Regulatory Affairs
Search Results: Regulatory Affairs
1-15 of 3913 results
FDA expands GSK’s Trelegy Ellipta indication in COPD
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline and Innoviva’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) to treat a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who had an acute worsening of respiratory symptoms.
Regulatory Affairs > News
Pfizer biosimilar of Roche's cancer drug fails to get FDA approval
By PBR Staff Writer
The US Food and Drug Administration (FDA) has declined to approve Pfizer’s proposed biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab) and asked for more technical information.
Regulatory Affairs > News
Alnylam signs settlement agreement with Dicerna to resolve trade secret misappropriation claims
Alnylam Pharmaceuticals has entered into a settlement agreement with Dicerna Pharmaceuticals to resolve trade secret misappropriation claims against Dicerna, and counterclaims asserted by Dicerna, in pending litigation in the Superior Court of Middlesex County, Massachusetts.
Regulatory Affairs > News
FDA approves Tagrisso as first-line treatment for EGFR-mutated non-small cell lung cancer
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Tagrisso (osimertinib) as the first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.
Regulatory Affairs > News
Roche’s Hemlibra gets FDA breakthrough status in haemophilia A without inhibitors
By PBR Staff Writer
Roche has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Hemlibra (emicizumab) to treat people with haemophilia A without factor VIII inhibitors.
Regulatory Affairs > News
BMS’ Opdivo and Yervoy combo gets FDA approval for firstline RCC
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) combination of immuno-oncology drugs Opdivo (nivolumab) and Yervoy (ipilimumab) as first-line treatment for patients with a type of advanced renal cell carcinoma (RCC), or kidney cancer.
Regulatory Affairs > News
NSF International Launches Pharma Biotech eLearning
NSF International provides a comprehensive range of support services for the pharmaceutical industry covering consulting, training, auditing, remediation, quality systems and regulatory guidance on a global basis.
Regulatory Affairs > Press Releases
Is Fear of Risk Your Biggest Risk?
| By NSF International
In this white paper, NSF International's Martin Lush gives his insights into the pharmaceutical industry's relationship with risk. It includes five steps to help you become risk smart.
Regulatory Affairs > White Papers
Risk Assessment: A Closer Look
| By NSF International
NSF International’s Andy Barnett takes a deeper look into ICH Q9, Quality Risk Management, with particular focus on the failure mode and effects analysis tool for risk management.
Regulatory Affairs > White Papers
Aging Facilities
| By NSF International
Aging facilities is a trendy catchphrase that has taken hold in the biopharmaceutical industry. This white paper by NSF International’s Nicholas Markel provides a few questions to determine if you have an aging facility as well as how to address any issues you may have.
Regulatory Affairs > White Papers
FDA approves Clovis’ Rubraca for recurrent ovarian cancer
The US Food and Drug Administration (FDA) has approved Clovis Oncology’s Rubraca (rucaparib) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Regulatory Affairs > News
Indivior files patent lawsuits against Teva, Dr Reddy's and others
Indivior has filed patent lawsuits against Dr. Reddy's, Actavis, Par, Alvogen and Teva for infringement of United States Patent No. 9,931,305 (the '305 patent) relating to their respective proposed generic versions of the company's Suboxone (buprenorphine and naloxone) sublingual film product.
Regulatory Affairs > News
Proteostasis’ triple combination program secures FDA fast track status for cystic fibrosis
Proteostasis Therapeutics has secured fast track designation from the US Food and Drug Administration (FDA) for its triple combination program to treat cystic fibrosis.
Regulatory Affairs > News
EMA to review cemiplimab for treatment of advanced cutaneous squamous cell carcinoma
The European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery.
Regulatory Affairs > News
US and European regulators accept AstraZeneca’s applications for cancer treatments
By PBR Staff Writer
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted AstraZeneca’s applications for cancer treatments moxetumomab pasudotox and Lynparza (olaparib).
Regulatory Affairs > News
1-15 of 3913 results