June 1, 2017
Alexion names several new executives
Alexion Pharmaceuticals has named several leading chairs to its executive leadership team that will be effective from June 5, 2017.
Pharmaceuticals, Biotechnology and Life Sciences
Category: Approval
June 1, 2017
BLA approval for Novo Nordisk’s Rebinyn for heamophilia B
Rebinyn got US FDA’s approval and is hoped to become an important tool for physicians to help patients manage their bleeds.
May 31, 2017
Mylan may have overcharged U.S. for EpiPen by $1.27 billion: HHS
The U.S. government may have overpaid drugmaker Mylan N.V. by as much as $1.27 billion between 2006 and 2016 for its EpiPen emergency allergy treatment, the Department of Health and Human Services said on Wednesday.
May 31, 2017
Asia to be drug delivery technology market fastest-growing region
Drug delivery technology market grows from $1,179.20 billion to $1,669.40 billion at a CAGR of 7.2% from 2016-2021. Oral drug delivery segment is expected to account for the largest share while hospitals segment is expected to account for the largest share of the market and Asia is expected to be fastest-growing region.
May 31, 2017
FDA approves attention-deficit/hyperactivity disorder drug
Apotex, Teva Pharmaceuticals USA, Aurobindo Pharma and Glenmark Pharmaceuticals have won FDA’s approval to market atomoxetine in multiple strengths to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.
May 29, 2017
FDA OK’s expanded use of Novartis’s cancer drug
The US Food and Drug Administration (FDA) approved the expanded use of Novartis’s Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test.
May 25, 2017
FDA’s Advisory Committee recommends approval of Puma Biotechnology’s breast cancer drug
FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended approval of Puma Biotechnology’s PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer based on finding that the risk-benefit profile of neratinib is favorable.
May 25, 2017
FDA OK’s Roche’s arteritis drug
The U.S. Food and Drug Administration (FDA) has approved Roche’s Actemra/RoActemra (tocilizumab) subcutaneous injection for the treatment of GCA, a chronic and severe autoimmune condition.
May 24, 2017
FDA Advisory Committee recommends approval of Emmaus Life Sciences’s sickle cell disease drug
The Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10 to 3 that the overall Benefit-Risk profile of Emmaus Life Sciences’s Endari for the treatment of sickle cell disease (SCD) is favorable.
May 24, 2017
Merck’s Keytruda gets FDA’s approval as first cancer treatment for any solid tumor with a specific genetic feature
The U.S. Food and Drug Administration on Tuesday approved Merck’s Keytruda as a first cancer treatment for any solid tumor with a specific genetic feature.