Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos

Regulatory Affairs
Return to: PBR Home | Regulatory Affairs

Regulatory Affairs

CanTx gets FDA orphan drug designation for Cantrixil to treat ovarian cancer By PBR Staff Writer
CanTx, the Novogen-Yale joint venture, has received orphan drug designation from the US Food and Drug Administration (FDA) for its chemotherapy candidate drug, Cantrixil, to treat ovarian cancer.
Regulatory Affairs > News
CymaBay gets FDA orphan drug status for MBX-8025 to treat hypertriglyceridemia By PBR Staff Writer
US-based biopharmaceutical firm CymaBay Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for MBX-8025 to treat patients with hyperlipoproteinemia types I or V (Fredrickson classification).
Regulatory Affairs > News FDA accepts for filing Bayer's sBLA for Betaconnect to treat RRMS By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted the filing Bayer's supplemental biologics license application (sBLA) for Betaconnect (proposed name), another delivery option for Betaseron (interferon beta-1b), a treatment for relapsing-remitting multiple sclerosis (RRMS).
Regulatory Affairs > News
See more Regulatory Affairs news

Latest Regulatory Affairs News and Insight

View all Regulatory Affairs news or find news targeted to your interests
FDA accepts for filing Bayer's sBLA for Betaconnect to treat RRMS
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted the filing Bayer's supplemental biologics license application (sBLA) for Betaconnect (proposed name), another delivery option for Betaseron (interferon beta-1b), a treatment for relapsing-remitting multiple sclerosis (RRMS).
Regulatory Affairs > News
Pfizer's lung cancer drug Xalkori gets FDA breakthrough therapy status
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Pfizer's Xalkori (crizotinib) to treat patients with ROS1-positive non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
Specialised Project & Technology Transfer- Laboratory Equipment & Automated Systems
| By SHL Technologies
A US-based company dedicated to developing intelligent inspection solutions and equipment for the biotechnology, pharmaceutical, and medical device industries wanted to partner with an established manufacturer, possessing design and engineering capabilities as well as appropriate in-house quality systems. With lab equipment that finds defects in medical syringes, vials, cartridges, test tubes, and other medical containers, it was vital for the manufacturing partner to have ISO13485 and ISO9001 quality systems in place.
Regulatory Affairs > White Papers
Design-To-Build – Laboratory Handling Equipment
| By SHL Technologies
A leading high-end laboratory handling and diagnostics equipment manufacturing company devoted to helping scientists meet challenges regularly faced in the lab, approached SHL Technologies with a request to develop benchtop laboratory tube array handling equipment. This equipment had to be available in a modular set-up and capable of pick-and-place sorting, weight measurement, and barcode reading.
Regulatory Affairs > White Papers
Complex Module Manufacturing – IC testing Devices
| By SHL Technologies
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.
Regulatory Affairs > White Papers
Specialised Project & Technology Transfer – Precision Neurosurgical Equipment
| By SHL Technologies
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.
Regulatory Affairs > White Papers
Supply Chain Management – Surface Mount Technology & Solar Cell Manufacturing
| By SHL Technologies
A leading provider of screen printing equipment located in the UK with an established presence in China was looking for a manufacturing partner that was capable of taking over their supply chain management while maintaining international quality standards. With markets largely located in Asia, the company hoped to find a partner within the region that not only possessed the key manufacturing capabilities required, but one that could also offer western style management to ensure that the technology transfer would go smoothly.
Regulatory Affairs > White Papers
SHL Technologies to Exhibit at MEDTEC Europe 2015
SHL Technologies, a group company of SHL Group, will be exhibiting at MEDTEC Europe 2015 in Messe Stuttgart Germany from April 21 – 23 at Booth#D61 in Hall 5.
Regulatory Affairs > Press Releases
SHL Technologies introduces Case Studies
As contract manufacturing company that provides various manufacturing services to the medtech industry, SHL Technologies has over the years gained a credible track record of successful project collaborations. To help better connect with current and potential customers, SHL Technologies has selected 5 unique case studies to not only showcase the diverse and robust manufacturing capabilities the company offers, but how they are applied and executed to ultimately result in high quality end-products.
Regulatory Affairs > Press Releases
Amgen gets FDA approval for heart failure drug Corlanor
By PBR Staff Writer
Amgen has secured approval from the US Food and Drug Administration (FDA) for Corlanor (ivabradine), an oral medication, to reduce the risk of hospitalization for worsening heart failure.
Regulatory Affairs > News
View all Regulatory Affairs news or find news targeted to your interests