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
FDA Policy/General
Federal Register notice: FDA has announced fiscal year 2020 rates for the establishment and re-inspection fees related to entities that compound human drugs and register as outsourcing facilities. They are: small business establishment fee ($5,599), non-small business establishment fee ($18,288), and inspection fee ($16,798) for
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-
Devices
FDA has cleared 510(k)s for four previously cleared Zeus Scientific tests with new indications to aid in diagnosing Lyme disease. The tests represent the “first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection entitled “Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities.” The collection supports proposed research on operational barriers and opportunities related to the outsourcing facility market and business viability; knowledge and operational barriers and opportunities
FDA Policy/General
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
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.
Devices
FDA has approved an Intersect Ent PMA for its Straight Delivery System for use in placing the company’s Propel Mini steroid-releasing implant in the ethmoid sinus. The company says Propel is intended to help maintain the sinus opening while delivering mometasone furoate directly where it is needed, improving
FDA Policy/General
Federal Register notice: FDA has determined that Andrx Labs’ Fortamet (metformin hydrochloride) extended-release tablets, 500 mg and 1 g, were not withdrawn from sale for safety or effectiveness reasons. The determination means that FDA can continue to approve ANDAs that refer to these products as long as they meet
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;
FDA Policy/General
DEVICES FDA has approved a Cook Medical PMA for its lower-profile Zenith Alpha Thoracic Endovascular Graft, indicated for the endovascular treatment of patients with isolated lesions within the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair. The device features a 16-20 French delivery
FDA Policy/General
Daiichi Sankyo, Inc., the U.S. subsidiary of Daiichi Sankyo Company, will establish a new U.S. headquarters in Basking Ridge, NJ to continue collaboration between the business segments, enabling innovation in its existing and emerging therapeutic areas such as cardiology, oncology, pain and other areas where there are unmet
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
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Metal Expandable Biliary Stents — Premarket Notification (510(k)) Submissions.” It provides recommendations for information and testing that should be included in submissions for metal expandable biliary stents and their associated delivery systems intended to provide luminal patency of malignant
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
Devices
FDA has cleared a MiRus 510(k) for the Cygnus Anterior Cervical Plate System. The device features an “I-beam design“ and the metal alloy used in the plate allows for a smaller footprint than other marketed devices, the company says. Its narrower profile will lead to “less retraction and
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