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.
Pharmaceuticals, Biotechnology and Life Sciences
Category: North America
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
Novartis warns of U.S. price pressure on Sandoz generics
Novartis warned on Wednesday that price pressure on its generics drugs in the United States has intensified in the second quarter, cutting into its Sandoz division’s sales growth in the world’s largest healthcare market.
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 26, 2017
Drug approvals bounce back as R&D labs churn out new winners
The number of new drugs approved for sale in United States and Europe has bounced back this year, suggesting a marked slowdown in 2016 was an aberration rather than a sign of flagging research and development productivity.
May 25, 2017
Diplomat to sell Sanofi’s and Regeneron’s rheumatoid arthritis drug in U.S.
Diplomat Pharmacy will sell Sanofi’s and Regeneron Pharmaceuticals’s Kevzara (sarilumab), recently approved by the FDA to treat adults with moderately to severely active rheumatoid arthritis (RA) who have an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs).
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.