Vaxart, a privately held company developing vaccines that are administered by tablet rather than...
The recent FDA approval of Harvoni, Gilead Sciences’ once-daily, single-tablet regimen to treat...
Vertex announced that the FDA’s Pulmonary Allergy Drugs Advisory Committee voted 13-2 to recommend approval of KALYDECO® in people with cystic fibrosis ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory gene, which is the indication being reviewed by the FDA.
The FDA has accepted the filing of a New Drug Application for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being studied for the treatment of adults with type 2 diabetes.
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the FDA voted 7 to 0 to support the approval of AIN457, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
The October issue of Pharmaceutical Processing describes Capsugel’s merger with Bend Research and Encap to create a comprehensive solid dosage form solutions group. The issue also features articles on supply chain trends including how to reduce risk, managing a clinical supply chain, a look at the best printing and coding solutions, and the move to the fully connected enterprise. Other articles focus on particle size analysis, disposable chromatography technologies, and monitoring potency assays.
The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in Hylenex, and the Patheon facility in Greenville, North Carolina, for production of finished Hylenex product.
The U.S. Food and Drug Administration says it has approved new labeling for another opioid designed to limit painkiller abuse. The FDA said Friday that Pfizer Inc.'s Embeda can have labeling indicating that it has properties expected to reduce abuse of the drug when it is crushed and taken orally or snorted.
Chimerix has received FDA clearance to proceed with a trial examining the safety and effectiveness of its brincidofovir tablets in patients who have the virus.
Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix should remain on the anti-smoking drug until it can reevaluated based on new, rigorous study information. Eleven advisers to the Food and Drug Administration voted to retain the so-called black box warning.
The development of a vaccine to prevent Ebola virus disease will be accelerated with support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).
Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities.
Hospira has announced the voluntary recall of certain lots of several products in its LifeCare™ line of flexible intravenous solutions due to the potential for leakage.
Federal regulators say Pfizer has provided low-quality evidence to support its request to remove a bold-letter warning from its anti-smoking drug Chantix about suicidal behavior. The twice-a-day tablet has carried the FDA's strongest warning label, known as a black box, since 2009 following reports of suicidality, hostility and depression among some patients.
This NDA requests FDA approval of palbociclib, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.
Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, today announced that the FDA has approved VELCADE® for injection for use in previously untreated patients with mantle cell lymphoma. VELCADE is the first treatment in the United States to be approved for use in previously untreated patients with MCL.
Genentech announced that the FDA has accepted to file the company's supplemental Biologics License Application and granted Priority Review of Lucentis® for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7 million Americans. The FDA confirmed action date is February 6, 2015.
Bristol-Myers Squibb has decided that it will not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.
Officials at Texas Health Presbyterian Hospital said Monday that their patient, Thomas Eric Duncan, is in critical condition and being treated with brincidofovir, an oral medicine developed by Chimerix Inc.
Shares of Sunesis Pharmaceuticals tanked Monday, wiping out all their gains for 2014 and then some, after the drug developer said its treatment for an aggressive form of blood cancer missed its main goal in late-stage testing.
AbbVie has announced that the FDA has approved the extension of the HUMIRA indication for moderately to severely active polyarticular juvenile idiopathic arthritis to reducing signs and symptoms in patients ages 2 and older. HUMIRA was approved in the United States in 2008 for polyarticular juvenile idiopathic arthritis in patients ages 4 and older.
Zogenix has submitted a Food and Drug Administration application for a new formulation of Zohydro that is designed to be more difficult to snort or inject — two common methods for abusing painkillers. Zogenix expects approval in the first quarter of 2015, which would allow the drugmaker to replace the older version of Zohydro in the second quarter.
FDA Approves NeuroGenetic Pharmaceuticals Application to Begin Clinical Trials for Its Alzheimer’s Disease CompoundSeptember 29, 2014 12:06 pm | News | Comments
The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application from NeuroGenetic Pharmaceuticals, Inc. (NGP) to begin clinical trials on its NGP 555 compound to treat and prevent Alzheimer’s disease (AD).
Allergan announced today that the U.S. Food and Drug Administration (FDA) has approved OZURDEX® (dexamethasone intravitreal implant) 0.7 mg, a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema (DME).
Alimera Sciences and pSivida said Friday the FDA approved their eye disease implant Iluvien. Iluvien is an implant delivered by injection that is intended to treat diabetic macular edema, a condition that can cause blurred vision and blindness.
The FDA cleared Humira as a treatment for moderate to severe Crohn's disease in children ages six and older when those children haven't been helped by other treatments, AbbVie said. Humira can be administered at home, unlike similar drugs used to treat the condition.
Pacira Pharmaceuticals Inc. said Thursday that it received a warning letter from regulators about marketing for an injectable drug that numbs post-surgical pain that the letter says is misleading.
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