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Regulatory Affairs
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FDA approves Lilly's LARTRUVO in combination with doxorubicin for soft tissue sarcoma
Eli Lilly and Company has secured approval from the US Food and Drug Administration (FDA) for LARTRUVO (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adults with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.
Regulatory Affairs > News
Shire's ONIVYDE approved in Europe for pancreatic cancer
The European Commission (EC) has granted marketing authorization for Shire's ONIVYDE (pegylated liposomal irinotecan hydrochloride trihydrate), also known as nal-IRI or MM-398, to treat metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine-based therapy.
Regulatory Affairs > News
FDA approves Genentech’s Tecentriq for metastatic non-small cell lung cancer
Roche’s subsidiary Genentech has secured approval from the US Food and Drug Administration (FDA) for cancer immunotherapy Tecentriq (atezolizumab) to treat people with metastatic non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
NSF Health Sciences Pharma Biotech
NSF partners with you to provide world-class regulatory and compliance consulting, auditing and training on a global basis.
Regulatory Affairs > Suppliers
FDA's ODE-I denies PTC Therapeutics' DMD drug appeal
The Office of Drug Evaluation I (ODE-I) of the US Food and Drug Administration (FDA) denied PTC Therapeutics' first appeal of the refuse to file letter issued by the FDA's Division of Neurological Products (DNP) on February 22, 2016 regarding the company's New Drug Application (NDA) for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).
Regulatory Affairs > News
Trevi Therapeutics unveils positive results from phase 2 trial in prurigo nodularis
Trevi Therapeutics, which is developing oral Nalbuphine®ER for chronic pruritus conditions, announced positive results from its phase 2 trial for the treatment of moderate to severe prurigo nodularis.
Regulatory Affairs > News
Lundbeck wins FDA approval for intravenous Carnexiv for temporary treatment of seizures
By PBR Staff Writer
Pharmaceutical firm Lundbeck has secured approval from the US Food and Drug Administration (FDA) for Carnexiv (carbamazepine) injection as intravenous short-term replacement therapy for several seizure types.
Regulatory Affairs > News
FDA approves Orexo’s low-dose Zubsolv to treat opioid dependence
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved a new low dose version of Orexo's treatment for opioid dependence.
Regulatory Affairs > News
European Commission approves transfer of marketing authorisation for Alprolix to Sobi
The European Commission (EC) has approved the transfer of the marketing authorization for Alprolix (eftrenonacog alfa), a recombinant clotting factor therapy developed for the treatment of haemophilia B, from Biogen to Swedish Orphan Biovitrum (Sobi), making Sobi the marketing authorization holder (MAH) in the EU.
Regulatory Affairs > News
Meet SHL at 2016 PDA Universe of Pre-filled Syringes and Injection Devices
At this year’s PDA Universe of Pre-filled Syringes & Injection Devices, SHL will be showcasing both new technologies and time-tested solutions at two locations – Booth #411 and Table Top #1.
Regulatory Affairs > Press Releases
FDA approves Janssen Biotech's STELARA for Crohn’s disease
The US Food and Drug Administration (FDA) has approved Janssen Biotech's STELARA (ustekinumab) to treat moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers.
Regulatory Affairs > News
FDA approves expanded use of Novartis’ Ilaris to treat three rare periodic fever syndromes
By PBR Staff Writer
Novartis has secured three new approvals from the US Food and Drug Administration (FDA) for the expanded use of Ilaris (canakinumab) to treat three rare types of Periodic Fever Syndromes.
Regulatory Affairs > News
Sanaria's preventative vaccine for malaria gets FDA fast track designation
The US Food and Drug Administration (FDA) has granted Fast Track designation for Sanaria's preventative vaccine for malaria, Sanaria PfSPZ Vaccine.
Regulatory Affairs > News
FDA approves Janssen’s new type 2 diabetes combination therapy
By PBR Staff Writer
Janssen Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for a fixed-dose combination therapy to treat adults with type 2 diabetes.
Regulatory Affairs > News
FDA approves Sarepta Therapeutics' Duchenne muscular dystrophy drug
The US Food and Drug Administration (FDA) has granted accelerated approval for Sarepta Therapeutics' EXONDYS 51 (eteplirsen) as a once weekly intravenous infusion of 30 milligrams per kilogram for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping.
Regulatory Affairs > News

PBR Supplier Recommendations

NSF Health Sciences Pharma Biotech
NSF partners with you to provide world-class regulatory and compliance consulting, auditing and training on a global basis.... Regulatory Affairs > Suppliers
SHL Group - Pen Injectors, Autoinjectors and Inhaler Systems
SHL is a privately-owned developer, designer and manufacturer of advanced drug delivery devices.... Regulatory Affairs > Suppliers
Vaisala - Supplier of Continuous Monitoring Systems for Controlled Life Science Environments
Vaisala is a world leader in environmental and industrial measurement systems and instrumentation. We offer measurement instrumentation, continuous monitoring systems and validation systems to measure and supervise environmental conditions, within regulated or controlled life science environments.... Regulatory Affairs > Suppliers
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
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PBR White Paper Recommendations

Reliable, Long-range Wireless Sensors for Environmental Monitoring By Vaisala pbr
The Vaisala viewLinc Monitoring System tracks environmental conditions wirelessly using Vaisala’s VaiNet wireless devices based on LoRa™* technology. By using a chirp spread spectrum (CSS)* wireless protocol, VaiNet provides robust communication that is extremely reliable over long distances and under harsh, complex and obstructed conditions.... Regulatory Affairs > White Papers Autoinjectors From Planning to Launch By SHL Group
Injectable drug delivery devices such as pen injectors and autoinjectors show a significant growth potential in the future. This white paper focuses on the development process of an autoinjector project from planning to launch and best practices on how to prepare for and address potential challenges along the way.... Regulatory Affairs > White Papers 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 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 See more
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