Drugs
The U.S. Pharmacopeia commends FDA for its draft guidance to enhance the utility and usability of the inactive ingredient database (IID) and says it has seen marked enhancements in the document. “We believe the information presented in the draft guidance will help reduce discrepancies between the IID and USP-
Drugs
CDER director Janet Woodcock and CBER director Peter Marks review in a New England Journal of Medicine editorial some of the regulatory, ethical, and other considerations that arise with true individualized therapies. After describing cases in which single patients were treated with an individualized gene therapy, Woodcock and Marks ask
Drugs
FDA has issued a guidance, Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination, describing an optional streamlined submission process for determining whether use of an investigational in vitro diagnostic (IVD) in a clinical trial for an oncology therapeutic is considered significant risk, nonsignificant risk,
Drugs
FDA has approved Octapharma’s Wilate (von Willebrand factor/coagulation factor VIII complex) for treating adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes. The human plasma-derived factor VIII was originally approved in
Drugs
FDA has denied a Public Citizen 11/15/17 petition asking that it immediately remove from the market all medications containing the angiotensin II receptor blocker olmesartan medoxomil, including branded drugs Azor, Benicar, Benicar HCT, and Tribenzor, as well as all generic versions of the drugs. FDA’s denial letter
Drugs
Clarus says FDA should establish clear written guidance on safety and efficacy standards required for oral testosterone-ester prodrugs as testosterone replacement therapy for adult men with a deficiency or absence of endogenous testosterone. A company petition also asks that the agency not approve any pending NDA for an oral
Drugs
FDA has issued Aurobindo a Form-483 after an inspection last month at the firm’s Unit 7 manufacturing facility in Telangana, India. It appears the agency has stepped up enforcement at the company following earlier inspections that uncovered data integrity and other concerns. Aurobindo says the September GMP inspection
Drugs
The Institute for Clinical and Economic Review (ICER) says it has identified seven drugs that lack evidence that was adequate to support a claim of additional clinical benefits to justify a price increase. The drugs listed in the group’s first annual report on unsupported price increases of prescription drugs
Drugs
Public Citizen says FDA should remove from the market Amag Pharmaceuticals’ Makena (hydroxyprogesterone caproate) and all of its generic forms, indicated for preventing pre-term birth in certain pregnant women, because it is not effective. The advocacy organization says it and an expert in maternal-fetal medicine filed a petition
Drugs
An 11/5-11/9/18 FDA inspection at Herbal Healer Academy, Mountain View, AR, found multiple violations of the Federal Food, Drug, and Cosmetic Act, according to a 9/12 Warning Letter. The letter first says the company takes orders for products that are listed with health claims on
Drugs
FDA has awarded $4.1 million to fund two new research grants for natural history studies in rare diseases, which are intended to help design efficient clinical trials to test future treatments. Natural history studies examine how specific diseases progress, “through the presymptomatic and clinical stages, to a final outcome
Drugs
Flatiron Health says it welcomes the revised International Council for Harmonization (ICH) E8(R1) guidance on general considerations for clinical trials, including changes that “recognize the increasingly important role a wider range of study designs and data sources can play in drug development.” The company comment says Flatiron particularly appreciates
Drugs
FDA has approved a Clinuvel NDA for Scenesse (afamelanotide) for increasing pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria. Scenesse, a melanocortin-1 receptor agonist that is administered subcutaneously, increases the production of eumelanin in the skin independent of
Drugs
California Gov. Gavin Newsom has signed state legislation to combat “illegal, secretive deals between pharmaceutical companies in which one drug company pays its competitor to delay the competitor’s research, production, or sale of a competing version of its drug.” A news release from state attorney general Xavier Becerra says
Drugs
FDA says it manually reviewed over 200 of NuCare Pharmaceuticals’ listing files from 8/2017 to the present and identified “many instances where the listing information failed to comply with the applicable requirements.” A 9/26 Warning Letter says the firm has failed to address many of the listing deficiencies
Drugs
A Philadelphia jury delivered an $8 billion punitive verdict against Johnson & Johnson and its alleged improper marketing of the antispychotic drug Risperdal, according to a Law.com article. The three-week trial in Murray v. Janssen Pharmaceuticals resulted in the largest penalty to date in the Risperdal litigation, which
Drugs
FDA says that heparin manufacturers are reporting that African swine fever in China is not affecting the drug’s manufacturing and distribution to the U.S. market. The blood thinner is used as a treatment for heart attack patients, and it is often prescribed to patients before and after certain
Drugs
Pfizer has agreed to license Akcea Therapeutics’ Akcea-AngPtl3-L, an investigational antisense therapy being developed for certain cardiovascular and metabolic diseases. The therapy is designed to reduce the production of angiopoietin-like 3 protein in the liver, a key regulator of triglycerides, cholesterol, glucose and energy metabolism, Akcea says.
Drugs
FDA has approved a Pfenex Inc. 505(b)(2) NDA for PF708 (teriparatide injection) that referenced Eli Lilly’s Forteo, indicated for treating osteoporosis in certain patients at high risk for fracture. According to Pfenex, Forteo had $1.6 billion in global sales last year. Pfenex says it has asked
Drugs
FDA has approved a Galderma NDA for Aklief (trifarotene) Cream, 0.005% for topically treating acne. Trifarotene, which is the first new retinoid molecule to receive FDA approval in more than 20 years, selectively targets retinoic acid receptor (RAR) gamma, according to the company. It is the first topical specifically
Drugs
FDA has granted Mereo BioPharma Group fast track status for navicixizumab and its use for treating high grade ovarian, primary peritoneal or fallopian tube cancer in patients who have received at least three prior therapies or prior bevacizumab. Navicixizumab is an anti-DLL4/VEGF bispecific antibody and one of two
Drugs
As part of FDA’s Safe Use Initiative, CDER director Janet Woodcock has announced a “funding opportunity for individuals and organizations to conduct further research about the safe use of medications in order to inform the development of innovative methods to mitigate or reduce risks related to medication use.” Research