Drugs
A National Institutes of Health (NIH) advisory committee approved 6/21 a proposal to use the CRISPR genome-editing technology in a human trial to help augment cancer therapies that rely on enlisting a patient’s T cells. The journal Nature reports that the NIH Recombinant DNA Research Advisory Committee
Drugs
Why does FDA turn its head when pharmaceutical companies publish glowing reports in medical journals about their drugs and clinical trial data, particularly when it goes against the agency’s own statistical analyses it performed when reviewing data in a marketing application? That is the question Duke University Medical Center
Drugs
AdvaMed says it would like to better understand the relationship between an FDA draft guidance on human factor studies and related clinical study considerations in combination product design and development and a recently issued guidance on applying human factors and usability engineering to medical devices. Commenting on the new draft,
Drugs
FDA and the European Medicines Agency (EMA) have expanded their international collaboration by setting up a new forum or “cluster” on patient engagement. The working group will teleconference several times a year to share experiences and best practices on the way the two agencies involve patients in drug development, evaluation
Drugs
Two drug compounding pharmacists from Alabama have been sentenced to 12 and 10 months in prison for their roles in distributing adulterated drugs that were compounded at the now-defunct Advanced Specialty Pharmacy doing business as Meds IV. David Allen, the former pharmacist-in-charge of Meds IV, and William
Drugs
FDA says it has approved an sNDA modifying the Risk Evaluation Mitigation Strategy (REMS) for Lundbeck’s anticonvulsant Sabril (vigabatrin) by removing some REMS elements. An agency statement says that FDA determined that although the risk of vision loss with Sabril still exists, the REMS should be modified to remove
Drugs
An FDA inspection at Burzynski Manufacturing Facility, Stafford, TX, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals, according to a 6/13 Warning Letter. Stanislaw Burzynski has been the subject of FDA Warning Letters and other enforcement actions at his Houston clinic since at least 2009.
Drugs
Visium Asset Management partner Sanjay Valvani, who was recently arrested and charged with insider trading in a scheme that involved a former FDA Office of Generic Drugs official (see earlier story), has been found dead in an apparent suicide at his New York home. Former FDA Office of Generic Drugs
Drugs
The National Institutes of Health (NIH) says that its new Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research “sets the expectation that multi-site studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research.
Drugs
In a decision that could hurt the drug and biologic industry over intellectual property rights, the U.S. Supreme Court has decided Cuozzo Speed Technologies, Inc. v. Lee, holding that, in an inter partes review, the Patent and Trademark Office (PTO) may give a patent claim its broadest reasonable interpretation
Drugs
Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization say they share FDA’s goal of ensuring adequate study of and labeling for use of drug and biological products in children. In a comment to an agency draft guidance on the content and process for submitting initial pediatric
Drugs
FDA and the Reagan-Udall Foundation are creating a “central repository or clearinghouse” where useful and relevant information on the expanded access process could be stored in one place — a “one-stop-shop” for physician and patients, according to a blog post by CDER deputy director for science operations Richard
Drugs
FDA has granted Fate Therapeutics a fast track designation for ProTmune for reducing the incidence and severity of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT). The company says it is currently investigating ProTmune in an open-label Phase 1/2 clinical trial that
Drugs
FDA has approved a Sangamo BioSciences IND for SB-913, a zinc finger nuclease (ZFN)-mediated approach designed as a single treatment with the potential to provide a long-lasting therapy for Mucopolysaccharidosis Type II (MPS II, Hunter syndrome). The company is planning a Phase 1/2 clinical trial to
Drugs
In another setback for the Obama Administration’s get-tough crackdown on FDA-regulated company executives in fraud cases, a jury in Boston federal court has acquitted former Warner Chilcott president W. Carl Reichel of conspiring to pay kickbacks to physicians. The case stemmed from an earlier government investigation that
Drugs
FDA has accepted for review an Emergent BioSolutions supplemental BLA seeking approval to make BioThrax (anthrax vaccine adsorbed) at the company’s large-scale manufacturing facility (building 55). “Emergent’s large-scale manufacturing facility, intended to increase the manufacturing capacity for BioThrax to an estimated 20 to 25 million doses
Drugs
Lannett is asking FDA to grant an AA therapeutic equivalence (TE) rating for its morphine sulfate oral solution, 100 mg/5 mL. The petition says that the company was told by a CDER staff person that the rating is required to claim the exception for payment of PDUFA establishment and
Drugs
FDA has posted drug safety labeling changes approved for 86 drugs, including a new Boxed Warning for risks of cardiovascular thrombotic events, heart failure, and edema for 39 drugs — Atnahs’ Anaprox (naproxen), Ansaid (flurbiprofen), Searle’s Arthrotec (diclofenac sodium/misoprostol), Cumberland’s Caldolor (ibuprofen), Depomed’s Cambia (diclofenac potassium), Cataflam
Drugs
Three Fish & Richardson attorneys say that Amgen has filed another Biologics Price Competition and Innovation Act (BPCIA)suit against Sandoz, this time for infringement of two key Neulasta patents. Writing in an online blog post, the attorneys say that Amgen claims that Sandoz’ filing of its aBLA for a
Drugs
FDA and Catalyst Pharmaceuticals have reached agreement on a confirmatory Phase 3 study protocol for Firdapse (amifampridine phosphate), indicated for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS). As part of the clinical protocol for the confirmatory study, Catalyst says it will initiate a small, single-center study with
Drugs
FDA has granted Vanda Pharmaceuticals three years marketing exclusivity due to a supplemental NDA approved last month for Fanapt (iloperidone) that modified and expanded its prescribing information for use as a maintenance treatment for schizophrenia in adults. The agency added the exclusivity notice to its Orange Book providing marketing protection
Drugs
A Nelson Hardiman blog post says that the 21st Century Cures Act would weaken FDA oversight of new drugs and new uses for existing drugs. The post says that the bill would allow “evidence from clinical experience” to substitute for evidence gathered from clinical trials. “Essentially, doctors’ anecdotes would be