Drugs
FDA has accepted for priority review a Merck NDA for vericiguat, an oral soluble guanylate cyclase stimulator indicated to reduce the risk of cardiovascular death and heart failure hospitalization following a worsening heart failure event in patients with symptomatic chronic heart failure with reduced ejection fraction, in combination with other
Drugs
Four Hogan Lovells attorneys say the Department of Justice (DoJ) is now arguing to the Supreme Court that none of the provisions of the Patient Protection and Affordable Care Act may be severed from the unconstitutional provisions of the act. If the court agrees, they write in an online post,
Drugs
FDA’s Cardiovascular and Renal Drugs Advisory Committee provides a mixed vote (8 to 7) in favor of approval for Mallinckrodt’s terlipressin and its use to treat adults with hepatorenal syndrome (HRS) Type 1. The acute and life-threatening syndrome involves acute kidney failure in people with cirrhosis. A
Drugs
FDA has cleared a Clinical Computer Systems 510(k) for the Obix BeCA fetal monitor. The monitor features the company’s “Locate and Track” technology that detects and maintains contact with the fetal heartbeat. It also has high sensitivity ultrasound transducers that supports fetal monitoring in antenatal and difficult labor
Drugs
FDA has notified Tricida that the agency has identified deficiencies in the NDA for its drug candidate veverimer that is designed to treat metabolic acidosis in patients with chronic kidney disease. The company says it was told the deficiencies preclude discussion of labeling and postmarketing requirements at this time. Tricida
Drugs
FDA says it has approved changes to the labeling for Gilead’s Epclusa (sofosbuvir and velpatasvir) to provide for its use in treating chronic HCV infection in treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis. An agency notice summarizes the specific changes to the
Drugs
Four authors from law and medical schools are questioning the FDA reliance on objective evidence in approving medical products, arguing that it is difficult to obtain such evidence in treatments for brain injuries. The Stanford Technology Law Review article says the current agency regulatory approval process for new drugs and
Drugs
A Pennsylvania federal judge says that Teva will be the focus of the first trial over an alleged “overarching” industry-wide conspiracy to fix generic drug prices. Three other bellwether trials involving schemes to fix prices on three specific drugs will proceed on separate tracks, the judge said. Bloomberg Law
Drugs
FDA has approved a Janssen Pharmaceutical Companies supplemental BLA for tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA). The drug was approved in 2017 for treating adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Janssen says Tremfya is the first treatment
Drugs
FDA says that commissioner Stephen Hahn will be the keynote speaker at a 7/21 virtual public meeting seeking input on reauthorization of the Generic Drug User Fee Amendments of 2017 for FY 2023-2027 (GDUFA 3). The current GDUFA 2 authorization expires at the end of FY 2022 (9/
Drugs
FDA commissioner Stephen Hahn says the cross-Center Coronavirus Treatment Acceleration Program (CTAP), involving CBER and CDER staff, has reviewed more than 230 trials for potential Covid-19 treatment therapies. In a CTAP update report, Hahn also says there now are more than 510 Covid drug developmemt programs in planning
Drugs
FDA has issued a complete response letter seeking additional chemistry, manufacturing, and controls information from Verrica Pharmaceuticals for its NDA for VP-102, the company’s investigational proprietary drug/device combination to treat molluscum contagiosum. A company notice says the agency did not identify any clinical deficiencies. Verrica says it
Drugs
TriNetX has signed an agreement with the FDA Sentinel program under which the agency is licensing the full TriNetX analytics suite that provides direct access to de-identified real-world data in the TriNetX U.S. network for the FDA Office of Surveillance and Epidemiology and the Sentinel operations center.
Drugs
FDA has issued CytoDyn a refusal to file letter on its BLA for leronlimab (PRO 140), a CCR5 antagonist used in combination therapy with highly active antiretroviral therapy for highly treatment-experienced HIV patients. FDA’s letter said the BLA does not contain certain information needed to complete a substantive
Drugs
FDA has just released the FDA-483 issued following a 1/14-2/8/19 agency inspection at RC Outsourcing, Lowellville, OH. The eight inspection observations were: * failing to follow written production and process control procedures in the execution of production and process control functions; * failing to have a written
Drugs
Genentech says the Phase 3 IMagyn050 study showed that the addition of Tecentriq (atezolizumab) to Avastin (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival for front-line treatment of women with newly-diagnosed advanced-stage ovarian cancer. The company says safety data indicated that
Drugs
FDA reviewers are raising safety concerns about a GlaxoSmithKline BLA for belantamab mafodotin which heads to an Oncologic Drugs Advisory Committee meeting 7/14 for the proposed indication for treating adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38
Drugs
Sens. Marco Rubio (R-FL) and Elizabeth Warren (D-MA) have introduced legislation directing the Federal Trade Commission and the Treasury Secretary to study the United States’ over-reliance on foreign countries and the impact of foreign direct investment on the U.S. pharmaceutical industry and DNA analysis industries. A
Drugs
FDA has published a guidance, Risk Evaluation and Mitigation Strategies: Modifications and Revisions, with information on how the agency defines the types of changes to an approved risk evaluation and mitigation strategy (REMS), how application holders should submit changes to an approved REMS, and how FDA will process submissions from
Drugs
FDA says it is planning to begin high-priority domestic inspections (on-site surveillance) for medical products and other regulated products during the week of 7/20. Resuming domestic inspections will depend on the data about the “virus’ trajectory in a given state and locality and the rules and guidelines
Drugs
FDA has posted a drug safety-related labeling change for Eli Lilly and Incyte’s NDA for Olumiant (baricitinib 2mg), a once-daily oral drug for treating adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor inhibitor therapies.
Drugs
FDA has approved a Mylan and Fujifilm Kyowa Kirin Biologics Co. BLA for Hulio (adalimumab-fkjp), a biosimilar to AbbVie’s Humira (adalimumab), for treating rheumatoid arthritis, juvenile idiopathic arthritis (four years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis, in both