FDA Approves New Treatment for Certain Digestive Tract Cancers

The US Food and Drug Administration (FDA) has approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumours (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated [...]

By |2018-02-07T11:37:19+00:00February 7th, 2018|Industry News|Comments Off on FDA Approves New Treatment for Certain Digestive Tract Cancers

First Treatment for Breast Cancer with a Certain Inherited Genetic Mutation

The US Food and Drug Administration (FDA) has expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasised), and whose tumours have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat [...]

By |2018-01-17T16:29:46+00:00January 17th, 2018|Industry News|Comments Off on First Treatment for Breast Cancer with a Certain Inherited Genetic Mutation

First Short-Acting ‘Follow-on’ Insulin Product to Treat Diabetes

The US Food and Drug Administration (FDA) has approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and paediatric patients aged three years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a [...]

By |2017-12-13T10:21:05+00:00December 13th, 2017|Industry News|Comments Off on First Short-Acting ‘Follow-on’ Insulin Product to Treat Diabetes

New Reassurance on the Safety of Biosimilars

Biosimilars have been available in the European Union since 2006. A new British Journal of Clinical Pharmacology analysis of publicly-available regulatory documents found no substantial differences in the reporting of safety information for biosimilars and related originators. The analysis included 19 biosimilars and six originators. Overall, 55 general safety concerns (12 low, 21 medium, and [...]

By |2017-11-29T10:22:37+00:00November 29th, 2017|Industry News|Comments Off on New Reassurance on the Safety of Biosimilars

FDA Approves First Two-Drug Regimen for Certain Patients with HIV

The US Food and Drug Administration has approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment. Juluca is a fixed-dose tablet containing two previously approved drugs (dolutegravir and rilpivirine) to treat [...]

By |2017-11-29T10:18:54+00:00November 29th, 2017|Industry News|Comments Off on FDA Approves First Two-Drug Regimen for Certain Patients with HIV

New Treatment for Adults with Mantle Cell Lymphoma Approved

The US Food and Drug Administration (FDA) has granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. ‘Mantle cell lymphoma is a particularly aggressive cancer,’ said Richard Pazdur, MD, Director of the FDA’s Oncology Centre of Excellence and acting director of [...]

By |2017-11-02T16:04:43+00:00November 2nd, 2017|Industry News|Comments Off on New Treatment for Adults with Mantle Cell Lymphoma Approved

Improved Access to Reports of Adverse Drug Reactions

The US Food and Drug Administration has launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information. ‘ Tools like [...]

By |2017-10-04T08:53:31+00:00October 4th, 2017|Industry News|Comments Off on Improved Access to Reports of Adverse Drug Reactions

First Biosimilar for the Treatment of Cancer Approved

The US Food and Drug Administration has approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in America for the treatment of cancer. ‘Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is [...]

By |2017-09-20T08:37:42+00:00September 20th, 2017|Industry News|Comments Off on First Biosimilar for the Treatment of Cancer Approved

FDA Approves New Antibacterial Drug

The US Food and Drug Administration has approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria. ‘The FDA is committed to making new [...]

By |2017-09-13T08:44:58+00:00September 13th, 2017|Industry News|Comments Off on FDA Approves New Antibacterial Drug

FDA Approves New Treatment for Relapsed or Refractory Acute Lymphoblastic

The US Food and Drug Administration has approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). ‘For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life-expectancy is typically low,’ commented Richard Pazdur, MD, Director of [...]

By |2017-08-23T08:58:47+00:00August 23rd, 2017|Industry News|Comments Off on FDA Approves New Treatment for Relapsed or Refractory Acute Lymphoblastic