This week the UK Government and the European Commission published a draft Brexit...
- Draft Brexit withdrawal agreement: what does it mean for the pharma industry?
- South Korean regulator publishes final ruling on Samsung BioLogics’ accounting violations
- The problem with drug patents: can a new global approach help?
- FDA grants priority review to AstraZeneca’s Lynparza for ovarian cancer
- Spanish authorities restrict prescription of Nolotil after British patient deaths
Draft Brexit withdrawal agreement: what does it mean for the pharma industry?
This week the UK Government and the European Commission published a draft Brexit withdrawal agreement. Like with every industry, the document has implications for the pharmaceutical industry, including clarification about the lack of disruption to supplies during the transition period and sharing of marketing authorisation information between the UK and EU member states.
The Future of the Pharmaceutical Industry
Ever participated in one of those benchmarking exercises? When a (usually) fresh-faced consultant asks a lot of questions and fills in a spreadsheet comparing what you do with your competitors? Well, beware.
FDA agrees to review Roche’s Tecentriq combination for breast cancer
The US Food and Drug Administration (FDA) has accorded priority review status to the supplemental biologics licence application (sBLA) of Roche’s Tecentriq (atezolizumab) as a combination therapy for breast cancer.
South Korean regulator publishes final ruling on Samsung BioLogics’ accounting violations
South Korea’s financial regulator Securities and Futures Commission (SFC) has issued its final decision regarding Samsung BioLogics' alleged breach of accounting rules.
The problem with drug patents: can a new global approach help?
Many countries do not have the equivalent to the US’s Orange book, and as a result health official are waste time establishing whether drug patents have been taken out on medicines. As a solution, leading biopharmaceutical companies, the UN’s World Intellectual Property Organization (WIPO) and the IFPMA have worked together to develop Pat-INFORMED, an innovative global gateway.
FDA grants priority review to AstraZeneca’s Lynparza for ovarian cancer
The US Food and Drug Application (FDA) has agreed for priority review of a supplemental New Drug Application (sNDA) of AstraZeneca’s Lynparza (olaparib) as a maintenance treatment for ovarian cancer.
Lung Cancer Awareness Month highlights tumour testing and early detection
November is Lung Cancer Awareness Month, turning the spotlight on to the world’s deadliest cancer with the hopes of raising global awareness of treatment options and reducing the stigma associated with the disease.
FDA grants priority review status for Dupixent in atopic dermatitis
Sanofi and Regeneron Pharmaceuticals have received priority review status from the US Food and Drug Administration (FDA) for the supplemental biologics license application (sBLA) of Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis.
Spanish authorities restrict prescription of Nolotil after British patient deaths
Spain’s healthcare regulator the Agency of Medicines and Medical Devices (AEMPS) has published a review of popular pain drug Nolotil (metamizole) following rising complications and deaths associated with the side effects of the medications in British patients.
FierceBiotech Executive Summit: Brexit remains a major concern for UK pharma
Post-Brexit UK medicines regulations have been a major talking point for the healthcare industry for over two years. With no agreement having yet been reached between the UK and EU on whether the UK will maintain or sever its ties with the European Medicines Agency (EMA), the healthcare industry is still grappling with what to expect from, and how to prepare for, the UK’s departure from the EU on March 29, 2019.
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