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Regulatory Affairs

Sanofi, Regeneron secure EC approval for Kevzara to treat rheumatoid arthritis By PBR Staff Writer
Sanofi and Regeneron Pharmaceuticals have secured approval from the European Commission (EC) for Kevzara (sarilumab) in combination with methotrexate (MTX) to treat adult patients with moderately to severely active rheumatoid arthritis (RA) in adult patients.
Regulatory Affairs > News
European Medicines Agency recommends approval of Humira biosimilar Imraldi By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis' Imraldi for approval, which is a biosimilar candidate referencing Humira (adalimumab).
Regulatory Affairs > News Shire gets FDA approval for ADHD drug Mydayis By PBR Staff Writer
Shire has secured approval from the US Food and Drug Administration (FDA) for its Mydayis (mixed salts of a single-entity amphetamine product) to control attention deficit hyperactivity disorder (ADHD) in patients 13 years and older.
Regulatory Affairs > News
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Shire gets FDA approval for ADHD drug Mydayis
By PBR Staff Writer
Shire has secured approval from the US Food and Drug Administration (FDA) for its Mydayis (mixed salts of a single-entity amphetamine product) to control attention deficit hyperactivity disorder (ADHD) in patients 13 years and older.
Regulatory Affairs > News
Sandoz gets EC nod for Rixathon to treat blood cancers and immunological diseases
By PBR Staff Writer
Novartis subsidiary Sandoz has secured approval from the European Commission (EC) for its Rixathon (biosimilar rituximab) to treat blood cancers and immunological diseases.
Regulatory Affairs > News
Adamis’ Epinephrine pre-filled syringe secures FDA approval
Adamis Pharmaceuticals’ Epinephrine Injection, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) (“PFS”) has secured approval from the US Food and Drug Administration (FDA) for the emergency treatment of allergic reactions (Type I) including anaphylaxis.
Regulatory Affairs > News
FDA extends Dysport use for lower limb spasticity in adults
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Ipsen’s Dysport (abobotulinumtoxinA) injection to treat lower limb spasticity in adults.
Regulatory Affairs > News
NSF details how Changing Behaviours can Reduce Risk and Cost
A client investigation identified inconsistencies in hand sanitization, failed retraining efforts and continued problems at an annual cost of over £1.2 million in lost time and unsalable batches. This pharma training case study demonstrates how NSF can help you change GMP behaviours and reduce risk and costs.
Regulatory Affairs > Case Studies
NSF asks why Annex 1 is Important to you
| By NSF Health Sciences Pharma Biotech PBR
This white paper details the key reasons for the revision to EudraLex Volume 4, Annex 1: Manufacture of Sterile Medicinal Products. It outlines what you should be asking yourself regardless of the dosage form you are responsible for. It also includes a simple tool to assess the impact on your organization when there is a regulatory change.
Regulatory Affairs > White Papers
Pfizer, Eli Lilly get FDA fast track status for chronic pain drug Tanezumab
By PBR Staff Writer
Pfizer and Eli Lilly have secured fast track status from the US Food and Drug Administration (FDA) for tanezumab to treat chronic pain in patients with osteoarthritis (OA) and chronic low back pain (CLBP).
Regulatory Affairs > News
Heightened FDA Enforcement for Sterility Issuesin Pharma Biotech with NSF
| By NSF Health Sciences Pharma Biotech PBR
NSF analysed all of the warning letters issued to pharma and biologic manufacturers for sterility issues since 2015. This white paper provides detailed insight into our analysis. It includes relative charts and a table with a summary of the regulations cited by the FDA as well as recommendations for closing your compliance gaps.
Regulatory Affairs > White Papers
NSF: Essential Rules When Investigating GMP Deviations During Sterile Processing
| By NSF Health Sciences Pharma Biotech PBR
This white paper by John Johnson outlines the key attributes to consider during sterile products manufacturing. It also details five key non-negotiables for investigating pharmaceutical GMP deviations or deficiencies in sterile processing.
Regulatory Affairs > White Papers
NSF Explains the Points to Consider when Auditing a Terminally Sterilised Drug Product
| By NSF Health Sciences Pharma Biotech PBR
When conducting an audit of the terminally sterilized pharmaceutical product process, the essential checklist outlined in this white paper by Maxine Fritz will help.
Regulatory Affairs > White Papers
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