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Roche’s Hemlibra secures FDA approval for hemophilia A with inhibitors
By PBR Staff Writer
Roche’s Hemlibra (emicizumab-kxwh) has been approved by the US Food and Drug Administration (FDA) for routine prophylaxis to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have factor VIII inhibitors.
Regulatory Affairs > News
Lynne Byers and David Waddington Join NSF International’s Pharma Biotech Service in Europe
New leaders each bring over 30 years of management and quality assurance experience to NSF International
Regulatory Affairs > Press Releases
Ultragenyx’s Mepsevii secures FDA approval for Mucopolysaccharidosis VII
By PBR Staff Writer
Ultragenyx Pharmaceutical’s enzyme replacement therapy Mepsevii (vestronidase alfa) has secured approval from the US Food and Drug Administration (FDA) for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome) in both children and adults.
Regulatory Affairs > News
AstraZeneca gets FDA nod for Fasenra to treat severe eosinophilic asthma
By PBR Staff Writer
AstraZeneca, along with its wholly owned subsidiary MedImmune, has secured approval from the US Food and Drug Administration (FDA) for Fasenra (benralizumab) for the treatment of severe eosinophilic asthma.
Regulatory Affairs > News
US FDA approves first drug with digital ingestion tracking system
By PBR Staff Writer
Otsuka Pharmaceutical has secured approval from the US Food and Drug Administration for its Abilify MyCite (aripiprazole tablets with sensor), an antipsychotic drug that has an embedded sensor to digitally track if patients have ingested their medication.
Regulatory Affairs > News
Sprycel approval expanded to include treatment of children with Ph+ CML in chronic phase
The US Food and Drug Administration (FDA) has expanded the indication for Bristol-Myers Squibb’s Sprycel (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).
Regulatory Affairs > News
EMA’s CHMP recommends Amgen and Allergan’s ABP 215 to treat certain types of cancer
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended to approve ABP 215 for the treatment of certain types of cancer.
Regulatory Affairs > News
Merck gets FDA approval for Prevymis to prevent CMV infection and disease in adult allogeneic stem cell transplant patients
Merck has announced that the US Food and Drug Administration (FDA) has approved Prevymis (letermovir) once-daily tablets for oral use and injection for intravenous infusion.
Regulatory Affairs > News
Roche secures FDA approvals for cancer drugs Zelboraf and Alecensa
By PBR Staff Writer
Roche has secured approvals from the US Food and Drug Administration (FDA) for its blood cancer drug Zelboraf (vemurafenib) and lung cancer drug Alecensa (alectinib).
Regulatory Affairs > News
FDA lifts clinical hold on Cellectis phase 1 trials with UCART123 in AML and BPDCN
The US Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on Phase 1 trials of Cellectis’ UCART123 product candidate in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Regulatory Affairs > News
Novartis seeks EMA approval for CTL019 for two indications
By PBR Staff Writer
Novartis is seeking approval from the European Medicines Agency (EMA) for its CTL019 (Kymriah or tisagenlecleucel) to treat two forms of blood cancer.
Regulatory Affairs > News
FDA advisory committees recommend approval of Indivior's RBP-6000 to treat opioid use disorder
Indivior has announced that the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration (FDA) voted 18 to 1 to recommend approval of RBP-6000 for the treatment of opioid use disorder (OUD).
Regulatory Affairs > News
AstraZeneca’s Calquence secures FDA approval for mantle cell lymphoma
By PBR Staff Writer
AstraZeneca’s Calquence (acalabrutinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
Regulatory Affairs > News
FDA approves new dosing for Xarelto to reduce risk of VTE
Janssen Pharmaceuticals reported that 10mg once-daily dose of Xarelto (rivaroxaban) has been approved by the US Food and Drug Administration (FDA) for reducing the continued risk for recurrent venous thromboembolism (VTE) after at least six months of initial anticoagulation therapy.
Regulatory Affairs > News
Lannett, Celgene sign settlement and license agreement related to Thalomid
Lannett has entered into a settlement and license agreement with Celgene, which resolves patent infringement litigation in the US related to Celgene's Thalomid.
Regulatory Affairs > News

PBR Supplier Recommendations

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
NSF International
NSF International’s pharma biotech services include world-class regulatory and compliance consulting, auditing, residential and on-site pharmaceutical training and clinical testing on a global basis. ... Regulatory Affairs > Suppliers
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PBR White Paper Recommendations

Do you have a robust and compliant CAPA System? By NSF Health Sciences Pharma Biotech PBR
Pharma biotech companies around the globe are struggling to juggle numerous priorities and challenges. One of their biggest struggles is to effectively manage CAPAs.... Regulatory Affairs > White Papers How to write to Regulatory Agencies when things go wrong By NSF Health Sciences Pharma Biotech PBR
Your essential guidance on what to do next after you receive a less than positive regulator's audit report. ... Regulatory Affairs > White Papers 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 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 See more
1-15 of 3869 results