Pharmaceuticals, Biotechnology and Life Sciences
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.
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.
Inventiva, a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, has appointed Dr Nanna Lüneborg as its Board member, succeeding Mr Philippe Goupit.
A person in Germany treated with Roche Holding AG’s new multiple sclerosis drug Ocrevus has been diagnosed with an often-deadly brain infection after switching from another medication earlier this year, the Swiss drugmaker said on Wednesday.
Bone Therapeutics has appointed Steve Swinson and Damian Marron to its Board of Directors as Non-Executive Directors.
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.
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.
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).
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.