FDA: latest news - GoINPHARMA
Tuesday, 22 January 2019 - 3:42

FDA

The value of human tissue studies in Translational Research

The increasing gap between R&D expenditures and the approval of new medicines by regulatory authorities is a matter of debate between R&D managers of the pharmaceutical industry since the 2000s. An analysis of the number of NMEs (New Molecular Entities)…

FDA approves Roche’s Hemlibra, novel therapy for hemophilia A

Roche has announced that FDA has approved Hemlibra (emicizumab) for routine prophylaxis in adults and children with haemophilia A with factor VIII inhibitors.  Approximately 30% of haemophilia A patients can develop inhibitors against factor VIII replacement therapies. This puts them…

Rare diseases: FDA awards grants over 6 million dollars

FDA has announced it has awarded six grants for rare diseases research. Specifically, the studies will focus on rare disease natural history, that is the course a disease takes from its onset, through the presymptomatic and clinical stages, to a…

FDA approves test to detect Zika virus in blood donations

FDA has approved the cobas Zika test, by Roche Molecular System, in order to detect the Zika virus in plasma obtained from volunteer donors of whole blood and blood components. The test detects the virus in blood donations, it is…

FDA: which is the best approach to drug assessment studies?

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, warned a workshop at the National Academies of Sciences, Engineering, and Medicine that the clinical trials system appears inadequate, but new ways to collect and assess the necessary data…

FDA approves Austedo, Teva’s treatment for tardive dyskinesia

Teva Pharmaceutical announced that FDA has approved Austedo (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults. The product was already approved last April for the treatment of chorea associated with Huntington’s disease. Tardive dyskinesia is a disabling and…

FDA approves Novartis’ Kymriah, first CAR-T therapy

Novartis announced that FDA has approved Kymriah (tisagenlecleucel – CTL019) suspension for intravenous infusion. Kymriah is the first CAR-T (Chimeric Antigen Receptor T cell) ever approved and is indicated for the treatment of refractory acute lymphoblastic leukemia (ALL) in adults…

Keytruda: first drug approved in US for biomarker-based cancers

FDA has approved for the first time a drug for the treatment of tumors based on a biomarker rather than the location in the body where they originated. The drug is MSD’s Keytruda (pembrolizumab), which was granted approval, by priority…

ALS: FDA approves Mitsubishi Tanabe Pharma’s Radicava

FDA today approved Mitsubishi Tanabe Pharma’s Radicava (edaravone) to treat patients with ALS (amyotrophic lateral sclerosis), also referred to as Lou Gehrig’s disease. After learning about the use of the product to treat ALS in Japan, the Administration contacted the…

FDA approves Xadago (Zambon) for Parkinson’s treatment

Zambon Group announced today, jointly with Newron Pharmaceuticals and US WorldMeds, that FDA has approved Xadago (safinamide). Xadago is a treatment for Parkinson’s disease which acts as a selective MAO-B inhibitor, in combination with levodopa/carbidopa. The approval has been granted…

FDA accepts two sBLAs for MSD’s Keytruda

MSD announced that FDA has granted Priority Review for two sBLAs (supplemental Biologics License Application) for Keytruda (pembrolizumab), an anti-PD-1 treatment for patients with metastatic or locally advanced urothelial carcinoma. The sBLAs refer to the use of the product as…

FDA approves Trulance for treatment of CIC

FDA approved Trulance (plecanatide), by Synergy Pharmaceuticals Inc., for the treatment of CIC (Chronic Idiopathic Constipation) in adult patients. The product works locally in the upper gastrointestinal tract to stimulate secretion of intestinal fluid and support regular bowel function. It…

FDA: new guidance on product communications, even off-label

The FDA released two draft guidance documents on how drug and device makers should communicate information about their products. In one of the documents, the US Agency set out guidelines on how to promote products for off-label use. Even if…

FDA in 2016 by the figures

What follows are the figures related to FDA activity in 2016. The US Agency approved 22 new drugs — down from 45 in 2015. However, some approvals were relevant, including those of MSD’ s Zepatier, Genentech’s Tecentriq and Sarepta’s much-debated…

FDA assesses early life anesthetic exposure

FDA remarked that the repeated or lengthy use of general anesthetic and sedation drugs during surgical procedures on children younger than three years, and pregnant women in their third trimester, may adversely affect brain development in children. The most recent…

FDA, OK for Eucrisa, Pfizer’s topical treatment for atopic dermatitis

Pfizer announced that FDA approved Eucrisa (crisaborole) ointment 2%. This is a novel non-steroidal topical PDE-4 (phosphodieterase-4) inhibitor for the treatment of mild-to-moderate atopic dermatitis in patients two years of age and older. The product is the first and only…

FDA grants fast track for Eisai/Biogen’s BACE inhibitor

Eisai announced today that its product E2609, BACE (Beta-secretase Cleaving Enzyme) inhibitor, has received Fast Track designation. The product is currently in Phase III development, specifically in clinical trials designed in order to assess its efficacy for early Alzheimer’s disease….

FDA, Response Letter for sarilumab

Regeneron Pharmaceuticals and Sanofi today announced that FDA issued a Complete Response Letter (CRL) regarding the BLA for sarilumab, an investigational interleukin-6 receptor antibody for the treatment of moderate-to-severe rheumatoid arthritis. The Response Letter refers to certain issues identified during…

FDA warning: hepatitis C drugs entail risk of HBV reactivation

FDA has detected serious risks for some patients who have been infected with the hepatitis B virus (HBV) and are being treated with DAA (direct-acting antiviral) drugs for hepatitis C (HCV). The US Agency has identified 24 cases of HBV…

FDA approves Medtronic’s “artificial pancreas”

FDA has approved Medtronic’s MiniMed 670G hybrid closed looped system. This is the first device approved by the US Agency that monitors glucose and allows to deliver the appropriate dose of basal insulin in patients with type-1 diabetes, 14 years…

FDA, priority review for Sanofi/Regeneron’s dupilumab in atopic dermatitis

Sanofi and Regeneron Pharmaceuticals today announced that FDA has accepted for priority review the BLA (Biologics License Application) for dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis. The PDUFA (Prescription Drug User Fee Act) should…

FDA approves Amjevita, a biosimilar to Humira

FDA has approved Amjevita, as a biosimilar to Humira (adalimumab) for treating multiple inflammatory diseases in adult patients. The drug is indicated for moderately to severely active rheumatoid arthritis, Crohn’s disease, ;active ulcerative colitis and plaque psoriasis. Amjevita has also…

Sarepta’s eteplirsen, first muscular dystrophy drug, has been approved

FDA approved today Sarepta’s Exondys 51 (eteplirsen) injection. This is the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). It is particularly indicated for patients with a specific mutation, which affects 13% of the population with DMD….

FDA, new possible approaches to cancer clinical trials

On a press release on its website, FDA focuses on trial design evaluation methods in oncology, in order to make the system more efficient and to more rapidly deliver new treatment options to patients. Therefore, FDA is working with the…