Regulatory Affairs
Search Results: Regulatory Affairs
1-15 of 3835 results
Bristol-Myers’ Yervoy approved in Europe for pediatric melanoma
The European Commission (EC) has approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for the treatment of pediatric patients 12 years and older with unresectable or metastatic melanoma.
Regulatory Affairs > News
FDA grants priority review for daratumumab in front line multiple myeloma
Genmab announced that the US Food and Drug Administration (FDA) has granted priority review to the supplemental biologics license application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib, melphalan and prednisone to treat patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
Regulatory Affairs > News
AstraZeneca secures approvals for cancer and asthma drugs in Japan
By PBR Staff Writer
AstraZeneca has secured approvals for its cancer drug Lynparza (olaparib) and asthma drug Fasenra (benralizumab) from the Japanese Ministry of Health, Labour and Welfare for the treatments of ovarian cancer and bronchial asthma, respectively.
Regulatory Affairs > News
USPTO invalidates J&J’s patent on prostate cancer drug Zytiga
By PBR Staff Writer
The US Patent & Trademark Office (USPTO) has invalidated a Johnson & Johnson (J&J) patent on prostate cancer drug Zytiga (abiraterone acetate).
Regulatory Affairs > News
Novartis’ Kymriah nabs speedy reviews in US, Europe for lymphoma treatment
By PBR Staff Writer
Novartis’ CAR-T cell therapy Kymriah (tisagenlecleucel) has been granted fast-tracked reviews in the US and Europe for the treatment of relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
Regulatory Affairs > News
Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA
Sandoz, a Novartis division, announced that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira.
Regulatory Affairs > News
Shire’s haemophilia A drug Adynovi secures approval in Europe
The European Commission (EC) has granted marketing authorization for Shire’s Adynovi [Antihemophilic Factor (Recombinant), PEGylated], an extended half-life recombinant factor VIII (rFVIII) treatment, for on-demand and prophylactic use in patients 12 years and older living with hemophilia A.
Regulatory Affairs > News
Midatech gets FDA IND approval to begin trial of brain cancer treatment
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Midatech Pharma’s investigational new drug (IND) application to carry out a study of an investigational nano-inclusion product, MTX110, to treat fatal childhood brain cancer DIPG.
Regulatory Affairs > News
FDA approves Lynparza in germline BRCA-mutated metastatic breast cancer
AstraZeneca and Merck have secured approval from the US Food and Drug Administration (FDA) for Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been earlier treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
Regulatory Affairs > News
Endo receives subpoena from US Attorney Office on products featuring oxymorphone
Endo International's subsidiary Endo Pharmaceuticals has received a grand jury subpoena from the US Attorney's Office for the Southern District of Florida seeking documents and information relating to products containing oxymorphone.
Regulatory Affairs > News
AstraZeneca’s Fasenra gets approval in Europe for severe eosinophilic asthma
By PBR Staff Writer
AstraZeneca has secured approval from the European Commission (EC) for Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe eosinophilic asthma.
Regulatory Affairs > News
AbbVie’s Upadacitinib gets FDA breakthrough designation for atopic dermatitis
AbbVie’s investigational, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
Regulatory Affairs > News
FDA expands use of Amgen's XGEVA drug
Amgen has secured approval from the US Food and Drug Administration (FDA) for its supplemental biologics license application (sBLA) of XGEVA (denosumab) to expand the currently approved indication to prevent skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
Regulatory Affairs > News
Novartis’ Promacta gets FDA breakthrough designation for severe aplastic anemia
By PBR Staff Writer
Novartis’ drug Promacta (eltrombopag) has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for first-line treatment of severe aplastic anemia (SAA).
Regulatory Affairs > News
Cantex's CX-01 gets FDA orphan drug status to treat acute myeloid leukemia
Cantex Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for CX-01 to treat acute myeloid leukemia (AML).
Regulatory Affairs > News

PBR Supplier Recommendations

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 International
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 International
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 International
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 International
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 International
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
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