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Regulatory Affairs

FDA panel recommends Pfizer’s epoetin alfa biosimilar to treat anemia By PBR Staff Writer
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of Pfizer's biosimilar to Amgen’s anemia drug Epogen (epoetin alfa) across all indications.
Regulatory Affairs > News
FDA approves Merck’s Keytruda for cancer patients with certain biomarkers The US Food and Drug Administration (FDA) has granted accelerated approval to Merck’s Keytruda for patients whose cancers have a specific genetic feature (biomarker).
Regulatory Affairs > News UK’s CMA accuses Merck of breaching competition law The UK’s Competition and Markets Authority (CMA) has issued a statement of objections to pharmaceutical firm Merck Sharp & Dohme Limited (MSD).
Regulatory Affairs > News
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Latest Regulatory Affairs News and Insight

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NSF International's Pharma Biotech Must-Have App
NSF International, a leading provider of support services for the pharmaceutical industry, providing consulting, training, auditing, testing, remediation, quality systems and regulatory guidance on a global basis, is pleased to announce the launch of its new pharma biotech app.
Regulatory Affairs > Press Releases
NSF Regulatory Radar: 21st Century Cures Act, Promoting Innovation
The Cures Act aims to promote Drug Development Tools and Continuous Manufacturing innovations to speed up and enhance the development process of new therapeutics and reduce the failure rate by formalizing them within the regulatory framework.
Regulatory Affairs > Press Releases
Genentech’s Actemra approved by FDA for giant cell arteritis treatment
Genentech’s Actemra (tocilizumab) subcutaneous injection has been approved by the US Food and Drug Administration (FDA) for the treatment of giant cell arteritis.
Regulatory Affairs > News
NSF at the 2nd PDA Europe Annual Meeting, 13-14 June, 2017, Berlin, Germany
NSF International’s pharma biotech team is proud to be attending the 2nd PDA Europe Annual Meeting, which will be held on the 13 and 14 June in Berlin.
Regulatory Affairs > Press Releases
EC launches probe into Aspen's pricing practices for cancer drugs
The European Commission has initiated a formal investigation to see whether Aspen Pharma had excessively priced five life-saving cancer medicines.
Regulatory Affairs > News
FDA turns down generic version of GSK's asthma/COPD inhaler Advair Diskus
By PBR Staff Writer
Vectura and its partner Hikma Pharmaceuticals announced that the US Food and Drug Administration (FDA) turned down VR315, a generic version of GlaxoSmithKline’s asthma/COPD inhaler Advair Diskus.
Regulatory Affairs > News
Connect with SHL at Prefilled Syringe Seminar 2017 Tokyo
SHL Group is excited to announce that it will exhibit at the Prefilled Syringes Seminar 2017 Tokyo on 23-24 May, 2017.
Regulatory Affairs > Press Releases
NSF Pharma Biotech Webinar’s – Changing GMP Behaviours and the Quality Culture
View this short complimentary webinar by Martin Lush, Global Vice President of NSF Pharma Biotech and Medical Devices - Martin gives his insights on how your company can go about changing GMP behaviours and in doing so change quality culture.
Regulatory Affairs > Press Releases
Meet NSF at the Royal Pharmaceutical Society’s 15th Joint Qualified Person Symposium
NSF International’s pharma biotech team is proud to be sponsoring the Royal Pharmaceutical Society’s 15th Joint Qualified Person (QP) Symposium, which will be held on the 17th of May 2017 in London, England.
Regulatory Affairs > Press Releases
FDA approves Novartis’ Rydapt for AML and rare blood disorders
By PBR Staff Writer
Novartis’ Rydapt (midostaurin) has secured approval from the US Food and Drug Administration (FDA) in newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM).
Regulatory Affairs > News
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