint of objective response rate (ORR) of PF-05280014 versus Herceptin, taken in combination with paclitaxel,
Drugs
FDA has set a user fee review goal date of 7/7/2017 for an Emmaus Life Sciences NDA for its orally administered pharmaceutical grade L-glutamine treatment for sickle cell disease. The submission is based on data from a Phase 3 study that demonstrated a reduction in the frequency
Drugs
FDA published 11/29 in the Federal Register a final rule specifying import data that must be submitted through the agency’s Automated Commercial Environment (ACE) when an FDA-regulated product is offered for import into the U.S. Writing in an FDA Voice blog post, agency deputy commissioner for
Drugs
Prescription Lab Compounding Pharmacy and Stonegate Pharmacy have been cited in two recent Warning Letters as part of FDA’s increased scrutiny of drug compounding operations. In a Warning Letter to Prescription Lab, the agency said it observed a serious deficiency in its practices for producing sterile drug products. Specifically,