Drugs
Boehringer Ingelheim says FDA should ensure that any NDA for a fixed-dose, triple-combination, inhaled drug product intended to treat patients with chronic obstructive pulmonary disease is not approved as safe and effective unless it meets Combination Rule requirements. In a petition, the company asks that FDA not approve
Drugs
FDA has cleared a GenMark Diagnostics 510(k) for both its ePlex instrument and Respiratory Pathogen Panel. The company describes ePlex as a transformational new in vitro diagnostic platform that integrates nucleic acid extraction, amplification, and detection processes into an automated, sample-to-answer system. The panel detects over 20
Drugs
FDA has issued Coherus BioSciences a complete response letter on its BLA for a biosimilar copy of Amgen’s Neulasta (pegfilgrastim), indicated for reducing the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated
Drugs
Gilead Sciences has submitted an NDA for a once-daily single tablet regimen containing bictegravir (50 mg), an investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) for treating HIV-1 infection in adults. The drug product has demonstrated high rates of virologic suppression and no treatment-
Drugs
FDA has accepted for review a Synergy Pharmaceuticals supplemental NDA for Trulance (plecanatide) for treating adults with irritable bowel syndrome with constipation. The user fee review target date is 1/24/2018. Trulance is currently approved for treating adults with chronic idiopathic constipation. The submission is based on data from
Drugs
Eli Lilly says it is planning a BLA before year-end after reporting positive results from three Phase 3 studies of galcanezumab, an investigational treatment for preventing episodic and chronic migraine, including data on several key secondary endpoints for galcanezumab compared to placebo at both studied doses. Data from EVOLVE-
Drugs
Public Citizen senior advisor Sidney Wolfe is criticizing FDA for originally approving Endo Pharmaceuticals’ controversial pain drug Opana ER (oxymorphone hydrochloride extended release) while condemning the company for being defiant in announcing that it is reviewing the agency’s request (see earlier story) to remove the product from the market.
Drugs
Pediatric Oncology Meeting Planned for 6/21-22 Federal Register notice: FDA announces a 6/21-22 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting. 06/8/2017 FDA Vaccines Panel Meeting to Review Hep B Vaccine Federal Register notice: FDA announces a 7/28 Vaccines and Related
Drugs
FDA has granted an OncoSec Medical an orphan drug designation for ImmunoPulse IL-12 (tavokinogene telsaplasmid) for treating unresectable metastatic melanoma. OncoSec is beginning a pivotal trial called PISCES trial to evaluate the safety and efficacy of ImmunoPulse IL-12 and pembrolizumab (Merck’s Keytruda) in patients with metastatic melanoma
Drugs
FDA has approved a Teva Pharmaceuticals ANDA for the first generic copy of Gilead’s Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg) for treating HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-
Drugs
The 21st Century Cures Act added a new section to the Federal Food, Drug, and Cosmetic Act on Qualification of Drug Development Tools that established an updated multi-stage process for drug development tool qualification. In an online notice, FDA says the process includes three submission milestones — Letter of Intent,
Drugs
FDA is asking Endo Pharmaceuticals to remove its Opana ER (oxymorphone hydrochloride) opioid pain medication from the market based on a concern that the drug’s benefits may no longer outweigh its risks. An agency news release says it is the first time FDA has taken steps to remove a
Drugs
FDA has removed a clinical hold to allow Inovio Pharmaceuticals to begin a Phase 3 study to evaluate the efficacy of its DNA-based immunotherapy, VGX-3100, to treat cervical dysplasia caused by human papillomavirus (HPV). Inovio says the study will evaluate VGX-3100 in regressing cervical HSIL (high-grade
Drugs
A Matrix Global Advisors paper estimating the market for REMS (Risk Evaluation and Mitigation) and other restricted distribution programs concludes that while there are valid public health reasons for restricted access programs for certain drugs, brand manufacturers can use the programs to block generic competition, with a direct negative impact
Drugs
The Trump Administration 6/6 said it has decided to allow NIH director Francis Collins to remain in his post. “I am honored to continue as the director of the National Institutes of Health and consider it a great privilege to serve at a time of unprecedented opportunity to advance
Drugs
A Stat online investigative report says FDA’s highly-touted Sentinel initiative, which mines insurance data and medical records to identify possible drug risks, “has had little measurable impact…. Ten years and $207 million later, critics question whether Sentinel can adequately identify risks involving drugs that are already in consumers’
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) on clinical consultative review of drugs regulated within the Office of New Drugs (OND). The document describes the clinical consultative review process for INDs, NDAs, BLAs, and supplemental NDAs and BLAs. The procedures “are intended to ensure quality and consistency
Drugs
FDA has cleared a W. L. Gore 510(k) for its Gore Synecor Preperitoneal Biomaterial hernia repair device, which offers treatment options for the full range of hernia cases, with configurations for both intraperitoneal and preperitoneal placement. The company says the device’s placement between tissue layers “makes tissue ingrowth
Drugs
Former FDA associate commissioner Peter Pitts says the agency should facilitate the exchange of truthful and non-misleading information between doctors and drug companies so that doctors would be better able to prescribe medications off-label to help their patients. Writing online for The Hill, Pitts says doctors currently make
Drugs
Novartis says an interim analysis of data from its Phase 2 JULIET study of tisagenlecleucel (CTL019) in adult patients with relapsed or refractory diffuse large B-cell lymphoma showed a three-month overall response rate of 45%, with 37% achieving a complete response and 8% achieving a partial response. Investigators
Drugs
FDA has approved a Hologic PMA supplement for the Genius 3D Mammography exam and its use being superior to standard 2D mammography for routine breast cancer screening of women with dense breasts. The device has been available in the U.S. since 2011, and the newly approved physician labeling is
Drugs
FDA says it is reviewing the safety of Roche’s Actemra (tocilizumab) for treating adults with moderate to severe rheumatoid arthritis. A Stat News article 6/5 raised safety concerns after it analyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs, and “found clear evidence that the