Incheon-based Samsung Bioepis won a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for its Remicade biosimilar, paving the way for more competition in reimbursed markets in Europe.
What began as a bad week for embattled blood-testing company and former Wall Street darling Theranos veered toward worse yesterday when a federal inspection report was released, finding the accuracy of the company's revolutionary device consistently failed to meet even its own standards.
In 2008, contaminated raw heparin from China was tied to the deaths of dozens of U.S. dialysis patients, leading the FDA to realize it needed inspectors in China to oversee manufacturers. But a House investigation, launched that year and still ongoing, is questioning whether the FDA has done enough and whether the tainted heparin may still be getting into the U.S.
Miami-based OPKO said on Wednesday that it has received a complete response letter for a drug it hopes to launch yet this year. But the reason for the CRL had nothing to do with the safety, efficacy or labeling of the drug. Instead, OPKO execs say, it was laid entirely at the feet of Catalent, the contract manufacturer that is manufacturing OPKO's candidate.
A new rotavirus vaccine created under a joint public-private partnership in India has launched this week to fight the serious and often fatal diarrheal disease in young children.
Biopharma companies that have struggled to make a splash in the U.S. or European markets with their new treatments are increasingly turning to China for a reprieve.
The Japan approval of AstraZeneca's Tagrisso (osimertinib), a first-in-class drug used to treat non-small cell lung cancer (NSCLC), represents a potential major change in treatment options in the country and brings on a comparison with the state-of-play with therapies available in China.
India's Lupin said in a Bombay Stock Exchange filing on Tuesday that it had received four observations for two plants at its Mandideep site following a two-week inspection by the FDA in February.
Japan has approved a new biosimilar of Sanofi's blockbuster Lantus (insulin glargine) as its creator Biocon chalks up a much-needed win after a tough 2015.
India's Central Drugs Standard Control Organization and the Department of Biotechnology have published guidelines on biosimilars that detail the regulatory path to marketing authorization.