Drugs
An 11/7 petition filed by Lassman Law & Policy on behalf of an unnamed client asks FDA not to approve a pending NDA for Amryt Pharma’s Filsuvez (oleogel-S10) to treat cutaneous manifestations of junctional and dystrophic epidermolysis bullosa (EB) without additional clinical data demonstrating it is safe
Drugs
After an almost 18-year career at FDA, former FDA reviewer Sarah McGarry has joined consulting firm Greenleaf Health as senior vice president of drug and biological products. “As an infectious disease specialist, Sarah dedicated much of her career to CDER’s antivirals division, where she played a significant role
Drugs
FDA has published a guidance, Real-Time Oncology Review, with recommendations to applicants on the process for submitting selected NDAs and BLAs with oncology indications for review under Real-Time Oncology Review (RTOR). The document does not address the agency’s expedited programs and notes that ROTR is separate from
Drugs
Imbria Pharmaceuticals says it is planning a Phase 3 study of ninerafaxstat, a novel cardiac mitotrope and partial fatty acid oxidation inhibitor, in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). The move comes as the company is reporting data from its Phase 2 IMPROVE-HCM clinical trial, which it
Drugs
Nurse Assist has recalled 0.9% sodium chloride irrigation USP and sterile water for irrigation USP due to the potential for a lack of sterility assurance. The products were sold under the following brands: Nurse Assist, Cardinal, Covidien, Halyard Owens Minor, Idexx, Mac Medical, McKesson, Medichoice Owens Minor, Medline, Sol,
Drugs
In a bid to stimulate the domestic pharmaceutical industry and secure the U.S.’s drug supply chains, Congresswoman Claudia Tenney (R-NY) has introduced the Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. The bill proposes various tax incentives aimed at enticing pharmaceutical companies
Drugs
FDA has republished a 3/2021 guidance, Covid-19 Container Closure System and Component Changes: Glass Vials and Stoppers, with a note that the document is intended to remain in effect until 8/7/2024 unless superseded by a revised final guidance before that date. The guidance collated recommendations for
Drugs
Three CDER researchers say 39% of the 240 requests for a breakthrough therapy designation (BTD) submitted from 1/1/2017 through 12/31/2019 were granted by the agency, while 61% were denied. Writing in the open-source Therapeutic Innovation & Regulatory Science, the researchers say approval of requests was
Drugs
FDA has released the 20-page form FDA-483 issued following a 10/12-10/20 inspection at Kilitch Healthcare India, a sterile drug manufacturing facility in Navi, Mumbai, Maharashtra, India. The 14 inspection observations were: * failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug
Drugs
In a major move aimed at curbing rising drug prices and promoting fair competition, the Federal Trade Commission (FTC) has challenged the legitimacy of more than 100 patents listed in FDA’s Orange Book (also known as “Approved Drug Products with Therapeutic Equivalence Evaluations”). The disputed patents are held by
Drugs
Attorney Douglas Farquhar and senior regulatory expert Richard Lewis (Hyman, Phelps & McNamara) say the fact that FDA has conducted fewer than 10 remote interactive evaluations (RIEs) at drug manufacturing sites since 4/2021 is a “missed opportunity,” given that on-site inspections dropped off dramatically three years ago due
Drugs
Law firm Sidley has petitioned FDA on behalf of an unnamed client asking that it not grant orphan-drug exclusivity (ODE) to Pyros Pharmaceuticals’ vigabatrin oral solution (PYR-003), indicated for infantile spasms, unless Pyros can demonstrate that its version of vigabatrin is “clinically superior” to all previously approved versions.
Drugs
Kodiak Sciences says it will conduct another clinical study to support a single BLA for tarcocimab tedromer and its use in three indications — macular edema following retinal vein occlusion, wet age-related macular degeneration and non-proliferative diabetic retinopathy (NPDR). Kodiak says the regulatory pathway was recently discussed with FDA
Drugs
FDA has granted Plus Therapeutics an orphan drug designation for rhenium obisbemeda, an injectable radiotherapy for treating breast cancer with leptomeningeal metastases (LM). The therapy is currently being evaluated in the ReSPECT-LM Phase 1/2a dose escalation clinical trial. FDA previously granted rhenium obisbemeda a fast track designation for
Drugs
FDA has posted a final guidance entitled “Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory.” The document provides technical specifications for submitting clinical outcome assessment (COA) data that use “Item Response Theory (IRT)” under CDER’s Patient-Focused Drug Development program. It explains that
Drugs
FDA has approved a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) tablets 10 mg and 20 mg, a potassium-competitive acid blocker for treating adults with all grades of erosive esophagitis (also known as erosive gastroesophageal reflux disease (GERD)) and relief of heartburn associated with erosive GERD. Approval is based on
Drugs
FDA has published a final guidance entitled “Submitting Patient-Reported Outcome Data in Cancer Clinical Trials.” The document provides technical specifications for submitting patient-reported outcome (PRO) data collected in cancer clinical trials to support a marketing application for a medical product in oncology. It defines a PRO as a
Drugs
House Committee on Oversight and Accountability chairman James Comer (R-KY) and Subcommittee on Health Care and Financial Services chairwoman Lisa McClain (R-MI) are calling on FDA to provide extensive information on its response to a growing number of what they say are critical drug shortages delaying and prohibiting
Drugs
FDA has accepted for review a Supernus Pharmaceuticals NDA resubmission for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease. The agency has set a user fee review action target date of 4/5/2024. FDA 10/2022 issued a
Drugs
The Harvard Drug Group (doing business as Major Pharmaceutical and Rugby Laboratories) has recalled all lots of polyvinyl alcohol, 1.4% lubricating eye drops and lubricating tears eye drops (dextran/hypromellose, 0.1%/0.3%). The products are supplied by Velocity Pharma and Harvard Drug Group received information from FDA
Drugs
Eli Lilly says that an FDA review decision for its experimental Alzheimer’s drug donanemab has been pushed back to the first quarter of 2024. It had previously expected an agency decision by 12/31. In an 11/2 earnings call, Lilly said FDA asked for more time to evaluate
Drugs
Three CDER Office of Clinical Pharmacology researchers say their comprehensive retrospective analysis of the data supporting manufacturing changes for licensed monoclonal antibodies and Fc-fusion proteins “provides an understanding of the regulatory experience and industry practice, which could facilitate developing appropriate comparability approaches to support manufacturing changes in the future.