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Clinical trial sites using software to obtain patients’ informed consent remotely should make sure that data is stored securely, the FDA says in Friday draft guidance on handling electronic informed consents. Read More
China is opening its market to biosimilars, issuing the country’s first-ever guideline on the technical review of the products and criteria for establishing biosimilarity. Read More
The FDA Friday gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More
Hospira will have to delay the opening of its new Visakhapatnam, India, plant because of persistent problems turned up during FDA inspections of the facility. Read More
Bristol-Myers Squibb's cancer drug Opdivo has gained a new indication as a second line treatment for metastatic squamous non-small cell lung cancer that has progressed after platinum-based chemotherapy. Read More
Two state legislatures are considering biosimilar substitution bills, but are taking opposite approaches to the issues of prescriber notification and patient consent. Read More
A federal judge has sided with a Paragraph IV ANDA from Teva and struck down the patents protecting Actavis subsidiary Warner Chilcott’s postmenopausal osteoporosis drug Atelvia. Read More