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Quality problems at an India contract manufacturer are prompting Sagent Pharmaceuticals to recall its injectable atracurium besylate and shift manufacturing of the drug to its U.S. facility, leading to a likely shortage of the product. Read More
Merck signed an agreement with the Medicines Patent Pool opening the door to lower-cost pediatric versions of its HIV drug Isentress in 92 countries with high rates of HIV infection. Read More
South Korea-based Celltrion launched its biosimilar of Janssen’s autoimmune disease therapy Remicade in another 12 European markets, bringing the product’s total presence to 31 countries. Read More
Santarus and Cosmo Technologies have sued Actavis charging its Paragraph IV ANDA against Santarus’ ulcerative colitis therapy Uceris infringes the drug’s patents. Read More
Mexican regulators laid out rules for older biosimilars registered prior to Oct. 19, 2011, when the country’s biosimilarity rules were first established, mandating that companies conduct clinical trials to prove biosimilarity. Read More
The FDA on Monday granted accelerated approval to Novartis’ Farydak, the first histone deacetylases inhibitor for use in treating multiple myeloma. Read More
Drugmakers will be able to make major changes to their products faster under a new European Medicines Agency policy of scheduling new variations reviews weekly rather than monthly. Read More
Three European industry groups are asking the European Commission to block an Italian law that encourages off-label drug use, saying it is driven entirely by economics at the expense of patient health. Read More
Novartis has agreed to divest all of its BRAF and MEK inhibitor drug assets in order to move forward with its $16 billion acquisition of GlaxoSmithKline’s oncology portfolio. Read More
The branded version of Gilead’s pricey blockbuster hepatitis C therapy Sovaldi is expected on Indian pharmacy shelves in the second quarter of this year, distributed under an exclusive licensing agreement with Mylan’s Indian subsidiary. Read More