Drugs
FDA and the European Medicines Agency have published a report on their 11/26/18 workshop with stakeholders on support for quality development in early access approaches such as PRIME (priority medicines) and Breakthrough Therapy designation. “Experience to date has shown that applicants face challenges to complete quality and manufacturing
Drugs
FDA has published a draft guidance, General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products, to assist sponsors of NDAs, BLAs, and supplements who plan to conduct clinical studies in neonatal populations. The document says the guidance supplements a 2014 draft guidance on general clinical pharmacological considerations
Drugs
In a case involving a patent dispute between two drug companies, Washington Legal Foundation (WLF) has asked the 1st Circuit Court of Appeals to limit those who have standing to sue for damages for alleged antitrust violations. The WLF amicus brief says antitrust standing should be limited to those who
Drugs
HHS secretary Alex Azar told CNBC 7/30 that President Donald Trump is working on a proposal to allow the U.S. to import drugs from Canada. “I just got off the phone with him,” Azar said, “working on a plan on how we can import drugs safely and effectively
Drugs
A 12/11/18-1/2/19 FDA inspection at the Scientific Solutions Global drug manufacturing facility, Carle Place, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other issues. A just-released 6/28 Warning Letter says specific violations were: * failing to have,
Drugs
California attorney general Xavier Becerra says he has reached four settlement agreements with drug companies who entered into “pay-for-delay” agreements to delay lower-priced prescription drugs from entering the market. The settlements will result in the companies making payments of nearly $70 million to the state, he says.
Drugs
Public Citizen says the Federal Trade Commission should block the proposed merger of Pfizer’s Upjohn unit with Mylan because it is anti-consumer. The consumer advocacy group says the proposal “would merge two notorious price gouging and allegedly price fixing firms into a generics behemoth that swallows product lines
Drugs
CDER says that starting 8/19, pre-assigned NDA, IND, BLA, and DMF number requests can be submitted through the Center’s NextGen Portal. FDA made that option available for ANDAs in June, a notice says. The notice identifies benefits of submitting requests through the portal as ease of use,
Drugs
Bipartisan leaders of the House Energy and Commerce Committee are asking for an FDA briefing on (1) the potential threat to the U.S. heparin supply due to the outbreak of African swine fever in China and (2) any contingency plans in the event of a serious shortage. In a
Drugs
FDA has accepted for review a Sunovion Pharmaceuticals NDA for dasotraline, a novel dopamine and norepinephrine reuptake inhibitor for treating patients with moderate-to-severe binge eating disorder (BED). The agency has set a 5/14/2020 review action target date. The submission is based on data from two 12-
Drugs
FDA has granted Orchard Therapeutics a Regenerative Medicine Advanced Therapy designation for the company’s ex vivo autologous hematopoietic stem cell-based gene therapy (OTL-103) for treating Wiskott-Aldrich Syndrome (WAS). The designation was based on data from an interim analysis of a registrational trial in patients with severe
Drugs
FDA has posted a Form 483 after completing an inspection of First Pharma Associates in Spokane, WA last month. The inspection cited the firm for non-microbial contamination that was observed in the production area. FDA said its investigator observed personnel manually contacting the inner surface of containers and closures.
Drugs
FDA has issued a revised draft guidance, Rare Pediatric Disease Priority Review Vouchers. The document incorporates public comments received on an initial draft and provides FDA’s thinking on the Advancing Hope Act of 2016 provisions, which updated the definition of a rare pediatrics disease as one that is both
Drugs
Metal Expandable Biliary Stents Guide Federal Register notice: FDA makes available a final guidance entitled “Metal Expandable Biliary Stents — Premarket Notification (510(k) Submissions.” 07/26/2019 Info Collection on Device Export Approval Letters Federal Register notice: FDA sends to OMB an information collection extension for “Export of Medical Devices;
Drugs
FDA has posted a final guidance entitled “Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.” The document addresses the agency’s current thinking regarding the overall development program and clinical trial designs for systemic drugs administered to the kidney transplant recipient to support an indication of preventing delayed
Drugs
The Senate Finance Committee has voted 19-9 to advance the Prescription Drug Pricing Reduction Act (see earlier story). The Congressional Budget Office scored the bill and said it would save taxpayers, patients and the government $130 billion. If signed into law, committee leaders said the measure would modernize and
Drugs
FDA has approved a Black Boxed warning about an increased risk of blood clots and death with Pfizer’s tofacitinib (Xeljanz, Xeljanz XR) 10 mg twice daily dose,which is used in patients with ulcerative colitis. In addition, tofacitinib’s use for ulcerative colitis will be limited to certain patients
Drugs
FDA has granted Aeglea BioTherapeutics a breakthrough therapy designation for pegzilarginase, indicated for treating Arginase 1 Deficiency, a rare progressive disease presenting in early childhood that results in severe complications and early mortality. The designation is based on data from a Phase 1/2 and ongoing Phase 2 open-label
Drugs
FDA has cleared a Resonea 510(k) for the Drowzle Sleep Apnea Pre-screening Device, a smartphone app that records and analyzes respiratory patterns during sleep for the purpose of in-home screening for obstructive sleep apnea. Results from the app are intended to be used to assist healthcare professionals
Drugs
FDA has released the FDA-483 issued following a 5/7-5/31 inspection at QuVa Pharma, a Bloomsbury, NJ, outsourcing facility. The six inspections observations were: * the quality control unit lacks responsibility to approve and reject all procedures or specifications affecting the identity, strength, quality, and purity of drug
Drugs
Bristol-Myers Squibb says that part 2 of the Phase 3 CheckMate-227 trial did not meet the primary endpoint of overall survival with its Opdivo (nivolumab) plus chemotherapy versus chemotherapy in patients with first-line non-squamous non-small cell lung cancer, regardless of PD-L1 status. The company
Drugs
FDA has accepted for priority review an Epizyme NDA seeking accelerated approval for tazemetostat, indicated for treating metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. The agency has set a user fee review action target date of 1/23/2020. The submission is based primarily on data