Posted by Jack Mans, Plant Operations Editor -- Packaging Digest, 4/16/2013 4:06:47 PM The U.S. Food and Drug Administration (FDA) has announced that it is extending the deadline for comments on a 300-page traceability report created by the ...
Tags: FDA, IFT Traceability, Packaging
Pharming Group and Santarus have announced the submission of Ruconest (recombinant human C1 esterase inhibitor) biologics license application to the FDA. Investigational drug Ruconest 50 U/kg is being developed for the treatment of acute ...
BioFire Diagnostics has submitted 510(k) Application to the US Food and Drug Administration (FDA) for its FilmArray Blood Culture Identification (BCID) Panel. The BCID panel provides automatic results for the most common infectious causes ...
Tags: Biofire, Filmarray Blood Culture
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Carticept Medical's new computer-controlled injection system. The new Navigator Delivery System (DS) is designed to increase the efficiency, comfort, safety and ...
BD Medical, a division of Becton, Dickinson and Company, has introduced BD UltraSafe PLUS passive needle guard in the US. The FDA-cleared anti-needlestick safety device is developed by an anti-needlestick device company Safety Syringes, ...
Tags: Bd Medical, Needle Guard
The USFDA has accepted Otsuka Pharmaceutical's new drug application (NDA) of tolvaptan for priority review to treat autosomal dominant polycystic kidney disease (ADPKD). The filing was based on Phase III clinical trial results of the drug ...
Tags: Otsuka Tolvaptan NDA, Medicine
Indian pharmaceutical company Dr Reddy's Laboratories has initiated recall of over 117,000 bottles of its tizanidine tablets from the US market over labeling issue. The United States Food and Drug Administration (USDA) issued a ...
Tags: printing, Dr Reddy's Laboratories
Pfizer has received breakthrough therapy designation from the United States Food and Drug Administration (FDA) for its investigational compound Palbociclib, a potential treatment for patients with breast cancer. The breakthrough therapy ...
Tags: Cancer Drug, Pfizer, Therapy Designation
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Teleflex's ISO-Gard Mask with ClearAir technology. The ISO-Gard Mask is designed to reduce waste anesthetic gas (WAG), exhaled by the patients who are recovering in ...
Tags: FDA, Drug, Anesthetic Gas
Mercodia, a developer of immunoassays, has entered into a collaboration agreement with Profil Institute for Clinical Research. Under the alliance, Mercodia will offer its enzyme-linked immnosorbent assays (ELISA) as a component for Profil ...
Tags: Profil Institute, Mercodia, Clinical
The US Food and Drug Administration (FDA) has cleared Sophono's Alpha 2 magnetic implant system for use with magnetic resonance imaging (MRI). The clearance allows US patients implanted with Sophono Alpha 2 abutment-free, bone conduction ...
Tags: FDA, Drug, magnetic implant system
Activaero has reported the positive results from its phase II trial in children with mild to moderate asthma. The proof-of-concept trial was conducted with Activaero's drug-device combination consisting of budesonide in liquid formulation ...
Tags: Activaero, phase II trial, moderate asthma
Aeterna Zentaris has signed a co-development and profit sharing agreement with Ergomed Clinical Research for AEZS-108 in endometrial cancer. Ergomed has been selected as the contract clinical development organization to conduct the Phase ...
Inventiva and Novalix have entered into a strategic alliance to discover the clinical candidates, targeting nuclear receptors. As part of the agreement, Inventiva and NovAliX offer pharmaceutical and biotech companies a set of fully ...
Tags: NovAliX, clinical candidates
Private equity firm Water Street Healthcare Partners has invested in CCBR-SYNARC, to expand its global presence in the pharmaceutical services sector. The investment marks the health care firm's first investment from its new fund, Water ...