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Audentes gets orphan status for At001 to treat XLMTM in US and Europe
By PBR Staff Writer
US-based Audentes Therapeutics has received orphan drug designation from the FDA and the European Medicines Agency (EMA) for its AT001, an investigational product being developed to treat X-Linked Myotubular Myopathy (XLMTM), a rare, severe, inherited disorder.
Regulatory Affairs > News
FDA, EMA accept regulatory applications for Boehringer's Giotrif/Gilotrif to treat advanced squamous cell carcinoma of lung
Boehringer Ingelheim announced that both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted filing applications for afatinib for the treatment of patients with advanced SCC of the lung progressing after treatment with first-line chemotherapy.
Regulatory Affairs > News
FDA gets orphan drug designation for Tocagen's Toca 511 & Toca FC to treat glioblastoma
Tocagen, a clinical-stage immuno-oncology company, announced that the US Food and Drug Administration has granted orphan drug designation to the company's lead immuno-oncology product candidate, Toca 511 & Toca FC, for the treatment of glioblastoma.
Regulatory Affairs > News
Santen gets approval of TAPROS in China to treat open-angle glaucoma and ocular hypertension
Santen Pharmaceutical announced that it received an import drug license of TAPROS Ophthalmic Solution 0.0015% for the treatment of open-angle glaucoma and ocular hypertension in China on July 27, 2015 with required procedures completed on August 21st.
Regulatory Affairs > News
Amgen submits NDA for new intravenous calcimimetic etelcalcetide to treat SHPT in CKD patients
By PBR Staff Writer
Amgen has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for etelcalcetide (formerly AMG 416) to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis.
Regulatory Affairs > News
FDA expands use of Novartis' Promacta to include treatment for chronic ITP
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved an expanded use for Novartis' Promacta (eltrombopag) to include children one year of age and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
Regulatory Affairs > News
Corbus gets FDA fast track status for Resunab to treat systemic sclerosis
By PBR Staff Writer
Corbus Pharmaceuticals Holdings has secured fast track status from the US Food and Drug Administration (FDA) for Resunab to treat systemic sclerosis (scleroderma), a serious, life-threatening autoimmune disease.
Regulatory Affairs > News
FDA grants rare pediatric disease designation for BioMarin's drisapersen to treat DMD
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted rare pediatric disease designation for BioMarin Pharmaceutical's drisapersen, a potential treatment for patients with Duchenne Muscular Dystrophy (DMD) who are amenable to exon 51 skipping treatment.
Regulatory Affairs > News
Sobi, Menarini announce Australian approval for Kineret in Juvenile Idiopathic Arthritis
By PBR Staff Writer
Swedish Orphan Biovitrum (Sobi) along with its partner, A. Menarini Australia has announced the receipt of marketing authorisation for Kineret (anakinra) in Australia.
Regulatory Affairs > News
Health Canada approves Alexion's Strensiq to treat patients with hypophosphatasia
Alexion Pharma Canada, a subsidiary of Alexion Pharmaceuticals (ALXN), announced that Health Canada has approved Strensiq (asfotase alfa) as enzyme replacement therapy for patients with confirmed diagnosis of paediatric-onset hypophosphatasia (HPP).
Regulatory Affairs > News
Veloxis’ Envarsus XR gets orphan drug status for kidney transplant rejection prophylaxis
By PBR Staff Writer
Denmark-based Veloxis Pharmaceuticals has received orphan drug status by the US Food and Drug Administration (FDA) for its Envarsus XR (tacrolimus extended-release tablets).
Regulatory Affairs > News
EC grants marketing authorisation to Unituxin (dinutuximab) for paediatric high-risk neuroblastoma
United Therapeutics Corporation has announced that the European Commission (EC) has granted Marketing Authorisation for Unituxin™ (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT).
Regulatory Affairs > News
FDA accepts sNDA for review of Takeda and Lundbeck's brintellix in MDD patients
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for review to add clinical data regarding the effect of Takeda and Lundbeck's Brintellix (vortioxetine) on certain aspects of cognitive function in adults with major depressive disorder (MDD) to the current product label.
Regulatory Affairs > News
FDA accepts La Jolla's IND for LJPC-401 to treat iron overload
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted La Jolla Pharmaceutical's investigational new drug application (IND) for its new formulation of hepcidin, LJPC-401, being developed for the treatment of iron overload, which occurs as a result of diseases such as hereditary hemochromatosis (HH) and beta thalassemia.
Regulatory Affairs > News
Taro’s Keveyis get FDA approval to treat primary hyperkalemic and hypokalemic periodic paralysis
By PBR Staff Writer
Taro Pharmaceutical Industries has received approval from the US Food and Drug Administration (FDA) for Keveyis (dichlorphenamide) 50mg tablets to treat primary hyperkalemic and hypokalemic periodic paralysis.
Regulatory Affairs > News

PBR Supplier Recommendations

Rentschler - High-Performance Biopharmaceutical Development and Manufacturing
Identifying the most appropriate contract manufacturer who can best fulfil what you need for your lead pharmaceutical candidate is a real challenge. With over 40 years’ experience, Rentschler is one of the industry leaders for contract development and manufacturing.... Regulatory Affairs > Suppliers
ERT - Getting it done. Right.
ERT is a leading global provider of high-quality patient safety and efficacy endpoint data collection solutions for use by biopharmaceutical companies during clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle.... Regulatory Affairs > Suppliers
3R PHARMA CONSULTING - Reducing Regulatory Risk
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SHL is a privately-owned developer, designer and manufacturer of advanced drug delivery devices.... Regulatory Affairs > Suppliers
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NNIT specialises in using IT to optimise the complex processes inherent in the life sciences industry. We are an international consultancy in the development, implementation, validation and operation of IT for the life sciences industry. ... Regulatory Affairs > Suppliers
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PBR White Paper Recommendations

Single-Use-Bioprocesses – Hype or Future Technology? By Rentschler
Single-use bioreactors offer many advantages for the manufacturing of biopharmaceuticals. They are used in approximately two thirds of all new bioprocesses in the biopharmaceutical market and have become indispensable in biopharmaceutical development and production processes. ... Regulatory Affairs > White Papers Specialised Project & Technology Transfer- Laboratory Equipment & Automated Systems By SHL Group
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 Group
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 Group
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 Group
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 See more
1-15 of 3359 results